1. Proposed FOB Legislation Patent Provisions AIPLA Mid-Winter Conference Biotechnology Committee Donald R. Ware, Foley Hoag LLP January 24, 2008

2. 2 Patent Provisions in Pending Bills  Access to Live Saving Medicines Act (Waxman Bill) –HR 1038 (Waxman), S 623 (Clinton-Schumer) –Patent litigation under control of FOB applicant  Inslee Bill –No IP provisions  Biologics Price Competition and Innovation Act of 2007 –S1695 (Kennedy, Enzi, Clinton, Hatch, Senate Committee on Heath, Education, Labor and Pensions (HELP)) –First wave of patent litigation requires negotiation of which patents can be litigated prior to launch –Second wave of patent litigation permits at-risk FOB launch  New House bill to be filed shortly –IP provisions designed to provide for resolution of patent challenges prior to expiration of data exclusivity period

3. 3 IP Concerns of Innovators  Access to Information –Limitations on who gets access impractical –Information in follow-on application insufficient for infringement analysis –No mechanism to obtain sample of biological material  Notification to third party patent owners (e.g., universities) –Fairness –Standing requirements may require joinder of patent owners –Time periods may be impractical for university patent owners  Bifurcated litigation –Inefficient and costly –Invitation to gamesmanship  Potential for FOB product launch prior to adjudication –180 days too short for PI, let alone completion of litigation –Permanent injunction provision will not prevent launch  Unfairness of patent sanctions

4. Proposed FOB Legislation Patent Provisions Donald R. Ware Foley Hoag LLP 155 Seaport Boulevard Boston, MA 02210 617 832 1167 dware@foleyhoag.com