Teva Pharmaceuticals USA, Inc. v. Sandoz, Inc.

723 F.3d 1363, 107 U.S.P.Q. 2d (BNA) 1655, 2013 WL 3836240, 2013 U.S. App. LEXIS 15208
CourtCourt of Appeals for the Federal Circuit
DecidedJuly 26, 2013
Docket2012-1567, 2012-1568, 2012-1569, 2012-1570
StatusPublished
Cited by12 cases

This text of 723 F.3d 1363 (Teva Pharmaceuticals USA, Inc. v. Sandoz, Inc.) is published on Counsel Stack Legal Research, covering Court of Appeals for the Federal Circuit primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Teva Pharmaceuticals USA, Inc. v. Sandoz, Inc., 723 F.3d 1363, 107 U.S.P.Q. 2d (BNA) 1655, 2013 WL 3836240, 2013 U.S. App. LEXIS 15208 (Fed. Cir. 2013).

Opinion

MOORE, Circuit Judge.

The defendants in these consolidated patent infringement actions (collectively, Appellants) appeal from the district court’s judgment that various claims of the nine patents-in-suit asserted by the plaintiffs (collectively, Teva) are infringed, and from the court’s holdings regarding indefiniteness, nonenablement, and obviousness. 1 We hold that Group I claims are invalid for indefiniteness, but that Group II claims have not been proven indefinite. 2 We also hold that the district court did not err in its conclusions that the claims are infringed, and that the Appellants failed to prove that the claims would have been obvious and are not enabled. Accordingly, we affirm the district court’s judgments of infringement and no invalidity with respect to Group II claims, reverse its judgment of no invalidity with respect to Group I claims, and remand.

*1367 Background

Appellants submitted Abbreviated New Drug Applications (ANDAs) to the Food and Drug Administration (FDA) seeking approval to market generic versions of Copaxone®, a drug used in treating multiple sclerosis. Two proposed generic products, the Mylan accused product and the Sandoz accused product, are at issue in this appeal. Teva, which markets Copaxone®, sued Appellants for patent infringement under 35 U.S.C. § 271(e)(2)(A). The patents-in-suit, which share a common specification, are listed in the Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) entry for Copaxone®. The patents-in-suit include claims reciting a product called copolymer-1 and claims reciting methods of making copolymer-1.

Copolymer-1 consists of four different amino acids (alanine, glutamic acid, lysine, and tyrosine) combined in a certain ratio to make a polypeptide product. A sample of polymeric material like copolymer-1 typically consists of a mixture of individual polymer molecules that have varying molecular weights. There are different ways to describe the resulting distribution of molecular weight values. One approach uses statistical measures, including the peak average molecular weight (M p), number average molecular weight (Mn), and weight average molecular weight (Iw). Mp is the molecular weight of the most abundant molecule in the sample. Mn is the arithmetic mean, or the total mass of all the molecules in the sample divided by the total number of molecules. Mw is still another average molecular weight measure that is calculated differently from M p and M n. In a typical polymer sample, M p, M n, and Mw have different values.

A second approach describes how many molecules in a polymer sample have molecular weights that fall within an arbitrarily set range. For example, if 99% of the constituent molecules in a sample have molecular weights between 1 kilodalton (kDa) and 100 kDa, the sample may be described as having 99% of its mole fraction within the molecular weight range of 1 kDa to 100 kDa.

The claims of the patents-in-suit use both approaches. Claim 1 of the '589 patent is representative of Group I claims, which use the first approach:

Copolymer-1 having a molecular weight of about 5 to 9 kilodaltons, made by a process comprising the steps of: reacting protected copolymer-1 ...; and
purifying said copolymer-1, to result in eopolymerl having a molecular weight of about 5 to 9 kilodaltons.

'589 patent claim 1 (emphases added). Claim 1 of the '430 patent is representative of Group II claims, which use the second approach: “Copolymer-1 having over 75% of its mole fraction within the molecular weight range from about 2 kDa to about 20 kDa....” '430 patent claim 1 (emphasis added).

In its claim construction order, the district court did not distinguish in detail between the different contexts in which the term “molecular weight” is used in Group I and Group II claims. The court rejected the Appellants’ argument that the term “molecular weight” was insolubly ambiguous because it could refer to M p, M n, Mw, or yet another average molecular weight measure. Teva Pharms. USA, Inc. v. Sandoz, Inc., 810 F.Supp.2d 578, 586-93, 596 (S.D.N.Y.2011) (Markman Order). It construed “molecular weight” as Mp and held that the claims are not indefinite. Id. After a bench trial, the court held that the asserted claims are not invalid for obviousness or lack of enablement, and that the Mylan and Sandoz accused products infringe all of the asserted claims. Teva Pharms. USA, Inc. v. Sandoz, Inc., 876 F.Supp.2d 295 (S.D.N.Y.2012) (Opinion).

*1368 This appeal followed. We have jurisdiction under 28 U.S.C. § 1295(a)(1).

Discussion

I. Definiteness

A patent’s specification “must conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor ... regards as the invention.” 35 U.S.C. § 112(b) (2012). “A claim is indefinite only when it is not amenable to construction or insolubly ambiguous.” Biosig Instruments, Inc. v. Nautilus, Inc., 715 F.3d 891, 898 (Fed.Cir.2013). To prove indefiniteness, “an accused infringer must demonstrate by clear and convincing evidence that one skilled in the relevant art could not discern the boundaries of the claim based on the claim language, the specification, the prosecution history, and the knowledge in the relevant art.” Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1366 (Fed.Cir.2011). Indefiniteness is a question of law that we review de novo. Id. at 1365-66.

Appellants argue that the term “molecular weight” renders all of the asserted claims indefinite because it can refer to different measures, including Mp> M w, and M n. They contend that the scope of the claims varies significantly depending on the measure and that a skilled artisan cannot ascertain the boundaries of the claims. Appellants argue that Teva inconsistently defined “molecular weight” as M w and M p during prosecution of two of the familial patents, reinforcing the ambiguity. Further, Appellants contend that the specification does not resolve which molecular weight measure is intended.

Appellants also contend that their indefiniteness arguments apply equally to Group I and Group II claims. They argue that even Group II claims, which refer to a molecular weight range, “necessarily refer to a copolymerl percentage above or below a certain average molecular weight.” San-doz Reply Br. 17.

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723 F.3d 1363, 107 U.S.P.Q. 2d (BNA) 1655, 2013 WL 3836240, 2013 U.S. App. LEXIS 15208, Counsel Stack Legal Research, https://law.counselstack.com/opinion/teva-pharmaceuticals-usa-inc-v-sandoz-inc-cafc-2013.