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Articles

Is the Safe Harbor Too Safe for Certain Biologic Patents?

August 27, 2013

Articles

Is the Safe Harbor Too Safe for Certain Biologic Patents?

August 27, 2013

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This article appeared in Pharmaceutical Compliance Monitor, August 16, 2013, and is reproduced with permission.

Pharmaceutical companies rely heavily on the exclusivity afforded by patents as a strategy for recovering costs associated with drug development and generating profits from new drug sales. In an attempt to balance the rewards of patent protection with the wide-ranging benefits of generic drug availability, Congress passed the Drug Price Competition and Patent Term Restoration Act (Hatch-Waxman Act) in 1984. The “safe harbor” exemption of the Hatch-Waxman Act was intended to provide a narrow exception to patent infringement to facilitate generic drug entry into the market. However, the politically compromised, vague wording of the law has allowed the safe harbor exemption to be interpreted by the courts in ways that would expand the exemption to include a host of activities that Congress likely never intended.

In the 1990 landmark case of Eli Lilly v. Medtronic, the Supreme Court held that the safe harbor exemption applies not only to drugs, but also to medical devices. Moreover, several recent court decisions have interpreted the law’s broad phrases “solely for uses” and “reasonably related” in ways that have further expanded the safe harbor exemption.

Are Post-Approval Activities “Reasonably Related?”

Please read “Is the Safe Harbor Too Safe for Certain Biologic Patents?” for the answer to that question.

If you have any questions about this article or would like to discuss this topic further, please contact the authors, Terry Mahn or Dr. Erin Baker, or your Fish attorney.

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