Taking Biologics for Granted? Takings, Trade Secrets, and Off-Patent Biological Products

By: Andrew Wasson

Biologics are complex medicines which are often genetically engineered, and which are sure to play an important role in curing some of humankind’s worst diseases. Not surprisingly, generic companies want a part of the biologic market. The FDA believes that it has the authority to approve off-patent versions of biologics that were originally regulated under the Food, Drug & Cosmetic Act, but in order to effectively do so the FDA would have to rely on findings based on data produced by the brand name companies. This iBrief examines whether the FDA’s reliance on previous findings would give rise to a valid claim under the Takings Clause of the U.S. Constitution. In the end, it concludes that the FDA’s proposed action likely would not constitute a taking.

Cite: 2005 Duke L. & Tech. Rev. 0004

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