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).

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