Monday, April 22, 2013 Preview
By Andrew Williams --
This week, the 2013 BIO International Convention is in Chicago, home of the Patent Docs. If you are planning on attending, you probably already know that the amount of information and opportunities available can be daunting. Therefore, we would like to provide a preview of some of the sessions or other opportunities that might be of interest to Patent Docs readers. This is not, however, meant to be an exhaustive list of events (far from it), and it is not meant to be an endorsement of these events over any others in particular. Instead, we are just highlighting various events that caught our eye as presented and described in the BIO schedule. Moreover, Patent Docs authors and contributors will be present at BIO as part of the MBHB contingent, and Patent Docs readers are encouraged to stop by the MBHB booth (#3684) to discuss any of these sessions, whether you think Chicago-style pizza is better than Chicago-style Hot Dogs, or just about any other topic that is of interest to you.
BIO kicks off on Monday with several breakout sessions that might be of interest to readers of this blog. In addition, the Exhibitor Hall will be open for business. However, there are no Super Sessions scheduled for Monday, and there is no keynote luncheon. In the evening, the Welcome Reception will occur on Navy Pier between around 7:00 pm to 9:00 pm.
Biotech Patenting and Tech Transfer Track
The Biotech Patenting and Tech Transfer breakout session track is one that readers of this blog usually find interesting, and this year is no exception. On Monday afternoon, this track is featuring a couple of sessions that highlight global considerations for patent protection and procurement. One of these sessions, The Unitary Patent: How Will it Affect the Biotech Sector and Your Business, is moderated by Patent Docs author Donald Zuhn. This session, which is scheduled on Monday from 3:45 pm to 5:00 pm, will explore the new unitary patent system that the EU Council recently passed. Once the system is ratified, these unitary patents will be valid in all of the participating countries, and a centralized patent court in Paris (with branches in London and Munich) will handle the litigations related to these patents. This session promises to review the political background of patent systems in Europe, analyze the expected benefits of this system for the applicants, and devise new strategies to allow optimal benefit from the new legal framework. The speakers are Victor Kaas, Director of Biotechnology at the European Patent Office; Cyra Nargolwalla, Partner at Cabinet Plasseraud; and Alexander Natz, Director General of EUCOPE.
Former Undersecretary of Commerce for Intellectual Property and USPTO Director David J. Kappos will be moderating the other global patent law session in this track on Monday (2:30 pm to 3:30 pm): How Much is Enough? Comparing Canadian, European, Japanese and U.S. Patent Utility Requirements for Biopharmaceutical Inventions. As the session description points out, there have been 18 pharmaceutical patents rendered invalid or unenforceable in Canada on the grounds of lack of utility. This session will provide both viewpoints regarding these developments, Patrick Kierans, Senior Partner at Norton Rose (Toronto) will argue that Canada's utility requirement runs counter to Canada's obligations to numerous international trade agreements, and Tim Gilbert, Partner at Gilberts LLP (Toronto) will argue that these invalidations reflect flawed patent applications and sound Canadian patent law. The discussion will also include Bert Oosting, Partner at Hogan Lovells (Amsterdam); Takashi Fujita, with Akabe, Ikubo & Katayama (Tokyo); and David Kappos, currently Partner at Cravath Swain and Moore (New York), all of whom will provide the global context to this issue.
Personalized Medicine and Diagnostics Track
Many, if not all, of the sessions from this breakout track tend to be of interest to Patent Docs readers. However, one highlight will be Monday from 10:15 am to 11:30 am: How IP Issues Impact Innovations in Biomarker Diagnostics & Personalized Medicine. The description of this session explains that personalized medicine research and development require considerable costs, and the innovators in the field need to seek enforceable patents to protect their inventions and investments. Jan Skouv, Director IPR of Exiqon A/S, will moderate the session with Simon O’Brien, Chartered Patent Attorney at D. Young & Co.; John Tessensohn, Board Member at Shusaku Yamamoto Patent Attorneys; and David Gass, Partner at Marshall Gerstein & Borun as speakers. In addition, to discussing the recent court decisions regarding patent-eligibility, and the impact they will have on diagnostics, they will analyze how the U.S., EP, and JP patent offices are examining such applications, and discuss enforcement issues, such as territoriality and joint infringement considerations.
Manufacturing of Biologics and Drugs Track
Perhaps not on the radar of many readers of this blog, this breakout track has a session on Monday between 10:15 am and 11:30 am that may be of interest this week, and may continue to be of interest in the future: Biosimilars Manufacturing and Supply Chain Stability: What Does the Current Drug Shortage Crisis Suggest for Biosimilars? As the description for this session explains, there is a drug shortage crisis in this country because hundreds of generic drugs are in short supply, or will soon be. This has profound implications for both the patients that do not have access to these drugs, and for the future of drug innovation. The FDA is trying to prevent any harm from these shortages, but the extent to which these drug shortages will threaten public health is unknown. This is critical to keep in mind when considering the FDA's implementation of the new approval pathway for biosimilars. It needs to be considered whether such biosimilars will also be at risk for shortages, and what preventative measures could be taken. This session will be moderated by Andrew Spiegel, CEO of the Colon Cancer Alliance, and will include as speakers Kenneth Getz, Director of Sponsored Research Programs and Research at Tufts Center for the Study of Drug Development; and Richard Lit, Vice President, Global Regulatory Affairs, Amgen Inc.