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Momenta Pharms., Inc. v. Teva Pharms. USA Inc.

United States Court of Appeals, Federal Circuit

November 10, 2015


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[Copyrighted Material Omitted]

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Appeals from the United States District Court for the District of Massachusetts in Nos. 1:10-cv-12079-NMG, 1:11-cv-11681-NMG, Judge Nathaniel M. Gorton.

DEANNE MAYNARD, Morrison & Foerster LLP, Washington, DC, argued for plaintiffs-appellants. Also represented by BRIAN ROBERT MATSUI, MARC A. HEARRON. Plaintiff-appellant Momenta Pharmaceuticals, Inc. also represented by ROBERT S. FRANK, JR., DANIEL C. WINSTON, Choate, Hall & Stewart LLP, Boston, MA. Plaintiff-appellant Sandoz Inc. also represented by THOMAS P. STEINDLER, McDermott, Will & Emery LLP, Washington, DC.

HENRY C. DINGER, Goodwin Procter LLP, Boston, MA argued for defendant-appellee Teva Pharmaceuticals USA Inc. Also represented by JAMES C. REHNQUIST, EMILY L. RAPALINO, ELAINE BLAIS, ROBERT FREDERICKSON, III; DAVID M. HASHMALL, JOSHUA AARON WHITEHILL, New York, NY.

PRATIK A. SHAH, Akin, Gump, Strauss, Hauer & Feld, LLP, Washington, DC, argued for defendants-appellees Amphastar Pharmaceuticals, Inc., et al. Also represented by EMILY CURTIS JOHNSON, ANTHONY TOBIAS PIERCE, JAMES EDWARD TYSSE.

MARK R. FREEMAN, Appellate Staff, Civil Division, United States Department of Justice, Washington, DC, for amicus curiae United States. Also represented by CAROLINE D. LOPEZ, BENJAMIN C. MIZER; DAVID J. HOROWITZ, ELIZABETH H. DICKINSON, ANNAMARIE KEMPIC, WENDY VICENTE, Office of the General Counsel, Food and Drug Division, United States Department of Health and Human Services, Silver Spring, MD; THOMAS W. KRAUSE, SCOTT C. WEIDENFELLER, FARHEENA YASMEEN RASHEED, WILLIAM LAMARCA, Office of the Solicitor, United States Patent and Trademark Office, Alexandria, VA.

Before DYK, MOORE, and WALLACH, Circuit Judges.


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[116 U.S.P.Q.2d 1962] Wallach, Circuit Judge.

Plaintiffs-appellants Momenta Pharmaceuticals, Inc. and Sandoz Inc. (collectively, " Momenta" ) appeal the district court's decision finding Teva Pharmaceuticals USA Inc. (" Teva" ) does not infringe U.S. Patent No. 7,575,886 (" the '886 patent" ). In a companion case, Momenta appeals the district court's decision finding Amphastar Pharmaceuticals, Inc., International Medication Systems, Ltd., Actavis, Inc., and Actavis Pharma, Inc. (collectively, " Amphastar" ) do not infringe the '886 patent.

For the reasons set forth below, this court affirms the district court's holdings that neither Teva nor Amphastar infringes under 35 U.S.C. § 271(g) (2012). However, this court vacates the district court's grant of summary judgment in favor of Amphastar to the extent it was based on the erroneous determination that Amphastar's activities fall within the § 271(e)(1) safe harbor and therefore do not infringe under 35 U.S.C. § 271(a). We accordingly remand as to Amphastar for further proceedings consistent with this opinion.


Enoxaparin is an anticoagulant that helps to prevent blood clots that was first approved for marketing in the United States in 1993 under the trade name Lovenox. In 2010, Momenta became the first company to market a generic version of enoxaparin. Momenta is also the assignee of the '886 patent, which is directed to a process used to ensure each batch of generic

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enoxaparin meets certain quality standards.

Teva, another generic manufacturer, sought to enter the enoxaparin market. It does not manufacture enoxaparin itself, but sources the product from Chemi S.p.A., an Italian company that manufactures, analyzes, tests, packages, and labels Teva's generic version of enoxaparin, which Teva then imports into the United States. Momenta sued Teva for infringement of the '886 patent on the grounds it intended to market in the United States an enoxaparin product that was manufactured using a process covered by the '886 patent.

The district court found Teva's conduct did not infringe because it fell within the safe harbor from infringement provided by 35 U.S.C. § 271(e)(1), which states 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, [116 U.S.P.Q.2d 1963] or sale of drugs." 35 U.S.C. § 271(e)(1).[1] The district court also rejected Momenta's contention that Teva's sales in the United States 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." Id. § 271(g) (emphasis added). The district court reasoned that the patented process related to " quality control release testing" and was " not a method of making enoxaparin." J.A. (-1274, -1277) 7.

Amphastar is also a generic manufacturer of enoxaparin. Unlike Teva, however, Amphastar manufactures its enoxaparin product within the United States. Momenta asserts the district court erred in granting summary judgment of non-infringement of the '886 patent in favor of Amphastar. According to Momenta, Amphastar's use of the patented method in the United States as part of the manufacture of enoxaparin infringes the '886 patent, and this infringement does not fall within the safe harbor of 35 U.S.C. § 271(e)(1). It further argues Amphastar's sale of enoxaparin in the United States infringes under 35 U.S.C. § 271(g).

In a prior appeal by Amphastar at the preliminary injunction phase, this court held that it was " unlikely that Momenta will succeed on the merits of its infringement claim." Momenta Pharms., Inc. v. Amphastar Pharms., Inc. ( Momenta I ), 686 F.3d 1348, 1361 (Fed. Cir. 2012). On remand from Momenta I, the district court found " [Amphastar's] activities are . . . protected by the safe harbor" of § 271(e)(1), which decision forms the basis of the present appeal. J.A. (-1276, -1278) 9.

Momenta appeals the district court's grants of summary judgment in favor of Teva and Amphastar. This court has jurisdiction under 28 U.S.C. § 1295(a) (2012).[2]


I. Standard of Review

This court reviews summary judgment decisions under the law of the regional circuit. MicroStrategy Inc. v. Bus.

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Objects, S.A., 429 F.3d 1344, 1349 (Fed. Cir. 2005). The First Circuit reviews such decisions de novo. Adamson v. Walgreens Co., 750 F.3d 73, 78 (1st Cir. 2014).

II. Teva's and Amphastar's Enoxaparin Products Are Not " Made By" Momenta's Patented Process [3]

Section 271(g) prohibits the unauthorized importation into the United States, or sale or use within the United States, of a " product which is made by a process patented in the United States." 35 U.S.C. § 271(g) (emphasis added). A key issue on appeal is therefore whether Teva's and Amphastar's enoxaparin products are " made by" Momenta's patented process within the meaning of § 271(g). We conclude they are not.

Momenta argues that " made" means " manufactured," and that its patented method is " a crucial interim step used directly in the manufacture of [Teva's] product[s]." Appellants' Br. (-1274, -1277) 59 (internal quotation marks and citation omitted); see also Appellants' [116 U.S.P.Q.2d 1964] Br. (-1276, -1278) 54 (" Amphastar uses Momenta's method as an intermediate step in the multi-step process of manufacturing its drug." ). Specifically, Momenta asserts its " method is used [by Teva] 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]." Appellants' Br. (-1274, -1277) 59, 62; see also Appellants' Br. (-1276, -1278) 54 (" Amphastar uses Momenta's method . . . to select the individual batches of interim enoxaparin preparation it will further process into final drug product." ). Momenta also notes " [t]he [U.S. Food and Drug Administration's ('FDA')] Good Manufacturing Practice ['GMP'] regulations define '[m]anufacture' and 'processing' of drug products as including 'testing[] and quality control of drug products.'" Appellants' Br. (-1274, -1277) 59 (quoting 21 C.F.R. § 210.3(b)(12)); see also Appellants' Br. (-1276, -1278) 54.

Although Momenta's arguments are not without merit, it is more consonant with the language of the statute, as well as with this court's precedent, to limit § 271(g) to the actual " ma[king]" of a product, rather than extend its reach to methods of testing a final product or intermediate substance to ensure that the intended product or substance has in fact been made. See 35 U.S.C. § 271(g) (" made by" ). " In patent law, as in all statutory construction, [u]nless otherwise defined, words will be interpreted as taking their ordinary, contemporary, common meaning." Bilski v. Kappos, 561 U.S. 593, 603, 130 S.Ct. 3218, 177 L.Ed.2d 792 (2010) (alteration in original) (internal quotation marks and citations omitted). Dictionaries define the verb forms of " make" to involve ...

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