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Patent Law

: Philip Brooks’ Patent Infringement Updates

Prepare Now for the New Framework for Approval of Follow-on Biologics

By Philip Brooks

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The following is excerpted from a May 18, 2010 Intellectual Property Alert by N. Nicole Endejann and Lana A. Gladstein of Pepper Hamilton LLP:

The Biologics Price Competition and Innovation Act of 2009 (the Act), signed into law on March 23, 2010, amended Section 351 of the Public Health Service Act (42 U.S.C. Section 262) and 35 U.S.C. § 271(e) (providing that it shall be an act of infringement to submit an application seeking approval of a generic biological product) to create a statutory framework for FDA approval of follow-on-biologics as "biosimilar" to or "interchangeable" with a "reference product." "Reference product" is defined in the Act as the single biological product licensed under Section 351(a) against which a follow-on biological product is evaluated.

The Act differs from its Hatch-Waxman counterpart for approval of generic small-molecule pharmaceuticals in several important respects and presents a new frontier for the FDA, the reference product sponsors and the follow-on biologic applicants. On October 1, 2010, as mandated by the Act, the Secretary of Health and Human Services will present to Congress a five-year plan for its proposed review process of follow-on biologics. While the uncertainties associated with the process will have to be worked out over time, innovators and follow-on biologics companies should take steps now to prepare for the potentially lengthy and contentious approval process.