The 2015 BIO International Convention begins in two weeks in Philadelphia.  For the past few years, we have provided a series of previews with the goal of making the large amount of information and opportunities available at BIO less daunting for our readers.  This year is no exception, so 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.  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 (#3226) to discuss these sessions (or whatever other topic is of interest to you).

One topic that is sure to be on the minds of many of the patent practitioners in the biotech and pharmaceutical space is that the new biosimilar pathway of the Biologics Price Competition and Innovation Act ("BPCIA") was first utilized this year.  Of course, the first such application was filed by Sandoz to market a biosimilar version of Amgen's NEUPOGEN^® (filgrastrim) biologic drug product.  And, in a somewhat unexpected twist, Sandoz refused to participate in the disclosure and patent exchange provision of the BPCIA, the so-called "Patent Dance."  In fact, this case is particularly timely because the Federal Circuit is going to hear oral arguments in the Amgen v. Sandoz case tomorrow, June 3, 2015.  The Court is being asked to determine whether the "Patent Dance" provisions of the BPCIA are mandatory when a biosimilar application is filed, or whether they are optional as the Northern District of California Court determined them to be.  The Federal Circuit may also ultimately provide guidance for determining when a preliminary injunction is warranted.

Interestingly, the Intellectual Property track at the BIO convention will not contain a session focused directly on the BPCIA and the biosimilar pathway.  This is perhaps not surprising in view of the fact that there has been a devoted session to this pathway almost every year since the BPCIA was enacted.  And with no party yet utilizing this pathway, there was less to discuss about it with every passing year.  Nevertheless, it is widely believed that the Patent Trial and Appeal Board ("PTAB") may become a major battleground for many biosimilar patent challenges.  Therefore, it is possible that biosimilars will be discussed at an Intellectual Property track session entitled "The Impact of USPTO Inter Partes Review Proceedings on (Bio)Pharma."  The description of the session indicates that "[t]his session will focus on the fairness of IPRs and how generic, brand and non-practicing entities are using IPRs strategically to force settlements, achieve licensing objectives and secure freedom to operate."  The session also promises to discuss how IPRs are impacting raising capital, partnering and developing patent portfolios.  This session will take place on Tuesday, June 16, from 2:00 PM – 3:15 PM.  The speakers will be Administrative Patent Judge Jacqueline Wright-Bonilla; Paul Golian, Vice President & Assistant General Counsel, Intellectual Property at Bristol-Myers Squibb Company; Joseph Kenny, Chief Patent Counsel at ImmunoGen, Inc.; and Gary Margolis, Principal, General Counsel & COO at DRI Capital.  The session will be moderated by Eric Steffe of Sterne Kessler, Goldstein & Fox PLLC.

The introduction of biosimilars and interchangeable biologic products will not only have an impact on the Federal level, but still affect the individual states as well.  The BIO convention will correspondingly have a special program on Tuesday, June 16, from 2:00 PM – 3:15 PM entitled "The Impact Biosimilars Will Have on States."  The description suggests that the panel will explore what state policy makers will do to ensure that patients have access to these new medicines.  The speakers include Pam Lampitt, Assemblywoman of the State of New Jersey; Javier Coindreau, Vice President, Global Medical Affairs for Pfizer Biosimilars; Earl Dye, Director, Technical Regulatory Policy & Strategy in Genentech's Washington, DC Regulatory Affairs Office; Angela Lively, Senior Vice President at ADVI; and Kipp Snider, Director, State Government Affairs, Amgen.  This special program will be moderated by Topper Ray, President of Communications, Bravo Group.

Of course, the U.S. is not the only country address the issue of follow-on biologics.  As a final example of a session aimed at biosimilars, the Regulatory Science track will offer "Global Regulatory Trends for Biosimilars and Biotherapeutics" on Wednesday, June 17, from 10:15 AM to 11:30 AM.  This session promises to "look at the establishment of guideline and implementation of regulatory approval in emerging markets, developing markets and multilateral forums such as APEC and WHO."  The panel will focus on risk assessment for non-comparable biologics, clinical and non-clinical considerations, naming, interchangeability, and labelling.  The confirmed speakers are Ivana Knezevic, Scientist, Technologies, Standards and Norms Team – Department of Essential Medicines and Health Products with the World Health Organization ("WHO"); and Matthew Frankel, Ph.D., U.S. Head, Medical Affairs at Sandoz Biopharmaceuticals.  The session will be moderated by Elizabeth Krutoholow, Companies Analyst for Bloomberg Intelligence.

Be on the look-out for the next installment of BIO 2015 previews next week.  In the meantime, with biosimilars on your mind, please check back for our analysis of the Amgen v. Sandoz oral hearing in the next few days.