Top Stories of 2012: #4 to #7

by McDonnell Boehnen Hulbert & Berghoff LLP

New_Year_Ball_Drop_Event_for_2012_at_Times_SquareReflecting upon the events of the past twelve months, Patent Docs presents its sixth annual list of top biotech/pharma patent stories.  For 2012, we identified fifteen stories that were covered on Patent Docs last year that we believe had (or are likely to have) the greatest impact on biotech/pharma patent practitioners and applicants.  On Monday and Tuesday, we counted down stories #15 to #8, and today we count down stories #7 to #4 as we work our way towards the top three stories of 2012.  As with our other lists (2011, 2010, 2009, 2008, and 2007), links to our coverage of these stories (as well as a few links to articles on related topics) have been provided in case you missed the articles the first time around or wish to go back and have another look.  As always, we love to hear from Patent Docs readers, so if you think we left something off the list or disagree with anything we included, please let us know.

7.  Federal Circuit Interprets § 271(e)(1) Safe Harbor as Extending to Post-approval Activities

In a case involving whether certain post-approval activities fall within the "safe harbor" of 35 U.S.C. § 271(e)(1), a divided panel of the Federal Circuit in August vacated a preliminary injunction granted by the District Court, holding that acts taken after approval fell with the safe harbor.  According to the majority, it was significant that Congress had not (expressly) limited the scope of the safe harbor to the Food, Drug and Cosmetic Act but had "broadly" included within the scope of the safe harbor "any federal law" that "regulates the manufacture, use, or sale of drugs."  Thus, the majority rejected Momenta's contention that the process and quality control information obtained from Amphastar's infringement was not submitted to the FDA but was retained by defendants, as these "batch records" must be maintained "for at least one year after expiration of the batch" of generic enoxaparin and must be "readily available for authorized inspection" by the FDA."  The majority opinion states that "[w]e therefore hold that post-approval studies that are 'reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs' fall within the scope of the § 271(e)(1) safe harbor."  Momenta's request for rehearing en banc was denied by the Federal Circuit in November.

For information regarding this and other related topics, please see:

• "Momenta Pharmaceuticals Inc. v. Amphastar Pharmaceuticals, Inc.: 'The Rest of the Story,'" August 13, 2012
• "Momenta Pharmaceuticals, Inc. v. Amphastar Pharmaceuticals, Inc. (Fed. Cir. 2012)," August 9, 2012
• "Chief Judge Rader (Not Surprisingly) Gets it Right about Chimerical 'Tragedy of the Anti-Commons,'" August 6, 2012

6.  Implementation of Biosimilar Regulatory Pathway Proceeds Despite Opposition

In February, the U.S. Food and Drug Administration published its long-awaited draft guidance on the development of biosimilar products.  The FDA's guidance consisted of three documents:  Scientific Considerations in Demonstrating Biosimilarity to a Reference Product, Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product, and Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009.  The FDA then spent the next few months collecting comments regarding the draft guidance, and in May held a hearing on the draft guidance, where researchers, payors, patient and physician groups, and industry advocates provided their thoughts on the FDA's first attempt to clarify the logistics as to the operation of the BPCIA.  The FDA's efforts to implement the BPCIA, however, did not push implementation of the biosimilar regulatory pathway up to #6 on this year's list.  No, it was the Supreme Court's landmark decision in June upholding the Patient Protection and Affordable Care Act (PPACA) -- of which the BPCIA is a part -- as constitutional under the taxation clause of the Constitution that lifted this topic to #6.  While the Supreme Court's decision in National Federation of Independent Business v. Sebelius did not constitute a direct challenge to the BPCIA, there were a handful of direct challenges to aspects of the BPCIA.  For example, President Obama took yet another shot at the 12-year data exclusivity period specified under the BPCIA in his 2013 budget proposal, calling for a modification of the length of exclusivity to facilitate faster development of generic biologics by "award[ing] brand biologic manufacturers seven years of exclusivity rather than 12 years under current law."  The same modification had been included in the President's 2012 budget proposal.  In addition, Abbott filed a Citizen Petition with the FDA in April, requesting that the agency refrain from accepting biosimilar applications under the BPCIA that cite reference products (biologics) for which a biologics license application (BLA) was submitted to the FDA prior to March 23, 2010 (when the PPACA was signed into law).  Interestingly, in a letter to the FDA, Rep. Anna Eshoo (D-CA), who was one of the principal authors of the BPCIA, stated that "[w]hile Abbott's Citizen Petition argues that pre-BPCIA approved biologic products cannot be subject to the law, l want to state very emphatically that it was Congressional intent for the new pathway to apply to biologics approved before and after the passage of the Affordable Care Act."  In October, the FDA sent a letter to Abbott noting that the agency "has been unable to reach a decision on [Abbott's] petition because it raises complex issues requiring extensive review and analysis by Agency officials."  The agency did not provide a date by which it would respond.

For information regarding this and other related topics, please see:

• "Rep. Eshoo Expresses Views on Abbott's Biosimilars Petition in Letter to FDA," October 25, 2012
• "FDA Continues to Review Abbott Petition on Biosimilars," October 24, 2012
• "Affordable Care Act Survives Supreme Court Review Largely Unscathed, Clearing Way for Biosimilars," June 28, 2012
• "BIO International Convention 2012 Preview - Part II: BIO and Biosimilar Regulations throughout the World," June 12, 2012
• "House Passes User Fee Bill," May 31, 2012
• "Senate Passes User Fee Bill," May 29, 2012
• "FDA Holds Public Hearing on Biosimilar Draft Guidance," May 20, 2012
• "BIO Comments on FDA Biosimilars Guidance: Demand More Testing, Permit Fewer Differences," April 25, 2012
• "Abbott Asks FDA to Refuse Certain Biosimilar Applications," April 23, 2012
• "FDA Discusses Initial Considerations for Biosimilar Guidance Documents," February 27, 2012
• "President's Latest Budget Proposal Seeks Decrease of Data Exclusivity Period and Elimination of Pay-for-Delay Agreements," February 21, 2012
• "More on FDA Draft Guidelines for 'Follow-on' Biologic Drug Approval Pathway," February 14, 2012
• "FDA Publishes Draft Guidelines for Biosimilar Product Development," February 9, 2012

5.  Federal Circuit Confirms Patent Eligibility of Isolated DNA

In August, the Federal Circuit in Association for Molecular Pathology v. U.S. Patent and Trademark Office, decided on remand that, the Supreme Court's decision in Mayo v. Prometheus notwithstanding, claims to isolated human DNA satisfy the requirements of 35 U.S.C. § 101.  Each of Judge Lourie's majority opinion, Judge Moore's concurring opinion, and Judge Bryson's opinion concurring in part and dissenting in part substantially tracked their opinions when the panel first decided AMP v. USPTO.  Had the case ended here, the Federal Circuit's decision would have placed higher on our list (perhaps foreshadowing one of the stories to be discussed in the final installment of our Top Stories series).

For information regarding this and other related topics, please see:

• "Patent Eligibility and Biology," August 23, 2012
• "Association for Molecular Pathology v. United States Patent and Trademark Office (Fed. Cir. 2012)," August 16, 2012
• "AMP v. USPTO -- Federal Circuit Confirms Patent Eligibility of Isolated DNA," August 16, 2012
• "The Proper Scope of DNA (or "Gene") Patent Claims," August 1, 2012
• "Myriad and Prometheus: Do Patents 'Preempt' Follow-On Research?" July 29, 2012
• "Federal Circuit Hears Oral Argument in AMP v. USPTO Remand," July 23, 2012
• "Myriad Genetics Files Supplemental Brief in AMP v. USPTO," July 19, 2012
• "Supplemental Brief for Appellees in AMP v. USPTO," July 19, 2012
• "Biopharmaceutical Companies Weigh-In on Myriad Case," July 17, 2012
• "Health Care Professionals Contend That Isolated DNA and cDNA Are Patent Ineligible," July 16, 2012
• "Coalition of Amici File Brief in Support of Myriad," July 15, 2012
• "Dr. James Watson: Human Genes Should Not Be Patented," July 12, 2012
• "Scientist-Law Professor Files Amicus Brief in Myriad Case," July 11, 2012
• "U.S. Government: Mayo Decision Supports Prior Argument That Isolated Genomic DNA Is Not Patent Eligible," July 10, 2012
• "IPO Amicus Brief Argues for Patent Eligibility of Myriad's Isolated DNA Claims and Method Claim 20," July 9, 2012
• "Eli Lilly & Co. File Amicus Brief in AMP v. Myriad," June 27, 2012
• "Biotech Companies Send Letter on Myriad Case to Attorney General and Solicitor General," June 19, 2012
• "Parties and Amici File Briefs in Myriad Case," June 17, 2012
• "The Aussies Are At It Again," June 14, 2012
• "Federal Circuit Declines Invitation to Reconsider Standing Question," June 13, 2012
• "Plaintiffs Respond to Myriad's 'Suggestion' of Mootness or, Alternatively, Motion for Remand in AMP v. USPTO," June 10, 2012
• "Myriad Files Motion 'Suggesting' Mootness or Seeking Remand in AMP v. USPTO," May 30, 2012
• "Federal Circuit Sets Schedule for AMP v. USPTO," April 30, 2012
• "Supreme Court Remands Myriad Case," March 26, 2012

4.  Supreme Court Grants Certiorari in Monsanto v. Bowman

In October, the Supreme Court granted certiorari in Monsanto v. Bowman, against the advice of the U.S. Solicitor General.  In Bowman, Monsanto's complaint arose from farmer Bowman's "second planting" of herbicide resistant seed that was made using so-called "commodity seed" (seed sold by farmers to local grain elevators for commodity use, for example, as cattle feed).  After planting this seed, which was significantly cheaper than Roundup Ready® seed, farmer Bowman tested the crop for Roundup® resistance and found that substantial amounts of the seed were resistant.  He used Roundup® on these plantings and then replanted the seed.  The District Court granted summary judgment of patent infringement and entered judgment against farmer Bowman, and the Federal Circuit affirmed.  The question presented to the Supreme Court is:

Whether the Federal Circuit erred by (1) refusing to find patent exhaustion in patented seeds even after an authorized sale and by (2) creating an exception to the doctrine of patent exhaustion for self-replicating technologies?

For information regarding this and other related topics, please see:

• "Supreme Court Grants Certiorari in Monsanto v. Bowman," October 22, 2012
• "Bowman Responds to Solicitor General," September 12, 2012
• "Solicitor General Recommends the Supreme Court Deny Cert in Bowman v. Monsanto," August 30, 2012

Image of New Year's Eve ball drop for 2012 in Times Square (above) by Replytojain, from the Wikipedia Commons under the Creative Commons Attribution-ShareAlike 3.0 Unported license.



DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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