TEVA Pharms. USA, Inc. v. Sandoz Inc.

• Decision Date: 29 August 2011
• Docket Number: 09 Civ. 8824 (BSJ) (AJP).,Nos. 08 Civ. 7611 (BSJ) (AJP),s. 08 Civ. 7611 (BSJ) (AJP)
• Parties: TEVA PHARMACEUTICALS USA, INC., et al., Plaintiffs, v. SANDOZ INC., et al., Defendants.Teva Pharmaceuticals USA, Inc., et al., Plaintiffs, v. Mylan Pharmaceuticals Inc., et al., Defendants.
• Court: U.S. District Court — Southern District of New York

2011 Markman 4001076

810 F.Supp.2d 578

TEVA PHARMACEUTICALS USA, INC., et al., Plaintiffs,

v.SANDOZ INC., et al., Defendants.Teva Pharmaceuticals USA, Inc., et al., Plaintiffs,

v.Mylan Pharmaceuticals Inc., et al., Defendants.

Nos. 08 Civ. 7611 (BSJ) (AJP)

09 Civ. 8824 (BSJ) (AJP).

United States District Court, S.D. New York.

Aug. 29, 2011.

David M. Hashmall, Jeffrey A. Simes, Jonathan Aaron Auerbach, Joseph B. Crystal, Goodwin Procter, LLP, Elizabeth J. Holland, Miriam London Martinez, Steven Jeffrey Lee, Carolyn Anne Blessing, Patrice Polyxene Jean, Kenyon & Kenyon, New York, NY, Daryl L. Wiesen, John T. Bennett, Nicholas K. Mitrokostas, Goodwin Procter, LLP, Boston, MA, William G. James, II, Kenyon & Kenyon LLP, Washington, DC, for Plaintiffs.

Anders T. Aannestad, Brian Matthew Kramer, David C. Doyle, Morrison & Foerster LLP, San Diego, CA, Karen Louise Hagberg, Richard B. Mills-Robertson, Morrison & Foerster LLP, Andrew Levine, Friedman Kaplan Seiler & Adelman LLP, Beth D. Jacob, Schiff Hardin LLP, New York, NY, David L. Anstaett, Sarah C. Walkenhorst, Perkins Coie, L.L.P., Madison, WI, Ricardo Solano, Jr., Friedman Kaplan Seiler & Adelman LLP, Newark, NJ, for Defendants.

Memorandum and Order

BARBARA S. JONES, District Judge.

Plaintiffs Teva Pharmaceuticals USA, Inc., Teva Pharmaceutical Industries Ltd., Teva Neuroscience, Inc., and Yeda Research and Development Co. Ltd. (collectively, “Teva”) filed suit for patent infringement and declaratory judgment against Defendants Sandoz Inc., Sandoz International GmbH, Novartis AG, and Momenta Pharmaceuticals, Inc. (collectively, “Sandoz”).¹ Teva subsequently filed suit for patent infringement and declaratory judgment, with respect to the same patents, against Defendants Mylan Pharmaceuticals Inc., Mylan Inc., and Natco Pharma Ltd. (collectively, “Mylan”) (collectively with Sandoz, “Defendants”). The two actions are now consolidated.

The issue before the Court is the proper construction of the nine patents-in-suit.² The nine patents contain a total of seventy-eight claims. All are related as continuation or divisional patents that claim priority to U.S. Patent Application Serial No. 08/344,248, filed November 23, 1994, which is a continuation-in-part of U.S. Patent Application Serial No. 08/248,037, filed May 24, 1994. The patents-in-suit also share a common specification.³

BACKGROUND

Teva manufactures and markets Copaxone, a drug used to treat multiple sclerosis (“MS”). Sandoz and Mylan each filed an Abbreviated New Drug Application with the United States Food and Drug Administration seeking approval to manufacture and sell a generic version of Copaxone in the United States. Shortly thereafter, Teva filed separate suits against Sandoz and Mylan.

The active ingredient in Copaxone is glatiramer acetate, a composition of copolymer–1. The claims of the patents-in-suit pertain to copolymer–1 with particular molecular weight characteristics, methods of manufacturing copolymer–1 with such characteristics, and methods for treating MS using copolymer–1 with such characteristics.

The crux of both Defendants' claim construction argument is that the patent claims are indefinite because the patents fail to specify the type of molecular weight being claimed or the standards and conditions by which the claimed molecular weight should be determined. Sandoz previously moved for summary judgment on this basis. The Court denied Sandoz's motion. Mylan subsequently filed its own motion for a summary judgment finding of invalidity on the basis of indefiniteness under 35 U.S.C. § 112. Because the Court finds the patent claims can be construed, Mylan's motion for summary judgment is DENIED.

LEGAL STANDARD

“[C]laim construction is a matter of law” decided by courts. Markman v. Westview Instruments, Inc., 52 F.3d 967, 979 (Fed.Cir.1995) ( en banc ). “[T]he focus in construing disputed terms in claim language is not the subjective intent of the parties....” Id. at 986. Courts must, rather, perform an “objective” inquiry into “what one of ordinary skill in the art at the time of the invention would have understood the term to mean.” Id.

In Phillips v. AWH Corp., the Federal Circuit set forth the prevailing process for construing patent claims. 415 F.3d 1303 (Fed.Cir.2005) ( en banc ). First, claim terms should “ ‘generally [be] given their ordinary and customary meaning.’ ” Id. at 1312 (citations omitted). “[T]he ordinary and customary meaning of a claim term is the meaning that the term would have to a person of ordinary skill in the art in question at the time of the invention, i.e., as of the effective filing date of the patent application.” Id. at 1313 (citations omitted). Second, “because patentees frequently use terms idiosyncratically,” in cases where “the meaning of a claim term as understood by persons of skill in the art is ... not immediately apparent,” courts should look to “ ‘sources available to the public that show what a person of skill in the art would have understood disputed claim language to mean.’ ” Id. at 1314 (citation omitted). “Those sources include[,]” in the following order of significance, “ ‘the words of the claims themselves, the remainder of the specification, the prosecution history, and extrinsic evidence concerning relevant scientific principles, the meaning of technical terms, and the state of the art.’ ” Id. (citations omitted).

Indefiniteness, like claim construction, “is a legal question.” Young v. Lumenis, Inc., 492 F.3d 1336, 1344 (Fed.Cir.2007) (citation omitted). Because patents are “presumed to be valid, the evidentiary burden to” prove indefiniteness “is one of clear and convincing evidence.” Id. at 1345 (citation omitted). To satisfy Section 112's “definiteness requirement, the boundaries of the claim, as construed by the court, must be discernible to a skilled artisan based on the language of the claim, the specification, and the prosecution history, as well as her knowledge of the relevant field of art.” Power–One, Inc. v. Artesyn Techs., Inc., 599 F.3d 1343, 1350 (Fed.Cir.2010) (citation omitted). A claim is indefinite when it “is ‘not amenable to construction or [is] insolubly ambiguous.’ ” Id. (citation omitted). “[A] claim is not indefinite merely because it poses a difficult issue of claim construction.” Id. (citation omitted). “ ‘[I]f the meaning of the claim is discernible, even though the task may be formidable and the conclusions may be one over which reasonable persons will disagree, ... the claim [is] sufficiently clear to avoid invalidity on indefiniteness grounds.’ ” Id. (citation omitted). In addition, “the fact that some experimentation may be necessary to determine the scope of the claims does not render the claims indefinite.” Exxon Research & Eng'g Co. v. United States, 265 F.3d 1371, 1379 (Fed.Cir.2001) (citation omitted).

DISCUSSION

1. “Copolymer–1”

The term “copolymer–1” appears in all of the asserted claims. The specification describes “copolymer–1” as “a mixture of polypeptides composed of alanine, glutamic acid, lysine, and tyrosine in a molar ratio of approximately 6:2:5:1, respectively. It is synthesized by chemically polymerizing the four amino acids forming products with average molecular weights of 23,000 daltons (U.S. Pat. No. 3,849,550).” ('808 patent at 1:32–37.) The “object” of the invention, according to the specification, is “to provide an improved composition of copolymer–1” with a lower average molecular weight and fewer higher molecular weight species. ( Id. at 1:38–39; 1:64–2:14.)

Sandoz argues that while the final composition may have a lower molecular weight, the copolymer–1 claimed in the patents must be synthesized by starting with copolymer–1 that has an average molecular weight of 23,000 daltons. Sandoz contends that the patent teaches that the prior art (U.S. Patent No. 3,849,550 (“'550 patent”)) results in the formation of a copolymer–1 mixture with a molecular weight of 23,000 daltons. Sandoz is wrong.

Example 1 in the specification describes preparation of copolymer–1, “according to” methods described in the '550 patent, that “had an average molecular weight of 12 KDa.” ( Id. at 2:53–55, 3:14–16.) As a result, a person of ordinary skill in the art would not read 23,000 daltons into the definition of copolymer–1, as Sandoz claims. See Phillips, 415 F.3d at 1316 (“the specification necessarily informs the proper construction of the claims”) (citation omitted).

Sandoz also argues that copolymer–1 should be construed as having a “random amino acid composition.” Sandoz points to a statement in the prosecution history, where Teva distinguished the patents-in-suit from an earlier European patent application, EPA 0 383 620 (“'620 patent application”). Teva stated that “[t]he copolymer–1 [of the '620 patent application] ... is distinguished from copolymer–1 of [the patents-in-suit] insofar as ... [t]he copolymer–1 of the '620 application does not have a random amino acid composition.” (Kramer Decl. Ex. 9 ('476 patent prosecution, Amendment Under 37 C.F.R. § 1.111, at 4) ( Teva v. Sandoz claim construction).) From this statement, Sandoz concludes that the copolymer–1 in the patents-in-suit must be “random.”

Sandoz provides only a sliver of Teva's response, however. Viewed in its entirety, Teva's statement is clear that the distinction was not based on randomness:

The copolymer–1 of the '620 application does not have a random amino acid composition, but rather is derived from blocks of nucleotides, ... which results in copolymer–1 having arrangement of specific blocks of polypeptide sequences.... [S]ince the copolymer–1 of the present application is not composed [of] specific blocks of polypeptides sequences, it is clearly distinguished over the copolymer–1 disclosed in the '620 patent.

( Id.) The Court also accepts Teva's expert's (Dr. Gregory Grant) representation that a person of ordinary skill in the art would understand that while the copolymer–1 referred to in the patents-in-suit is...