Proposed FOB LegislationPatent Provisions

AIPLA Mid-Winter Conference

Biotechnology Committee

Donald R. Ware, Foley Hoag LLP

January 24, 2008

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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

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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

Proposed FOB LegislationPatent Provisions

Donald R. Ware

Foley Hoag LLP

155 Seaport Boulevard

Boston, MA 02210

617 832 1167

dware@foleyhoag.com