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The Medicines Co. v. Mylan Inc.

United States District Court, N.D. Illinois, Eastern Division

June 2, 2014

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

MEMORANDUM OPINION AND ORDER

AMY J. ST. EVE, District Judge.

Defendants Mylan Inc., Mylan Pharmaceuticals Inc., and Bioniche Pharma USA, LLC (collectively, "Mylan") move in limine to preclude Plaintiff The Medicines Company ("TMC") from presenting evidence or argument at trial relating to Mylan's alleged copying of TMC's Improved Angiomax® product. ( See R. 417, Mylan Mot.) For the following reasons, the Court denies Mylan's motion.

BACKGROUND

This action arises out of a patent infringement case involving U.S. Patent No. 7, 582, 727 (the "727 Patent"), which "relates to a compounding process for preparing a pharmaceutical batch(es) of a drug product or a pharmaceutical formulation(s) comprising bivalirudin as an active ingredient." (727 patent at col. 2 ll. 29-32.) Bivalirudin is the active ingredient in TMC's Angiomax® drug product, an injectable anticoagulant used to prevent blood clotting during coronary procedures. TMC has sold Angiomax® since 2001.

Before expiration of the 727 patent, 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 Improved Angiomax®. TMC claims that Mylan's proposed bivalirudin drug product infringes several claims of the 727 patent.[1] Mylan disputes that its bivalirudin drug product infringes the asserted claims and contends, moreover, that the 727 patent is invalid for obviousness, among other reasons.

To rebut Mylan's obviousness argument, TMC intends to offer evidence that Mylan and several other generic pharmaceutical companies copied its Improved Angiomax® drug. TMC states that its evidence will show that Mylan purchased, tested, and analyzed TMC's Improved Angiomax® lot number 916438, among others, to determine its impurity profile. According to TMC, Mylan then reverse engineered Improved Angiomax® to create its own generic bivalirudin product with the same active and inactive ingredients as Improved Angiomax® and an Asp9 impurity level below about 0.6%. Mylan seeks to exclude this evidence from trial, relying on recent Federal Circuit precedent holding that evidence of copying is not probative of nonobviousness in Hatch-Waxman cases because the FDA requires generic drug manufacturers to demonstrate that their drug is bioequivalent to an approved drug in order to receive approval of their ANDA. ( See R. 419, Mylan Mem. at 5-7.)

LEGAL STANDARD

Although the Federal Rules of Evidence do not explicitly authorize in limine rulings, the practice has developed pursuant to the district court's inherent authority to manage the course of trials. See Luce v. United States, 469 U.S. 38, 41 n.4, 105 S.Ct. 460, 83 L.Ed.2d 443 (1984). In limine rulings avoid delay and allow the parties the opportunity to prepare themselves and witnesses for the introduction or exclusion of the applicable evidence. See Wilson v. Williams, 182 F.3d 562, 566 (7th Cir. 1999); United States v. Connelly, 874 F.2d 412, 416 (7th Cir. 1989). The Court will grant a motion in limine only when the evidence is clearly inadmissible for any purpose. See Jonasson v. Lutheran Child & Family Servs., 115 F.3d 436, 440 (7th Cir. 1997); Betts v. City of Chicago, 784 F.Supp.2d 1020, 1023 (N. D. Ill. 2011).

The Court has broad discretion in ruling on evidentiary issues before trial. See Christmas v. City of Chicago, 682 F.3d 632, 640 (7th Cir. 2012). If the in limine procedural environment makes it too difficult to evaluate an evidentiary issue, the Court may defer ruling on the motion until trial. See Jonasson, 115 F.3d at 440. Additionally, regardless of the Court's initial ruling on a motion in limine, the Court may alter its ruling during the course of trial if warranted. See Empire Bucket, Inc. v. Contractors Cargo Co., 739 F.3d 1068, 1071 n.3 (7th Cir. 2014); Farfaras v. Citizens Bank & Tr. of Chicago, 433 F.3d 558, 565 (7th Cir. 2006). These principals apply with even greater force in a bench trial where "the trial judge has flexibility to provisionally admit testimony or evidence and then discount or disregard it if upon further reflection it is entitled to little weight or should not have been admitted at all." Bone Care Int'l, LLC v. Pentech Pharma., Inc., No. 08-cv-1083, 2010 WL 3894444, at *1 (N.D. Ill. Sept. 30, 2010); see also SmithKlineBeecham Corp. v. Apotex, Corp., 247 F.Supp.2d 1011, 1042 (N.D. Ill. 2003) (Posner, J.) ("In a bench trial it is an acceptable alternative to admit evidence of borderline admissibility and give it the (slight) weight to which it is entitled."), vacated upon rehearing en banc and aff'd on other grounds, 403 F.3d 1331 (Fed. Cir. 2005).

ANALYSIS

A patent may not issue "if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains." See 35 U.S.C. § 103; see also In re Cyclobenzaprine Hydrochloride Extended-Release Capsule Patent Litig., 676 F.3d 1063, 1068 (Fed. Cir. 2012). Obviousness is a question of law based on the following factual findings: "(1) the scope and content of the prior art; (2) the differences between the claims and the prior art; (3) the level of ordinary skill in the art; and (4) objective indicia of nonobviousness." InTouch Techs., Inc. v. CGO Comm'cns, Inc., ___ F.3d ___, 2014 WL 1855416, at *16 (Fed. Cir. May 9, 2014) (citing Graham v. John Deere Co. of Kansas City, 383 U.S. 1, 17-18, 86 S.Ct. 684, 15 L.Ed.2d 545 (1966)). Courts must consider all four factors before reaching a conclusion regarding obviousness. Id.

The fourth factor, objective indicia of nonobviousness, "play[s] a critical role in the obviousness analysis." Leo Pharma. Prods., Ltd. v. Rea, 726 F.3d 1346, 1358 (Fed. Cir. 2013). The Federal Circuit has repeatedly emphasized that objective indicia "may often be the most probative and cogent evidence of nonobviousness in the record." See Mintz v. Dietz & Watson, Inc., 679 F.3d 1372, 1378 (Fed. Cir. 2012) (quoting Ortho-McNeil Pharma. v. Mylan Labs., Inc., 520 F.3d 1358, 1365 (Fed. Cir. 2008)). These indicia "provide objective evidence of how the patented device is viewed in the marketplace, by those directly interested in the product" at the time of the invention. See id. (quoting Demaco Corp. v. F. Von Langsdorff Licensing Ltd., 851 F.2d 1387, 1391 (Fed. Cir. 1988)). In doing so, they help "inoculate the obviousness analysis against hindsight." Id .; see also Graham, 383 U.S. at 36, 86 S.Ct. 684, 15 L.Ed.2d 545 (recognizing that the objective indicia of obviousness "guard against slipping into use of hindsight" and help "resist the temptation to read into the prior art the teachings of the invention in issue").

In some cases, evidence that the defendant or other competitors have copied a product embodying the claimed invention can provide objective evidence of nonobviousness.[2] See Wm. Wrigley Jr. Co. v. Cadbury Adams USA LLC, 683 F.3d 1356, 1364 (Fed. Cir. 2012). Courts, however, have questioned whether copying can serve as evidence of nonobviousness in the ANDA context. See Bayer Healthcare Pharmas., Inc. v. Watson Pharmas., Inc., 713 F.3d 1369, 1377 (Fed. Cir. 2013); Purdue Pharma Products L.P. v. Par Pharmaceuticals, Inc., 377 Fed.App'x 978, 983 (Fed. Cir. 2010). The Hatch-Waxman Act requires a generic drug manufacturer to demonstrate that its generic formulation has the same active ingredients, route of administration, dosage form, strength, and bioequivalency[3] as an already approved drug. See 35 U.S.C. § 355(j)(2)(A)(ii)-(iv). In Eli Lilly & Co. v. Zenith Goldline Pharmaceuticals, Inc., the District Court for the Southern District of Indiana found that, as a result of these requirements, evidence of copying carries little weight in the ANDA context, explaining that

[w]hen the invention in question is a drug that has won FDA approval as safe and effective, the incentive to copy is strong. In fact, the ANDA procedures established by the Hatch-Waxman Act require generic drug manufacturers to copy the approved drug. Variations undermine the FDA's ability to assume that if the patented ...

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