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Schering Corporation, et al v. Mylan Pharmaceuticals

August 22, 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NOT FOR PUBLICATION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 a motion for partial summary judgment filed by Plaintiffs, Schering Corporation and MSP Singapore Company LLC (collectively, "Schering"), on July 8, 2011, seeking summary judgment on certain of Defendant Mylan Pharmaceuticals, Inc.'s ("Mylan's") inequitable conduct defenses and counterclaims, and a motion for partial summary judgment also filed by Schering on July 8 seeking summary judgment on the issue of infringement and on Mylan's invalidity defenses of indefiniteness, inherent anticipation, and lack of enablement. The Court has considered the submissions of the parties in support of and in opposition to the present motions and decides the matter without oral argument pursuant to Rule 78 of the Federal Rules of Civil Procedure. For the reasons set forth below, Schering's motions are granted in part and denied in part.

I. BACKGROUND

On December 16, 2009, Schering filed a Complaint alleging that Mylan's filing of an Abbreviated New Drug Application (ANDA) infringed two of Schering's patents, specifically United States Patent Nos. RE37,721 ("the '721 patent") and 5,846,966 ("the '966 patent"). (Schering's Local Civ. R. 56.1 Stmt. of Uncontested Facts in Support of Their Mot. for Summ. J. on Mylan's Inequitable Conduct Defenses and Counterclaims ["SOF"] ¶ 9.) The '721 patent discloses the hydroxy-substituted azetidinone compound ezetimibe, which is marketed and sold commercially as the drug Zetia. In non-scientific terms, Zetia is used to reduce cholesterol levels by blocking the absorption of cholesterol from a person's diet. The '966 patent discloses the combination of ezetimibe with an HMG CoA reductase inhibitor, another type of drug that is designed to reduce cholesterol levels. This combination is marketed and sold commercially as the drug Vytorin.

On June 14, 2011, the '721 patent reissued as the United States Patent No. RE42,461 ("the '461 patent"). (SOF ¶ 6.) On June 15, 2011, this Court issued a Markman Opinion and Order construing certain terms in claims 8, 9, 12, and 13 of the '721 patent and in claims 1 and 3 of the '966 patent. (Docket Entry Nos. 209 ["Markman Op."], 210.) Thereafter, Schering sought and was granted, without opposition, leave to amend its Complaint, and on July 25, 2011, an Amended Complaint was filed alleging infringement of the '461 and '966 patents. (Docket Entry No. 254.) On July 8, 2011, Schering filed the instant motions for partial summary judgment.*fn1

II. LEGAL STANDARD

A court shall grant summary judgment under Rule 56(c) of the Federal Rules of Civil Procedure "if the pleadings, the discovery and disclosure materials on file, and any affidavits show that there is no genuine issue as to any material fact and that the movant is entitled to judgment as a matter of law." Fed. R. Civ. P. 56(c).

On a summary judgment motion, the moving party must show, first, that no genuine issue of material fact exists. Celotex Corp. v. Catrett, 477 U.S. 317, 323 (1986). The burden then shifts to the non-moving party to present evidence that a genuine issue of material fact compels a trial. Id. at 324. In so presenting, the non-moving party must offer specific facts that establish a genuine issue of material fact,not just "some metaphysical doubt as to the material facts." Matsushita Elec. Indus. Co., Ltd. v. Zenith Radio Corp., 475 U.S. 574, 586--87 (1986). Thus, the non-moving party may not rest upon the mere allegations or denials in its pleadings. See Celotex, 477 U.S. at 324. Further, the non-moving party cannot rely on unsupported assertions, bare allegations, or speculation to defeat summary judgment. See Ridgewood Bd. of Educ. v. N.E. ex rel. M.E., 172 F.3d 238, 252 (3d Cir. 1999). The Court must, however, consider all facts and their reasonable inferences in the light most favorable to the non-moving party. See Pennsylvania Coal Ass'n v. Babbitt, 63 F.3d 231, 236 (3d Cir. 1995).

III. DISCUSSION

Mylan has stated that it withdraws both its inherent anticipation defense and its claim of inequitable conduct for Schering's alleged false statements during the prosecution of the '461 patent regarding "preventing" atherosclerosis. (Mylan's Br. In Opp'n to Pl.'s Mot. for Partial Summ. J. of Infringement and No Invalidity with Respect to Certain Mylan Defenses and Countercl. ["Mylan's Certain Defenses Opp'n Br."] at 5--6, 10--11; Mylan's Br. in Opp'n to Pl.'s Mot. for Partial Summ. J. as to Certain of Mylan's Inequitable Conduct Defenses and Countercl.

["Mylan's Inequitable Conduct Opp'n Br."] at 6.) As such, Schering's motions for summary judgment on Mylan's inherent anticipation defense and its claim of inequitable conduct for the alleged false statements will be denied without prejudice pending Mylan's filing of a Second Amended Answer.*fn2 Mylan likewise does not oppose Schering's motion for summary judgment on (A) the issue of infringement, but Mylan does oppose Schering's motions for summary judgment on its defenses and counterclaims of (B) inequitable conduct for failure to disclose certain metabolite information to the United States Patent and Trademark Office (PTO) in connection with Schering's prosecution of the '721 and '966 patents, (C) indefiniteness of certain claims in the '461 and '966 patents, and (D) lack of enablement of certain claims in the '461 patent. The Court addresses these issues in turn.

A. Infringement

Schering's Amended Complaint alleges that Mylan's proposed ANDA products infringe claims 3 and 10--13 of the '461 patent and "one or more" claims of the '966 patent. (Am. Compl. ΒΆ 39.) Schering now moves for summary judgment that those products literally infringe claims 3 and 10--13 of the '461 patent and claims 2--4 of the '966 patent. (Schering's Br. in Supp. of Their Mot. for Partial Summ. J. of Inf. and No Invalidity with Respect to Certain Mylan Defenses and Countercl. ["Schering's Certain Defenses Opening Br."] at 8.) Mylan's August 1, 2011 brief in opposition to Schering's motion indicated that Mylan planned to enter a joint stipulation on the issue of infringement and asked the Court to defer ruling on the matter pending such stipulation. (Mylan's Certain Defenses Opp'n Br. at 6.) However, by way of a letter dated August 17, 2011, Mylan informed the Court that the parties ...


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