Momenta Pharma., Inc. v. Teva Pharma. USA Inc.

In Momenta Pharma., Inc. v. Teva Pharma. USA Inc., Nos. 2014-1274, -1277, -1276, and -1278 (Fed. Cir. Nov. 10, 2015) ("Momenta II"), the Federal Circuit found that, pursuant to 35 U.S.C. § 271(g), "made" is limited to steps directly related to manufacturing products and excludes isolated quality control steps. The court also revisited its prior ruling in Momenta Pharma., Inc. v. Amphastar Pharms., Inc., 686 F.3d 1348 (Fed. Cir. 2012) ("Momenta I"), and based on the fuller record, decided that post-approval quality control batch testing does not fall within the 35 U.S.C. § 271(e)(1) safe harbor.

This appeal arose from ANDA litigation involving generic versions of Lovenox® (enoxaparin), which is prescribed to prevent blood clots. Momenta I, 686 F.3d at 1349. Enoxaparin is a low molecular weight version of heparin and is produced by breaking the heparin polysaccharide into smaller oligosaccharide fragments. Id. at 1349-50. Unlike traditional small molecule pharmaceuticals, such as penicillin, enoxaparin is not a single molecule but rather a combination of several different molecules. Id. at 1350. This molecular diversity presents an issue for ANDA filers - how to establish bioequivalence to Lovenox®? Id. To address this issue, the FDA identified five "standards for identity" that provide enough information to conclude that a generic enoxaparin is the "same" as Lovenox®. Id. Pursuant to these standards, the FDA required "equivalence in disaccharide building blocks, fragment mapping, and sequence of oligosaccharide species," and suggested that disaccharide identity could be determined via standard experimental techniques. Id. at 1350-51.

Momenta Pharmaceuticals and Sandoz, Inc., collaborated to bring the first generic enoxaparin to market. Momenta II, slip op. at 4. Momenta is also the assignee of U.S. 7,575,886 (the 886 patent), which relates to "methods and products associated with analyzing and monitoring heterogeneous populations of sulfated polysaccharides," such as enoxaparin. Id.; the 886 patent at Abstract. Claim 6 is representative:

A method for analyzing an enoxaparin sample for the presence or amount of a non naturally occurring sugar associated with peak 9 of FIG. 1 that results from a method of making enoxaparin that included β-eliminative cleavage with a benzyl ester and depolymerization, comprising: providing an enoxaparin sample that has been exhaustively digested with two or more heparin degrading enzymes;

using a separation...