The Biotechnology Industry Organization (for now, at least; more on that later), or BIO, held its 2015 BIO International Convention in Philadelphia June 15-18, with more than 15,000 attendees and in excess of 1,700 exhibitors in the exhibit hall. Along with many special programs, such as the Biotechnology Entrepreneurship Boot Camp, the convention provided dozens of educational tracks and panel discussions, directed to nearly 20 topic areas that included infectious diseases, intellectual property, next-generation biotherapeutics, oncology, orphan and rare diseases, personalized medicine and diagnostics, regulatory science and translational research.
In addition, there were several Super Sessions on such topics as “Ensuring Patient Access to Innovative Medicine,” “M&A and Capital Allocation: Everything Old is New,” “Investment Incentives to Combat Antimicrobial Resistance (AMR),” “Accelerating Innovation in the 21st Century,” “Riding the Bull Market: What’s In Store for Biotech Dealmakers in 2015,” “The Next Step: How Companies Build Successful Therapeutic Franchises from the Ground Up” and “Scientific American World View—Biotech: The Many Spheres of Influence.”
The intellectual property track contained panels on many issues of current and continuing concern, including patentability of antibodies and the impact of inter partes review on biopharma patents. Casting a pall over the proceedings was the recent Federal Circuit decision in the Ariosa v. Sequenom case, which affirmed a lower court ruling that claims to a diagnostic blood test for (among other things) Down syndrome were patent-ineligible. Emphasizing the importance of this issue were two back-to-back sessions on the topic of patent eligibility under Section 101 of the Patent Act, and both discussed the Ariosa case and its negative effects on patenting and progress for genetic diagnostics and personalized medicine.
The first of these sessions, “The Evolving Landscape of Patentable Subject Matter,” featured Raoul Tamayo from the the U.S. Patent and Trade Office (PTO) and P. Michael Walker from E.I. DuPont de Nemours and Co.
Tamayo discussed the Patent Office’s reaction to recent Supreme Court case law (including Mayo v. Prometheus and AMP v. Myriad) and how the PTO has adapted its examination practices to accommodate these cases (as well as Federal Circuit cases decided in the aftermath). Walker brought the industry perspective, discussing the impact of both increased difficulty in obtaining patents and the even more troubling reality that many existing patents have had their validity compromised and thus their value diminished by these rulings.
The panel discussion “Inventions Patentable: Evaluating Proposed Amendments to Section 101,” while optimistically titled, was even more pessimistic regarding the current state of affairs. This panel included former Federal Circuit Chief Judge Paul Michel; former PTO Director David Kappos; Robert Armitage, formerly senior vice president and general counsel at Eli Lilly & Co.; and Phillip Johnson, senior vice president for intellectual property policy and strategy at Johnson & Johnson. The message from this panel was clear: While there are several proposed legislative “fixes” for the problems encountered in satisfying the patent eligibility requirements of Section 101, crafting legislation that makes the appropriate corrections without being burdened by provisions that make matters worse is unlikely.
Armitage reminded his listeners that whatever is done will need be done in a way that does not provoke the Supreme Court to render a decision making these distinctions entirely categorical, so that only a Constitutional amendment would be able to reverse them. The last session in this series, “Patentable Subject Matter Around the World: Life Science Inventions in Canada, Europe, China, Australia and New Zealand,” merely accentuated how much U.S. law has diverged from the international norm regarding patent eligibility of life-sciences-related inventions.
On a brighter note, new BIO Chairman Ron Cohen announced that BIO will be changing its name to the Biotechnology Innovation Organization. The change “better expresses the essence of what our member companies represent,” according to Cohen, who is also CEO of Acorda Therapeutics. Jim Greenwood, longtime BIO president and CEO, called it “a great move that will help clarify for policymakers and the public the heart of our industry—scientific innovation that will help to heal, feed and fuel the world.” This change will be effective early in 2016.
The next BIO International Convention will be held in San Francisco from June 6-8, 2017.
Kevin Noonan is a partner with the law firm McDonnell Boehnen Hulbert & Berghoff LLP and represents biotechnology and pharmaceutical companies on a myriad of issues. A former molecular biologist, he is also the founding author of the Patent Docs weblog, http://patentdocs.typepad.com/.