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Janet Linn Authors LexisNexis Article on Hatch-Waxman Pre-Suit Considerations for Generic Drug Companies

May 22, 2019

Intellectual Property counsel Janet Linn authored an article featured in LexisNexis’s Lexis Practice Advisor titled, “Hatch-Waxman Pre-suit Considerations from the Generic Perspective.” In the article, Janet discusses how counsel for generic drug companies should prepare for patent litigation under the Drug Price Competition and Patent Term Restoration Act of 1984, better known as the Hatch-Waxman Act.

Janet explains, “Careful pre-suit preparation increases the likelihood of a favorable result, whether through litigation or settlement, and minimizes the small, but real, risk of a fees award against your client that may result from insufficient attention to pre-suit issues.”

Janet notes that effective preparation for Hatch-Waxman patent litigation requires extensive business, technical and legal input. The governing law is complicated and continually evolving, and pending legislation could change the rules once again. She goes on to say, “Because of the complexities of Hatch-Waxman litigation and the interrelationship of regulatory, patent, and litigation considerations, it is best to involve both outside counsel and technical experts in the process as early as possible.”

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