Federal Circuit Interprets Two Important Infringement Provisions

In a single decision issued for companion cases Momenta Pharmaceuticals, Inc. v. Teva Pharmaceuticals USA Inc. and Momenta Pharmaceuticals, Inc. v Amphastar Pharmaceuticals, Inc., the Federal Circuit interpreted two important sections of the infringement statute, 35 USC § 271. In one portion of its decision, the court adopted a literal interpretation of § 271(g), holding that the statute only applies if the accused product was synthesized by a patented process. In another portion of its decision, the court decided that the post-manufacture testing at issue constituted "routine" post-approval activities that were not protected by the safe harbor of § 271(e)(1). In so doing, the court backpedaled from its 2012 decision in Momenta Pharmaceuticals, Inc. v. Amphastar Pharmaceuticals, Inc., where it held that Amphastar's activities were "anything but routine."

The Patent At Issue

The patent at issue was Momenta's U.S. Patent 7,575,886, which is discussed in more detail in this article on the court's first decision in Momenta v. Amphastar. According to the recent Federal Circuit decision, Momenta asserts its "method is used ... to select and separate batches of intermediate drug substance that conform to [United States Pharmacopoeial Convention] requirements for enoxaparin from batches that do not," and that selected batches are then "further process[ed]."

The accused products are generic versions of Lovenox® (enoxaparin), an anticoagulant used to prevent blood clots.

The Federal Circuit opinion was authored by Judge Wallach and joined by Judge Moore. Judge Dyk concurred-in-part and dissented-in-part.

"Made By" Under § 271(g)

Momenta asserted infringement under § 271(g), which provides in pertinent part:

Whoever without authority imports into the United States or offers to sell, sells, or uses within the United States a product which is made by a process patented in the United States shall be liable as an infringer, if the importation, offer to sell, sale, or use of the product occurs during the term of such process patent.

The district court found no violation of § 271(g), based on its determination that the '866 patent related to "quality control release testing" and was "not a method of making enoxaparin" as the statute required.

On appeal, Momenta argued that the "made by" language of the statute encompasses the entire manufacturing process, and "that its patented method is 'a crucial interim step used directly in the manufacture of [Teva's]...