Quality Control Testing of Drug is Not Patent Infringement

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Federal Circuit Review No. 76-1.
Quality Testing Of Drug Product Is Not Protected By Section 271(e)(1) Safe Harbor and is Not A Process for Making A Product Under Section 271(g)

Momenta Pharms., Inc. v. Teva Pharms. USA Inc., No. 2014- 1274, 2014-1277, 2014-1276, 2014-1278, 2015 U.S. App. LEXIS 19554 (Fed. Cir. Nov. 10, 2015) (Before Dyk, Moore, and Wallach, J.) (Opinion for the court, Wallach, J.). Click Here for a copy of the opinion.

In a November 10 ruling, the Federal Circuit held that routine quality control testing of each batch of a generic drug as part of the commercial production process, after FDA approval, is not protected by the Hatch-Waxman safe harbor provision of 35 U.S.C. § 271(e)(1).  However, infringement only occurs under 35 U.S.C. § 271(g), as a result of “making” a product, which does not include quality control testing.

Appellant Momenta was the first company to manufacture and sell a generic version of the anticoagulant enoxaparin, and it is also the assignee of the patent-in-suit, which is directed to a process used to ensure that each batch of generic enoxaparin meets certain quality control standards.  Appellee Teva sought to enter the enoxaparin generic market but not to manufacture enoxaparin, instead sourcing the product from Chemi S.p.A.  Chemi manufactures, analyzes, tests, packages, and labels Teva’s generic version of enoxaparin and would import it into the United States.  Appellee Amphastar is also a generic manufacturer of enoxaparin; however, Amphastar manufactures its enoxaparin product within the United States.

Momenta sued both parties for infringement of its quality control patent under §271(g), which can be read to cover activities in the U.S. and abroad, although it is traditionally applied to infringing activity abroad. Momenta also alleged that Amphastar’s activities in the U.S. infringed its patent under §271(a). The district court found that the accused quality control testing by both defendants was protected by the safe harbor provisions of 35 U.S.C. § 271(e)(1). It is not infringement for a party 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.”  The district court also found that the defendants’ U.S. sales could not constitute infringement under § 271(g), which prohibits selling “within the United States a product which is made by a process patented in the United States.” The patented process related to “quality control release testing” and was covered by § 271(g), because it was “not a method of making enoxaparin.”  Momenta appealed the judgments.

On appeal, the Federal Circuit affirmed the district court’s holdings that there could be no infringement under 35 U.S.C. § 271(g) and it vacated the summary judgment that potentially infringing activities fell within the § 271(e)(1) safe harbor provision.  The Court affirmed that the defendants’ enoxaparin products were not “made by” the process covered by the patent in suit, because the patented quality control testing was not a method of manufacture.  The Court took care to distinguish the process of making a final product from the various testing methods implemented before the final product has actually been “made.”

Addressing the § 271(e)(1) safe harbor provision, the Court held that defendants’ post-approval, commercial production process for quality control purposes was not shielded from infringement. Such activities relate to ongoing commercial production and sale of the patented product and are not solely directed to providing information to the FDA.  The Court remanded for further proceedings on infringement under §271(a) for Amphastar’s domestic use of the patented process.


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