Wednesday, April 24, 2013 Preview
By Andrew Williams --
The 2013 BIO International Convention is beginning to wrap-up on Wednesday in Chicago, but you won't want to miss the events scheduled for this day. 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, the best part of your BIO experience so far this year, or just about any other topic that is of interest to you.
BIO is again in full swing on Wednesday with the last day of breakout sessions and Super Sessions. In addition, if you get a chance, check out the keynote luncheon featuring Senator Alan Simpson and Erskine Bowles, the co-chairs of President Obama's National Commission on Fiscal Responsibility and Reform. The program, moderated by James C. Greenwood, President and CEO of BIO, is entitled Debt, Taxes, Government Services and Politics – Is There a Way Out? In addition, don't miss the Gala Reception at the Field Museum between 7:45 pm and 9:30 pm.
Biotech Patenting and Tech Transfer Track
This breakout session track only has two sessions scheduled for Wednesday, but they both promise to be interesting. One of these sessions deals with a topic that is on the minds of most patent attorneys, whether in the U.S. or abroad -- how should we proceed under the new First Inventor to File regime introduced by the America Invents Act (AIA). This session, which is between 10:30 am and 11:30 am, will present an interesting perspective by comparing it to European patent practice, and will be titled: The Morning After!: What to do in U.S. & European Patent Prosecution Following the Enactment of AIA. The impressive list of speakers includes Sjoerd Hoekstra, Director of Biotechnology of the European Patent Office (EPO); Barbara Renda, Assistant General Counsel of Pfizer Inc.; and Mary Till, Legal Advisor at the United States Patent and Trademark Office (USPTO). The focus of the session will be a discussion of the best way to proceed in the parallel "first-to-invent" and "first-inventor-to-file" systems from the perspective of the EPO, the USPTO, and the biotech industry. Similarities and differences between the two systems will also be discussed. Thomas Kokalski, Shareholder at Vedder Price will moderate.
The other session in this track on Wednesday will occur between 9:00 am and 10:15 am, and is titled IP Strategies for the Developing World. The session will address the question of how to protect inventions in countries with poor or inconsistent systems in place. It is these developing countries that can have the fastest growing markets for health care, but the lack of protections can be a barrier to providing access to necessary medical innovations. The panel, which includes Ruth Atherton, Associate General Counsel of The Bill & Melinda Gates Foundation; Edmund Pitcher, Partner at Goodwin Proctor, LLP; and Yves Ribeill, President and CEO of Scynexis, Inc., will outline strategies for both for-profit and non-profit groups to globalize their innovative products. Una Ryan, Managing Partner at Golden Seeds will moderate the discussion.
Market Access and Commercialization
This breakout session track is offering a session that might be of interest to Patent Docs readers, but might be slightly off their radar. On Wednesday morning, between 9:00 am and 10:15 am, this track will offer: Automatic Substitution of Biologics: Who decides and with what Criteria? The new U.S. biosimilar law could produce its first approval this year in the U.S., but it is unclear how this category will be incorporated into the U.S. health care system. The problem is the uncertainty surrounding the word "interchangeable," for example determining when and under what circumstances automatic substitution can occur for biological medicines. The situation becomes murky considering that federal statute defines what can be designated as interchangeable, but state law generally governs pharmacy practice. The speakers, including Joseph Miletich, Senior Vice President of Research and Development for Amgen Inc.; Michael Rodrigues, Senator in the Massachusetts State Senate; and Christine Simmon, Senior Vice President, Policy & Strategic Alliance, Generic Pharmaceutical Association (GPhA), will discuss potential substitution policy to ensure safety while maximizing savings. Erika Leitzan, Special Counsel at Covington & Burling LLP will moderate.
There are several "Super Sessions" offered on Wednesday that might be of interest to the readers of this blog. First, a panel will discuss the Patient Protection and Affordable Care Act (ACA), and the impact it might have on the biotechnology industry. This session is entitled Affordable Care Act is Here to Stay, and it will occur between 10:00 am and 11:30 am. The panel will address the impact that the ACA might play on patient access to prescription drugs, biologics, and vaccines, and will consider the implications of State decisions on Exchanges, benchmark benefit plans, and Medicaid expansion.
In the afternoon on Wednesday, BIO will present a couple of Super Sessions. First, between 2:00 pm and 3:30 pm, a panel of representatives from many major pharmaceutical and biotech companies will discuss The Return of the Pipeline Deal. Since 2007, there has been a decline in pipeline deals across biotech, and it appears that large pharma and big biotech have been harder to entice for small start-ups. This panel of industry leaders will discuss the future of deal-making in such an environment. Concurrent with this session, between 2:30 pm and 3:30 pm, Scientific American will present Get Your WORLDVIEW On: A Special Scientific American Presentation. This session will provide a country-by-country outlook of the best innovation climates for life science knowledge development.