Momenta Pharmaceuticals, Inc. et al. v. Teva Pharmaceuticals USA Inc. / Momenta Pharmaceuticals, Inc. et al. v. Amphastar Pharmaceuticals, Inc.


Docket Nos. 2014-1274, 2014-1277, 2014-1276, 2014-1278

DYK(D), MOORE, WALLACH
November 10, 2015

Brief Summary: Both of Teva’s and Amphastar’s products were therefore found not to be “‘made by’ Momenta’s patented process for the purposes of § 271(g).” However, Amphastar’s activities were found to be routine, not “reasonably related to obtaining FDA approval”, “related to ongoing commercial manufacture and sale”, and not protected by § 271(e)(1).

Summary: Momenta and Sandoz appealed DC decisions that neither Teva nor Amphastar infringe US 7,575,886 relating to a process for ensuring “each batch of generic enoxaparin [Lovenox] meets certain quality standards” (“All of the asserted claims…are directed to ‘[a] method for analyzing an enoxaparin sample.”) As summarized below, the FC panel affirmed that neither party infringes under § 271(g) (2012) (“made by a process patented in the United States”), but vacated the DC grant of SJ to Amphastar because it erroneously concluded its “activities fall with the § 271(e) safe harbor and therefore do not infringe under 35 U.S.C. § 271(a).” Regarding § 271(e)(1) / § 271(g), the DC “reasoned that the patented process related to ‘quality control release testing’ and was ‘not a method of making enoxaparin”. The FC panel concluded § 271(g) is “limit[ed]…to the actual ‘ma[king]’ of a product” and does not extend “to methods of testing a final product or intermediate substance to ensure that the intended product or substance has in fact been made” (Bayer, FC 2003) (“the patented process [was] not used in the actual synthesis of the drug product”). Here, the FC panel wrote, “[n]o assertion is made…that the enoxaparin samples on which tests are performed are themselves incorporated into the finished product or imported into the United States, nor do the tests create or give new properties to the enoxaparin substaince in batches that are selected for further processing” (“not ‘made by’ a patented process within § 271(g) if it is used merely to determine whether the intended product of a separate and perhaps separately-patented process has in fact already been manufactured”). Both of Teva’s and Amphastar’s products were therefore found not to be “‘made by’ Momenta’s patented process for the purposes of § 271(g).” The DC grant of SJ to Teva was therefore affirmed as its manufacturing takes place outside of the US. Momenta argued the DC incorrectly granted SJ to Amphastar because its manufacturing in the US infringes under § 271(a) and is not protected by the § 271(e)(1) safe harbor. The FC panel explained that while § 271(e)(1) is “sufficiently broad’ to ‘leave[] adequate space for experimentation and failure on the road to regulatory approval” and may include “promot[ional]” activities if those are “consistent with the collection of data necessary for filing an application with the [FDA]…for approval” (AbTox, FC 1997), it “does not apply to information that may be routinely reported to the FDA, long after marketing approval has been obtained” (Classen, FC 2011). The opinion explained 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”. And Amphastar’s activities were found to be routine, not “reasonably related to obtaining FDA approval”, “related to ongoing commercial manufacture and sale”, and not protected by § 271(e)(1). The grant of SJ to Amphastar was therefore vacated. Judge Dyk’s dissent in part argued the decision with respect to Teva was incorrect (“Quality control, according to the majority, is not used to ‘make’ a product. This seems to me too limited a construction of § 271(g).”)

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