BIOTECH BUZZ, August 2013

BIOTECH BUZZ

August, 2013

 


Programs……………………………………………………………………………………………………………………………………….. 2

2013 Annual Meeting, Washington DC, Friday October 25, 3:30-5:30: Overcoming Barriers to New Technologies (120 minutes CLE) 2

Case Law Reports…………………………………………………………………………………………………………………………… 3

Teva Pharmaceuticals USA, Inc. v. Sandoz, Inc., reported by Sung Park, George Washington University Law School, Washington, D.C., USA…………………………………………………………………………………………………………………………………………………… 3

Novozymes A/S v. Dupont Nutrition Biosciences APS, reported by Yeu-Yan Perng, University of Washington Law School, Seattle, Washington, USA……………………………………………………………………………………………………………………….. 3

USPTO Relations Subcommittee…………………………………………………………………………………………………….. 3

HELP!  Agenda of First BCP Meeting (1996) Needed…………………………………………………………………. 3

Plant Biotechnology Subcommittee Report…………………………………………………………………………………… 3

Plant IP Protection in Europe…………………………………………………………………………………………………….. 3

Claims must encompass more than a single plant variety……………………………………………………… 3

Claims must recite more than “essentially biological processes for the production of plants” 3

Claims to markers useful for breeding may be acceptable……………………………………………………. 4

Biosimilars Subcommittee Report………………………………………………………………………………………………….. 5

Biocomparable Medicaments in Mexico…………………………………………………………………………………… 5

Legal Framework in Mexico………………………………………………………………………………………………….. 6

Requirements for Bio-comparable Medicaments…………………………………………………………………. 6

 


Programs

2013 Annual Meeting, Washington DC, Friday October 25, 3:30-5:30: Overcoming Barriers to New Technologies (120 minutes CLE)

Periodically the public appears to turn against what is new, yet it wants the benefits attending the new technologies. At present, antagonism is evident towards new technologies including GMO plants and resulting foods, medical advances in diagnostics and use of stem cells, and computer related innovations. As result of this antagonism, coupled with an attitude that all “natural” things belong to the public, protection of intellectual property is increasingly difficult to obtain. On the other hand, the public wants to ensure accessibility to food, better medical diagnosis through, for example, biomarkers, repair of body parts through use of stem cells, and convenience of computers.

In this context, the Biotechnology Committee and the Food and Drug Committee will sponsor a joint educational session (120 minutes of CLE) that will consider the history of the public’s love-hate relationships with new technologies and will include discussion of causes of these conflicting attitudes and their effects on progress. The global status of intellectual property protection in patent offices, regulatory agencies, and the courts will be analyzed to elucidate the issues involved. Solutions for meeting these concerns and attitudes and proposals for developing programs of public education and fostering policies for protecting intellectual property that are beneficial to the public will be presented.

Alice Martin and Bruce Vrana, co-chairs of our Plant Biotechnology subcommittee, will moderate the all-star panel that they put together:

History of Genetic Technologies: Acceptance and Hurdles to Protection Dr. Ananda Chakrabarty, Distinguished University Professor, University of Illinois at Chicago

Addressing Public Fears of New Technologies Professor Jay P. Kesan, College of Law, University of Illinois

International IP Protection for Plants Dr. Humphrey Foote, Senior Associate, AJ Park

Regulatory Issues in Protection of Plant Products, GMOS, Diagnostics TBD

Public Policy and Education Issues Sarah Hull, Head, Syngenta External Affairs

Please join us in Washington in October for this excellent, educational program!

Case Law Reports

Case Law Report Link

Teva Pharmaceuticals USA, Inc. v. Sandoz, Inc., reported by Sung Park, George Washington University Law School, Washington, D.C., USA.

Nos. 2012-1567 – 1570 (Fed. Cir. July 26, 2013) (holding invalid as indefinite claims directed to average molecular weight values). 

Novozymes A/S v. Dupont Nutrition Biosciences APS, reported by Yeu-Yan Perng, University of Washington Law School, Seattle, Washington, USA.

Nos. 2012-1433 (Fed. Cir. July 22, 2013) (holding invalid for lack of adequate description claims directed to alpha-amylase variants). 

 

USPTO Relations Subcommittee

HELP!  Agenda of First BCP Meeting (1996) Needed

The PTO organizers of the Biotech/Chem/Pharma Customer Partnership Meetings would like a copy of the agenda of the very first BCP meeting, which was held in November 1996.  Please search your records and if you have a copy, please send to Suzannah at ssundby@sgrlaw.com.  Thanks!

Plant Biotechnology Subcommittee Report

Plant IP Protection in Europe

Contributed by Frances Salisbury of Mewburn Ellis LLP, Manchester, UK

Patents for plant inventions have made headlines in Europe recently, confirming that, despite the European Union’s strict policies on growing genetically modified crops, there is still considerable commercial interest in this area and the associated intellectual property rights.  Nearly 3000 applications for a community plant variety right (PVR) are received by the Community Plant Variety Office annually, with the EPO receiving around 700 applications for patents relating to plants. 

Claims must encompass more than a single plant variety

The European Patent Convention (“EPC”) prohibits the granting of patents to plant varieties (in favour of plant variety rights), and this exclusion has been interpreted as excluding only claims to specific varieties.  It is now established that the exclusion is not an absolute bar to the granting of patent rights for plants per se.

Protection for plants under patent law potentially extends further than under PVRs, encompassing all plants exhibiting a particular trait.  Moreover, the exceptions to that protection are different; European patent law, for example, generally does not include an exception for cultivating farm saved seed.

Claims must recite more than “essentially biological processes for the production of plants”

The EPC does exclude protection for “essentially biological processes for the production of plants or animals,” and this has recently been the subject of high profile cases before the Enlarged Board of Appeal, the highest judicial authority at the EPO. 

The recent “Broccoli” (Enlarged Board of Appeal Decision G2/07) and “Tomatoes” (Enlarged Board of Appeal Decision G1/08) cases both claimed methods for producing plants.  In Broccoli, plants with high levels of particular glucosinolates were obtained by marker-assisted breeding. In Tomatoes, plants with better preservation properties were screened by selecting ripe fruit with lower skin wrinkling (and thus lower fruit water content).  In each case the Enlarged Board determined that the claims defined an essentially biological process (namely sexual crossing and selection), and thus were excluded from patentability.  In order to escape the exclusion, the Board concluded that a claimed method needs to include something more than just a human intervention or technical step; the necessity for human intervention to perform the method steps was not enough.  Instead, the technical means or human intervention has to be decisive to the result obtained.

The decisions make it clear that the exclusion does not apply to methods where a gene is introduced by methods other than sexual crossing.  Established genetic engineering methods using particular genes could therefore still be patentable.  However, in order to escape the exclusion, the method must not explicitly or implicitly include the crossing or selection steps, so careful claim drafting is required.

These recent decisions apply to methods of producing plants, not to the patentability of the products obtained, and thus the patentability of plants obtained by essentially biological processes is consequently uncertain.  Relevant questions have been asked of the Board in a further referral of the Tomatoes case (pending referral G2/12), but both parties subsequently withdrew their appeals, and so the legal status of this case is somewhat unclear.  In any case, it appears that the Enlarged Board will have to decide on the issue, with similar questions having now been asked in a new referral of the Broccoli case (G1/13).

The Enlarged Board may also be questioned on this issue in another case.  Monsanto’s “melon” patent, which claims a virus resistant melon plant and its fruit, is presently the subject of opposition proceedings before the EPO.  This opposition is, however, at a very early stage and it will likely be several years before the relevant questions can even be asked of the Enlarged Board.

As mentioned above, plants are not excluded from patentability per se, provided that the claims encompass more than a single plant variety, so the question is how far the exclusion relating to essentially biological processes extends. 

The Dutch courts recently decided that to allow claims encompassing radish plants obtained by essentially biological processes would be in direct contradiction to the EPC exclusion.  The decisions of member states are not binding on the EPO, but this decision of an experienced court will undoubtedly feature in the opposition proceedings.  Moreover, the EPO face considerable pressure from political bodies and pressure groups not to allow such cases.

Of course, inventions relating to plants and production methods that involve genetic engineering and the introduction of genes through techniques other than sexual crossing and selection can still be patented in Europe, provided that those crossing and selection steps are not included in the method.

Claims to markers useful for breeding may be acceptable

It is also worth noting, in this post-Myriad world, that nucleotide and amino acid sequences remain patentable in Europe (indeed, the patentability of such sequences is written into the EPC).  The molecular markers useful in crossing and selection processes may therefore be patentable in their own right.  

Biosimilars Subcommittee Report

Biocomparable Medicaments in Mexico

Contributed by Eugenio Perez and Janett Lumbreras, Uhthoff Gomez Vega + Uhthoff, Mexico City, Mexico.

Mexico has an estimated population of 118 million people. It is the second largest market of pharmaceuticals in Latin America and the eleventh in the world. Also, it is one of the ten largest drug producers worldwide. This position in the global scenario puts Mexico in a strategic position for the biotech and pharmaceutical industry.  For these reasons, Mexico now has a clear and transparent regulation on biotechnology-derived medicaments for both innovator and non-innovator participants.

The legal regulatory authority for approval of medicaments in Mexico is the Federal Commission for the Protection against Sanitary Risks (COFEPRIS). It is a decentralised organ of the Secretary of Health with technical, administrative and operational autonomy; it is responsible for protecting the Mexican population against sanitary risks, through sanitary regulation, control and promotion.

In September of 2009, an amendment to Mexican Health Law was enacted and provided the initial legal framework for regulating biotechnological medicaments. Article 222bis of the General Health Law provides that a biotechnological medicament is considered as any substance that has been produced by molecular biotechnology and that has a therapeutic, preventive or rehabilitative effect, which is presented in a pharmaceutical form and identified by its pharmacological activity, physical, chemical and biological properties.

The Article also provides that the innovator biotechnological medicaments shall be reference for non-innovator biotechnological medicaments, named bio-comparable medicaments. The way to identify these products will be determined in the Mexican Regulations.

The term “biosimilar” was not adopted in Mexico, as in other countries, due to the existence of a Mexican pharmaceutical company called “Similares”, which is translated as “Similars” in English, which would have rendered the possibility of creating confusion among consumers. 

The main distinction between bio-comparable drugs and generics of small molecule or chemical synthesis drugs are that bio-comparable medicaments and the innovator medicaments are not to be considered identical, mainly due to the production processes from which they derive (i.e., different cell lines, different cell batches, different cell culture conditions, different downstream processing of proteins, etc.).

To obtain a Sanitary Registration (Regulatory Marketing Authorization) for biotechnological medicaments, the applicant must meet with the requirements and tests to demonstrate the quality, safety and efficacy of the product, in accordance with the General Health Law, its Regulations and other legal provisions, and once the biotechnological medicament is sold, strong pharmacovigilance should be performed and passed under the corresponding regulations.

Applicants for a Sanitary Registration of a bio-comparable drug have to provide their own data with regard to the integrity of the active substance molecule, the biological activity of the medicament, and certain safety and efficacy clinical data in patients with the same disease or condition as the innovator.

When a bio-comparable medicament shows different and improved activities due to its differences with the innovator, it may be patentable as a selection invention.

Some of the risks of treating bio-comparable medicaments as generics could be: they may have different effect in the body, different potency, different half-life, potential for cross-reactivity, potential for immunogenicity, etc…

Legal Framework in Mexico

  • Ø  Health General Law;
  • Ø  Regulation for Health Supplies;
  • Ø  Guidelines for biocomparables published by COFEPRIS (in force on April 17, 2012);
  • Ø  Applicable related regulations;
  • Ø  Regulation for New Molecules Committee (in force on February 24, 2012); and
  • Ø  Subcommittee for the Assessment of Biotechnological Products.

Requirements for Bio-comparable Medicaments

Under the new regulations, bio-comparable drugs must be reviewed under strict regulatory rigor to ensure the same level of patient safety as the innovator and to assure that the bio-comparable drug responds and acts through the same mechanisms of action as the innovator in the body, for this, in vivo and in vitro studies are foreseen. Only tests that are considered unnecessary and are not related to patient safety may be foregone in the reviews for bio-comparable drugs. Other important tests are those related to the pharmaceutical form of the medicament, dose, efficacy, and form of administration. The reference product must have a Sanitary Registration in Mexico and non-infringement patents related to the innovator product must be observed by COFEPRIS before issuing a Sanitary Registration to a bio-comparable product .

The regulations for bio-comparable drugs have been developed in accordance to the complexity of the process. The concept of “case by case” review has been implicitly accepted, so it depends on each product as well as the quantity and quality of studies and tests required.

The registration procedure and release of the batch take place in working groups of increasing complexity, where academic participation will be encouraged.

The biotechnological medicaments must include on their labels:

  • ·         name of the manufacturer,
  • ·         country of origin,
  • ·         place of packaging, and
    • ·         name of importer, if any.

The bio-comparable product must have the same International Commune Denomination that the medicament of reference without denoting a separation on the Basic Table keys and of the catalogs of medicaments of the health institutions assigned for these.

For more information, see the following websites:

http://dof.gob.mx/nota_detalle.php?codigo=5214882&fecha=19/10/2011

http://www.cibiogem.gob.mx/Norm_leyes/Documents/normatividad-SSA/LGS.pdf

http://www.diputados.gob.mx/LeyesBiblio/regla/n328.pdf

BIOTECH BUZZ

July, 2013

 


Programs……………………………………………………………………………………………………………………………………….. 2

2013 Annual Meeting, Washington DC, October 2013: Overcoming Barriers to New Technologies (120 minutes CLE)            2

Webinars……………………………………………………………………………………………………………………………………….. 3

ACLU v. Myriad Genetics: Navigating the Isolated DNA Patentability Jungle – July 24, 2013……… 3

Plant Biotechnology Subcommittee Report…………………………………………………………………………………… 4

Plant IP Protection in Canada…………………………………………………………………………………………………….. 4

“Plant cells”, but not “plants”, are patentable……………………………………………………………………….. 4

Plant cells generated through traditional plant breeding……………………………………………………… 4

Blaming-the-bean………………………………………………………………………………………………………………….. 4

Biosimilars Subcommittee Report………………………………………………………………………………………………….. 5

New Biosimilar Guidelines in Europe…………………………………………………………………………………………. 5

Introduction………………………………………………………………………………………………………………………….. 5

Background and Problems with the Current Guidelines……………………………………………………….. 6

The New Draft Guidelines……………………………………………………………………………………………………… 6

Conclusions, Outlook and Recommendations……………………………………………………………………….. 8

More clarity for complex biosimilars: Europe approves the first follow-on mAb……………………… 8

Supreme Court Denies Cert in Momenta: Section 271(e)(1) Safe Harbor Converted to a “Land of Confusion”?         9

Case Law Reports…………………………………………………………………………………………………………………………. 11

Wyeth v. Abbott Labs., reported by Lynn C. Tyler and Michael R. Brunelle, Barnes & Thornburg LLP, Indianapolis, IN, USA.   11

 


Programs

2013 Annual Meeting, Washington DC, October 2013: Overcoming Barriers to New Technologies (120 minutes CLE)

Periodically the public appears to turn against what is new, yet it wants the benefits attending the new technologies. At present, antagonism is evident towards new technologies including GMO plants and resulting foods, medical advances in diagnostics and use of stem cells, and computer related innovations. As result of this antagonism, coupled with an attitude that all “natural” things belong to the public, protection of intellectual property is increasingly difficult to obtain. On the other hand, the public wants to ensure accessibility to food, better medical diagnosis through, for example, biomarkers, repair of body parts through use of stem cells, and convenience of computers.

In this context, the Biotechnology Committee and the Food and Drug Committee will sponsor a joint educational session (120 minutes of CLE) that will consider the history of the public’s love-hate relationships with new technologies and will include discussion of causes of these conflicting attitudes and their effects on progress. The global status of intellectual property protection in patent offices, regulatory agencies, and the courts will be analyzed to elucidate the issues involved. Solutions for meeting these concerns and attitudes and proposals for developing programs of public education and fostering policies for protecting intellectual property that are beneficial to the public will be presented.

Alice Martin and Bruce Vrana, co-chairs of our Plant Biotechnology subcommittee, will moderate the all-star panel that they put together:

History of Genetic Technologies: Acceptance and Hurdles to Protection Dr. Ananda Chakrabarty, Distinguished University Professor, University of Illinois at Chicago

Addressing Public Fears of New Technologies Professor Jay P. Kesan, College of Law, University of Illinois

International IP Protection for Plants Dr. Humphrey Foote, Senior Associate, AJ Park

Regulatory Issues in Protection of Plant Products, GMOS, Diagnostics TBD

Public Policy and Education Issues Sarah Hull, Head, Syngenta External Affairs

Please join us in Washington in October for this excellent, educational program!


Webinars

ACLU v. Myriad Genetics: Navigating the Isolated DNA Patentability Jungle – July 24, 2013

The AIPLA will host a webinar at 12:30 pm EDT on July 24, 2013 to discuss the implications of the Supreme Court’s landmark decision in ACLU v. Myriad Genetics.  The confirmed speakers are Greg Castanias, who was counsel for Myriad, Josh Sarnoff, who filed an amicus brief on behalf of 15 law professors, and Manny Vacchiano, who is Lead Patent Counsel of Life Technologies, Inc. 

Debora Plehn-Dujowich of Drinker, Biddle & Reath LLP, chair of our Webinars subcommittee, will moderate the webinar. Below are the expected topics.

  • Constitutional questions, answered?
  • Consequences of the case for § 101 jurisprudence; does splitting the baby make sense?
  • Legislative action to “remedy”?
  • Where do comparative diagnostic claims stand after both Myriad and Mayo
  • Are claims to all primers now invalid? What about if the primer is made of synthetic DNA that is somehow modified, but the sequence is the same as that found in nature?
  • Future litigation at U.S. Supreme Court and Court of Appeals for the Federal Circuit.
  • Practical claiming strategies in light of Myriad and Mayo
  • What does “markedly different” mean? What changes have to be made to a natural product to make it patentable?
  • Are claims to isolated polypeptide sequences covering human proteins that are in therapeutic use no longer valid? Or is Myriad limited to isolated DNA?
  • What method claims are still possible?
  • What affect on patent office prosecution tactics? 
  • How will existing gene patents be challenged in post-grant proceedings at the USPTO?
  • How can one protect one’s existing gene patents from future challenges?
  • Will holders of gene patents seek reissue? What types of claims will they seek?
  • What does the decision mean for future litigation?
  • What does the decision mean for protein therapeutics, and other products that are arguably “found in nature”? What about antibodies?
  • How does this extend beyond biotech and chemical cases, e.g., software?
  • When will the USPTO issue guidelines and what will they be?
  • Comments on EPO practice
  • The Myriad versus Mayo “sandwich” and the Myriad versus Mayo “ocean of grey space.”
  • In-house perspectives
  • Clearing molecular diagnostic products
  • Licensing issues? Do licenses have to be re-negotiated?
  • Is the reaction of the press and public appropriate?

Further information about cost and CLE can be found at the AIPLA site.
Plant Biotechnology Subcommittee Report

Plant IP Protection in Canada

Contributed by Mark Pidkowich, Smart & Biggar Fetherstonhaugh, Vancouver, BC, Canada

The Canadian agriculture and agri-food system is a modern, competitive, and growing part of the international economy.  Canada is the sixth-largest exporter in the world after the EU, U.S., Brazil, China and Argentina, and the sixth-largest importer, with exports and imports valued at $40.3 billion and $31.0 billion, respectively.  Of the $40.3 billion in exports, oilseeds and oilseed products accounted for 26.2%, while grains and grain products accounted for 24.4%.  In 2011, Canada was the single largest producer of rapeseed (~$4.5 billion in exports), the seventh largest producer of both wheat and soybeans (~$4.5 billion and ~$1.4 billion in exports, respectively), and the eleventh largest producer of maize (~$0.6 billion). 

Unsurprisingly, Canadian patents will be an essential component of many agribusiness portfolios.

“Plant cells”, but not “plants”, are patentable

The Canadian Intellectual Property Office (“CIPO”) considers that “higher life forms”, including plants and plant seeds or parts, are not patentable. However, it is possible to claim “a cell” of a plant, or a method of making or using the plant.  In Monsanto Canada Inc. v. Schmeiser (“Schmeiser”), 2004 SCC 34, the Supreme Court of Canada held that a claim to a “plant cell” is infringed by someone who grows plants from seed.

It is also possible to claim “use” of a plant for a particular purpose, such as for producing a crop or a plant product (e.g. oil), thereby avoiding the need to claim a cell per se

Plant cells generated through traditional plant breeding

Canadian patents issue routinely in connection with inventions involving plants that have been transformed with a heterologous coding sequence, without limitation to a particular variety.

However, complications arise where conventional breeding methods are involved in the production of the plant.  CIPO historically has considered cross-breeding methods to be non-statutory subject matter and, with some exceptions, will not grant claims to methods involving the straightforward breeding of known varieties.  Claims to plant cells produced by such methods, and uses of such plants, may be permitted, but CIPO generally requires limitations to a particular plant variety as deposited under the Budapest Treaty.

According to CIPO, cross-breeding methods are not patentable because they are processes which occur “essentially according to nature, with no significant technical intervention by man.”   CIPO’s policy is based largely the Supreme Court of Canada’s 1989 decision in Pioneer Hi-Bred Ltd. v. Canada (Commissioner of Patents), in which the Court expressly declined to decide whether or not plants produced by cross-breeding were statutory subject-matter under the Canadian Patent Act.  Furthermore, the Court opined that human intervention was indeed necessary for breeding where the male and female reproductive organs of the soybean are contained in the same flower, and require artificial intervention to hybridize two different lines and produce a new one.  Accordingly, CIPO’s position with respect to cross-breeding may be ripe for a challenge.

Blaming-the-bean

In its recent decision in Bowman v. Monsanto Company (“Bowman”), the U.S. Supreme Court held that the initial authorized sale of a patented seed does not permit a farmer to reproduce patented seeds through planting and harvesting without the patent holder’s permission.   Whereas the U.S. Supreme Court decision was based on the finding that Bowman’s reproduction of the patented seeds constituted “making” new copies of the invention, Canadian courts could possibly be more receptive to a “blame-the-bean” defense.

In Schmeiser, the Supreme Court of Canada held that cultivation of a plant constituted “use” of the patented plant cell contained therein.  However, the Schmeiser decision did not involve plant material obtained through an authorized sale so as to make patent exhaustion an issue.  Accordingly, whether the purchase of commodity seed from a grain elevator would exhaust the patentee’s right to control the use of that seed in Canada, including production of a crop from the seed, remains an open question of law.  Nevertheless, the Supreme Court of Canada indicated that, contrary to Bowman, that it was not inclined to view the growth of a plant containing patented cells as “making” the claimed cells.

While it is quite possible that Canadian courts would conclude that growing a second generation of plants from purchased commodity seed constitutes infringing “use” of the patented cells, as in Bowman, Canadian patentees would be wise to buttress their patents with licensing terms that precisely express any conditions that are intended to affect the rights of subsequent purchasers of a patented item, and consider mechanisms putting such potential purchasers on notice.

 

Biosimilars Subcommittee Report

New Biosimilar Guidelines in Europe

Contributed by Kapil Tuladhar and Simon Wright, JA Kemp, London, UK.

Introduction

Most drugs currently on the market are small-molecule modulators.  Extensive studies are required to demonstrate the efficacy and safety of such molecules, prior to regulatory approval.  Generic small-molecule manufactures can take advantage of existing studies when seeking market authorisation, as active molecules can be faithfully copied.

However over the last 30 years, increasing numbers of biological molecules have gained approval.  With patents for these often lucrative molecules expiring, those considering entering the generic biological space face additional challenges over the traditional generics manufacturer.  This is largely down to the difficulty in independently reproducing biological molecules, owing to their complexity and sensitivity to manufacturing processes.

Thus, generic manufactures generally look to develop new biological medicinal products that are similar to an approved reference product, so-called biosimilars.  These follow-on products must undergo comparability studies to confirm their similarity to a reference, in terms of quality, safety, efficacy and biological activity.  However, determining just how similar a subsequence biological molecule is and how far existing data can be extrapolated to the follow-on compound, has challenged policymakers and regulators across the globe, including in Europe.

In the past three months, the European Medicines Agency (EMA) has released for consultation updated guidelines.  See Draft Guidelines on Similar Biological Medical Products (May 22, 2013 and June 3, 2013)  These seek to clarify some of the outstanding issues surrounding biosimilars.  Here, we provide a review these two documents.

Background and Problems with the Current Guidelines

The European overarching guidelines on biosimilar medicinal products entered force in 2005 and 2006.  See Guidelines on Similar Biological Medical Products (Oct. 30, 2005, Feb. 22, 2006 (Non-Clinical and Clinical Issues), and Feb. 22, 2006 (Quality Issues)).  Since 2006, 14 biosimilar medicines have received marketing authorization in Europe.  Many more are under development or awaiting regulatory approval.  In 2011, the EMA took the view in a series of concept papers that, in light of knowledge gained and the development of more complex biosimilar medicinal products, the existing guidelines needed to be reviewed, refined and updated.  See Concept Papers (Sept. 22, 2011 and Nov. 17, 2011).  In particular, the following points were considered.

  • ·         The principles of biosimilarty need to be explained more clearly.
  • ·         The term “biosimilar” needed to be better defined, given that numerous terms are currently used, often inappropriately.
  • ·         The feasibility of carrying out compatibility studies when pharmaceutical form, strength and route of administration are not the same between biosimilar and reference products.
  • ·         Whether a “very simple” biological molecule, could be authorised on the basis of comparative quality and bioequivalence only.
  • ·         Selection of the appropriate animal models, considering the “3R’s” principal of “replacement, reduction and refinement”.
  • ·         The list of surrogate markers for use in Phase III clinical trials could be expanded.

The New Draft Guidelines

The proposed new European guidelines on biosimilars finds legal basis largely in Directive 2001/83/EC of the European Parliament, as amended, relating to medicinal products for human use in the European Community.

Similar Biological Medicinal Products

The updated guideline on similar biological medicinal products outline the general principles to be applied for biosimilars and refine the application of the biosimilar approach, the choice of reference product and the principles of establishing biosimilarity.  Most significantly, and in contrast to the existing guidelines, it has been proposed that the EMA will accept, for “some studies,”[1] comparison to a reference product that has gained authorisation outside the European Economic Area (EEA).  However, the comparator will have to be authorised by an authority with similar scientific and regulatory standards as the EMA (i.e. ICH[2] countries).  In such cases, it will be necessary for an Applicant to demonstrate that an externally authorized comparator is representative of the reference product authorized within the EEA.  However this should, in theory, be easier than repeating non-clinical and clinical trials just for the EEA.

In this guideline, the EMA does not provide explicit guidance as to what a significant difference would be, other than stating that studies must be sensitive enough to find such differences.  Rather, taking the approach of other regulators, the EMA acknowledges that a difference between a reference and test compound will depend on each product specifically.  Indeed, it is suggested that small differences, including added benefit, may not disqualify a product.  The Applicant will likely have to provide justification if comparative data suggests this applies to their product.  Unhelpfully in this regard, the guideline does not define any automatically disqualifying characteristics.

Non-clinical and Clinical Issues

A new draft guideline setting out the EMA’s current position on the non-clinical and clinical issues surrounding biosimilars has also issued.  This is similar in many ways to the guideline discussed above, calling for a step-by-step approach to allow for heterogeneity between different biosimilars.  The steps in the process should move sequentially through in vitro studies, in vivo studies (if necessary) and clinical studies before moving on to pharmacokinetic, pharmacodynamic, safety and efficacy studies.  Further highlighting the step-wise approach, the guideline identifies the need to fine tune studies according to the results of the preceding studies.

The EMA states that in vitro studies need to be sensitive enough to detect differences between a biosimilar and reference, while also covering the pharmacological and toxicological aspects known to be relevant to the given reference formulation and/or product class.  When progressing to in vivo studies, the Applicant will need to justify that in vitro data is predictive of in vivo data.  The guidelines also discuss the need to choose an appropriate model system.  There is also the provision to proceeding straight to clinical studies if an appropriate animal system is not available.  The EMA provides additional guidance on the risk-baked approach for the design of non-clinical studies, together with the use of pharmacodynamic markers to demonstrate clinical comparability. 

The EMA updated their guidance on clinical study design, discussing the use non-inferiority studies versus equivalence studies.[3]  The agency states that equivalence studies with the appropriate sensitivity are preferred, unless the Applicant has a strong scientific reason to use non-inferiority methodologies.  The agency suggests that this should be discussed with the EMA prior to commencing the trial.  The choice of an appropriate patient population and of surrogate endpoints in efficacy trials is also discussed.  Finally, the design of immunogenicity studies and the extrapolation of efficacy and safety data from one therapeutic indication to another are discussed.

Specifically, the new guideline recommends that studies should be carried out on the follow-on product derived from the final manufacturing process, thus most closely reflecting the quality profile of commercial batches.  Deviations from this process will have to be “justified and supported by adequate additional bridging data.”

The EMA also discusses immunogenicity.  Applicants will have to justify and discuss in detail possible safety concerns associated with use of product.  The amount of data needed will depend on the nature of the reference product and/or product class.  It is highlighted that immunogenicity must be investigated in a comparable manner to studies conducted for the reference product, again unless the Applicant can justify otherwise.

Furthermore, data concerning one therapeutic indication cannot automatically be extrapolated to another indication.  While the EMA states that “this is not an argument for additional studies,” it will be necessary for manufacturers to provide additional arguments (and probably data, too) if they wish to gain approval for other indications.

The Present Position in Europe

In addition to the two guidelines discussed, a third guideline addressing quality issues (a revision of which was released for consultation in May 2012) will form part of the three overarching biosimilar guidelines defining the concept of biosimilars in Europe, and replacing the existing set of overarching guidelines.  These are, and will be, complemented by a set of existing and planned product-specific guidelines.

At present, a public consultation period is open on all three drafts, which is due to close in the fourth quarter of 2013.  The EMA is open to comments from stakeholders, with a view to refining the draft set of guidelines if necessary.  It is likely the revised guidelines will then enter force in 2014.

Conclusions, Outlook and Recommendations

At present, the European guidelines on biosimilars seem to be more developed than those in the USA.  However this may change in the future as the FDA develops its own set of guidelines.

Sensibly, the proposed European guidelines aim to facilitate global research, rather than requiring duplication of studies.  The power of large studies is highlighted and it will be even more necessary to consider the totality of evidence.  A clear understanding of the characteristics of the reference product will also be required.

There are, however, still outstanding issues and not all of the points set out in the original concept paper were fully considered in the draft guidelines.  The regulatory framework will continue to evolve with the field, become wider and providing more guidance.  For example, the first two monoclonal antibody biosimilars have been recommended for approval in Europe, and draft guidelines on monoclonal antibodies are currently being finalised.  See Press Release (June 28, 2013).

The EMA seems to acknowledge that guidelines are general and simplified.  Thus, if specific points relating to a sophisticated biosimilar arise, we recommend discussing this with the EMA prior to commencement of development.  It should be noted that the EMA evaluates biosimilars solely for the purpose of authorization, and does not recommend whether or not a biosimilar should be used interchangeably with its reference.  If differences between a biosimilar and reference are discovered early on, there may be advantages to independently developing the follow-on compound, for example as a best-in-class therapy.

More clarity for complex biosimilars: Europe approves the first follow-on mAbs

Contributed by Ainslie Parsons and Noel Courage, Bereskin & Parr LLP, Toronto, ON, Canada.

The European Medicines Agency (EMA) recently recommended granting marketing authorizations to two biosimilar versions of Johnson & Johnson’s rheumatoid arthritis blockbuster drug Remicade®.  See Press Release (June 28, 2013). The active substance of Remicade® is infliximab, a chimeric humane-mouse monoclonal antibody (mAb). Remicade® has been authorized in the European Union since August 1999. The EMA’s acknowledgment that Celltrion’s Remsima and Hospira’s Inflectra can be compared to Remicade is the first time that mAbs have been deemed to be biosimilar in the EU.  In the bigger picture, this provides further insight on the EMA’s criteria for approving biosimilars of complex biologics. 

Unlike generic versions of small molecule pharmaceuticals, follow-on versions of biologic drugs (biosimilars) have a similar, but not identical, active ingredient as an approved innovator drug. In particular, there can be differences in structure, formulation, impurities or immunogenicity between the two products which can make it difficult to compare the biosimilar to the innovator drug. The biosimilar manufacturer must provide substantial supporting data to regulators in comparison to conventional follow-on small molecule pharmaceuticals. 

The EMA has authorized a total of 12 biosimilar medicines to date including biosimilar versions of somatropin (recombinant human growth hormone), filgrastim (granulocyte colony-stimulating factor analog) and epoetin alfa (synthetic erythropoietin). However, mAbs present additional comparability challenges compared to these early commercial biologics given their size and complexity. For example, mAbs can be 10 to 15 times larger than human growth hormone and erythropoietin.

In May of 2012, the EMA released guidance setting out an approval pathway for mAbs. See Guideline on similar biological medicinal products containing monoclonal antibodies – non-clinical and clinical issues (May 30, 2012). The EMA issued its opinions on Remsima and Inflectra by reference to this Guideline. This Guideline, like all the EMA biosimilars guidelines, emphasizes the demonstration of comparability to the reference drug. The EMA found that both Remsima and Inflectra had a comparable quality, safety and efficacy profile to Remicade.

The recommendation by the EMA to approve Remsima and Inflectra provides additional guidance to those planning to market their own biosimilar antibodies. Indeed, it has been estimated that there were at least 49 biosimilar mAbs under development as of September 2011. See Citeline’s Pipeline Database. It will also be interesting to see how other jurisdictions such as the United States, which introduced a specialized, abbreviated approval pathway for biosimilars in March of 2010[4] but has yet to approve a biosimilar, will treat follow-on antibodies.

Supreme Court Denies Cert in Momenta: Section 271(e)(1) Safe Harbor Converted to a “Land of Confusion”?

Contributed by Lynn Tyler and Michael Brunelle, Barnes & Thornburg LLP, Indianapolis, IN, USA.

The May issue of the Biotech Buzz included commentary on the then-pending cert petition in Momenta Pharms., Inc. v. AmphaStar Pharms., Inc., 686 F.3d 1348 (Fed. Cir. 2012) (“Momenta”), a case interpreting the infringement safe harbor in 35 U.S.C. § 271(e)(1). The Supreme Court has now denied cert in Momenta, as it did in Classen Immunotherapies, Inc. v. Biogen-IDEC, 659 F.3d 1057, 1070 (Fed. Cir. 2011), which also concerned the scope of § 271(e)(1). This article offers some thoughts on the current state of the law on this issue.

As previously summarized by Angie Sebor and Vicki Norton (Biosimilars sub-committee co-chair), the partially-overlapping Federal Circuit panels that decided Classen and Momenta were divided on the issue of whether 35 U.S.C. § 271(e)(1) can shield post-approval use of a patented technology.  Judge Newman wrote for the majority in Classen, addressing the question of whether § 271(e)(1)’s safe harbor shielded the defendants’ post-approval activities from infringement where Classen’s method patents were directed to methods of screening and identifying immunization schedules associated with lower risk of chronic disease. The defendants’ post-approval activities included evaluating suggested associations between vaccines, reporting on recommended immunization schedules, and reporting adverse vaccine effects to the FDA.  The Federal Circuit majority reversed the district court’s ruling that the defendants’ activities fell within the § 271(e)(1) safe harbor provision and held instead that the safe harbor is “limited to activities conducted to obtain pre-marketing approval of generic counterparts of patented inventions” and that the “statute does not apply to information that may be routinely reported to the FDA long after marketing approval has been obtained.”  Judge Moore dissented, opining that the majority’s analysis and construction of the safe harbor provision were “contrary to the plain language of the statute and clear Supreme Court guidance” (referencing Merck KGaA v. Integra Lifesciences I, Ltd., 545 U.S. 193 (2005), among other cases), and “[n]owhere does that statute limit the safe harbor to pre-approval uses.”

In Momenta, Judge Moore wrote for the majority, reaching a conflicting result by holding that Amphastar’s use of Momenta’s patented process for analyzing drug quality during the manufacture of enoxaparin (generic Lovenox) for commercial sale fell within the safe harbor.  Amphastar argued that because the continued testing was an FDA condition for marketing approval, its post-approval testing fell within the plain language of the safe harbor of § 271(e)(1). The Federal Circuit panel majority sided with Amphastar, concluding that the language of §271(e)(1) is broad and unambiguously applies to submissions under any federal law, provided that the law regulates the manufacture, use or sale of drugs, and is not only directed to activities related to submission for FDA approval. The court further held that the phrase “reasonably related to the development and submission of information” in the statute does not mean that the use of the patented invention must necessarily result in the actual submission of information to the FDA. The majority found that Amphastar’s requirement to retain testing records to be readily available for authorized inspection by the FDA upon request satisfied the requirement.  In a dissenting opinion, Chief Judge Rader urged that Amphastar’s activity was not solely for developing and submitting information to the FDA, but also for manufacturing a product to sell in commerce. Chief Judge Rader further commented that by ignoring the meaning of the term “solely” in the statute, the majority expanded the limited reach of § 271(e)(1) to “essentially render manufacturing method patents worthless.”

At the time the Solicitor General weighed in against granting cert, it was widely reported (at least in patent law circles) that the Solicitor’s advice was to deny cert because the Federal Circuit had limited Classen in Momenta. That may be a correct reading of the cases. On the other hand, one could easily argue that some of the broad language of Judge Moore’s majority opinion in Momenta is simply inconsistent with Classen, as shown by her reliance on similar reasoning in her Classen dissent and notwithstanding the fact that, in Momenta, she recognized that the court was “bound” by Classen. 686 F.3d at 1358. To the extent the cases conflict, Classen controls, not Momenta, because a “panel is obligated to follow the earlier case law which is the binding precedent,” not the more recent case. See Johnston v. IVAC Corp., 885 F.2d 1574, 1579 (Fed. Cir. 1989). This is “[b]ecause a panel of [the Federal Circuit] lacks the authority to overrule one of the court’s precedents.” Midwest Indus., Inc. v. Karavan Trailers, Inc., 175 F.3d 1356, 1359 (Fed. Cir. 1999); see also Kingsdown Med. Consultants, Ltd. v. Hollister Inc., 863 F.2d 867, 876 n.16 (Fed. Cir. 1988) (en banc) (“[P]recedent may not be changed by a panel.”).

The result, unfortunately, is that any firm operating in a regulated industry to which § 271(e)(1) may apply continues to face unnecessary risk and uncertainty over the scope of the “safe” harbor. Can one rely on the seemingly broad language of the statute? Will any activities other than the precise ones at issue in Classen be deemed to fall within its “routine reporting” exception (if that is a proper characterization)? If so, which one(s)? How much expense will be added to any litigation to resolve these issues? Companies evaluating whether to spend tens or hundreds of thousands on patents that may protect methods of testing the purity, quality or other aspects of a biologic or multi-million dollar investments in development of a biosimilar would like to be, and should be, able to answer these questions in advance with a high degree of confidence. Based on the current state of the law, they cannot and that should be intolerable.

Another relevant question: Wasn’t the Federal Circuit created to promote uniformity in patent law? The apparent conflict between Classen and Momenta should be resolved en banc at the earliest opportunity.

Case Law Reports

Case Law Report Link

Wyeth v. Abbott Labs., reported byLynn C. Tyler and Michael R. Brunelle, Barnes & Thornburg LLP, Indianapolis, IN, USA.

Nos. 2012-1223, -1224 (Fed. Cir. June 26, 2013) (affirming district court’s finding of lack of enablement for claim encompassing broad class of compounds where specification only disclosed one such compound). 


[1]The key phrase “some studies” is yet to be defined.

[2]International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use

[3]In contrast to equivalence studies, non-equivalence studies typically require fewer patients, but are unable to reveal if a follow-on product is superior to the reference.

[4] The Biologics Price Competition and Innovation (BPCI) Act was enacted on March 23, 2010 as part of a US Health Reform Bill (the Patent Protection and Affordable Health Care Act).

BIOTECH BUZZ JUNE, 2013

Programs

2013 Annual Meeting, Washington DC, October 2013: Overcoming Barriers to New Technologies (120 minutes CLE)

Periodically the public appears to turn against what is new, yet it wants the benefits attending the new technologies. At present, antagonism is evident towards new technologies including GMO plants and resulting foods, medical advances in diagnostics and use of stem cells, and computer related innovations. As result of this antagonism, coupled with an attitude that all “natural” things belong to the public, protection of intellectual property is increasingly difficult to obtain. On the other hand, the public wants to ensure accessibility to food, better medical diagnosis through, for example, biomarkers, repair of body parts through use of stem cells, and convenience of computers.

In this context, the Biotechnology Committee and the Food and Drug Committee will sponsor a joint educational session (120 minutes of CLE) that will consider the history of the public’s love-hate relationships with new technologies and will include discussion of causes of these conflicting attitudes and their effects on progress. The global status of intellectual property protection in patent offices, regulatory agencies, and the courts will be analyzed to elucidate the issues involved. Solutions for meeting these concerns and attitudes and proposals for developing programs of public education and fostering policies for protecting intellectual property that are beneficial to the public will be presented.

Alice Martin and Bruce Vrana, co-chairs of our Plant Biotechnology subcommittee, will moderate the all-star panel that they put together:

History of Genetic Technologies: Acceptance and Hurdles to Protection

Dr. Ananda Chakrabarty, Distinguished University Professor, University of Illinois at Chicago

Addressing Public Fears of New Technologies

Professor Jay P. Kesan, College of Law, University of Illinois

International IP Protection for Plants

Dr. Humphrey Foote, Senior Associate, AJ Park

Regulatory Issues in Protection of Plant Products, GMOS, Diagnostics

TBD

Public Policy and Education Issues

Sarah Hull, Head, Syngenta External Affairs

Please join us in Washington in October for this excellent, educational program!

Webinars

ACLU v. Myriad Genetics: Navigating the Isolated DNA Patentability Jungle – July 24, 2013

AIPLA will host a webinar at 12:30 pm EDT on July 24, 2013 to discuss the implications of the Supreme Court’s landmark decision in ACLU v. Myriad Genetics.  The confirmed speakers are Greg Castanias, who was counsel for Myriad, Josh Sarnoff, who filed an amicus brief on behalf of 15 law professors, and Manny Vacchiano, who is Lead Patent Counsel of Life Technologies, Inc.  Look for a formal announcement in your email.

Debora Plehn-Dujowich of Drinker Biddle, chair of our Webinars subcommittee, has led the development of this program together with the On-line Programs Committee of AIPLA.  Lynn Tyler of Barnes & Thornburg will moderate the webinar.  Below are the expected topics. 

  •          Constitutional questions, answered?
  • ·         Consequences of the case for §101 jurisprudence; does splitting the baby make sense?
  •          Effect on post-grant proceedings at USPTO
  •          Legislative action to “remedy?”
  •          Future litigation at Supreme Court and Fed Circuit
  •          Practical claiming strategies in light of Myriad and Mayo
  • ·         Method patents that are still possible
  •          What affect on patent office prosecution tactics?
  •          What does the decision mean for future litigation?
  •          How does this extend beyond biotech and chemical cases to, say, software?
  •          When will the USPTO issue guidelines and what will they be?
  •          The Myriad versus Mayo “sandwich” and the Myriad versus Mayo “ocean of grey space.”
  •          In-house perspectives
  •          Clearing molecular diagnostic products
  •          Is the reaction of the press and public appropriate?

 

1.  How will existing gene patents be challenged in post-grant proceedings at the USPTO?  How can one protect one’s existing gene patents from future challenges?

2.  Will holders of gene patents seek reissue?  What types of claims will they seek?

3.  What does the decision mean for protein therapeutics, and other products that are arguably “found in nature”?  What about antibodies?

4.  What does “markedly different” mean?  What changes have to be made to a natural product to make it patentable?

5.  Are claims to isolated polypeptide sequences covering human proteins that are in therapeutic use no longer valid?  Or is Myriad limited to isolated DNA?

6.  Where do comparative diagnostic claims stand after both Myriad and Prometheus?

7.  Are claims to all primers now invalid?  What about if the primer is made of synthetic DNA that is somehow modified, but the sequence is the same as that found in nature?

8.  Licensing issues?  Do licenses have to be re-negotiated?

9.  Changes at the USPTO in view of Myriad?  Will they issue thorough guidelines?

10.          Comments on EPO practice

 

Diagnostic and Gene Patenting Subcommittee: Members Reflect on Myriad

Karen Canady: Supreme Court Limits Gene Patents to Sequences Not Found in Nature

By Karen Canady, Canady + Lortz, Los Angeles, CA

In an opinion authored by Justice Thomas, a unanimous Supreme Court held that a naturally-occurring segment of DNA is not patent-eligible because it is a product of nature.  The decision was released June 13, 2013, in Association for Molecular Pathology et al. v. Myriad Genetics, Inc. et al., and is referred to as “the Myriad case.”  More background on the claims at issue and the history of the case can be found here.  

The Court found the act of isolating the segment of DNA from surrounding genetic material, even though chemical bonds are broken to create a non-naturally-occurring molecule, is not sufficient to create an invention.  DNA that differs from natural DNA, including complementary DNA (cDNA) from which the non-coding introns have been removed, is eligible for patenting.  While the opinion closed with a clear statement of what was not within the ruling, such as methods of manipulating genes or altered natural genetic sequences, the narrow ruling itself has broad implications for all natural products.

The decision emphasized that the claims before the Court “are simply not expressed in terms of chemical compositions, nor do they rely in any way on the chemical changes that result from the isolation of a particular section of DNA.”  The distinction was made between claims that “focus on the genetic information encoded in the BRCA1 and BRCA2 genes” and patents based on the “creation of a unique molecule.”  This emphasis on claims directed to the genetic information raises the question of whether recitation of “synthetic” or “recombinant” in a claim directed to a segment of DNA that is otherwise based on a nucleotide sequence found in nature will be considered enough to distinguish the non-natural chemical entity.  Today’s decision does, however, lend certainty to the patenting of cDNA, which may have significant value for biotechnology developments based on gene discovery. 

Clearly implicated by this ruling are patent claims directed to isolated proteins and purified natural products.  It is unclear how much alteration by human intervention is sufficient for a product derived from nature to be deemed eligible for patenting.  For example, the decision suggests (but does not directly state) that purification may not be a sufficient human intervention to create a patent-eligible invention.  Going forward, patent applicants will want to choose language that clearly defines human-made products and excludes entities that differ from their natural counterparts solely by isolation from a natural source.  Looking back, patentees will likely seek to correct issued patents written when “isolated” was considered sufficient to distinguish a composition of matter relating to a newly-discovered gene or protein from a corresponding product as it occurs in nature.

For technologies that rely on discovery of previously unknown natural genetic sequences or isolated biomolecules, investors may be hesitant to expend resources to bring natural products to market, particularly in light of last year’s Supreme Court decision in Mayo v. Prometheus.  The Mayo decision held certain claims to diagnostic methods were not patent-eligible as directed to a natural principle.  To ensure the public obtains the benefits of new biomedical developments, it will be important to maintain the incentive to seek patent protection.  Patenting requires the applicant to disclose how to make and use the invention in exchange for a limited period of exclusivity.  The alternative for innovators is to withhold new discoveries in the form of trade secrets.  Trade secret protection can be maintained indefinitely for products and processes that cannot easily be reverse engineered. Historically, the U.S. has recognized the benefits of public disclosure provided by patent publications, and has supported commercialization of natural products through issuance of patents. 

Going Forward

While it is unknown at present to what extent the holding of Myriad will be applied to natural products beyond genomic DNA, it is reasonable to assume that claims to other nucleic acid molecules such as primers and probes as well as proteins, including antibodies and enzymes, and cells, are likely to be scrutinized for patent eligibility.  Practitioners drafting new patent claims and those prosecuting pending applications will want to ensure ample support for products clearly defined as a new molecule or other composition of matter.  Rather than relying on terms such as “isolated” or “purified”, claim drafters should recite in the claim features that cannot be found in a corresponding natural form. 

For example, if the isolation from its natural environment means the product no longer has other entities bound to it, it may be advantageous to recite it as free of such entities.  If the protein in isolated form is only stable when fused to a heterologous polypeptide or formulated with a sugar, it could be claimed in this form.  Some natural products may be difficult to define in a manner that clearly distinguishes a new entity that differs from the natural form.  In such cases, one could recite a composition comprising the entity at a concentration clearly beyond any occurring in nature, or include within the composition an additional ingredient that would be necessary to practical and effective use of the composition, such as an adjuvant or vehicle for storage, transport and/or delivery.  In the case of unmodified stem cells, it may be necessary to recite critical components of a culture medium.

Although the Court in the Myriad case made it clear that synthetic or human-made molecules would constitute patent-eligible subject matter, it is not certain that recitation of “synthetic” or “recombinant” in the claims is sufficient.  Such terms should suffice, and would be a suitable compromise to most parties seeking patent protection.  In view of the uncertainty, however, a back-up claim should be retained that recites an additional feature further distinguishing the claimed subject matter from any naturally-occurring counterpart.

Looking Back

Patentees can review their patent portfolios and identify claims whose validity may be in question as a result of the holding in Myriad.  Correction of claims that are now invalid as directed to a product of nature can form the basis for a reissue application.  Care should be taken to review the support in the original specification to ensure suitable amended claims can be pursued without being considered new matter.  Where related applications are still pending, these can be used to further bolster the patent protection through an alternate claim strategy, an option that may be particularly appealing where the validity of issued claims in not clearly in question.

 

Alice Martin: Facing the Issues in Myriad as Interpreted by the United States Patent and Trademark Office

By Alice O. Martin, Ph.D., J.D., Barnes & Thornburg LLP, Chicago, IL.

The U.S. Supreme Court decision in Association for Molecular Pathology v. Myriad Genetics, Inc. (“Myriad”) that isolated DNA is not patentable because it is a “product of nature” is one more step in the global attack against ownership of anything “natural.” The problems are what is “natural” and why is ownership “bad”? In the landmark decision Diamond v. Charkrabarty, the U.S. Supreme Court allowed patenting of genetically altered microorganisms that eat oil, opening the door for incredible advances in medicine and agriculture. In Myriad, the Court indicated that the bacterium in Chakrabarty was different from natural strains, whereas the BRCA DNA isolated by Myriad was also found in nature. Following that reasoning the Court carved out some wiggle room for patent eligibility under 35 U.S.C. § 101 of (1) cDNA, which is not found in nature because generally introns are removed from genomic DNA; (2) DNA with coding sequences not found in nature; e.g., the order of nucleotides is altered; (3) “synthetic” DNA if the structure not found in nature; and (4) methods of using or manipulating DNA. So all is not lost for medical and agricultural innovations of the future. In fact, the patent at issue in Myriad still has many unchallenged claims.

This Supreme Court decision, following on other decisions from the Federal Circuit and the Supreme Court making it more difficult to obtain patents on inventions that involve any kind of biological material, will still have a chilling effect on progress. Many granted patents could be at risk in view of Myriad. Inventors and legal practitioners trying to obtain sufficient patent protection to justify receiving sufficient financial support to fully develop basic inventions and carry them through extremely expensive clinical trials and regulatory approvals, have an added burden. Inventors and practitioners will have to examine the inventions to see at what stage they might be patentable, and how they should be claimed. This could result in improved patents, but could also increase reliance on “trade secrets.”

On June 13, 2013, the United States Patent and Trademark office (USPTO) issued a Memorandum to the Patent Examining Corps for the Patent Examination Policy under Myriad.  The memo can be found here

Myriad significantly changes the Office’s examination policy regarding nucleic acid-related technology. The purpose of this memorandum is to provide preliminary guidance to the Patent Examining Corps.

In the past, isolated and/or purified molecules were patent eligible To be in an issued patent, other criteria had to be satisfied, e.g., novelty, utility and non-obviousness. The June 13, 2013 memo changes the game:

Examiners should now reject product claims drawn solely to naturally occurring nucleic acids or fragments thereof, whether isolated or not, as being ineligible subject matter under 35 U.S.C. § 101.

Although not stated, there may be requirements to prove a nucleic acid sequence could not appear nature, which may be difficult. This kind of argument was raised by examiners in the early days of recombinant DNA patent seeking. Also, although method claims are patent eligible according to Myriad, the United States Patent and Trademark Office instructed examiners that “[o]ther claims, including method claims, that involve naturally occurring nucleic acids may give rise to eligibility issues and should be examined under the existing guidance in MPEP 2106, Patent Subject Matter Eligibility.”

The Myriad holding is likely broader in scope than just referring to human DNA. There is no assurance the decision is limited to human DNA and cDNA, e.g., plant DNA, microorganisms with no introns removed from DNA, an isolated RNA sequence complementary to the full length of a DNA sequence, may not be eligible. Proteins and other compounds “simply isolated” from nature are likely not eligible.

Questions to consider in claim drafting include: What does the invention do in nature? Does it have “markedly different” characteristics as the court indicated was why the Chakrabarty microorganisms were patent eligible?

Inventions can be modified with non-naturally occurring claim elements such as constructs that do not exist in nature, fusion molecules, and vectors with molecules. However, “comprising” in claims will likely cause problems if, natural products could fall within claim scope. Can “something more” required by the court to be contributed by the inventor be shown? For cDNA, the “something more” was intron removal, but that is likely to be an obvious process at present, therefore not likely to end in a patent.

According to Myriad, synthetic DNA is only patent eligible if it is not also found in nature, e.g., fragments of genomic DNA are not patent eligible. Non-natural nucleic acids or amino acids in sequences could make molecules patent eligible, but if such do not affect function compared to the natural sequence, there could still be rejections.

The issues raised by Myriad are far from settled, even in the United States Patent and Trademark Office:

The USPTO is closely reviewing the decision in Myriad and will issue more comprehensive guidance on patent subject matter eligibility determinations, including the role isolation plays in those determinations.

What needs to be considered for patents already issued or pending applications? Narrowing reissues may be filed if there is support. Can patents and patent applications be challenged by third parties under Myriad? Post-grant review is limited to patent claims with effective filing dates on/or after March 16, 2013; Ex Parte Reexamination, Inter Partes Reexamination, and Inter Partes Reviews are limited to §§ 102 and 103 rejections using patents and printed publications.

In a broad sense, this step by the Supreme Court down a path of increased difficulty in obtaining patents is not the end of progress in medicine and agriculture.  However, if certain segments of the public continue to chip away at a system that has benefitted mankind in the past, progress is compromised not only for diagnostics and treatments, but also for other biological inventions such as beneficial plants.

It is not clear what benefits the public receives by restricting protection of patents. Some of the end results the public desires—biomarkers to test for disease risks to facilitate prevention and crops to feed the world despite adverse environments and climate change—require funding and funders require patent protection. The closer biomarkers and drugs are to nature, the more likely they are to be effective, but the more likely they will be found patent ineligible! No anti-patent forces have produced a model to replace patents and demonstrated that the model will facilitate progress. “Trade secrets” increasingly touted as solutions, have the effect of hiding innovation, something the founding fathers who developed the patent system wanted to prevent. A useful consequence of the Myriad decision may be stimulation of more dialogues and joining of more groups interested in fostering new technologies.

 

USPTO Subcommittee

Report from BCP Customer Partnership Meeting – June 4, 2013

Reported by Julie Broadus Meigs, Womble Carlyle Sandridge & Rice, LLP, Tysons Corner, VA.

Copies of the handouts from this meeting and from prior meetings can be obtained at http://www.cabic.com/bcp/.  The materials are also available at the American Intellectual Property Law Association (AIPLA) Biotechnology Committee web page.

TC 1600 Directors Wanda Walker, Jerry Lorengo, and Marjorie Moran (Acting) gave a brief introduction and welcome.

TC Quality and QAS Shop

By Bennett Celsa (Quality Assurance Specialist, TC 1600) and Joe Woitach (Supervisory Patent Examiner, AU 1633)

Mr. Celsa gave an overview of the new Corps Wide Quality Metrics:  (1) final disposition compliance rate, (2) in-process compliance rate, (3) first action on the merits search review, (4) complete first action on the merits review, (5) quality index report (QIR), (6) external quality survey, and (7) internal quality survey.  The first four metrics are based upon data from reviews of specific applications and are measured by the Office of Quality Assurance at the USPTO.  The last two metrics are based upon surveys performed by an independent party.  The fifth metric (QIR) is based upon statistical data taken from the USPTO PALM database that provide insight into USPTO’s ongoing efforts toward compact prosecution and pendency reduction. 

Mr. Woitach summarized the TC1600 efforts to improve QIR by developing training resources and best practices.  In 2012, 5 QIR factors were incorporated into the examiner review process:  (1) actions per disposal, (2) number of RCEs in total disposals, (3) re-opening of prosecution after final, (4) non-final actions other than first action on the merits, and (5) restrictions after first action on the merits.  Based upon examiner training efforts last year, including an emphasis on telephonic communications, the percentage of restrictions not made on a second or subsequent action has improved.  The main focus for 2013 is to decrease the number of actions per disposal and the number of RCEs.  In particular, the USPTO has encouraged interviews after final and during prosecution, patterns in repeated filing of RCEs are being investigated, and examiners with a disproportionate number of disposals for RCE are being identified so that docket management issues may be addressed.  In an effort to reduce overall application pendency, the effective filing date (not the RCE filing date) is used for prioritization of examiner dockets, and counts for consideration of RCEs have been reinstated. 

There were numerous questions from practitioners about training being provided to examiners with a high number of actions, as well as to examiners with an unusually low number of actions per disposal, which may similarly indicate poor examination.  There was also discussion of the benefits of examiner interviews and the challenges associated with conducting in-person interviews with examiners who are part of the hoteling program.  The presenters discussed USPTO efforts to incorporate video interviews at USPTO campuses, and there were views expressed from the audience that the webex video interviews were nevertheless not ideal.  To formalize an expression of these perceived shortcomings, the presenters suggested that practitioners associate with a high level corporation, law firm, or association that could submit a letter of concern. 

Best Practices in Reissue, Before and After September 16, 2012

By Jean Vollano (Quality Assurance Specialist, TC 1600)

Ms. Vollano provided a tutorial of best practices for pursuing reissue applications, including key changes imposed by the America Invents Act.  A review of her slides is an excellent first step prior to filing documents in a reissue application.  Ms. Vollano is eager to assist practitioners as they navigate through the relevant rules so that reissue applications proceed efficiently.  She may be contacted at 571-272-0648.

Recent Case Law: Narrowing/Broadening Reissues

By Bennett Celsa (Quality Assurance Specialist, TC 1600)

Mr. Celsa presented highlights of recent judicial decisions impacting reissue practice.  With respect to narrowing reissues, the CAFC has held that a new dependent claim can be the basis of a reissue application under 35 U.S.C. § 251 (In re Tanaka (98 USPQ2d 1331 (Fed. Cir. 2011)).  With respect to broadening reissues, the CAFC has held that an intent to broaden within two years following issuance permits later broadening of disclosed, but unclaimed embodiments in a manner unrelated to any broadening aspect identified within the two-year period (In re Stats, 671 F3d 1350, 101 USPQ2d 1930 (Fed. Cir. 2012)).  Mr. Celsa also discussed the recapture rule for reissue claims of intermediate scope.  To avoid recapture, a narrowing limitation in a broadened reissue claim must be related to the surrendered subject matter and be distinguishable over the prior art, for example, by modifying but not eliminating the added limitation (In re Mostafazadeh, 643 F3d 1353, 98 USPQ2d 1639; In re Youman, No. 2011-1136, 2012 WL 1598089).  Several examples addressing recapture were presented. 

Petitions

By Thurman Page (Supervisory Patent Examiner, Office of Petitions)

Mr. Page gave a summary of the various petitions reviewed by the Office of Petitions and provided guidance about specific petition requirements, including new requirements under the America Invents Act.  Practitioners are encouraged to use the ePetition process, which has been recently expanded to include the following ePetitions:  Request for Withdrawal as Attorney or Agent of Record (37 CFR 1.36), Petition to Withdraw from Issue after Payment of the Issue Fee (37 CFR 1.313(c)(1), (2), or (3)), Petition to Accept Late Payment of Issue Fee (37 CFR 1.137(b)), Petition for Revival of an Application based on Failure to Notify the Office of a Foreign or International Filing (37 CFR 1.137(f)), Petition for Revival of an Application for Continuity Purposes Only (37 CFR 1.137(b)), Petition for Revival of an Abandoned Patent Application Abandoned Unintentionally (37 CFR 1.137(b)), and Petition to Correct Assignee After Payment of Issue Fee (37 CFR 3.81(b)).  In contrast to the prior PDF-based ePetitions (Petition to Make Special (37 CFR 1.102) and Petition to Accept Unintentional Delayed Payment of the Maintenance Fee (37 CFR 1.378(c)), which require download and completion of a fillable PDF Form, the new web-based ePetitions are completely filled out online and granted immediately upon submission if the petition meets all of the requirements.  A Quick Start Guide with additional information is available at http://www.uspto.gov/patents/process/file/efs/guidance/epetition-quickstart.pdf

There were numerous questions and concerns about the current pendency of petitions.  Mr. Thurman responded that practitioners should call the Office to ensure that the petition was not miscoded upon filing.  With respect to petitions for reconsideration of patent term adjustment (37 CFR 1.705(d)), he advised that the Office was waiting for the Federal Circuit’s decision in Exelixis, Inc. v. Kappos prior to acting upon these petitions. 

Future Meeting

The next scheduled meeting will be 10 September 2013.  Please refer to http://www.cabic.com/bcp/  for the schedule announcement and agenda.  If there are any issues or topics that you wish to be discussed, please share your ideas with the Customer Partnership Team: Bennett Celsa (QAS TC 1600); Sue Lie (SPE AU 1616); Karlheinz Skowronek (SPE AU 1654); and Cecilia Tsang (571-272-0562 or cecilia.tsang@uspto.gov).

Questions

If you have any questions regarding the content of this summary, or would like further details of the live discussion, you are welcome to the Biotech Committee/USPTO Relations Subcommittee co-chairs: Julie Meigs (jmeigs@wcsr.com) and Suzannah Sundby (ssundby@sgrlaw.com).

Case Law Reports

Case Law Report Link

Organic Seed Growers and Trade Ass’n v. Monsanto Company, reported by Bruce Vrana, Syngenta Biotechnology, Inc., Research Triangle Park, NC, USA.

No. 2012-1298 (Fed. Cir. June 10, 2013) (affirming lack of declaratory judgment jurisdiction where patentee stated that it had no intention of suing the declaratory judgment plaintiffs).

Dey, L.P. v. Sunovion Pharmaceuticals, Inc., reported by Lynn C. Tyler and Michael R. Brunelle, Barnes & Thornburg LLP, Indianapolis, IN, USA.

Nos. 2012-1428 (Fed. Cir. May 20, 2013) (reversing district court’s finding of invalidity based on prior use under 35 U.S.C. § 102(b)). 

 

Announcement: 2013-2014 Biotechnology Committee Chair and Vice Chair

Chair: Suzannah Sundby

Wayne Sobon, in-coming AIPLA President, invited Suzannah Sundby of Smith, Gambrell & Russell in DC to become chair of the Biotechnology Committee for the period October, 2013 – October, 2014.  Suzannah accepted the invitation. 

Suzannah has served as co-chair of our USPTO Relations subcommittee for the last 3.5 years.  She participated actively in the preparation of AIPLA’s written submissions in 2012 to the USPTO on genetic testing and on the USPTO’s proposed change in sequence listing protocol.  In 2013, she led the development of AIPLA’s comments to the USPTO about improving the sequence listing process.  She has spoken and written widely on a wide variety of IP issues and she was a panelist at AIPLA’s 2013 spring meeting in a session titled “An Evolving Patent Claim Quagmire of Eligibility and Infringe-ability – Recent Developments in Patent Claim Eligibility and Joint Infringement.” 

Carol Nielsen of Nielsen IP Law, who was in-line to become Biotech Chair, decided to invest her passion and talent in the Chemical Practice Committee as vice chair.  We wish her and them all the best.  We expect to collaborate with Carol and the Chemical Practice group on many things.

Vice Chair: Tim Meigs

Wayne Sobon also invited Tim Meigs of Becton Dickinson to become Vice Chair for the period October, 2013 – October, 2014.  Tim accepted the invitation. 

Tim is very well-known on the Biotechnology Committee and around AIPLA.  He served the Biotechnology Committee as microsite steward for a few years and since 2011 he has chaired our Programs subcommittee.  Tim participated for many years as a trainer in AIPLA’s Biotech Boot Camp and he held the Chair position on the Education committee.  

Suzannah and Tim are working with the committee’s present leadership team on transition.

BIOTECH BUZZ, April, 2013

Join the Committee on LinkedIn!

The Biotech committee is now a sub-group on Linked-In.  We can use this social networking group to better keep in touch with each other.  For example, the linked in page will allow you to send messages to each other or engage in group discussions and informal polls without clogging the inboxes of people who do not wish to participate. 

Also, for those of you who are interested in getting more involved, the Linked-In group will be used by subcommittee chairs to call for volunteers on projects and to announce events, such as CLE webinars or interesting news items.

Of course, participation is voluntary.  If interested in joining, please follow the directions below.

Step 1.  If you are not a member of Linked-In, please join.  It’s free.  Just click on the following link and follow the directions: https://www.linkedin.com/reg/join.

Step 2. Once you have joined, go to the search spot at top (look for the magnifying glass).

Step 3.  Search “American Intellectual Property Law Association” and request to join.

Step 4.  Go back to the Search bar, search for “AIPLA FDA Committee”, and request to join.  You can restrict by “group” using the drop down menu just to the left of the search bar.  Also, joining the main AIPLA group is required because you have to join the main group to join any subgroup, such as the Biotech committee.  For each request to join, it should say that your approval is pending.  The AIPLA IT staff will check that you are actually a member, and if so, approve you.

Step 5.  Start posting.

If you have any questions, please contact William Childs at William.Childs@dbr.com.

Programs

AIPLA Spring Meeting, Seattle Westin Hotel, May 1-3, 2013

May 2, 3:30 – 5:30, Biotechnology IP Practice in Latin America (120 Minutes of CLE)

The Biotechnology Committee and the IP Practice in Latin America Committee are collaborating to present 2 hours of CLE on some of the latest and most important issues affecting patent practitioners who procure and maintain patent protection on biotechnology related inventions in Latin America. The topics to be addressed will cover (1) status of plant variety patent protection; (2) biological pharmaceuticals and biosimilars; (3) whether protection is available for diagnostics and gene patenting; and (4) any specific peculiarities in each country in obtaining and maintaining patent protection (i.e., compulsory licensing issues). The speakers will be:

Ignacio Manuel Sanchez Echagüe, Marval O’Farrell & Mairal, Buenos Aires, Argentina

Leonor Galvão de Botton, Murta Goyanes, Rio de Janeiro, Brazil

Luis Diego Castro, Castro & Pal Asociados, San José, Costa Rica

Eugenio Pérez, Uhthoff, Gómez Vega & Uhthoff, Mexico City, Mexico

May 2, 3:30 – 5:30, “Reverse Payments” – Food and Drug, Antitrust, ADR Joint Session

Biotech members may want to be aware of a session that conflicts with our joint CLE session with IP Practice in Latin America (see above).  The Food and Drug, Antitrust, and Alternate Dispute Resolution committees have planned a panel on so-called “reverse payment” settlements in ANDA litigations, which is the topic of the FTC v. Actavis case before the US Supreme Court this term.  The anticipated panel includes Steve Shadowen of Hilliard & Shadowen LLC, Guy Donatiello of Endo Pharmaceuticals Inc., an economics professor offering an economic perspective, and a representative of the ADR committee.  Look for additional details on this topical panel in April issue of the Biotech Buzz.

Biotech Social, Seattle Westin Hotel, Thursday, May 2, 5:30 – 6:30.

Please join us for drinks, light hors d’oeuvres, and socializing with panelists and committee members at a place yet to be selected within the Seattle Westin Hotel after our CLE sessions on Thursday.  ~5:30 – ~6:30.  As usual, it’s a cash bar.

AIPLA Trip to Mexico City—June 5-7, 2013

AIPLA members, including AIPLA’s Executive Director, Todd Dickinson, AIPLA’s current President, Jeffrey Lewis and at least one of the AIPLA’s Board Members, Mike Martinez, will be visiting Mexico City June 5th-7th in 2013.  Biotech committee members would be welcome to attend.  If you wish to be part of AIPLA’s delegation, go to http://www.marriott.com/hotels/travel/mexjw-jw-marriott-hotel-mexico-city/ to book your room directly over the Internet.  The normal rate is $399.99 plus tax, per night.  However, we were able to obtain a group preferred rate of $237.00 plus tax, per night.  The Group Code to use over the Internet is AIPAIPA.  If you book your rooms over the phone, then the Group Code is simply AIPLA.  If you are attending, book your room immediately and then please let James Larson know.

Webinars

Myriad: Mirth or Melancholy? Date TBD – Soon after Supreme Court decision

The AIPLA Biotech Committee plans to put on a webinar about Myriad soon after the Court issues its decision.  So far Professor Joshua Sarnoff, counsel for amici curiae “Fifteen Law Professors, and Barbara Rudolph of Finnegan Henderson have confirmed their participation.  We expect Greg Castanias, who argued for Myriad at the Court, to participate, and we are hopeful that one of the plaintiffs’ attorneys will also participate.  Stay tuned for the date and time of the webinar and the full list of presenters.

Reprise of Spring Meeting Joint Session on Biotechnology IP Practice in Latin America (120 Minutes of CLE), Date TBD

The Biotechnology Committee and the IP Practice in Latin America Committee will collaborate to present 2 hours of CLE via webinar on some of the latest and most important issues affecting patent practitioners who procure and maintain patent protection on biotechnology related inventions in Latin America. See above for specific topics and presenters.

Case Law Reports

Case Law Report Link

The Association for Molecular Pathology, et al, v. Myriad Genetics, Inc. et al.

Reported by Victoria S. Lee and Amelia F. Baur, PhD, Finnegan, Henderson, Farabow, Garrett & Dunner LLP, Washington, D.C., USA.

 

No. 12-398 (Sup. Crt. April 15, 2013) (summary of U.S. Supreme Court oral arguments in case related to patentability of isolated DNA). 

Berish Rubin and Sylvia L. Anderson v. The General Hospital Corporation.

Reported by Rachel L. Carnaggio, Fennemore Craig, P.C., Denver, Colorado, USA.

 

No. 2011-1439 (Fed. Cir. Mar. 28, 2012) (inventorship dispute between independent research teams gives rise to an interference because the parties were not collaborating). 

Biosimilars Subcommittee

Momenta Seeks Supreme Court Review of Whether Safe-Harbor Applies to Post-Approval Uses of a Drug

Contributed by Angie Sebor and Vicki Norton.

Following split decisions by the Federal Circuit in Classen Immunotherapies, Inc. v. Biogen IDEC, GlaxoSmithKline & Merck & Co., 659 F.3d 1057 (Fed. Cir. 2011) and Momenta Pharmaceuticals, Inc. v. Amphastar Pharmaceuticals, Inc., 686 F.3d 1348 (Fed. Cir. 2012), Momenta has petitioned the Supreme Court to consider the scope of the safe harbor under 35 U.S.C. § 271(e)(1).  More specifically, the Question Presented by Momenta in its petition is “[w]hether the use of a patented invention in the course of post-approval manufacture of a drug for commercial sale, where the FDA requires that a record of that manufacturing activity be maintained, is exempted from liability for patent infringement under Section 271(e)(1) as ‘solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use or sale of drugs.’”  Amphastar initially waived its right to file a response to the petition, but the Supreme Court called for a response, which suggests to some commentators that the Court is showing interest in the case.  Amicus briefs in support of Momenta are due on May 2, 2013.  If the Supreme Court decides to hear the Momenta case, it could resolve the recent split decisions by two Federal Circuit panels and provide more certainty to biologic drug and biosimilar manufacturers.  In Classen, GSK had also petitioned for certiorari, but the Supreme Court denied GSK’s petition on January 14, 2013.

The Federal Circuit panels deciding both Classen and Momenta were divided on the issue of whether 35 U.S.C. § 271(e)(1) can shield post-approval use of a patented technology.  Judge Newman wrote for the majority in Classen, addressing the question of whether §271(e)(1)’s safe harbor shielded the defendants’ post approval activities from infringement where Classen’s method patents were directed to methods of screening and identifying immunization schedules associated with lower risk of chronic disease.  The defendants’ post-approval activities included evaluating suggested associations between vaccines, reporting on recommended immunization schedules, and reporting adverse vaccine effects to the FDA.  The Federal Circuit majority reversed the district court’s ruling that the defendants’ activities fell within the § 271(e)(1) safe-harbor provision and held instead that the safe harbor is “limited to activities conducted to obtain pre-marketing approval of generic counterparts of patented inventions” and that the “statute does not apply to information that may be routinely reported to the FDA long after marketing approval has been obtained.”  Judge Moore dissented, opining that the majority’s analysis and construction of the safe harbor provision were “contrary to the plain language of the statute and clear Supreme Court guidance” (referencing Merck KGaA v. Integra Lifesciences I, Ltd., 545 U.S. 193 (2005)), and “[n]owhere does that statute limit the safe harbor to pre-approval uses.”

In Momenta, Judge Moore wrote for the majority, reaching a conflicting result by holding that Amphastar’s use of Momenta’s patented process for analyzing drug quality during the manufacture of enoxaparin for commercial sale fell within the safe harbor.  Amphastar argued that because the continued testing was an FDA condition for marketing approval, its post-approval testing fell within the plain language of the safe harbor of §271(e)(1).  The Federal Circuit panel majority sided with Amphastar, concluding that the language of §271(e)(1) is broad and “unambiguously applies to submissions under any federal law, providing that the law ‘regulates the manufacture, use or sale of drugs’, and is not only directed to activities related to submission for FDA approval.  The court further held that the phrase “reasonably related to the development and submission of information” in the statute does not mean that the use of the patented invention must necessarily result in the actual submission of information to the FDA—the majority found that Amphastar’s requirement to retain testing records to be readily available for authorized inspection by the FDA upon request satisfied the requirement.  In a dissenting opinion,Chief Judge Rader urged that Amphastar’s activity was not solely for developing and submitting information to the FDA, but also for manufacturing a product to sell in commerce.  Chief Judge Rader further commented that by ignoring the meaning of the term “solely” in the statute, the majority expanded the limited reach of §271(e)(1), to “essentially render manufacturing method patents worthless.”

The Biosimilar Subcommittee will continue to monitor the Momenta case, and will provide a more in depth report on the impact of Classen and Momenta following a Supreme Court ruling on the merits, or its denial of Momenta’s petition.

 

Summary of FDA Draft Guidance on Formal Meetings for Biosimilar Development Programs

Contributed by Vicki Norton, Duane Morris LLP, San Diego, California, USA.

 

On March 11, 2013 the FDA issued a “Draft Guidance on Formal Meetings Between the FDA and Biosimilar Biological Product Sponsors or Applicants” (“Draft Guidance”) (see also 78 Fed. Reg. 19492, April 1, 2013). 

Following enactment of the Biosimilar User Fee Act of 2012 (BsUFA), FDA had committed to achieving certain performance goals in a BsUFA goal letter from the Secretary of HHS to Congress (“FDA Commitment Letter”), including management goals for formal meetings that occur between the FDA and sponsors or applicants during development of a biosimilar biological product. 

The Draft Guidance provides a unified approach to the formal meetings between sponsors or applicants and the FDA during the development of biosimilar products.  In addition, the Draft Guidance discusses principles of good meeting management practices (“GMMPs”) and describes standardized procedures for requesting, preparing, scheduling, conducting and documenting the formal meetings.  The Draft Guidance describes five types of formal meetings and targeted dates: 

The Biosimilar Initial Advisory meeting is the FDA’s initial assessment limited to a general discussion regarding whether licensure under section 351(k) of the Public Health Services Act may be feasible for a particular product, and, if so, general advice on the expected content of the development program.  These meetings should be scheduled within 90 calendar days of FDA receipt of a written meeting request and meeting package.

No user fee is due for the Biosimilar Initial Advisory meeting.  However, fees for the remaining four Types of Biosimilar Product Development (BPD) meetings must be paid in advance?

A BPD Type 1 meeting is a meeting that is necessary for an otherwise stalled BPD program to proceed, and include meetings to discuss clinical holds, special protocol assessment meetings after receipt of FDA evaluation of protocols, meetings to discuss important safety issues, and dispute resolution meetings.  BPD Type 1 meetings should be scheduled within 30 calendar days of FDA receipt of a written meeting request and meeting package.

A BPD Type 2 meeting is a meeting to discuss a specific issue such as proposed study design or endpoints, or to discuss questions where the FDA will provide targeted advice regarding an ongoing BPD program.  This meeting includes substantive review of summary data but does not include FDA review of full study reports.  BPD Type 2 meetings should be scheduled within 75 calendar days of FDA receipt of a written meeting request and meeting package.

A BPD Type 3 meeting is a meeting to provide in-depth data review and advice regarding an ongoing BPD program, including substantive review of full study reports, FDA advice regarding the similarity between the proposed biosimilar biological product and the reference product, and FDA advice regarding the need for additional studies, including design and analysis.  BPD Type 3 meetings should be scheduled within 120 calendar days of FDA receipt of a written meeting request and meeting package.

A BPD Type 4 meeting is a meeting to discuss the format and content of a biosimilar biological product application or supplement to be submitted under section 351(k).  BPD Type 4 meetings should be scheduled within 60 calendar days of FDA receipt of a written meeting request and meeting package.

The five types of formal meetings were previewed in the FDA Commitment Letter and the related Proposed Recommendations for a User Fee Program for Biosimilar and Interchangeable Biological Product Applications for Fiscal Years 2013 Through 2017 (76 Fed. Reg. 76424, December 7, 2011).  However the Draft Guidance indicates that an overview of the proposed development be provided and specifies that the biosimilar application provide preliminary comparative analytical similarity data to enable the FDA to make a preliminary determination as to whether licensure under section 351(k) of the PHS Act may be feasible for a particular product. 

Itemized details of what the Meeting requests should include are summarized:   

1. Product name. 2. Application number (if applicable). 3. Proposed proper name (or proper name if post-licensure). 4. Structure (if applicable). 5. Reference product name. 6. Proposed indication(s) or context of product development. 7. The type of meeting, along with the rationale for requesting the meeting type. 8. A brief statement of the purpose of the meeting, including a brief background of the issues underlying the agenda.  It also can include a brief summary of completed or planned studies and clinical trials or data to be discussed at the meeting, the general nature of critical questions to be asked, and where the meeting fits in overall development plans.   9. A list of the specific objectives/outcomes the requester expects from the meeting. 10. A proposed agenda, including estimated times needed for each agenda item. 11. A list of questions, grouped by discipline. Each question should be precise, and there should be a brief explanation of the context and purpose for each question. 12. A list of all individuals who will attend the requested meeting from the sponsor’s or applicant’s organization and consultants. 13. A list of FDA staff, if known, or disciplines, asked to participate in the requested meeting. 14. Suggested dates and times for the meeting that are within or beyond the appropriate time frame of the meeting type being requested. 15. The proposed format of the meeting (i.e., face-to-face meeting, teleconference, or videoconference) (see Section VI of the Draft Guidance).

Items 8-14 elaborate on items 1(a-g) previously outlined in the FDA Commitment Letter, while items 1-7 in the Draft Guidance appear to relate to background information on the proposed biosimilar development program.  In other respects, the discussion of the 5 types of formal meetings in the Draft Guidance largely tracks earlier FDA’s earlier description of the five types of formal meetings.

Comments on the Draft Guidance are due May 31, 2013.

 

International Issues Subcommittee

Europe: A Family Affair: How claims of a “mother” patent were found to lack novelty in view of a “daughter” divisional application

Contributed by René Raggers, EP&C, Utrect, The Netherlands

 

The Technical Board of Appeal of the European Patent Office (EPO) recently determined in decision T 1496/11 that a divisional application (“daughter”) can be prior art against its own mother application.

Although the patent in this case is not “biotech” it is a good example on how the EPO looks at “self-collision” and validity of priority claims:

Under the European Patent Convention Article 54(3), European patent applications with an earlier filing or priority date than the filing or priority date of a second European patent application, and which are published on or after the filing date of that second application, are prior art  for the purpose of examining the novelty of this second patent application.

Thus in the below example patent application A is prior art for novelty only for patent application B, although published after the filing of B:

 

T 1496/11 concerns a “mother” application and a “daughter” application that both claimed priority from the same Australian application.

The mother was patented with claim 1 relating to a “optical lens”. However, the priority document disclosed such “optical lens” only in combination with a “printed or embossed feature.” The Board held that the claim of the mother patent was not entitled to the priority date, because the claims could be practiced with or without using a “printed or embossed feature.”

Since the filed “daughter” applications was identical to the priority document, it thus became relevant under Article 54(3) (divisional) for claim 1 of the mother application (the daughter having an earlier priority date than claim 1 of the mother, and being published on or after the filing date of the mother). Since the description disclosed “an optical lens in combination with a printed or embossed feature”, the daughter takes away novelty of claim 1 of the mother.

 

This case shows the EPO’s strict view on the right to priority and provides consideration when prosecution patent applications before the EPO.

Plant IP Protection in Australia

Contributed by David Myers and Andrew Blattman of Spruson & Ferguson (Sydney)

 

Australia has a significant agricultural industry, with a gross value of crops in the order of 20 billion dollars annually (including cereals, cotton and canola, but also a significant fruit and vegetable sector). Moreover, the Australian industry is technology intensive, and new plant varieties developed in Australia or overseas are quickly being adopted to meet yield, market, disease and climatic demands.

Importantly, plants (including genetically modified plants) can be protected under both the Australian Plant Breeders Rights Act 1994 (the “PBR Act”) and the Australian Patents Act 1990, and protection under one system does not preclude obtaining concurrent protection under the other.

Plant breeders rights

A variety (plant, fungus or alga) is defined by a combination of physical, chemical or other biological (including disease resistance) characteristics expressed by the variety.  At least one characteristic must distinguish the variety from other commonly known varieties in order to be registrable.  The variety must also be “uniform” in the characteristics it expresses and be “stable” when bred over a number of generations.  The variety need not be previously undisclosed or even uncommercialised; commercial exploitation can occur in Australia up to one year before application, and can occur overseas (in UPOV member countries) up to four years before the making of the PBR application for most plants, or up to six years for trees and vines.  UPOV convention priority from a foreign application can be claimed, although this usually introduces prosecution complications and limitations, and is typically not necessary.

Examination of a PBR application usually requires the involvement of an expert for inspection of the variety and reporting to the PBR Office.  Relevant overseas DUS (Distinctiveness, Uniformity and Stability) test reports can facilitate examination, although a Qualified Person is still required to review such reports and file a report at the Australian PBR Office.

Before grant of a PBR, a deposit of propagating material must be made at an approved Genetic Resource Centre (GRC), and maintained thereafter for the duration of PBR protection.

PBR protection for a plant variety starts as ‘provisional protection’ during prosecution of the application (from the date the application passes formalities examination) and then officially starts from the date of grant of the PBR right and extends for up to 20 years for most plants and up to 25 years for varieties of trees and grape vines.

Protection under the PBR Act includes an exclusive right to produce or reproduce propagating material from the variety, and to sell, condition for sale, import or export such material.  Under limited circumstances, rights may extend to material harvested from the variety.  Rights may also extend to “essentially derived varieties”.  Exemptions to PBR infringement include use of a registered variety privately, for non-commercial purposes or for breeding other plant varieties.  A further exemption exists for farm-saved seed.

Independent of the usual infringement remedies (damages, account of profits and/or delivery up and destruction), the PBR Act also provides for prescribed penalties for infringement.

Patent rights

Patents legislation may provide a plant variety with protection for a period of up to 20 years, from the date of filing of the patent application.

In order to be patentable, a plant variety must meet the usual requirements, including that:

•      the plant be novel in an absolute sense, non obvious, and obtained using a reproducible method;

•      the plant exhibits improved or altered useful properties; and

•      derivation of the plant involves human intervention.

In deciding what constitutes human intervention, the Australian Patent Office treats the choice of parents and their selective breeding, followed by selection of the most desirable offspring as being sufficient.

Where an aspect of the invention claimed cannot be performed without a sample of the germplasm (which is most likely to be the case for a plant variety), a deposit at a Budapest Treaty Depository will most likely need to be made before the filing date of the patent application.

The scope of protection afforded by the patents system is significantly broader than that afforded by PBR.  Unlike PBR, a patent allows protection for the plant variety per se, as well as for:

•      any part of the plant (including harvested material, genes, proteins, other molecules);

•      use of the plant variety or its part(s);

•      methods of breeding plants using the protected variety and resulting progeny; and

•      products derived from the plant.

Biotech Buzz, February 2013

Webinars Subcommittee

FREE CLE: Reprise of the “Issues in Novel Venture Capital Financing for Biopharmaceutical Development” Panel from the 2012 Annual Meeting, March 26, 12:30 PM-2:00 PM EST

The Biotech Committee in partnership with the Chemical Practice Committee will present a free CLE-qualifying webinar reprising the well-attended (150+ people) and popular program from the 2012 AIPLA Annual Meeting titled “IP Issues in Novel Venture Financing of Biopharmaceutical Development.” The webinar will be held on March 26, 2013 from 12:30 pm to 2:00 pm EST.  The panel consists of Cindy Fuchs and Lili Portilla of the National Institute of Health and Translational Research Resources, Joel Nied of LeClairRyan, Mike Warner of Pfizer, and Greg Sieczkiewicz of Flagship Ventures.  They will discuss issues and opportunities in novel venture capital arrangements that are increasingly being used to fund clinical development of biopharmaceuticals.  Invitations to this program will be sent soon. Keep an eye on your inbox.

FREE: Doctrine of Equivalents, AIPLA Patent Law Committee Teleconference, March 5, 12:00 PM-1:00 PM EST

AIPLA’s Patent Law Committee invites you to a teleconference on recent Federal Circuit decisions on the Doctrine of Equivalents in Deere v. Bush Hog and Sandisk v. Kingston Technology.  The presentations should be no longer than 5 minutes per opinion to optimize opportunity for discussion.  You may use the following dial-in to participate in the teleconference:

Toll-Free call-in:                   1-(877) 219-6790 International call-in:            1-719-867-4954 Participant passcode:          610-993-4222

Case Law Reports Subcommittee

Case Law Report Link

Bowman v. Monsanto Co., et al., Brief for the United States as Amicus Curiae Supporting Affirmance, reported byCathy Kodroff, Howson & Howson, Fort Washington, Pennsylvania.

 

No. 11-796 (U.S. Sup. Crt.) (whether a patentee’s rights are exhausted as to subsequent generations of seeds after patented seeds have been purchased in an authorized sale for planting). 

Biosimilars Subcommittee

State Biosimilars Legislation Gains Foothold

Citing safety and regulatory concerns, legislatures in several states have introduced or planned bills designed to control or prevent substitution of biosimilar products – i.e., products approved under the new abbreviated pathway in 42 U.S.C. §262(k) – for biological products approved under 42 U.S.C. § 262(a).  The Alliance for Safe Biologic Medicines, which includes several biotech industry members and BIO, has also interjected concerns that the substitution of biosimilars will cause confusion in pharmacovigiliance studies.

The state bills propose varying degrees of control over substitution.  Each would prevent pharmacists from substituting a biosimilar for a pioneer biologic unless that FDA has already deemed the biosimilar “interchangeable.”  There appears to be little debate over that requirement. 

Most of the bills, however, further require pharmacists to notify doctors of substitution, acquire written consent from patients, and keep records of substitutions for a number of years in order to track adverse events.  For example, Illinois House Bill 5581 provides in part:

c) A pharmacy may substitute a prescription biosimilar product for a prescribed product only if:

(1) the biosimilar product has been determined by the FDA to be interchangeable with the prescribed product for the specified indicated use;

2) the prescribing physician does not designate in writing on the prescription that substitution is prohibited;

(3) the patient (or patient’s authorized representative) provides written consent for the substitution;

(4) the pharmacist notifies the prescriber in writing within 24 hours after the substitution; and

(5) the pharmacy and the prescribing physician retain a written record of the biosimilar substitution for a period of no less than 5 years.

Pending bills in Indiana and North Dakota appear to be identical to the Illinois bill.

                As another example, Virginia House Bill 1422, which has passed the House, provides in part:

§ 54.1-3408.04. Dispensing of interchangeable biosimilars permitted.

A. A pharmacist may dispense a biosimilar that has been licensed by the U.S. Food and Drug Administration as interchangeable with the prescribed product unless (i) the prescriber indicates such substitute is not authorized by specifying on the prescription “brand medically necessary” or (ii) the patient insists on the dispensing of the prescribed biological product…. No pharmacist shall dispense a biosimilar in place of a prescribed biological product unless the biosimilar has been licensed as interchangeable with the prescribed biological product by the U.S. Food and Drug Administration for the specific use.

B. When a pharmacist dispenses an interchangeable biosimilar in the place of a prescribed biological product, the pharmacist or his designee shall inform the patient prior to dispensing the interchangeable biosimilar and shall provide electronic, written, or telephonic notification of the substitution to the prescriber or his staff within five business days of dispensing the interchangeable biosimilar or as set forth in a collaborative agreement as defined in § 54.1-3300. Such notification shall be documented on the record of dispensing. The pharmacist or his designee shall also indicate, unless otherwise directed by the prescriber, on both the record of dispensing and the prescription label, the brand name or, in the case of an interchangeable biosimilar, the product name and the name of the manufacturer or distributor of the interchangeable biosimilar. Whenever a pharmacist substitutes an interchangeable biosimilar pursuant to a prescription written for a brand-name product, the pharmacist or his designee shall label the drug with the name of the interchangeable biosimilar followed by the words “Substituted for” and the name of the biological product for which the prescription was written. Records of substitutions of interchangeable biosimilars shall be maintained by the pharmacist and the prescriber for a period of not less than two years from the date of dispensing.

Proponents of biosimilars argue that these restrictions place unnecessary impediments on the distribution of otherwise interchangeable and more cost-effective medications. They also argue the these states are taking inconsistent positions by freely allowing substitution of regular small-molecule generics or even requiring substitution by pharmacists unless the physician or patient requests the brand-name.

Depending on particulars of state legislation, there could be conflict with the Biologics Price, Competition and Innovation Act provisions of the federal Patient Protection and Affordable Care Act.  The Act defines “interchangeability” to mean that “a biological product that is shown to meet the standards described in subsection [42 U.S.C. § 262] (k)(4), means that the biological product may be substituted for the reference product without the intervention of the health care provider who prescribed the reference product.”  Presumably, no state could enact law stating that a biological product that FDA finds to meet the stringent requirements of interchangeability in 42 U.S.C. § 262(k)(4) may not be substituted for a reference product that a health care provider prescribed.

Earlier this month, legislation proposing substitution restrictions failed to move to a vote in the Mississippi state legislature.  Similar bills remain on the table in several other states–Arizona, Arkansas, Colorado, Florida, Maryland, Massachusetts, Oregon, Pennsylvania, Texas, and Washington.  Thus, the debate over biosimilar substitution will continue as these bills move through state legislatures.

The potential impacts that restrictions on substitutability may have on the attractiveness of developing interchangeable biological products is uncertain at this time.

Submitted by Lynn Tyler and Michael Brunelle, Barnes & Thornburg LLP, Indianapolis, Indiana

Biosimilars Subcommittee: Updated Mission Statement and 2013-2014 Objectives

 

Kristin Connarn

Co-Chair

McDermott, Will & Emery LLP, Boston, Massachusetts US

Vicki Norton

Co-Chair

Duane Morris LLP, San Diego, California US

Lynn Tyler

Co-Chair

Barnes & Thornburg LLP, Indianapolis, Indiana US

 

The Biosimilars Subcommittee held an introductory call on Monday, February 4th at 1:00 PM EST to discuss objectives and plans for 2013.  The mission and objectives published in the January 2013 Biotech Buzz have been updated, as presented below, in view of that discussion.

Mission Statement 

The mission of the Biosimilars Subcommittee will be to monitor patent issues, litigation, and regulations pertinent to the development and commercialization of therapeutic and diagnostic biological products, including biosimilar and interchangeable products.  The Subcommittee will provide Committee leadership and membership with periodic reports, and play a role in advocacy considerations, when pertinent.  The Subcommittee will coordinate with AIPLA’s Food and Drug Committee in monitoring and reporting on regulatory issues relevant to biological products.

2013-2014 Objectives

The Biosimilars Subcommittee has the following objectives for 2013-2014:

  1. Work with AIPLA’s Food and Drug Committee to analyze and advise on Abbott’s citizen’s petition arguing that the BPCIA amounts to an unconstitutional taking, and comments submitted to FDA.
    1. Review the Citizen Petition and Comments submitted
    2. Consider whether to comment on the Citizen’s Petition

Estimated Event Date: First Quarter of 2013

 

  1. Reporting and Advising on FDA Guidances and Draft Guidances for the Regulation of Biosimilar and Interchangeable Products
    1. Report & Analyze Final Biosimilar Guidance(s) When Issued by FDA

1)       Once FDA issues Final Guidance(s) on Biosimilar Products, the Subcommittee will provide a practical document that summarizes the high points of the Guidances, including any changes from the draft Guidances and the FDA’s rationale for those change

    1. Analyze and Advise on FDA Proposed Interchangeable Product Regulations

1)       Once FDA proposes Guidances on the regulation of interchangeable biological products, the Subcommittee will provide a practical document that summarizes the high points of the Guidances, including the implications of the guidances on litigation strategy, in coordination with AIPLA’s Food and Drug Committee. 

2)       Consider whether to make any submissions during the FDA’s comment period.

Estimated Event Date: Soon After Issuance of Guidances or Draft Guidances

 

  1. Monitoring and Advocacy
    1. Analyze and report any possible impact from the Federal Circuit’s split decisions on the scope of the 271(e)(1) safe harbor on manufacturers of biologic drug products (CompareMomenta Pharm., Inc. v. Amphastar Pharm., Inc.. withClassen Immunotherapies, Inc. v. Biogen IDEC) 
    2. Monitor regulations and patent issues pertinent to the development of therapeutic and diagnostic biological products, including biosimilar products.
    3. Monitor litigation relating to the commercialization of biological products, including biosimilar products.
    4. Monitor for legislative proposals by Congress to shorten the biologic product regulatory exclusivity period of 12 years currently set forth in the Biologic Price Competition and Innovation Act (BPCIA).
    5. Monitor the impact of the BPCIA on state legislation.
    6. Coordinate with AIPLA’s Food and Drug Committee.
    7. Provide Committee leadership and membership with periodic reports.
    8. Play a role in advocacy considerations, when pertinent.

Estimated Event Date: Ongoing

 

  1. Outreach
    1. Hold regularly scheduled telephonic meetings to coordinate with Subcommittee members and other interested AIPLA members, and to discuss new developments

 

The Biosimilars Subcommittee would like to invite all interested AIPLA Biotech Committee members to join and participate. 

Estimated Event Date (Recurring): February 4, 2013 (first meeting)

 

Members of the subcommittee volunteered to work on Objectives 1, 2(A) and 3(A):

  • ·         Lynn, Kristin, and Sonsy will review Abbott’s citizen’s petition and consider appropriate vehicle for reporting the results of the review.  Lynn will coordinate with the FDA committee. 
  • ·         Angie and Vicki will analyze and report on any possible impact from the Federal Circuit’s split decisions on the scope of 271(e)(1) safe harbor on manufacturers of biologic drug products.
  • ·         Ronita will take the lead on monitoring when the final FDA Biosimilars guidances come out, and the committee will take action at that point to report and analyze the final documents.

 

FDA’S CDER Announces Biosimilar Guidance Documents Planned for 2013

On January 31, 2013, FDA’s CDER published a list of draft guidance document it plans to publish during calendar year 2013. At least two appear to be relevant to biosimilars, “Submission of Clinical Pharmacology Data as Evidence of Biosimilarity for Biologics and Protein Products” and “Formal Meetings Between the FDA and Biosimilar Biological Product Sponsors or Applicants.” So far, there is no word on when the FDA may finalize the three draft guidance documents on biosimilars issued about this time last year or issue draft guidance on interchangeability.

 

Diagnostics and Gene Patenting and Public Education Subcommittees

AIPLA Comments Again to the USPTO About Genetic Diagnostic Testing

On February 8, AIPLA submitted additional written comments to the USPTO regarding genetic diagnostic testing.  AIPLA’s written comments reiterate the comments that AIPLA submitted in March 2012 and the oral testimony that Karen Canady gave on behalf of AIPLA during a Public Roundtable at the USPTO in early January 2013.  AIPLA continues to oppose modifying patent eligibility or enforcement provisions with respect to confirmatory diagnostic testing.  

 

Plant Biotechnology Subcommittee

The “Standard Material Transfer Agreement” and Access to Plant Genetic Resources: To What are you Agreeing? 

1st of a Series on the SMTA from Mark Pidkowich of Smart & Biggar/Fetherstonhaugh, Vancouver, British Columbia, Canada

The Standard Material Transfer Agreement (SMTA) for use in the Multilateral System was drafted with the intentions of: 1) avoiding the imposition of burdens on receiving parties that may hamper access to the plant genetic resources, while 2) sealing gaps that may lead to the ‘leakage’ of material from the Multilateral System and jeopardize benefit sharing.  The tension between these objectives is somewhat difficult to resolve, as demonstrated by various practical problems the document poses for corporate players.

First, if a Recipient conserves any material that it receives pursuant to an SMTA, which it presumably would, Article 6.3 obligates the Recipient to become a “Provider” and make that conserved material available to third parties.  Article 5(a) of the SMTA dictates that the material must also be provided expeditiously in response to a request.  Essentially, utilization of material obtained under an SMTA creates the risk that the Recipient may become a de facto stock centre, with no ability to recoup its costs beyond the minimum involved (see Article 5(a)).  Moreover, the Recipient-cum-Provider is obligated to inform the Governing Body of all transfers made. 

Second, the SMTA also appears to fetter a Recipient’s control over the distribution of products that it develops with the materials it receives.  While no obligation is placed upon the Recipient to make its products incorporating the transferred material available to third parties, any such transfers that it does make must be made under the SMTA.  Accordingly, a Recipient may not itself be obligated to make its products under development available, but downstream recipients of those products would be so obligated.  This should pose a particular concern for multinational organizations accustomed to transferring material between affiliates, especially given that the Ad Hoc Advisory Technical Committee on the SMTA and the Multilateral System has recently opined that any transfer between different legal persons must be made with the SMTA.  Unless all aspects of an organization’s business are performed by a single legal entity, there seems little room for a company to avoid a transaction which triggers the obligation to transfer a product under development to third parties upon request.

Finally, while the SMTA imposes a number of anticipated and unanticipated obligations on the Recipient, it provides no mechanism to offload liability for breaches of the SMTA by subsequent recipients. Moreover, the Ad Hoc Advisory Technical Committee has indicated that the Provider should exercise some degree of due diligence when evaluating whether or not a transfer should be made in the first place.  Should a Recipient find itself obligated to serve as a stock centre as suggested above, it may also be in the unfortunate position of accepting liability for any leakage of material from the Multilateral System by an indefinite number of downstream recipients, or use of the transferred material for non-food or non-feed purposes.   The due diligence required to ensure that the material does not move to third parties without an SMTA, or that material is not used for unauthorized purposes, would create an immense burden for the Provider.

Accordingly, for-profit organizations comprising multiple legal entities would be wise to develop a strategy for the development and transfer of resources in advance of accepting any material pursuant to an SMTA.  The obligations flowing from the use of the SMTA may ultimately limit the participation in the Multilateral System.  Alternatively, recipients may choose to destroy received material after evaluating it, rather than maintaining it and invoking the obligation to provide it to third parties.  Regrettably, neither option seems to serve the larger goals of the treaty in terms of conservation of and access to plant genetic resources.

 

International Issues Subcommittee

Patentability of Plant Biotechnology Inventions in Argentina

Contributed by Cristian Bittel and Iván Alfredo Poli, Marval O’Farrell & Mairal, Buenos Aires, AR

Argentina is one of the world’s major agricultural producers, ranking third worldwide in production of soybeans and sunflower seeds and fifth in the production of maize. Argentina set forth a regulatory frame for genetically modified organisms (GMOs) in 1991, and 99% of the soybean cultivated at present are genetically modified.  Naturally, this has increased interest in protecting biotechnological inventions. What follows are the salient points of the legal situation for biotechnological inventions in Argentina.

a.             General principles

Like most jurisdictions, the general rule in Argentina is that all inventions are patentable, provided they are new, non-obvious, industrially applicable and lawful, and have been appropriately disclosed and claimed. The basic tenet provided by Article 17 of the Argentine Constitution is that “Every author or inventor is the exclusive owner of his work, invention or discovery for the term granted by law”. 

The specific rules on the patentability of biotechnology inventions are spread among various provisions of the Patent Law and its regulatory decree. The more relevant regulations are:

(a)           Section 6.g of the Patent Law (“For the purposes of this Law, the following items shall not be considered as inventions: […]  g) Any kind of living matter or substance already existing in nature”);

(b)           Section 6 of Regulatory Decree No. 260/96 (“Plants, animals, and essentially biological process for their reproduction shall not be considered to be patentable subject matter”);

(c)            Section 20 of the Patent Law and its regulating decree which set forth formal requirements of inventions involving microorganisms,

(d)           Section 7.b of the Patent Law (“The following are not patentable: […] b) The totality of biological and genetic material existing in nature or their replica in the biological processes implicit in animal, plant, and human reproduction, including genetic processes involving material capable of self-duplication in normal and free conditions, as occurs in nature”);

(e)           Article 27.3 of the TRIPS Agreement.

 

 

b.            Patentability of plants

Under the Guidelines of the Argentine Patent and Trademark Office (PTO), “product claims covering plants […] shall not be allowed, even when they are produced through a microbiological process”.  The basis for this position is the above-mentioned section 6 of the Regulatory Decree.

Legal commentators in Argentina have argued that the PTO’s view is unconstitutional as Section 6 of the Argentine Patent Law, to which section 6 of the Regulatory Decree is subordinate, only bars the patentability of plants existing in nature, but not all plants (such as GMOs).  Despite the questionable constitutionality of the PTO’s position, the limitations it places on claims directed to plants, and the importance of Argentina as an agricultural producer and exporter, no case law yet exists on this issue.  Accordingly, the time may be ripe for challenge in the courts.

c.             Patentability of proteins, genes and/or DNA sequences

Section 7 of the Patent Law provides that the “totality of biological and genetic material existing in nature or their replica” is not patentable, but then goes on to clarify “in the biological processes implicit in animal, plant, and human reproduction”.  Importantly, genetic material not used in processes implicit in animal, plant and human is not within the prohibition.

Consequently, protein and DNA sequences are protectable under the Argentine Patent Law, provided they comply with the patentability requirements (novelty, inventive step, industrial applicability).  The Argentine PTO considers that purification and/or isolation does not provide novelty to proteins or DNA sequences, and therefore only genetically modified DNA sequences or mutant proteins are patentable.

Although plants may not be patentable per se according to the Argentine PTO, a plant comprising a patented DNA sequence can be considered as infringing claims to the patented sequence.  Consequently, protection for a DNA sequence or a polypeptide may prove to be useful to obtain some protection on plants carrying them.

d.            Methods for obtaining plants

Section 7 clearly excludes only the biological and genetic material in the essentially biological processes. Thus, processes in which human intervention has a significant role in determining or controlling the desired result (such as genetic engineering) are acceptable. On the other hand, claims directed to classical cross and selection methods are not acceptable as they are considered to be essentially biological.

Usually, steps such as “growing a plant” are objected to as being essentially biological.  Including transformation steps or reference to molecular markers generally improves the chances of acceptance as this differentiates the method from an essentially biological method.

Biotech Buzz, December 2012

Programs

Two Programs and a “Table Topic” Discussion at Mid-Winter Institute, Tampa, FL, January 31, 2013

Join us in Tampa Florida on the afternoon of January 31, 2013 for three hours of CLE that the Biotechnology and Chemical Practice Committees have jointly planned.

IP Value for Personalized Medicine

Health agencies, payers, patients, and biopharma companies are on the bandwagon for personalized medicine. In-house lawyers from a spectrum of entities involved in personalized medicine will provide views about the role and the value of IP for new products and services, with focus on tech transfer and licensing. They will also touch on the effects of recent cases. How do they affect deals? Can personalized medicine correlations be validly claimed? To what extent might research exemptions limit patent rights? Have divided infringement concerns been alleviated? When could inherency be an insurmountable hurdle? How to avoid European patent exceptions. Business people and in-house lawyers from a very diverse spectrum of entities involved in personalized medicine and diagnostics will provide views about the value of IP for the development of new products and services. 

Judy A. Roesler of Roesler Law Offices, PLLC in Cary, NC will moderate a panel featuring Manny Vacchiano, Lead Patent Counsel, Life Technologies; Yuko Soneoka, Senior Corporate Counsel IP, Genome Health, Inc.; Robert L. Sharp, Patent Counsel, Eli Lilly and Company; Natalie Wright Curley, Managing Director of the Office of Technology Commercialization, MD Anderson Cancer Center; and Jarett Rieger, Director and Associate General Counsel of the Office of Technology Mgmt & Commercialization, Moffitt Cancer Center and Research Institute.  Please join us for a lively and informative discussion with in-house counsel across a broad spectrum of players in personalized medicine.

Aligning IP Strategies with Business Objectives Up and Down the Supply Chain

How does a company’s position in a supply chain affect IP strategies? How do companies that are suppliers and customers adjust their approaches to IP acquisition and licensing in light of business relationships? How do companies use IP to obtain value in the marketplace even when their businesses are not high tech? Business people and in-house lawyers along a supply chain will provide views about the value of IP for their businesses. How does a company’s position in a supply chain affect IP strategies?  How do companies that are suppliers and customers adjust their approaches to IP acquisition and licensing in light of business relationships?  How do companies use IP to obtain value in the marketplace even when their businesses might not be thought of as innovative? 

Business people and in-house lawyers along a supply chain will provide views about the value of IP for their businesses.  Carol Nielsen of Nielsen IP Law LLC in Houston will moderate a panel consisting of Richard Phillips, Chief Attorney Technology, ExxonMobil Chemical; Patrick Bengtsson, VP, Assoc. GC, IP, The Clorox Company; Valerie L. Calloway, Chief IP Counsel, Polymer Group, Inc.; and Nancy M. Klembus, Assistant General Counsel, Kimberly-Clark, Corp

“Table Topic” Leaders Needed for MWI Lunch Discussions, Thursday, January 31

If you are planning to attend the MWI in Tampa on Thursday, January 31 please join the table talk lead team to lead table discussions following the luncheon keynote address by Ford’s Bill Coughlin.  Thanks to the members who have already volunteered: Dave Cupar, Robin Chadwick, Brian Stanton, Timothy Meigs, Greg Lavorgna, Katherine Dover, Debora Plehn-Dujowich, Daniel Monaco, Roy Isaac, Dianne Elderkin, Valerie Calloway, and Brooke Schumm.

We could use a few more leaders.  Let Debora Plehn-Dujowich of Drinker Biddle know of your interest.

Webinars

Patentability of Diagnostic Methods and Biomarkers: A European Perspective – Slides and Recording Available

On December 18th, the Biotech Committee presented a dynamic and highly informative webinar titled “Patentability of Diagnostic Methods and Biomarkers: A European Perspective.”  The panelists were Oliver Kingsbury from Elkington and Fife, Russell Thom from Murgitroyd & Company, and Ana Suarez-Miles from Eli Lilly.  Debora Plehn-Dujowich moderated. 

 

Slides and a recording of the webinar are available. 

 

We thank Elkington and Fife and Murgitroyd & Company for sponsoring the webinar.

Reprise of Annual Meeting Presentations, TBD

The speakers at our Annual Meeting, discussed above, will reprise their presentations in a webinar on a date yet to be determined.  The presentations relate to antibody patenting in the US and Europe and novel venture financing for biotechs. 

Case Law Reports

Case Law Report Link

ButamaxTM Advanced Biofuels LLC, et al. v. E.I. Dupont de Nemours & Co., reported by Julia Kim.

Case No. 2012–1490 (Fed. Cir. Nov. 16, 2012) (affirming denial of preliminary injunction for patent related to biofuels because defendant raised a substantial question of validity). 

Petition to the Secretary of Health and Human Services to “March In” Against the Ritonavir Patents, reported by Nicholas Landau, Ph.D., Bradley Arant Boult Cummings, Birmingham, AL.

(Oct. 25, 2012) (PIRG petition the U.S. government to exercise its “march in” rights and force Abbott to grant a compulsory license to AIDS drug). 

PerkinElmer, Inc. v. Intema, Ltd., reported by Lynn C. Tyler and Michael R. Brunelle, Barnes & Thornburg LLP, Indianapolis, IN.

Case No. 2011-1577 (Fed. Cir. Nov. 20, 2012) (holding claims to method of diagnosing Down’s syndrome invalid under 35 U.S.C. §101 as not being directed to patentable subject matter). 

International Issues

Oh Canada! – So Promising, So Invalid

Reported by Daphne C. Lainson, Smart & Biggar, Ottawa, Ontario, Canada

There has been some continuing litigation following the Canadian Supreme Court’s finding that the sildenafil (the active ingredient in VIAGRA®) second medical use patent was void for insufficiency of disclosure (lack of utility).  A complete summary of the Canadian Supreme Court’s opinion was published in the November 2012 Biotech Buzz

Utility continues to be a common and unusual ground of invalidation of patents that cover marketed pharmaceutical products.  Eli Lilly and Company’s method of use patent covering its STRATTERA® product was invalidated on the basis of failing to meet Canada’s unique, judge-made utility requirements.  On November 7, 2012, Eli Lilly and Company served the government of Canada notice of intent to submit a claim to arbitration under Chapter 11 of the North American Free Trade Agreement in relation to the invalidation.  Lilly’s notice and the presentations and papers from a Comparative Law Symposium held in Ottawa, ON, CA on 4 April, 2012 are worth reading if you draft or prosecute applications with hopes to obtain valid protection in Canada.

CJEU Rules Against AstraZeneca in Abuse of Dominant Position Appeal (SPCs and Anti-Competition Law)

Reported by René John Raggers, EP&C, Utrecht, The Netherlands

On 6 December 2012, the Court of Justice of the European Union dismissed an appeal by AstraZeneca (AZ) against the General Court, which held that AZ had abused its dominant position with respect to its anti-ulcer drug, Losec. 

Regarding abuse of a dominant position concerning supplementary protection certificates (SPCs), the Court concludes that the General Court was fully entitled to hold that AZ’s consistent and linear conduct was a breach of competition on the merits and therefore an abuse of a dominant position.  Specifically, the General Court found that AZ’s conduct was characterized by submitting misleading representations to the patent offices and a lack of transparency by which AZ deliberately attempted to lead the patent offices and judicial authorities into error in order to keep its monopoly on the medicinal products market for as long as possible.

The judgment and the court’s press release provide additional insights into the dismissal.

Brüstle v. Greenpeace, German Federal Supreme Court, 27 November 2012, Case no. X ZR 58/07 (Neural Precursor Cell Patent Partially Invalidated).

Reported by Paul von Dongen, NautaDutilh N.V., Amsterdam, The Netherlands

On November 27, 2012, the German Federal Supreme Court (Bundesgerichtshof) ruled on the validity of the patent of Oliver Brüstle, relating to neural precursor cells and the procedure to cultivate these cells and use them in therapy of neural defects.  This invention could potentially play an important role in the treatment of diseases like Parkinson’s Disease and Multiple Sclerosis.

The European Patent Office granted the patent in 1999.  Greenpeace filed an action for annulment, arguing that the patent would violate public policy and accepted principles of morality because it relates to cells which could only be obtained by the destruction of human embryos.  The Federal Patent Court invalidated the patent for this reason.  The case went up to the Supreme Court which referred several questions to the Court of Justice of the European Union (“CJEU”).  In its decision of October 18, 2011 (Case C-34/10, Brüstle v. Greenpeace) the CJEU clarified that the prohibition to patent in case of the use of human embryos also applies if the patent relates to products for which the destruction of human embryos is necessary, even when the patent does not relates to the use of human embryos as such.

In this decision, the German Supreme Court follows the reasoning of the CJEU.  However, contrary to the Patent Court, the Supreme Court does not completely invalidate the patent.  The Supreme Court rules that the patent is valid to the extent the cells are produced without the destruction of human embryos.

The full reasoning of the Supreme Court is not yet published. See a press release regarding the judgment (in German).

Plant Biotechnology Subcommittee

Standard Material Transfer Agreement is the Gateway to the Multilateral System Under the International Treaty on Plant Genetic Resources for Food and Agriculture

The Plant Biotechnology Subcommittee was established this past July with a mission to foster awareness of key intellectual property issues that influence innovative plant research.  One institution already shaping the generation and dissemination of knowledge in the field of plant research is the Multilateral System (MLS) implemented under the International Treaty on Plant Genetic Resources for Food and Agriculture (IT PGRFA).  Under the MLS, member states agree to make the genetic diversity of the germplasm stored in their seed banks available to all in exchange for free access to commercialized products for further breeding and research (or royalty payments in lieu of free access).

The Standard Material Transfer Agreement (STMA) stands as the gateway to the MLS.  The SMTA is, in all important aspects, a non-negotiable instrument that must be executed by any party wishing to provide or receive seed under the MLS.  Under the SMTA, a recipient agrees to limit its use of transferred material to research, breeding, and training for food and agriculture, excluding any non-food or non-feed industrial purposes.  The SMTA also prohibits a recipient from seeking any intellectual property rights that may limit further access to the materials as received via the MLS.  Where the recipient conserves material received under the SMTA, it is further obligated to make such conserved material further available under another SMTA.  The SMTA further obligates the recipient to share all “non-confidential” information related to research and development using the transferred material.

The MLS and SMTA have been lauded as the first practical implementation of the fair sharing of benefits arising from the use of plant genetic resources.  However, benefit sharing under the SMTA is only triggered when a recipient commercializes a product derived from the transferred material.  Given its significance to the potential creation of any benefit that could be shared under the MLS, there remains a  surprising lack of commentary on what the SMTA means for those parties most likely to commercialize products, i.e. innovative plant biotechnology companies. 

Interestingly, of the more than 3500 shipments under the SMTA that have been disclosed by the International Rice Research Institute in the Philippines, only a handful of transfers have involved corporate recipients.  Does such anecdotal evidence illustrate a general mistrust of the SMTA on the part of corporate innovators and a corresponding reluctance to buy in to the MLS?  In a series of articles over the coming months, the Subcommittee shall seek to educate the membership on the SMTA and explore the issues that are most likely to present stumbling blocks to the wide embrace of the MLS by corporate innovators.  The Subcommittee further welcomes any contributions or comments from the membership in regards to issues they would like to see addressed.

USPTO Subcommittee

Combined TC3700 Medical Devices and TC1600 BioTech Customer Partnership Meeting, January 29, 2013 – NOTE WEBEX OPTION!

The upcoming USPTO Partnership Meeting in the Madison Auditorium in Alexandria, VA on January 29, 2013 will focus on the medical device industry, including diagnostics.  The purpose of the meeting is to bring industry stakeholders and patent examiners and directors from Technology Center 3700 (TC 3700) together to share ideas, experiences, and insights on best practices in advancing prosecution and provide a forum for discussing how the agency can improve and expand its relationship with the medical device technology community. 

Note: For the first time, you can participate via WEBEX.  More information and a link to registration (with WebEx option) can be found here.

8:30-9:00

Sign-in

9:00-9:30

Introductions

9:30-10:30

CPC

10:30-10:45

Break

10:45-11:45

Section 101 Issues

11:45-1:00

Lunch Break

1:00-2:00

AIA Update

2:00-2:15

Break

2:15-3:45

Round table discussions

 

If you would like to present a topic or would like to suggest a topic for future meetings contact the customer partnership team.

Happy Hour, January 29, 2013

Join Biotech members for a Happy Hour at the Trademark Bar in the Westin Alexandria, 2080 Jamieson Ave., 400 Courthouse Square, Alexandria, VA 22314 (just a couple blocks west of the USPTO) after the BCP Partnership meeting.