Addressing issues of infringement under 35 U.S.C. § 271(g) and the safe harbor provision of § 271(e), the U.S. Court of Appeals for the Federal Circuit upheld the district court’s ruling of non-infringement under § 271(g) and vacated the district court’s finding of non-infringement under 271(a) to the extent that finding was based on application of the § 271(e) safe harbor provision. Momenta Pharm., Inc. v. Teva Pharm., Inc. and Amphastar Pharmaceuticals, Inc., Case Nos. 14-1274, -1277 (Fed. Cir., Nov. 10, 2015) (Wallach, J.) (Dyk, J., concurring in part, dissenting in part).

Enoxaparin is an anticoagulant that helps to prevent blood clots. Momenta markets a generic version of enoxaparin, and is the assignee of a patent directed to a process used to ensure each batch of generic enoxaparin meets certain quality standards. Teva and Amphastar sought to enter the generic enoxaparin market. Teva used an Italian company to manufacture, analyze, test, package and label Teva’s generic version of enoxaparin, which Teva then imported into the United States. Unlike Teva, Amphastar manufactures its enoxaparin product within the United States. Momenta sued Teva and Amphastar for infringement of its patented process. The district court granted summary judgment that Teva’s and Amphastar’s sales in the United States did not constitute infringement under § 271(g) and that their conduct fell within the safe harbor from infringement provided by § 271(e). Momenta appealed.

Section 271(g) prohibits selling “within the United States a product which is made by a process patented in the United States.” In this case, the issue for the Court was whether Teva’s enoxaparin product was “made by” the claimed method. The Court ruled that the word “made,” as used in § 271(g), means “manufacture” and extends to the creation or transformation of a product, but does not extend to quality control steps, including testing to evaluate the properties of an already-synthesized substance. Because Momenta’s claimed process only involved evaluation of the properties of material that had already been made, the Court found that Teva’s and Amphastar’s enoxaparin product was not “made by” the claimed process.

Momenta also argues Amphastar’s use of the patented method within the United States infringes under § 271(a) and is not protected by the § 271(e)(1) safe harbor. The safe harbor provision of § 271(e) shields from infringement certain activities relating to submission of information to the U.S. Food and Drug Administration (FDA), including, for example, allowing generic drug manufacturers to perform the testing required for FDA approval before the patents in question expire. The safe harbor provision broadly encompasses pre-approval activities but does not shield post-approval “information that may be routinely reported to the FDA.”

In this case, the question for the Court was whether the information generated by Amphastar’s performance of the claimed process is of the type that is routinely (i.e., repeatedly, habitually, regularly) reported to the FDA. According to the Court, because Amphastar’s allegedly infringing activities involved post-approval quality control testing of each and every batch of enoxaparin, the information generated was of the type “routinely” recorded, retained and reported in accordance with FDA regulations and, therefore, was not protected by the § 271(e) safe harbor. Here, the Court drew a distinction between information that is “routinely” recorded and reported in this manner and “new” information that has not been previously submitted to the FDA. According to the Court, “new” information is information that may form the basis for supplemental applications or post-approval clinical trial results. Because the district court erred in finding that Amphastar’s activities fall within the § 271(e) safe harbor, the Court remanded the case to the district court to analyze the question of infringement under. § 271(a).

Judge Dyk dissented from the majority ruling as to non-infringement under § 271(g).  According to Dyk, whether a particular product was “made by” a claimed process should be reviewed on a case-by-case basis and, in the context of enoxaparin, the claimed process is an integral part of the manufacturing process that should be covered under § 271(g).

Judge Dyk also noted that the majority’s decision may create a loophole in the law of § 271(g) infringement with respect to purification and other quality-control processes. Specifically, the material subject to the claimed process was removed from, and not returned to, the commercial batch. As a result, according to the majority, the material that became the final commercial product was not “transformed by” the claimed process. By parsing the process in this way, the majority drew a distinction between quality control steps done using samples that are incorporated in the final product, which may fall within the purview of § 271(g), and quality control steps done using samples not incorporated into the final commercial product, which may be exempt from § 271(g).