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