BIO and the Prometheus Supreme Court Case
By Andrew Williams --
The 2012 BIO International Convention in Boston is less than two weeks away. If you are planning on attending, you probably already know that the amount of information and opportunities available at BIO can be daunting. Therefore, over the next two weeks, Patent Docs will be highlighting a few sessions or other opportunities, in thematic fashion, to help you navigate your way through the convention. For example, today we present opportunities for those attendees who have been thinking about how Prometheus is going to affect their research or practice (and we are not talking about Ridley Scott's highly anticipated new movie -- opening this Friday at a theater near you). Of course, 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 to discuss Prometheus (or whatever other topic is of interest to you) (#1335 – Hall A).
Last year, just prior to the 2011 BIO International Convention in Washington D.C., the Supreme Court granted certiorari in the Mayo Collaborative Services v. Prometheus Laboratories Inc. case. As Patent Docs readers are well aware, the claims at issue in that case involved optimizing drug dosage in the treatment of autoimmune diseases by determining the level of a metabolite in a patient. In the intervening year, the Supreme Court reversed the Federal Circuit's determination that the diagnostic claims were patent eligible, and instead held that they were unpatentable laws of nature, with any additional steps found in the claims to involve "well-understood, routine, conventional activit[ies] previously engaged in by researchers in the field." And, even though the opinion warned that patent eligibility should not depend on the "draftsman's art," there has already been plenty of discussion of how far-reaching Prometheus will be, and what a patent practitioner can do to ensure that any new or current claims will not suffer the same fate. BIO looks like it will be no exception to this trend. And, even though we are confident that there will be plenty of discussion throughout the convention, we are highlighting three break-out sessions that promise to address this case, and the issues it presents.
First, the Personalized Medicine and Diagnostics Track will present "IP Challenges for Personalized Medicine & Diagnostics," on Monday, June 18 at 2:00 to 3:30 pm. The session promises to look at how the ability to obtain patents to personalized medicine will be affected by the recent court cases of Myriad, Classen, and Prometheus, as well as the emotionally charged public perception of such patents. The panel will explore the tension between such public perceptions and the demonstrable benefits to patients of such "companion diagnostics" patents by highlighting the intersection of personalized medicine & intellectual property protection. Of course, just how companies can deliver on the promise of personalized medicine in this environment remains a question. This panel includes the Associate General Counsel of BIO, Hans Sauer; as well as Annabelle Bennett, Federal Court of Australia Judge; and Thomas Triolo, Senior Counsel at Merck & Co., Inc. The session will be moderated by Jennifer Gordon of Baker Botts L.L.P.
Not to be outdone, the Biotech Patenting and Tech Transfer Track will be presenting "IP issues Affecting Biomarker-Based Diagnostics and Personalized Medicine" on Wednesday, June 20, at 3:00-3:30 pm. This session includes a panel of international attorneys that will discuss the impact of recent court cases, legislation, and scientific issues on patent procurement and protection in the field of biomarkers and personalized medicine. The panel promises to focus on inventions relating to the use of genetic and non-genetic human variation to predict susceptibility to disease and/or identify patients that will benefit from personalized treatments. In addition to the impact of the America Invents Act and court decisions such as Myriad and Prometheus, the panel will discuss scientific issues are impacting patent procurement (such as what types of data are or can be required), and cross-border and joint infringement considerations that impact the ability to enforce such patents. The panel includes: Thorlakur Jonsson, Director of Intellectual Property of deCODE genetics ehf; Simon O'Brien, Chartered Patent Attorney with D. Young & Co.; John Tessensohn, Board Member of Shusaku Yamamoto Patent Attorneys; and David Gass of Marshall, Gerstein & Borun, LLP. This session will be moderated by Jan Skouv, Director IPR of Exiqon A/S.
Last, but certainly not least, the Biotech Patenting and Tech Transfer Track is also presenting "Recent Developments in Patentability: Prometheus, Myriad, Classen, and the Patentability of Diagnostic Claims," on Tuesday, June 19, at 8:30-9:45 am. This session promises to provide insights on these major court cases and the decision-making behind them. The panel of patent-law experts and practitioners will provide insights into cutting edge legal issues regarding diagnostic methods, will consider an insider's view of decision-making at the Supreme Court and Federal Circuit, and will identify the consequences of these cases for biotech companies. The panel includes: Kevin Marks, Vice President and General Counsel of Roche Molecular Diagnostics; John Whealan, Associate Dean for Intellectual Property at The George Washington University Law School; Neal Katyal of Hogan Lovells; and Seth Waxman of WilmerHale. This session will be moderated by Mark Fleming of WilmerHale.