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.
Originally published in Bloomberg BNA's Patent, Trademark & Copyright Journal - March 25, 2016.
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