U.S. Patent Practice – the PTAB, Federal Courts, and Patent Eligibility
The 2016 BIO International Convention has already begun in San Francisco, but most of the sessions and forums get underway beginning on Tuesday, June 7, 2016. Patent Docs has been highlighting a few sessions or other opportunities, in thematic fashion, to help you navigate your way through the convention. For example, today, we focus on issues surrounding the use of inter partes reviews ("IPRs") at the Patent Trial and Appeal Board ("PTAB"), and on issues surrounding patent eligibility for biotechnology inventions. 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 (#504) to discuss these sessions (or whatever other topic is of interest to you).
In the past three and a half years, IPR proceedings have been available for accused infringers, and just about anyone else, to challenge issued patents at the PTAB. Not surprisingly, their use has been a popular topic at recent BIO conventions. This year is no exception. First up in the Intellectual Property track is "Will the PTAB be a Road Block for Biotech? Lessons Learned from the First Three Years of Inter-Partes Review and Future Prospects." This session will take place at 2:15 PM on June 7 in Room West 3008. The description for the session notes that the PTAB has been invalidating claims and entire patents with a frequency that is alarming to those relying on patent protection in the Biotech space. Of course, most affected patents are in other fields, but this does not mean that biotech and pharma are being ignored. The panel will explore the various practices established by the PTAB, including claim construction and claim amendment practice, and the recent proposals for change to these procedures. In addition, the session will explore the intersection of PTAB and the BPCIA to see how IPRs are being used in the biosimilar context. The speakers on the panel are Teresa Stanek Rea, partner at Crowell & Moring LLP, former Acting Under Secretary of Commerce for Intellectual Property and former Acting Director of the U.S. Patent and Trademark Office; Michael Tierney, Lead Administrative Patent Judge at the PTAB, and Kevin Noonan, partner at McDonnell Boehnen Hulbert & Berghoff LLP (and Patent Docs co-author). The session will be moderated by William Kubetin, Managing Editor of Bloomberg BNA.
The Intellectual Property track has a second session that will address the issues of the PTAB and the BPCIA, but will also include issues related to the Hatch-Waxman statute. This session, entitled "Piecing Together the Hatch-Waxman, BPCIA and PTAB Puzzle: Revealing the Big Picture in Patent Challenges Brought in Multiple Fora," will take place in Room West 3008 at 3:30 PM on June 7, 2016. The description of this session notes that in 2015, there was a sizable increase in the number of IPR challenges to pharmaceutical and biotechnology patents. At least a part of this rise stems from the use of IPRs by generic drug companies and those preparing biosimilar drugs. IPRs can be seen as a parallel to district court litigation under the Hatch-Waxman Statute and as an alternative to the "patent dance" under the BPCIA. The session was "[d]esigned for corporate decision makers and practicing IP professionals," and promises to address the interplay between the PTAB and district court. The speakers for this session are Claire Vasios, Vice President of Intellectual Property for Alkermes Inc. and Lori Wolfe, Associate General Counsel, Specialty IP Litigation for Teva Pharmaceuticals USA, Inc. The session will be moderated by Nicholas Mitrostas of Goodwin Proctor.
A final session we will highlight in the Intellectual Property track will address how the Patent Office and U.S. Court system has been handling patent eligibility issues for biotechnology inventions. Entitled "Protecting Biomedical Innovation in a Shifting Patent-Eligibility Landscape," this session will take at 2:15 PM on June 8 in Room West 3008. The description of the session notes that the patent eligibility doctrine is not new, but that the Patent Office and Supreme Court have recently been invoking it to deny patent protection for otherwise "breakthrough" inventions. The judicially created subject matter exceptions of abstract ideas, laws of nature and natural phenomena are being used to exclude patents that are new and not obvious over the prior art. The panel promises to "discuss how stakeholders can maneuver the still-changing landscape in this challenging area and where it may be heading moving forward." The speakers on this panel include Robert Armitage, Consultant on IP strategy and policy matters (and former Senior Vice President and General Counsel at Eli Lilly and Company); Robert Bahr, Deputy Commissioner for Patent Examination Policy at the U.S. Patent Office, Gerard Devlin, Managing Counsel for IP Litigation, Office of General Counsel at Merck & Co., Inc., and Arthur Gajarsa, retired Federal Circuit Judge currently at Wilmer Hale. The session will be moderated by Teige Sheehan of Heslin Rothenberg Farley & Mesiti, P.C.
We look forward to seeing you this week at BIO 2016.
