Medicines Co. v. Mylan Inc.

• Decision Date: 16 December 2013
• Docket Number: No. 11-cv-1285,11-cv-1285
• Parties: THE MEDICINES COMPANY, Plaintiff, v. MYLAN INC., MYLAN PHARMACEUTICALS INC., and BIONICHE PHARMA USA, LLC, Defendants.
• Court: U.S. District Court — Northern District of Illinois

THE MEDICINES COMPANY, Plaintiff, v. MYLAN INC., MYLAN PHARMACEUTICALS INC.,and BIONICHE PHARMA USA, LLC, Defendants.

No. 11-cv-1285

UNITED STATES DISTRICT COURT NORTHERN DISTRICT OF ILLINOIS EASTERN DIVISION

Dated: December 16, 2013

MEMORANDUM OPINION AND ORDER

AMY J. ST. EVE, District Court Judge:

On February 23, 2011, Plaintiff The Medicines Company ("TMC") filed this action against Defendants Mylan, Inc., Mylan Pharmaceuticals Inc. and Bionche Pharma USA, LLC alleging infringement of United States Patents Nos. 7,582,727 (the "'727 patent") and 7,598,343 (the "'343 patent"). (R. 1, Compl.) On June 21, 2013, Defendants moved for summary judgment of non-infringement or, in the alternative, invalidity. (R. 275, Mot.)

For the following reasons, the Court grants Defendants' motion for summary judgment of non-infringement with respect to the '343 patent but denies it with respect to the '727 patent. The Court also denies Defendants' alternative motion for summary judgment of invalidity with respect to the '727 patent. Finally, the Court grants Defendants' motion for summary judgment on TMC's claim for willful infringement.

BACKGROUND

I. Northern District of Illinois Local Rule 56.1

"For litigants in the Northern District of Illinois, the Rule 56.1 statement is a critical, and required, component of a litigant's response to a motion for summary judgment. The purpose of the local rule is to make the summary judgment process less burdensome on district courts, by requiring the parties to nail down the relevant facts and the way they propose to support them." Sojka v. Bovis Lend Lease, Inc., 686 F.3d 394, 398 (7th Cir. 2012). Local Rule 56.1 assists the Court by "organizing the evidence, identifying undisputed facts, and demonstrating precisely how each side propos[es] to prove a disputed fact with admissible evidence." Bordelon v. Chicago Sch. Reform Bd. of Trustees, 233 F.3d 524, 527 (7th Cir. 2000). "The Rule is designed, in part, to aid the district court, which does not have the advantage of the parties' familiarity with the record and often cannot afford to spend time combing the record to locate the relevant information, in determining whether a trial is necessary." Delapaz v. Richardson, 634 F.3d 895, 899 (7th Cir. 2011) (internal quotations and citation omitted).

Local Rule 56.1(a)(3) requires the moving party to provide "a statement of material facts as to which the moving party contends there is no genuine issue." Cracco v. Vitran Exp., Inc., 559 F.3d 625, 632 (7th Cir. 2009). The nonmoving party then must file "a response to each numbered paragraph in the moving party's statement, including, in the case of any disagreement, specific references to the affidavits, parts of the record, and other supporting materials relied upon." Id. (citing Local Rule 56.1(b)(3)(B)). Pursuant to the Local Rules, the Court will not consider any additional facts proposed in the nonmoving party's Local Rule 56.1(b)(3)(B) response, but must rely on the nonmovant's Local Rule 56.1(b)(3)(C) statement of additional facts. See Ciomber v. Cooperative Plus, Inc., 527 F.3d 635, 643-44 (7th Cir. 2008). The Courtdisregards Local Rule 56.1 statements and responses that do not cite to specific portions of the record or that contain legal argument. See Cracco, 559 F.3d at 632; Cady v. Sheahan, 467 F.3d 1057, 1060 (7th Cir. 2006) (noting that the party's statement of material facts "did not comply with Rule 56.1 as it failed to adequately cite the record and was filled with irrelevant information, legal arguments, and conjecture"); Chicon v. Exelon Generation Co., L.L.C., 401 F.3d 803, 809-10 (7th Cir. 2005) ("A district court does not abuse its discretion when, in imposing a penalty for a litigant's non-compliance with Local Rule 56.1, the court chooses to ignore and not consider the additional facts that a litigant has proposed."). "When a responding party's statement fails to dispute the facts set forth in the moving party's statement in the manner dictated by rule, those facts are deemed admitted for purposes of the motion." Cracco, 559 F.3d at 632.

II. Relevant Facts

A. The Parties and the Court's Jurisdiction

Plaintiff TMC is a Delaware corporation with its principal place of business in Parsippany, New Jersey. (R. 277, Mylan L.R. 56.1 Stmt. ¶ 1.) Defendant Mylan Inc. is a Pennsylvania corporation with its principal place of business in Canonsburg, Pennsylvania. (Id. ¶ 2.) Mylan Inc. wholly owns the other two Defendants in this case—Mylan Pharmaceuticals Inc. and Bioniche Pharma USA, LLC, now known as Mylan Institutional LLC.¹ (Id. ¶¶ 3-4.) Mylan Pharmaceuticals Inc. is a West Virginia corporation with its principal place of business in Morgantown, West Virginia. (Id. ¶ 3.) Mylan Institutional LLC's principal place of business is in the Northern District of Illinois. (Id. ¶ 4.) The Court has subject matter jurisdiction overTMC's patent claims under 28 U.S.C. §§ 1331 and 1338(a), and venue is proper in this District pursuant to 28 U.S.C. §§ 1400(b) and 1391(c).

B. Bivalirudin Final Drug Product

The two patents-in-suit pertain to pharmaceutical formulations of bivalirudin and the process of making bivalirudin. (Compl. at Ex. A (the '727 patent) & Ex. B (the '343 patent); Mylan L.R. 56.1 Stmt. ¶ 21.) Bivalirudin is the active ingredient in TMC's Angiomax® drug product, an injectable anticoagulant used to prevent blood clotting during coronary procedures. (Mylan L.R. 56.1 Stmt. ¶¶ 9-10; R. 290, TMC Resp. Br. at 3.) TMC has sold Angiomax® since 2001. (Mylan L.R. 56.1 Stmt. ¶ 9.) Before expiration of the patents-in-suit, Mylan submitted Abbreviated New Drug Application ("ANDA") No. 202471 to the U.S. Food and Drug Administration ("FDA"), seeking approval to engage in the commercial manufacture, use, sale, offer for sale, and/or importation of a generic equivalent to Angiomax^®. (Id. ¶ 6.) TMC claims that Mylan's ANDA No. 202471 infringes several claims of the patents-in-suit. (Id. ¶¶ 22, 30.)

To create a bivalirudin final drug product, a drug manufacturer first must buy or make the bivalirudin active pharmaceutical ingredient ("API") and then perform a compounding process to adjust the acidity of the bivalirudin API to make the drug suitable for injection in patients. (See id. ¶ 13.) The compounding process involves three basic steps. (Id.) In the first step, the bivalirudin API is dissolved into a mannitol solution to form a bivalirudin solution. (Id.) The resulting bivalirudin solution has a pH level under 3.0, making it too acidic to inject into patients. (Id. ¶ 14.) Thus, in the second step, the bivalirudin solution is mixed with a pH-adjusting solution, such as sodium hydroxide, to raise the pH to an acceptable level. (Id. ¶¶ 13-14.) In the final step, the mannitol solution and the pH-adjusting solution are removed from the mixture to form the bivalirudin final drug product. (Id. ¶ 13.) During this compounding process, one of theamino acids in the bivalirudin API can convert into an aspartate if the pH level becomes too high. (Id. ¶¶ 11-12, 14, 46.) That conversion forms an impurity in the bivalirudin final drug product known as Asp⁹-bivalirudin. (Id. ¶ 12.)

The bivalirudin final drug product is sold in a single-use vial as a sterile freeze-dried cake. (Id. ¶ 9.) The bivalirudin cake must be reconstituted before injection by adding water to it. (Id.) Each cake contains 250 milligrams of bivalirudin, 125 milligrams of mannitol (a sugar), and sodium hydroxide (a base) to adjust the acidity of the drug. (Id.) Each cake also contains trace amounts of impurities, including Asp⁹-bivalirudin. (Id. ¶ 12.) High levels of Asp⁹-bivalirudin can negatively affect the stability and shelf-life of the bivalirudin final drug product. (See '727 patent at col. 2, ll. 16-19; '343 patent at col. 2, ll. 16-19.)

Before the inventions in the patents-in-suit, the compounding process used to make the bivalirudin final drug product resulted in inconsistent and high levels of the Asp⁹-bivalirudin impurity. (See TMC Resp. to Mylan L.R. 56.1 Stmt. ¶ 24.) The "old" compounding process resulted in at least two batches of TMC's final drug product that failed to meet FDA-approved specifications regarding the amount of allowable impurities. (Mylan L.R. 56.1 Stmt. ¶ 15.) The patents-in-suit pertain to an "improved" compounding process that Drs. Gopal Krishna and Gary Musso² developed, which reduced the generation of Asp⁹-bivalirudin impurities and made the Asp⁹-bivalirudin impurity levels more consistent across batches. (Mylan L.R. 56.1 Stmt. ¶¶ 24, 46.)

C. The Patents-In-Suit

TMC filed both patents-in-suit on July 27, 2008. (Id. ¶ 21.) The U.S. Patent and Trademark Office issued the '727 patent on September 1, 2009 and the '343 patent on October 6, 2009. (Id.) Both patents-in-suit shares the same title—"Pharmaceutical Formulations of Bivalirudin and Processes of Making the Same"—a nearly identical written specification, and a similar prosecution history. (See id. ¶¶ 21, 33, 58-59.) The '727 patent is a product patent (see '727 patent at col. 25-28), whereas the '343 patent is a product-by-process patent that claims the same bivalirudin final drug product as the '727 patent but with additional limitations regarding the manufacturing process.³ (See '343 patent at col. 27-28.) Both patents expire no later than January 27, 2009. (Mylan L.R. 56.1 Stmt. ¶ 21.)

1. The '343 Patent

TMC asserts that Mylan has infringed claims 1-3 and 7-11 of the '343 patent. (Id. ¶ 22.) Claim 1 is an independent claim, and claims 2-3 and 7-11 depend on claim 1. (Id.) Claim 1 states:

1. Pharmaceutical batches of a drug product comprising bivalirudin (SEQ ID NO: 1) and a pharmaceutically acceptable carrier, for use as an anticoagulant in a subject in need thereof, said batches prepared by a compounding process, comprising:

(i) dissolving bivalirudin in a solvent to form a first solution;

(ii) efficiently mixing a pH-adjusting solution with the first solution to form a second solution, wherein the

...