Reflecting upon the events of the past twelve months, Patent Docs presents its seventh annual list of top biotech/pharma patent stories. For 2013, we identified fourteen 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. Today, we count down stories #14 to #11, and then over the next few days, we will work our way towards the top three stories of 2013. As with our other lists (2012, 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. In addition, we will be offering a live webinar on the "Top Patent Law Stories of 2013" on January 21, 2014 from 10:00 am to 11:15 am (CT). Details regarding the webinar can be found here.
14. 23andMe Patent and Diagnostic Test Create Controversy
A patent issued to 23andMe, Inc. in September created some controversy for the Mountain View, California biotech company. The patent, U.S. Patent No. 8,543,339, is directed to a system for identifying a preferred gamete donor from among the plurality of donors based on a phenotype of interest, the genotype of a recipient, and the genotypes of the donors. In the wake of the '339 patent's issuance, 23andMe was criticized for its efforts to secure patent protection on a method of creating "designer babies," and in response, the company posted an article on its blog, stating that it "never pursued the concepts discussed in the patent beyond our Family Traits Inheritance Calculator, nor do we have any plans to do so." In an unrelated matter, the FDA issued a Warning Letter to 23andMe in November, demanding that the company stop selling its Personal Genomic Services (PGS) product without obtaining FDA approval. The FDA's letter was not well received by some healthcare consumers, who posted a petition on the "We the People" portion of the White House website, calling for the Obama Administration to overrule the FDA and permit 23andMe to continue to market the company's PGS product. Other consumers, however, initiated a class action lawsuit against 23andMe on behalf of "tens or hundreds of thousands of women" who may have used the PGS testing service.
For information regarding this and other related topics, please see:
• "23andMe Patent Creates Controversy," October 8, 2013
• "Bioethicists 'Urge Maximal Transparency' in Response to 23andMe Patent," October 14, 2013
• "FDA Threatens Agency Action Against 23andMe Over Personal Genetic Testing," November 25, 2013
• "Patients Push Back on FDA Threats to 23andMe Genetic Testing Products," November 26, 2013
• "23andMe Named in Class Action Lawsuit," December 3, 2013
13. Supreme Court Hears Oral Argument in Medtronic v. Boston Scientific
In November, the Supreme Court heard oral argument in the Medtronic Inc. v. Boston Scientific Corp. case, where the sole issue on appeal concerns whether the patent licensee or patent holder/licensor has the burden of proof on the issue of infringement/non-infringement in a declaratory judgment action brought by the licensee under Medlmmune. The Court is expected to issue its opinion before the end of June 2014.
For information regarding this and other related topics, please see:
• "Oral Argument in Medtronic Inc. v. Boston Scientific Corp.," November 7, 2013
• "Amicus Curiae Briefs in Medtronic v. Boston Scientific – Legal Scholars Support Medtronic; Tessera Supports Vacatur and Remand," November 4, 2013
• "Amicus Curiae Briefs in Support of Federal Circuit Opinion in Medtronic Inc. v. Boston Scientific Corp.," November 3, 2013
• "United States Weighs-In on the Medtronic Case," August 15, 2013
• "Supreme Court Grants Certiorari in Medtronic v. Boston Scientific," May 22, 2013
12. Debate Continues on 12-Year Data Exclusivity Period and Biosimilar Substitution
More than three years after President Obama signed the Patient Protection and Affordable Care Act (PPACA) into law, thereby establishing a biosimilar regulatory pathway in the U.S. via the Biologics Price Competition and Innovation Act (BPCIA), the Administration has continued to press for a reduction of the data exclusivity period from 12 years to 7 years. The debate over the data exclusivity period continued this year, but in the context of negotiations on the Trans-Pacific Partnership Agreement (TPP), a multilateral free trade agreement involving Australia, Brunei, Chile, Malaysia, New Zealand, Peru, Singapore, the United States, and Vietnam. In March, Senators Max Baucus (D-MT) and Orrin Hatch (R-UT), the Chairman and Ranking Member, respectively, of the Senate Committee on Finance, urged the Acting U.S. Trade Representative in a letter "to seek commitments from our trading partners that reflect the level of protection under U.S. law, for example 12 years of regulatory data protection for biologic pharmaceuticals." While the Biotechnology Industry Organization (BIO) expressed its support for the 12-year data exclusivity period, the AARP asked the U.S. Trade Representative not to sign onto the TPP if the trade agreement includes the 12-year data exclusivity period. While the data exclusivity period of the BPCIA was being debated in the context of the TPP, several states were debating legislation on biosimilar substitution under the BPCIA. In October, California Governor Jerry Brown vetoed a bill in that state that would have authorized a pharmacist to select a biosimilar when filling a prescription order for a prescribed biological product, provided that the prescriber did not personally indicate "Do not substitute." In a letter to the California Senate, Governor Brown noted that he vetoed the bill because the FDA had not yet determined the standards required for biosimilars to meet the higher threshold for interchangeability, and therefore, requiring physician notification would have been "premature."
For information regarding this and other related topics, please see:
• "AARP Seeks Reduced Data Exclusivity Period in TPP," October 31, 2013
• "Governor Brown Vetoes California Biosimilar Bill," October 16, 2013
• "California Biosimilar Bill Aligns with BIO Principles on Biologic Substitution," October 3, 2013
• "GPhA Opposes California Biosimilar Bill; Points to Report on Savings from Biosimilars," October 2, 2013
• "White Paper Asserts That Existing Trade Agreements Provide No Data Exclusivity for Biologics," August 26, 2013
• "BIO Reiterates Support for 12-Year Data Exclusivity Period for Biologics," August 20, 2013
• "Senators Back 12-Year Data Exclusivity Period for Biosimilars and President Obama (Once Again) Does Not," May 9, 2013
• "WLF Submits Comments on Abbott's Citizen Petition on Biosimilars," March 6, 2013
11. EU Council Signs Unified Patent Court Agreement, Taking Step Towards Unitary Patent System
In February, the Council of the European Union announced that twenty-four member states had signed the international agreement that would establish a Unified Patent Court (UPC), a specialized court having exclusive jurisdiction over infringement and validity questions related to unitary patents. The signing initiated the process of ratification by national parliaments, with ratification requiring at least thirteen member states (including France, Germany and the United Kingdom). Ratification of the UPC agreement will result in implementation of two EU regulations on the unitary patent. According to some reports, ratification may not take place until at least 2015 or 2016, or perhaps even 2017 or 2018. Spain, which did not sign the agreement, continued to challenge the regulations underpinning the Unitary Patent System in 2013.
For information regarding this and other related topics, please see:
• "News from Abroad: Spain's Further Challenges to the Unitary Patent Regulations," June 6, 2013
• "Member States Sign Agreement to Establish Unified Patent Court," February 21, 2013
