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Experiments with patented compounds or processes are sometimes necessary for Food and Drug Administration approval of a small-molecule drug, biologic, or medical device. The law exempts certain research and development activities using these patented compounds or processes. The two exemptions are (1) a judicially created exemption developed through case law and (2) an exemption created by the Hatch—Waxman Act (the “safe harbor” provision). This article analyzes the history of these exemptions and how the courts have inter­preted their scope and provides future perspectives on protecting research and development activities from liability.

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Alicia Russo has extensive experience litigating and prosecuting biologics, biotechnology, bioinformatics and pharmaceutical patents. She has a B.S. in Biology and Chemistry, and an M.S. in Biomedical Sciences. Alicia has published original papers in Science, Nature, Cell and the Proceedings of the National Academia of Sciences.

Methodology

Information contained in the Venable Fitzpatrick BiologicsHQ database relates to FDA-approved drug products listed in the CDER Purple Book or on the FDA website (www.fda.gov). Information relating to FDA licensed products, FDA-approved indications, and aBLA and 505(b)(2) applications is obtained from public sources including the U.S. FDA website (www.fda.gov). Information relating to litigations is given only for cases active from January 31, 2010 onward. Information relating to foreign biosimilar / biologics follow-on products approved in Australia, Canada, the E.U., Japan and South Korea is from public sources. Statistics graphics are compiled from information contained in the Venable Fitzpatrick BiologicsHQ database.

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