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Patent Docs: BIO International Convention Wrap-up
BIO, or the Biotechnology Innovation Organization (formerly known as the Biotechnology Industry Organization) held its latest BIO International Convention in San Francisco June 7-10, with almost 16,000 attendees and over 1,800 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 topics such as:
Delivery in Biotherapeutics
Orphan and Rare Diseases
Personalized Medicine and Diagnostics
Biofuels and Renewable Chemicals
Business Development and Finance
Emerging Opportunities in Global Markets
Food & Agriculture
Global Innovation Hubs
Value, Patient Access and Commercialization
In addition there were several “Super Sessions” on such topics as “Beyond the Cutting Edge: How to Enable Life Science Organizations Today for the Societal Challenges of Tomorrow,” “Seeking Healthcare Sustainability: The Economic Role of Drugs and Therapies,” “Curative Therapies: Aligning Policy with Science to Ensure Patient Access,” “Healthcare Disrupted: Moving Towards the Patient-Centered, Value-Driven Biopharma,” “Deal-Making in the Headwinds: How Will Market and Political Pressures Impact Biopharma Deals?” and Scientific American World View: Biotechnology in the Age of Convergence.”
The Intellectual Property track (naturally a focus for the Patent Docs column, given its usual subject matter) contained panels on many issues of current and continuing concern, including biosimilars, subject matter eligibility and the impact of inter partes review (IPR) on biopharma patents. Amid the uncertainty created by the Supreme Court’s Mayo/Alice case law and the question of whether the Court will correct it by granting certiorari in the Federal Circuit’s Ariosa v. Sequenom decision, recent guidances from the U.S. Patent and Trademark Office (PTO) were welcomed and addressed in two different presentations by Robert Bahr, deputy commissioner for patent examination.
The first of these back-to-back sessions, entitled “Protecting Biomedical Innovation in a Shifting Patent-Eligibility Landscape,” featured former Federal Circuit Judge Arthur Gajarsa, former Eli Lilly & Co. General Counsel Robert Armitage and Gerard Devlin, who is IP litigation counsel for Merck & Co. They discussed subject matter eligibility under U.S. law. This panel was followed by one entitled “No Patent, No Cure,” that contrasted U.S. law with the law in the European Union, featuring Francisco Fernandez y Branas, biotechnology director of the European Patent Office, Jean-Luc Gal from the European Commission and the PTO’s Bahr.
Another set of back-to-back panels explored the effects IPRs can have on biotechnology and pharmaceutical patents. The first of these, entitled “Will the PTAB be a Road Block for Biotech? Lessons Learned from the First Three Years of Inter-Partes Review and Future Prospects,” provided an exemplary hypothetical case, presented by Teresa Stanek Rea, former acting director of the PTO, representing the petitioner and this author representing the patentee. The issues were presented to the Hon. Michael Tierney, lead administrative patent judge for the Patent Trial and Appeal Board and included whether petitioner was the real party in interest and whether the board would grant discovery on this issue; whether the patentee was entitled to priority to its first-filed application; whether a poster presentation qualified as prior art; and whether the claims were obvious (as well as whether the board would permit a motion to amend the claims under the circumstances presented). The moderator of this panel, W. Randy Kubetin from Bloomberg BNA Healthcare, presented a report containing statistics for the biopharma IPRs that have been filed since the America Invents Act went into effect in 2012.
The second panel on this topic, entitled “Piecing Together the Hatch-Waxman, BPCIA and PTAB Puzzle: Revealing the Big Picture in Patent Challenges Brought in Multiple Fora,” discussed the interplay between these three pathways for challenging pharmaceutical and biopharma patents, and was presented by Claire Vasios, vice president of IP at Alkermes Inc., Lori Wolfe, associate general counsel at Teva Pharmaceuticals USA and Nicholas Mitrokostas from the Goodwin Proctor law firm.
Other topics of interest included recent activity regarding biosimilars, addressed in a panel entitled “Rise of the Biosimilars: Recent Developments and Strategies for Innovators and Biosimilar Applicants for Resolving Patent Disputes Under the BPCIA.” This panel included Christof Bull, associate general counsel at UCB; Charles Sholtz, vice president for IP at Coherus Biosciences and Immac (Casey) Thampoe, managing counsel, biologics and vaccines, at Merck & Co., and the members of the panel discussed recent district court and Federal Circuit case law involving application of the litigation provisions of the BPCIA in disputes between innovator biologic drug companies and biosimilar applicants.
Jim Greenwood, BIO president and CEO, delivered a cautionary keynote address that recognized the realities of the political campaign for U.S. president and the risks of “bad policy that spooks investors and starves our scientists of the resources they need.” Despite biotechnology successes cited by Greenwood in combating HIV/AIDS, hepatitis and “hundreds of diseases” including “leukemia, rheumatoid arthritis, multiple sclerosis, cystic fibrosis, lupus and rare disorders with uncommon names like Pompe and Gaucher,” he warned that “during this election season, our industry has become an easy scapegoat for the real and growing problem of patient access to affordable new medications.”
To counter this phenomenon, he cited a new educational campaign directed to the public, aimed at “refocus[ing] the public conversation on the true value of pharmaceutical innovation” that will “remind elected officials that, despite the rhetoric on drug prices, just one out of 10 biotech companies actually turns a profit” and that “90 percent of biotech clinical research goes toward projects that ultimately fail.” In the face of the challenges in explaining the complexities of the “innovation ecosystem,” BIO is simplifying its message to its essence: that its member companies’ efforts are saving lives.
The next BIO International Convention will be held in San Diego June 19-22, 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/.