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This case involved claims against two defendants, Teva and Amphastar.  The patent claims at issue involved a method for “quality control release testing” of an anticoagulant drug called enoxaparin.  Teva imported the accused generic drug from a foreign manufacturer whereas Amphastar manufactures its generic version in the U.S.  The district court held that neither Teva nor Amphastar infringe under 35 U.S.C. §271(g), and held that, in addition, Amphastar did not infringe under 35 U.S.C. §271(e)(1). 

Section 271(g) prohibits selling “within the United States a product which is made by a process patented in the United States.”  The court held that the term “made by” in Section 271(g) means the actual making of a product, as opposed to methods of testing a final product or intermediate substance to ensure that the intended product or substance has in fact been made.  Here, the claims relate to testing of intermediate products to determine whether they are suitable to be incorporated into the final product.  This is not “making” according to the court, and therefore neither Teva nor Amphastar can infringe under Section 271(g), because their products are not “made by” the patented process.

Section 271(e)(1) provides a safe harbor to use a patented invention “solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs” and its purpose is to facilitate market entry upon patent expiration.  Section 271(e)(1) does not apply to information that may be routinely reported to the FDA, long after marketing approval has been obtained.  Here, the court held that Amphastar’s quality control testing in the U.S. of each batch of generic enoxaparin as part of the post-approval, commercial production process was not related to the submission of information to the FDA.  Therefore, without the safe harbor of Section 271(e)(1), Amphastar directly infringed under Section 271(a). 

In his dissent in part, Judge Dyk argues that the majority errs by holding that there is no infringement under Section 271(g), because, in his view, quality control is part of the process of “manufacturing” a product. 

Momenta Pharmaceuticals, Inc. v. Teva Pharmaceuticals USA, Inc., Case Nos. 2014-1274, -1277 (November 10, 2015); Opinion by: Wallach, joined by Moore, Dyk, concurring in part and dissenting in part; Appealed From: United States District Court for the District of Massachusetts, Gorton, J. Read the full opinion here.

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