Teva Pharms. United States, Inc. v. Sandoz, Inc.

Citation723 F.3d 1363
Decision Date18 October 2013
Docket Number2012–1570.,2012–1568,2012–1569,Nos. 2012–1567,s. 2012–1567
PartiesTEVA PHARMACEUTICALS USA, INC., Teva Pharmaceutical Industries, Ltd., Teva Neuroscience, Inc., and Yeda Research and Development Co., Ltd., Plaintiffs–Appellants, v. SANDOZ, INC., and Momenta Pharmaceuticals Inc., Defendants–Appellants, and Mylan Pharmaceuticals Inc., Mylan Inc., and Natco Pharma Ltd., Defendants–Appellants, and Sandoz International Gmbh, and Novartis AG, Defendants.
CourtUnited States Courts of Appeals. United States Court of Appeals for the Federal Circuit

OPINION TEXT STARTS HERE

Elizabeth J. Holland, Kenyon & Kenyon, LLP, of New York, NY, argued for plaintiffs-appellees. Of counsel on the brief were William G. James, II, of Washington, DC; David M. Hashmall, Goodwin Procter, LLP, of New York, NY; John C. Englander, Henry C. Dinger, Daryl L. Wiesen, John T. Bennett, and Nicholas K. Mitrokostas, of Boston, MA.

Deanne E. Maynard, Morrison & Foerster, LLP, of Washington, DC, argued for defendants-appellants, Sandoz Inc., et al. With her on the brief were Brian R. Matsui, and Marc A. Hearron; David C. Doyle, Anders T. Aannestad and Brian M. Kramer, of San Diego, CA.

Evan R. Chesler, Cravath Swaine & Moore LLP, of New York, NY, argued for defendants-appellants, Mylan Pharmaceuticals, Inc., et al. On the brief were Shannon M. Bloodworth and Brandon M. White, Perkins Coie, LLP, of Washington, DC; and David L. Anstaett and David E. Jones, of Madison, WI. Of counsel was John Singleton Skilton, Perkins Coie, LLP, of Madison, WI.

Before RADER, Chief Judge, MOORE, Circuit Judge, and BENSON, District Judge.**

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.

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 ( Mp), number average molecular weight ( Mn), and weight average molecular weight ( Mw). 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 Mp and Mn. In a typical polymer sample, Mp, Mn, 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 copolymer1 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 Mp, Mn, 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 ).

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,Mw, and Mn. 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 Mw and Mp 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 copolymer1 percentage above or below a certain average molecular weight.” Sandoz Reply Br. 17. Appellants contend that, because all of the claims recite “molecular weight,” they must be indefinite.

Teva counters that the prosecution history clarifies that “molecular weight” should be construed as Mp. It contends that its response to an indefiniteness rejection of the '539 patent claims unequivocally stated that a person of skill in the art reading the specification would understand that the term “molecular weight” refers to Mp. Teva argues that the district court correctly determined that its response during prosecution of the '847 patent, where it stated that [o]ne of ordinary skill in the art could understand that kilodalton units implies [sic] a weight average molecular weight,” was not contradictory. J.A. 3229. It contends that a skilled artisan would discount this statement because it does not explicitly define “molecular weight” as Mw and because it contains an evident scientific error—any molecular weight measurement, not just Mw, may be expressed in kilodalton units.

Teva also contends that the specification resolves any ambiguity in the meaning of “molecular weight.” Teva contends that the specification's reference to the Size Exclusion Chromatography (SEC) method indicates that “molecular weight” means Mp because determining Mn and Mw requires further calculations from SEC data that the specification does not describe. It further argues that Figure 1 confirms this conclusion because only Mp can be obtained directly from the molecular weight plot in that figure.

Finally, Teva contends that Group II claims refer to exact molecular weight values and are therefore not ambiguous. It argues that Group II claims recite percentages of molecules in a copolymer–1 sample that fall within a specified molecular weight range, not average values.

We agree with Appellants that Group I claims are indefinite and agree with Teva that Group II claims are not. It is undisputed that Group I claims contain an ambiguity because their plain language does not indicate which average molecular weight measure is intended. Teva's attempt to resolve this...

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