Tuesday, April 23, 2013 Preview
By Andrew Williams --
The 2013 BIO International Convention continues on Tuesday in Chicago, home of the Patent Docs. We are presenting a preview of some of the sessions or other opportunities that might be of interest to Patent Docs readers. This preview 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, a session we didn't highlight (and why we should have), or just about any other topic that is of interest to you.
BIO is in full swing on Tuesday with several breakout sessions, Super Sessions, and a keynote luncheon. In addition, after the festivities during the day, there are many receptions scheduled throughout the evening and throughout the city. Please make sure to attend MBHB's reception later in the evening, where many of the Patent Docs will be enjoying themselves. If you don't already have an invite, please stop by our booth (#3684) during the day for details.
Biotech Patenting and Tech Transfer Track
This breakout session track, as always, has sessions all day that should be of interest to Patent Docs readers. For Tuesday's sessions, we will highlight those being presented in the morning, which can be thought of as thematically similar in that they both address issues caused by the current state of patent case law in the U.S. First, between 9:00 am and 10:15 am, this track presents the session: Multi-Party and Cross-Border Patent Issues Affecting Biotech Businesses. Speakers Paul Cantrell, Assistant General Patent Counsel at Eli Lilly and Company; Michael Kirschner, Assistant General Counsel at Baxter International, Inc.; and Bernd Allekotte, Partner at Grünecker, will discuss the challenges and potential solutions for protecting and enforcing patents in the U.S. and overseas. This has become increasing difficult with recent developments in U.S. case law that allow competitors to try to copy and divide infringement among multiple parties and/or in multiple countries. The panel will discuss the types of biotechnology innovations that are likely to give rise to multi-party and multi-jurisdiction enforcement issues. They will also discuss the impact of recent legislation, such as the America Invents Act. This session will be moderated by Matthew Nielsen, Partner at Marshall, Gernstein & Borun LLP.
The second session of the morning in this track, occurring between 10:30 am and 11:30 am, is: Myriad, Mayo, and Beyond: Developments in the Law of Patentable Subject Matter. There hasn't been a hotter issue in biotech case law in the past few years than this line of cases, and BIO has assembled a top-tier group of speakers to address it, including the Honorable Arthur Gajarsa (Retired), Former Senior Judge of the U.S. Court of Appeals for the Federal Circuit; Mary Till, Legal Advisor to the United States Patent and Trademark Office; and Seth Waxman, Partner at WilmerHale and former Solicitor General of the United States. The panel promises to address the latest developments related to whether isolated DNA molecules are patentable subject matter, so we assume that there will be plenty of speculation regarding the recent Supreme Court oral arguments in Myriad. In addition, the panel will consider the other recent developments in the courts and Congress that could affect the biotech industry. This session will be moderated by Mark Fleming, Partner at WilmerHale.
There are two sessions on Tuesday in unrelated tracks about the impact of biosimilars on the biotech industry. First, the Achieving Regulatory Approval and Compliance Track is presenting a session between 3:45 pm and 5:00 pm entitled: Biosimilars: Strategic Considerations for Regulatory Approval and Patents under the BPCIA. The description for this session notes that, to date, no generic biologics have been approved in the United States, despite Congress passing the Biologics Price Competition and Innovation Act (BPCIA) around two years ago. This is not true in Europe and Japan, which have seen the approval and marketing of such generic products. The panel, including Stephen Auten, Partner at Cozen O'Connor; Kenneth Dow, Assistant Patent Counsel and VP of Patents at Janssen Pharmaceutical Companies of J&J; and Jeff Kushan, Partner at Sidley Austin LLP, will discuss the regulatory and legal provisions of the BPCIA and provide insights and practical strategies. They will consider the regulatory and financial considerations to initiating and defending challenges under the BPCIA, alternative approval pathways, and biobetters vs biosimilars. The session will be moderated by John Marquardt.
The second track to include a Biosimilar session is the International Market Briefings track, although unfortunately it is being offered at approximately the same time, 3:15 pm to 5:00 pm. This session is entitled: Regulatory Review and Market Uptake of Biosimilars: The European Experience. The description of the session explains that since the introduction of the biosimilar pathway in Europe in 2005, numerous biosimilars have gained marketing authorization. The European Medicines Agency (EMA) is updating these overarching guidelines, and the European Commission is working to ensure access to and uptake of biosimilars. The speakers, Thomas Moore, Director of Value, Access and Policy at Amgen EuropaBIO, Peter Richardson, Head of Biologicals at the EMA, and Peter Stenico, Head of Commercial Operations for Western Europe for Sandoz European Generic Medicines Association, will discuss the challenges for biosimilars from an industry point of view. The session will be moderated by Salvatore D'Acunto, Head of Unit Food, Healthcare Industries, Biotechnology European Commission.
There are several "Super Sessions" that might be of interest to the readers of this blog. First, Ernst & Young will be presenting Beyond Borders Report 2013 in the morning from 10:00 am to 11:30 am. The new normal for the biotechnology industries business climate is a more selective venture capitalist, a more elusive IPO, and a more demanding alliance partner. However, on the flip-side, health care systems are shifting towards outcomes and pay-for-performance. The twin challenge for the industry is to boost efficiency and demonstrate economic value. The speakers for this session include Brian Edelman, Vice President of Corporate Finance and Investment for Eli Lilly and Company; Annalisa Jenkins, Head of Global Development and Medical at Merck Serono; Denise Pollard-Knight, Managing Partner at Phase4 Ventures Limited; and Richard Pops, Chairman, President, and CEO of Alkermes. They will present data on key metrics measuring the performance of the industry. The session will be moderated by Glen Giovannetti and Gautam Jaggi of Ernst & Young.
In the afternoon, G. Steven Burrill of Burrill & Company will present his annual State-of-the-Industry Report between 2:00 pm and 3:30 pm. The description for this session explains that governments worldwide are facing pressure to contain health care spending and develop reliable and environmentally sustainable sources of food, energy, and industrial products. Mr. Burrill's reports have been helping people understand similar developments in the biotech industry for the past 27 years. As the final Super Session of the day, several speakers will present Innovative Innovations: new Partners, New Partnershiops between 3:45 pm to 5:15 pm. This session promises to focus on recently created public and private sector partnerships, the goals of which is to improve the productivity of the biomedical research ecosystem.