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

United States Court of Appeals, Federal Circuit

June 18, 2015

TEVA PHARMACEUTICALS USA, INC., TEVA PHARMACEUTICAL INDUSTRIES, LTD., TEVA NEUROSCIENCE, INC., YEDA RESEARCH AND DEVELOPMENT CO., LTD., Plaintiffs-Appellees
v.
SANDOZ, INC., MOMENTA PHARMACEUTICALS INC., Defendants-Appellants, MYLAN PHARMACEUTICALS INC., MYLAN INC., NATCO PHARMA LTD., Defendants-Appellants, SANDOZ INTERNATIONAL GMBH, NOVARTIS AG, Defendants

Page 1336

Appeals from the United States District Court for the Southern District of New York in Nos. 08-CV-7611, 09-CV-8824, Judge Barbara S. Jones.

ELIZABETH HOLLAND, Goodwin Procter LLP, New York, NY, for plaintiffs-appellees. Also represented by DAVID M. HASHMALL; JOHN T. BENNETT, HENRY C. DINGER, JOHN C. ENGLANDER, NICHOLAS K. MITROKOSTAS, DARYL L. WIESEN, Boston, MA; WILLIAM G. JAMES, II, WILLIAM M. JAY, Washington, DC.

DEANNE MAYNARD, Morrison & Foerster LLP, Washington, DC, for defendants-appellants Sandoz, Inc., Momenta Pharmaceuticals Inc. Also represented by MARC A. HEARRON, BRIAN ROBERT MATSUI; ANDERS T. AANNESTAD, DAVID CLARENCE DOYLE, BRIAN M. KRAMER, San Diego, CA.

SHANNON BLOODWORTH, Perkins Coie, LLP, Washington, DC, for defendants-appellants Mylan Pharmaceuticals Inc., Mylan Inc., Natco Pharma Ltd. Also represented by BRANDON MICHAEL WHITE; DAVID LEE ANSTAETT, DAVID E. JONES, Madison, WI; EVAN CHESLER, Cravath Swaine & Moore LLP, New York, NY.

Before MOORE, MAYER, and WALLACH, Circuit Judges.[1] OPINION filed by Circuit Judge MOORE. Dissenting opinion filed by Circuit Judge MAYER.

OPINION

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Moore, Circuit Judge.

This case comes to us on remand from the Supreme Court, which vacated our earlier opinion reversing the district court's judgment that certain claims were not indefinite (Group I claims), and affirming the district court's holdings that other claims (Group II claims) were valid and infringed.[2] Teva Pharms. USA, Inc. v. Sandoz, Inc., 723 F.3d 1363 (Fed. Cir. 2013), vacated, Teva Pharms. USA, Inc. v. Sandoz, Inc., 135 S.Ct. 831, 190 L.Ed.2d 719 (2015). Relevant to the Group I claims, the Supreme Court held that the ultimate construction of a claim term is a question of law, subject to de novo review, and that underlying subsidiary fact findings are subject to clear error review. Teva, 135 S.Ct. at 837-38, 841-42. During that same time, the Supreme Court issued its opinion in Nautilus, Inc. v. Biosig Instruments, Inc. ( Nautilus II ), 134 S.Ct. 2120, 189 L.Ed.2d 37

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(2014), addressing the standard for indefiniteness. On remand, the parties submitted supplemental briefing explaining how the appeal should be resolved in light of the Supreme Court's Teva decision. See Teva Pharms. USA, Inc. v. Sandoz, Inc., No. 12-1567, (Fed. Cir. Feb. 20, 2015), ECF No. 137. Applying the legal standards set forth in the Supreme Court's Teva and Nautilus II decisions, we hold that the Group I claims are invalid for indefiniteness.[3]

Background

The facts of this case were recited in this court's previous opinion. In summary, Appellants submitted Abbreviated New Drug Applications (ANDAs) to the Food and Drug Administration (FDA) seeking approval to market generic versions of Copaxone$=P. Teva, which markets Copaxone(R), sued Appellants for patent infringement under 35 U.S.C. § 271(e)(2)(A). Claim 1 of the '808 patent recites a method of making a product called copolymer-1:

A method of manufacturing copolymer-1, comprising reacting protected copolymer-1 with hydrobromic acid to form trifluoroacetyl copolymer-1, treating said trifluoroacetyl copolymer-1 with aqueous piperidine solution to form copolymer-1, and purifying said copolymer-1, to result in copolymer-1 having a molecular weight of about 5 to 9 kilodaltons.

'808 patent claim 1 (emphases added).

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 three different measures of molecular weight relevant to this appeal: peak average molecular weight ( M p), number average molecular weight ( M n), and weight average molecular weight ( M w). Each measure is calculated in a different manner. The claim does not specify which measure to use and in a typical polymer sample, M p, M n, and M w have different values.

The district court rejected the Appellants' argument that the term " molecular weight" was indefinite. Teva Pharms. USA, Inc. v. Sandoz, Inc. ( Markman Order ), 810 F.Supp.2d 578, 586-93, 596 (S.D.N.Y. 2011). The district court found credible Dr. Grant's testimony that M p is the only type of average molecular weight that can be directly obtained from a chromatogram and calibration curve obtained by the analytical method described in Example 1 (Size Exclusion Chromatography or SEC). Id. at 588, 590. It noted that experts testified that M n and M w can be obtained from the chromatogram and calibration curve, but doing so would require additional data manipulation and calculations not disclosed in the specification. Id. It therefore credited Dr. Grant's opinion that Example 1 implies the use of M p. Id. The district court also found that Example 1 corresponds to Figure 1 in the patent specification. Id. at 588. It considered Appellants' argument that Figure 1 does not disclose M p because the peaks of the depicted curves do not match the molecular weight values reported in the legend. Id. at 590. The district court, however, accepted Dr. Grant's opinion that a person of ordinary skill would understand that the process of transferring data from a chromatogram

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could cause a shift in the peak of the curves. Id. It therefore concluded that the fact that the peaks do not match the listed molecular weights does not dissuade the conclusion that " molecular weight" means M p. Id. at 590-91. The district court determined that " the prosecution history also indicates [average molecular weight] refers to M p in the context of the patents-in-suit." Id. at 589. It rejected as irrelevant the patentee's response to an indefiniteness rejection during the prosecution of the '847 patent that " [o]ne of ordinary skill in the art could understand that kilodalton unit implies a weight average molecular weight." Id. at 591-92. It did so on the basis that the " statement was incorrect" because each type of average molecular weight can use the kilodalton. Id. at 592. It then concluded that one of ordinary skill would accept the patentee's statement during the prosecution of the '539 patent that average molecular weight means M p. Id. Having considered the claims, specification, prosecution history and extrinsic evidence, the district court determined that " molecular weight" means M p in the context of the claimed invention and held that the claims are not indefinite. Id.

We reversed the district court's judgment with respect to the Group I claims, holding them indefinite. Teva, 723 F.3d at 1368-69. Teva filed a petition for a writ of certiorari, arguing to the Supreme Court that in holding the claims indefinite, we erred by giving no weight to the district court fact findings. Pet. for Writ of Cert., Teva Pharms. USA, Inc. v. Sandoz, Inc., No. 13-854, 2014 WL 230926, at *13-14 (2014). Teva argued that this court's determinations in Cybor Corp. v. FAS Techs., Inc., 138 F.3d 1448 (Fed. Cir. 1998) (en banc) and Lighting Ballast Control LLC v. Philips Elecs. North America Corp., 744 F.3d 1272 (Fed. Cir. 2014) (en banc) that we review all aspects of claim construction de novo was incorrect and inconsistent with Fed.R.Civ.P. 52(a)(6). Brief for the Petitioner at 18, Teva Pharms. USA, Inc. v. Sandoz, Inc., No. 13-854 (2014). It argued that under Fed.R.Civ.P. 52(a)(6), we should only set aside a district court fact finding if such finding is clearly erroneous. The Supreme Court agreed.

The Supreme Court held that " it was proper to treat the ultimate question of the proper construction of the patent as a question of law in the way that we treat document construction as a question of law." Teva, 135 S.Ct. at 837. The reviewing court, however, should review subsidiary factual findings under the clearly erroneous standard. Id. at 838. The Court explained that " when the district court reviews only evidence intrinsic to the patent (the patent claims and specifications, along with the patent's prosecution history), the judge's determination will amount solely to a determination of law" which will be reviewed de novo. Id. at 841. If a district court needs to consult extrinsic evidence, for example, to understand the meaning of a term in the relevant art at the relevant time, the court may need to make subsidiary factual findings about that extrinsic evidence. Id. The Court explained that

if a district court resolves a dispute between experts and makes a factual finding that, in general, a certain term of art had a particular meaning to a person of ordinary skill in the art at the time of the invention, the district court must then conduct a legal analysis: whether a skilled artisan would ascribe that ...

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