ARTICLE
30 March 2016

Stay Versus Stay: How Litigation Stays Pending IPRs Impact the 30-Month

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Upon initiation of a patent infringement action between branded and generic pharmaceutical companies, the Hatch-Waxman Act (21 U.S.C. § 355(j)) provides for an automatic 30-month stay of
United States Intellectual Property

Upon initiation of a patent infringement action between branded and generic pharmaceutical companies, the Hatch-Waxman Act (21 U.S.C. § 355(j)) provides for an automatic 30-month stay of Food and Drug Administration approval of the Abbreviated New Drug Application (ANDA) for the proposed generic pharmaceutical product. As the legislative history of the Act makes clear, the purpose of the 30- month stay is to permit resolution of the underlying patent dispute before the generic product may enter the market.

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Originally published in BNA's Patent, Trademark and Copyright Journal on March 25, 2016.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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