Teva's Imported Generic Enoxaparin Products Manufactured Using Particular Quality Control Process Are Not "Made By" Patented Process Under 35 U.S.C. § 271(g)

In Momenta Pharmaceuticals, Inc. v. Teva Pharmaceuticals USA Inc., Nos. 14-1274, 14-1277 (Fed. Cir. Nov. 10, 2015), a divided Federal Circuit affirmed a district court’s summary judgment determination that Teva’s importation of generic versions of enoxaparin, which are manufactured outside the U.S. by particular processes directed to ensuring product batches meet certain quality requirements, did not infringe Momenta’s method patent claims under 35 U.S.C. § 271(g).

Momenta argued that “made” under § 271(g) means “manufactured,” and that its patented method is an important interim step used in manufacturing Teva’s generic products and is used by Teva to select and separate batches of intermediate drug substance that conform to certain quality requirements. The Federal Circuit explained, however, that the issue of whether Teva infringed Momenta’s patent claims under § 271(g) is limited to Teva’s “actual ‘ma[king]’ of” its particular enoxaparin product and does not extend to Teva’s particular “methods of testing a final product or intermediate substance to ensure that the intended product or substance has in fact been made.” The Court further stated that the issue of whether Teva “made” its particular product within the meaning of Momenta’s patent claims extends to “the creation or transformation of a product, such as by synthesizing, combining components, or giving raw materials new properties,” but does not extend to Teva’s testing to determine whether Teva’s already-synthesized drug substance possesses existing qualities or properties. Because the Court found that Momenta’s patented process is directed to analyzing existing product qualities of batch samples, which are not themselves incorporated into the finished product, and because the tests do not create or give new properties to the enoxaparin substance, the Court concluded that Teva’s generic products are not “made by” Momenta’s patented process under § 271(g).

In the related appeal involving the same patent but against Amphaster Pharmaceuticals, Inc., the Court remanded the district court’s determination that Amphastar’s domestic manufacture of generic versions of enoxaparin fell within the § 271(e)(2) safe harbor and therefore did not infringe Momenta’s patented process under § 271(a). The Federal Circuit held that the safe harbor provision in § 271(e)(1) did not shield Amphastar’s activities. Specifically, the Court stated that “[t]he routine quality control testing of each batch of generic enoxaparin as part of the post-approval, commercial production process is . . . not ‘reasonably related to the development and submission of information’ to the FDA,” but instead relates to post-approval activities not protected by the safe harbor. Accordingly, as to Amphastar, the Court remanded the case to the district court for further proceedings.

Judge Dyk concurred with the majority’s opinion that § 271(e)(1) did not immunize Amphastar but dissented as to the majority’s holding that Teva did not infringe under § 271(g). First, Judge Dyk explained that Momenta’s process is used to determine which batches of enoxaparin must be discarded and which may be incorporated in the final drug product and thus is “distinctly part of the manufacturing process.” Second, Judge Dyk stated that the majority’s limited interpretation of Teva’s activities under § 271(g) could lead to the anomalous result of patents on purification methods or other quality control testing integral to the regulatory and commercial viability of products being freely infringed simply by outsourcing those processes abroad.