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Schering Corporation, et al v. Mylan Pharmaceuticals

June 15, 2011

SCHERING CORPORATION, ET AL., PLAINTIFFS,
v.
MYLAN PHARMACEUTICALS, INC., ET AL., DEFENDANTS.



The opinion of the court was delivered by: Linares, District Judge.

NOT FOR PUBLICATION

OPINION

This matter comes before the Court by way of an application for claim construction by Plaintiffs, Schering Corporation and MSP Singapore Company LLC (collectively, "Schering"), and Defendants, Mylan Pharmaceuticals, Inc. ("Mylan"), Teva Pharmaceuticals USA, Inc., and Teva Pharmaceuticals Industries Ltd. (collectively, "Teva").*fn1 The parties seek construction of certain language contained in claims 8, 9, 12, and 13 of United States Patent No. RE37,721 ("the '721 patent") and claims 1 and 3 of United States Patent No. 5,846,966 ("the '966 patent") (collectively, the "patents-in-suit"). The Court held a Markman hearing on May 9, 2011. The Court has considered the parties' written and oral arguments and sets forth herein its construction of the disputed claim terms.

I. BACKGROUND

This patent infringement case involves two patents, the '721 patent and the '966 patent. The '721 patent discloses the hydroxylsubstituted azetidinone compound ezetimibe, which is marketed and sold commercially as the drug Zetia. Schering Corporation is the holder of the '721 patent, and MSP Singapore Company LLC is the exclusive licensee for Zetia. In non-scientific terms, Zetia is used to reduce cholesterol levels by blocking the absorption of cholesterol from a person's diet. Schering first filed the '721 patent on September 21, 1993. The United States Patent and Trademark Office ("PTO") issued the original patent in 1998 as U.S. Patent No. 5,757,115 ("the '115 patent") and thereafter reissued it as the '721 patent on May 28, 2002. The Food and Drug Administration ("FDA") approved ezetimibe on October 25, 2002. The patent contains three different types of claims: claims to (1) compounds (claims 1, 10, 11); (2) pharmaceutical compositions (claims 8, 12); and (3) methods of treating atherosclerosis using ezetimibe (claims 9, 13).

The '966 patent discloses the combination of ezetimibe with simvastatin. This combination is marketed and sold commercially as the drug Vytorin. Like ezetimibe, simvastatin is a drug that is designed to reduce cholesterol; however, statins, the class of drugs of which simvastatin is a member, work differently from ezetimibe in that they inhibit 3-hydroxy-3-methyglutaryl coenzyme A reductase ("HMG CoA reductase"), an enzyme that plays a role in the body's production of cholesterol. The application that led to the '966 patent was filed on October 14, 1997 as a division of the application which led to the '115 patent. The '966 patent contains two types of claims: claims to (1) compositions containing certain compounds in combination with HMG CoA reductase inhibitors (claims 1--5); and (2) methods of treating atherosclerosis using those compositions (claims 6--10).

On March 22, 2007, prior to any of the complaints in this consolidated action being filed, Schering initiated an infringement action against Glenmark Pharmaceuticals, Inc. ("Glenmark"). In that case, Schering alleged that Glenmark's ANDA filing in connection with a generic version of Zetia infringed certain claims of the '721 patent. On September 15, 2008, this Court issued a Markman Opinion construing the terms "administering" and "in need of such treatment" as used in claims 9 and 13 of the '721 patent. See Schering Corp. v. Glenmark Pharmaceuticals Inc., Civ. No. 07-1334, 2008 WL 4307189 (D.N.J. Sept. 16, 2008).

On or about November 5, 2009, Mylan filed an filed an abbreviated new drug application ("ANDA") with the FDA, seeking to market a generic version of Vytorin. Schering initiated the instant infringement action against Mylan on December 16, 2009, and on June 16, 2010, Schering initiated a second action against Mylan (Civil Action No. 10-3085). On or about February 19, 2010, Teva filed an ANDA with the FDA, seeking to market a generic version of Vytorin. On March 2, 2010, Schering initiated an infringement action against Teva (Civil Action No. 10-1058), and on September 1, 2010, Schering initiated a second action against Teva (Civil Action No. 10-4473). On December 13, 2010, the Court consolidated these four civil actions. In this consolidated action, Schering asserts that Mylan and Teva infringed claims 3, 7, 8, 9, 10, 11, 12, and 13 of the '721 patent and claims 2, 3, 4, 7, 8, and 9 of the '966 patent.

While the parties have agreed to constructions of a number of claim terms, the parties*fn2 dispute the interpretation of claims 8, 9, 12, and 13 of the '721 patent and claims 1 and 3 of the '966 patent.*fn3 Claims 8 and 12 of the '721 patent read as follows, with the disputed terms indicated by emphasis:*fn4

8. A pharmaceutical composition for the treatment or prevention of atherosclerosis, or for the reduction of plasma cholesterol levels, comprising an effective amount of a compound of claim 1 in a pharmaceutically acceptable carrier.

9. A method of treating or preventing atherosclerosis or reducing plasma cholesterol levels comprising administering to a mammal in need of such treatment an effective amount of a compound of claim 1.

The parties agree that claim 1 of the '721 patent claims a class of hydroxy-substituted azetidinone hypocholesterolemic agents, of which ezetimibe is a member. Claims 12 and 13 are essentially identical to claims 8 and 9, respectively, except that they depend from claims 10 and 11, rather than claim 1. The parties agree that claims 10 and 11 claim ezetimibe itself. (Joint Claim Construction and Prehearing Stmt. at 3.)

The disputed claims of the '966 patent read as follows, with the disputed terms indicated by emphasis:

1. A pharmaceutical composition for the treatment or prevention of atherosclerosis, or for the reduction of plasma cholesterol levels, comprising an effective amount of a compound represented by the formula I . . . or a pharmaceutically acceptable salt thereof . . . in combination with an HMG CoA reductase inhibitor in a pharmaceutically acceptable carrier.

3. A composition of claim 1 wherein the HMG CoA reductase inhibitor is selected from the group consisting of lovastatin, pravastatin, fluvastatin, simvastatin and atorvastatin.

The "formula I" referenced in claim 1 depicts the class of hydroxy-substituted azetidinone hypocholesterolemic agents of which ezetimibe is a member. The specifications of the '721 patent and the '966 patent are essentially identical.

II. LEGAL STANDARD

A court's analysis of a patent infringement claim is two-fold. Tate Access Floors, Inc. v. Interface Architectural Resources, Inc., 279 F.3d 1357, 1365 (Fed. Cir. 2002). The court must first define the meaning and scope of the patent claims as a matter of law. Markman v. Westview Instruments, Inc., 52 F.3d 967, 978 (Fed. Cir. 1995) (en banc), aff'd, 517 U.S. 370 (1996). The court then engages in a comparison of the claims as construed to the alleged infringing product (or method). Tate, 279 F.3d at 1365. At this stage, the Court must only engage in the first step.

Claim construction is a matter of law to be determined solely by the court. Phillips v. AWH Corp., 415 F.3d 1303, 1312 (Fed. Cir. 2005), cert. denied, 546 U.S. 1170 (2006). "It is a bedrock principle of patent law that the claims of a patent define the invention to which the patentee is entitled the right to exclude." Id. at 1312 (quotations omitted). In construing the terms of a patent, a court should look first to the language of the claim itself. Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996). The terms in the claim "are generally given their ordinary and customary meaning." Id. at 1582.*fn5 "[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." Phillips, 415 F.3d at 1313.*fn6 A court "must look at the ordinary meaning in the context of the written description and the prosecution history." Medrad, Inc. v. MRI Devices Corp., 401 F.3d 1313, 1319 (Fed. Cir. 2005). The court should turn to "those sources available to the public that show what a person of skill in the art would have understood disputed claim language to mean." Innova/Pure Water, Inc. v. Safari Water Filtration Sys., Inc., 381 F.3d 1111, 1116 (Fed. Cir. 2004).

To this end, the court should first examine the intrinsic record-the patent itself, including the claims, the specification and, if in evidence, the prosecution history. Vitronics, 90 F.3d at 1582 (citing Markman, 52 F.3d at 979). The specification "acts as a dictionary when it expressly defines terms used in the claims or when it defines terms by implication." Id. Indeed, the Federal Circuit has explained that the specification is " 'usually . . . dispositive . . . [and] the single best guide the meaning of a disputed term.' " Phillips, 415 F.3d at 1315 (quoting Vitronics, 90 F.3d at 1582). It is "entirely appropriate for a court, when conducting claim construction, to rely heavily on the written description for guidance as to the meaning of the claims." Id. at 1317. The specification is also an important guide in claims construction as it may contain "an intentional disclaimer, or disavowal, of claim scope by the inventor." Id. at 1316.

Additionally, the court should consult the patent's prosecution history as it "provides evidence of how the PTO and the inventor understood the patent." Id. Courts should be circumspect in reviewing a prosecution history as it represents "an ongoing negotiation between the PTO and the applicant, rather than the final product of the negotiation . . . ." Id. A district court may also examine extrinsic evidence: "all evidence external to the patent and prosecution history." Markman, 52 F.3d at 980; Phillips, 415 F.3d at 1317-18 (stating that the Federal Circuit "ha[s] authorized district courts to rely on extrinsic evidence"). Such evidence consists of testimony by the inventor or by experts, dictionaries, and treatises. Markman, 52 F.3d at 980. In particular, a court may find reference to technical dictionaries useful "in determining the meaning of particular terminology." See Phillips, 415 F.3d at 1318. However, extrinsic evidence is generally thought to be less reliable than the patent and prosecution history, id. at 1318-19; in essence, it is "less significant than the intrinsic record in determining the legally operative meaning of claim language," C.R. Bard, Inc. v. U.S. Surgical Corp., 388 F.3d 858, 862 (Fed. Cir. 2004) (quotation omitted). With this framework in mind, the Court now turns to the disputed claim language.

III. DISCUSSION

The parties have agreed that certain identical or similar terms used in the disputed claims should be construed together. The Court will thus address (A) the term "treatment of,"*fn7 as used in claims 8 and 12 of the '721 patent and claim 1 of the '966 patent, together with the term "treating," as used in claims 9 and 13 of the '721 patent; (B) the term "reduction of plasma cholesterol levels," as used in claims 8 and 12 of the '721 patent and claim 1 of the '966 patent, together with the term "reducing plasma cholesterol levels," as used in claims 9 and 13 of the '721 patent; (C) the term "administering," as used in claims 9 and 13 of the '721 patent; (D) the term "an effective amount," as used in claims 8, 9, 12, and 13 of the '721 patent and claim 1 of the '966 patent; (E) the term "pharmaceutically acceptable carrier," as used in claims 8 and 12 of the '721 patent and claim 1 of the '966 patent; and (F) the term "HMG CoA reductase inhibitor," as used in claims 1 and 3 of the '966 patent, together with the terms "lovastatin," "simvastatin," "pravastatin," "fluvastatin," and "atorvastatin," as used in claim 3 of the '966 patent.

A. "treatment of" / "treating"

The term "treatment of" is used in claims 8 and 12 of the '721 patent and claim 1 of the '966 patent. The term "treating" is used in claims 9 and 13 of the '721 patent. The parties agree that a common construction should be adopted for both terms. Schering proposes the construction, "to care for medically," while Mylan proposes, "stopping, slowing or reversing the progression of a disease."

Schering argues that the plain meaning of "treating" or "treatment" is to provide care to a patient and that the treatment of a medical condition does not imply that such treatment will be successful, i.e., stopped, slowed, or reversed. Schering points to several dictionary definitions to support its position. (See Schering's Opening Claim Constr. Br. ("Schering's Opening Br.") at 11.) Mylan responds that Schering's construction is overly vague, arguing that it could include non-pharmacological methods of treatment, such as physical therapy. (Tr. of Proceedings, May 9, 2011["Hr'g Tr."]), 11:15--12:19.) Mylan further argues that one does not "care for" a disease, but rather a patient, and the claims themselves state that it is the disease condition, atherosclerosis, that is actually treated, not the patient.*fn8 Mylan asserts that Schering's dictionary evidence in fact supports this interpretation, as one such dictionary refers to "car[ing] ...


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