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The Medicines Co. v. Mylan Inc.

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

May 15, 2014

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

MEMORANDUM OPINION AND ORDER

AMY J. STEVE, District Judge.

This is a patent infringement action by The Medicines Company ("TMC") against Defendants Mylan, Inc., Mylan Pharmaceuticals Inc. and Bionche Pharma USA, LLC alleging infringement of United States Patent No. 7, 582, 727 (the "727 patent"), a product patent.[1] In advance of trial, Defendants move to preclude three TMC experts, Dr. Alexander Klibanov, Gerald Mossinghoff, and Anthony Flammia, from offering opinions that assume the asserted claims in the 727 patent require the invention to meet specified maximum Asp9-bivalirudin impurity levels only "consistently." ( See R. 342.) Defendants claim that the opinions at issue are inconsistent with TMC's argument on summary judgment that the asserted claims do not contain a "consistently" limitation, and judicial estoppel therefore precludes TMC from introducing these opinions at trial. ( See R. 343.) For the following reasons, the Court grants Defendants' motion in part, denies it in part, and reserves ruling until trial in part.

BACKGROUND

I. The 727 Patent

The 727 patent is a product patent that pertains to pharmaceutical formulations of a drug product comprising bivalirudin as the active ingredient. Bivalirudin is the active ingredient in Angioma®, an injectable anticoagulant used in patients with unstable angina who are undergoing percutaneous transluminal coronary angioplasty. (R. 1, Compl. ¶¶ 11, 13.) 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 Angiomax®. TMC claims that the bivalirudin drug product proposed in Mylan's ANDA infringes claims 1-3, 7-10, and 17 of the 727 patent. Claim 1 is an independent claim, and the remaining asserted claims depend on Claim 1. Claim 1 states:

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, wherein the batches have a maximum impurity level of Asp9-bivalirudin that does not exceed about 0.6% as measured by HPLC.

Each asserted claim contains a limitation requiring the pharmaceutical batches at issue to have "a maximum impurity level of Asp9-bivalirudin that does not exceed about 0.6%" or less.[2]

II. Procedural History

In June 2013, Defendants moved for summary judgment of non-infringement or, in the alternative, invalidity. ( See R. 276.) One of the issues Defendants raised on summary judgment was whether the asserted claims require the invention to meet the maximum Asp9 impurity levels recited in the patent all of the time or only "consistently." Defendants argued that TMC's claim fails under either interpretation. If the asserted claims require that all pharmaceutical batches meet the maximum Asp9 impurity levels, Defendants argue that TMC's infringement claim fails because TMC cannot prove that Mylan's proposed bivalirudin product will always have maximum Asp9 impurity levels below about 0.6%. ( See R. 276, Defs. Summ. Jdgmt. Br. at 20-21.) If, on the other hand, the asserted claims require the pharmaceutical batches to meet the maximum Asp9 impurity levels only "consistently, "[3] Defendants argue that the asserted claims are invalid as anticipated by TMC's Original Angiomax® product, which had a maximum Asp9 impurity level below about 0.6% more than 87% of the time. ( See id. at 21-24.)

In response to Defendants' anticipation argument, TMC argued against reading a "consistently" limitation into the asserted claims. ( See R. 290, TMC Summ. Jdgmt. Resp. Br. at 30-31.) TMC pointed out (as Defendants also had) that the term "consistently" appears nowhere in the asserted claims and reading the term into the claims would improperly rewrite them. ( Id. at 31.) Based on TMC's representations, the Court decided not to address Defendants' anticipation argument on the merits because, in the end, neither side had advocated for reading "consistently" into the asserted claims. ( See Summ. Jdgmt. Op. at 42 n.9.) Both sides, in fact, expressly argued against interpreting the claims as containing a "consistently" limitation. ( See id. )

In the present motion, Defendants argue that the Court should prevent TMC and its experts from backsliding on TMC's argument on summary judgment that the asserted claims do not contain a "consistently" limitation. Specifically, Defendants seek to exclude TMC's experts from offering testimony "premised upon the assumption that the 727 patent claims require that the Asp9 maximums recited therein be met only consistently.'" (R. 342, Defs Mot. at 1.)

LEGAL STANDARD

"The admissibility of expert testimony is governed by Federal Rule of Evidence 702 and the Supreme Court's opinion in Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579, 113 S.Ct. 2786, 125 L.Ed.2d 469 (1993)." Lewis v. Citgo Petroleum Corp., 561 F.3d 698, 705 (7th Cir. 2009). Rule 702 provides, in relevant part, that "[i]f scientific, technical or other specialized knowledge will assist the trier of fact to understand the evidence or to determine a fact in issue, a witness qualified as an expert by knowledge, skill, experience, training or education, may testify thereto in the form of an opinion...." Id . See also Happel v. Walmart Stores, Inc., 602 F.3d 820, 824 (7th Cir. 2010).

Under the expert-testimony framework, courts perform the gatekeeping function of determining whether the expert testimony is both relevant and reliable prior to its admission at trial. See id. ; Power Integrations, Inc. v. Fairchild Semiconductor Int'l., Inc., 711 F.3d 1348, 1373 (Fed. Cir. 2013). In doing so, courts "make the following inquiries before admitting expert testimony: first, the expert must be qualified as an expert by knowledge, skill, experience, training, or education; second, the proposed expert must assist the trier of fact in determining a relevant fact at issue in the case; third, the expert's testimony must be based on sufficient facts or data and reliable principles and methods; and fourth, the expert must have reliably applied the principles and methods to the ...


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