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Proposed FOB Legislation Patent Provisions

Proposed FOB Legislation Patent Provisions. AIPLA Mid-Winter Conference Biotechnology Committee Donald R. Ware, Foley Hoag LLP January 24, 2008. Patent Provisions in Pending Bills. Access to Live Saving Medicines Act (Waxman Bill) HR 1038 (Waxman), S 623 (Clinton-Schumer)

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Proposed FOB Legislation Patent Provisions

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

  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. 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 LegislationPatent Provisions Donald R. Ware Foley Hoag LLP 155 Seaport Boulevard Boston, MA 02210 617 832 1167 dware@foleyhoag.com

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