Stay Versus Stay: How Litigation Stays Pending IPRs Impact the 30-Month Regulatory Stay in Hatch-Waxman Litigation

Stay Versus Stay: How Litigation Stays Pending IPRs Impact the 30-Month Regulatory Stay in Hatch-Waxman Litigation

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In this article published in BNA's Patent, Trademark and Copyright Journal, Andrea Weiss Jeffries and Nancy Schroeder detail the impact of the Hatch-Waxman Act on pharmaceutical companies and patent infringement actions.

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. Read the full article

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