BIO and World-Wide Intellectual Property Protection
By Andrew Williams --
The 2014 BIO International Convention begins next week in San Diego. 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 week, 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, in honor of the World Cup, we focus on the "International" aspect of the convention by highlighting opportunities for those attendees that wish to compare intellectual property issues around the globe. 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 (#1337) to discuss these sessions (or whatever other topic is of interest to you).
As any patent practitioner in the biotech and pharmaceutical space is aware, the various intellectual property protections available worldwide, with the varying requirements for patentability, can create a landmine for the unwary. For example, some countries encourage early filing to avoid potential prior art issues, thereby providing for quicker public access to the technology disclosed. Others, unfortunately, have heightened disclosure requirements, which counsels against filing until sufficient data is obtained. Moreover, the various countries' policies towards follow-on biologics or personalized medicine with accompanying diagnostics create a tension between disclosure in order to obtain patent protection and non-disclosure in order to maintain trade secrets. Several sessions across various tracks and forums will address some of these most difficult issues.
First on our list, the Emerging Opportunities in Global Markets Forum will present "Predictions for the Future: Biopharmaceuticals and Exclusivity" on Thursday, June 26 at 11:00 AM to 12:00 noon. The panel involved in this presentation will provide their perspective on the issue of follow-on biopharmaceuticals in various leading markets. Pathways for the approval of such drugs are either very new or still forming. Therefore, as the description of the session explains, decisions must be made in view of an uncertain legal and regulatory landscape, especially with regard to the intellectual property or regulatory exclusivity of these products. The panel will explore the state of the global regulatory pathways, and how they present both opportunity and risk. In addition, they will explain how organizations are dealing with new IP laws, and how these biopharmaceutical regulatory and IP systems will change strategies going forward. This panel includes the Associate General Counsel of BIO, Hans Sauer; as well as Sherry Knowles, currently of Knowles Intellectual Property Strategies; Stephen Auten, Partner at Taft and renowned for his LinkedIn Hatch-Waxman ANDA Litigation Forum; and James Shehan, Counsel at Hyman, Phelps & McNamara, P.C. The session will be moderated by Len Smith, currently General Counsel and Vice President of Heliae Development, LLC.
Another area of significant interest for patent professionals practicing on a global scale is the concerns regarding disclosure requirements for patent application in different countries. The problem becomes concrete when applicants need to decide whether to file an application with minimal data as soon as possible to minimize the changes of invalidating prior art, or to wait for additional data because of heightened disclosure requirements. Famously, the Canadian courts have invalidated at least two of Eli Lilly's successful drugs, as well as many other companies' pharmaceuticals, because they did not meet the "promise doctrine" for utility. In response, Eli Lilly has filed a Notice of Arbitration pursuant to the provision in the North American Free Trade Agreement (or NAFTA). In contrast to the restrictions placed on the post-filing evidence to support utility in Canada and China, the U.S. and Europe allow such evidence for already-filed applications. A session of the Intellectual Property track entitled "Show Me the Data! Threshold Patent Application Disclosure Requirements & Post-Filing Evidence Admissibility in the U.S., Europe, Canada & China" will explore how the patent offices in these countries and regions treat post-filing evidence, and identify strategies of preparing applications in view of these disparate policies. In addition, they will examine what impact the timing and availability of data acquisition has on filing applications in different jurisdictions worldwide. The panelists will be Arvie Anderson, Assistant General Patent Counsel at Eli Lilly and Company; Patrick Kierans, Senior Partner at Norton Rose, LLP in Toronto, Canada; Wen Cao, Patent Attorney with NTD Intellectual Property Attorneys in Shanghai, China; and Ute Kilger, Partner at Boehmert & Boehmert in München, Germany. The session will be moderated by Ed Haug, Managing Partner of Frommer Lawrence & Haug LLP, and will take place on Tuesday, June 24 at 4:15 PM to 5:15 PM.
As a final example, the Personalized Medicine & Diagnostic Forum with be presenting "Navigating the Intellectual Property Minefield to Protect Personalized Medicine Innovations Worldwide" on Thursday, June 26 at 1:00 PM to 2:00 PM. As pointed out in the description of this session, recent legal decisions and local policies have presented obstacles for obtaining IP protection involving personalized medicine. However, numerous drugs are being developed with companion diagnostics. Without sufficient IP protection to justify investments, many such therapies may never reach the market. This panel of U.S. and European attorneys will identify the primary IP obstacles and offer strategies for generating adequate IP protection for personalized medicine innovations. In addition, they will explore the impact that this IP will have for business and investment decisions in the major market countries. The panel includes Hans-Rainer Jaenichen, Partner at Vossius & Partner; Shihong Nicolaou, Intellectual Property Manager of the Technology Transfer Office, U.C.S.D; and Scott Rittman, Associate Chief Intellectual Property Counsel, Becton, Dickinson and Company. The panel will be moderated by Ned Israelsen, Managing Partner of Knobbe Martens Olson & Bear, LLP.
Be on the look-out for the next installment of BIO 2014 previews in the next few days.