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Fed. Circ. Limits Safe Harbor For Post-Approval Conduct

Law360, New York (November 17, 2015, 11:38 AM EST) -- The Federal Circuit’s Nov. 10 decision in Momenta Pharmaceuticals Inc. v. Teva Pharmaceuticals USA Inc. (“Momenta II”),[1] which reversed its earlier decision in Momenta Pharmaceuticals Inc. v. Amphastar Pharmaceuticals Inc. (“Momenta I”), [2] is particularly significant. The decision not only narrows the scope of safe harbor protection for post-approval conduct but also seemingly eliminates such protection for research tools patents.

Momenta I

In Momenta I (and II), the facts demonstrated that the U.S. Food and Drug Administration had approved Amphastar’s sales of generic Lovenox provided that each commercial batch was tested before marketing to ensure that the product met rigid specifications. Although...

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