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Medicines Company v. Mylan, Inc.

United States District Court, Seventh Circuit

May 24, 2013

The Medicines Company
Mylan, Inc.


AMY J. ST. EVE, District Judge.

Before the Court is Plaintiff's Motion to Strike Defendants' Commercial Success Expert Opinions. (R. 212, Pl.'s Mot.) For the following reasons, the Court denies the Motion.


I. Patents-in-Suit

Plaintiff The Medicines Company ("TMC") brought this lawsuit against Defendants Mylan Inc., Mylan Pharmaceuticals Inc., and Bioniche Pharma USA, LLC (collectively, "Mylan" or "Defendants"), asserting that Mylan infringed U.S. Patent Nos. 7, 582, 727 ("the '727 Patent") and 7, 598, 343 ("the '343 Patent" and collectively with the '727 Patent, the "patents-in-suit"). The patents-in-suit pertain to pharmaceutical formulations of Bivalirudin and the processes of making Bivalirudin. (R. 1, Compl.) Bivalirudin is the active ingredient in Angiomax®, an anticoagulant drug used in patients with unstable angina who are undergoing percutaneous transluminal coronary angioplasty. ( Id. ¶¶ 11, 13.) TMC markets Angiomax®. ( Id. ¶¶ 11, 13.)

II. Current Discovery Dispute

On April 29, 2011, Mylan served its initial interrogatories. Interrogatory #2 asked TMC to identify "the factual and legal basis for any objective indicia of nonobviousness" that TMC contended supported the validity of its patents-in-suit. (R. 220, Defs.' Mem. in Opp. to TMC's Mot. to Strike, Ex. 1, at 6.) On October 16, 2012, TMC served a supplemental response to Mylan's Interrogatory #2 indicating its intention to rely on evidence of commercial success as a secondary consideration of nonobviousness. (Defs.' Mem., Ex. 8, at 12). Two days later, on October 18, 2012, Mylan deposed Mr. Anthony Flammia as a Rule 30(b)(6) witness for TMC, including on TMC's commercial success contentions. (Pl.'s Mot., Ex. 12, Flammia Dep.)[1] On November 30 and December 14, the parties exchanged "amended final" invalidity and validity contentions, respectively. On November 19, 2012, the Court amended the scheduling order and set the deadlines of February 8, 2013 for opening expert reports, March 8, 2013 for rebuttal expert reports, and April 8, 2013 for reply expert reports. (R. 173, Minute Order.)

During the initial round of expert reports, Mylan served the report of Mr. David Auslander, Ph.D., dated February 4 relating to the invalidity of TMC's patents-in-suit. (Pl.'s Mem. 4, Ex. 12.) On March 8, TMC responded with the rebuttal expert report of Professor Alexander M. Klibanov and TMC's Rule 26(a)(2) disclosures, which stated that Mr. Flammia "may testify regarding the commercial success of... Angiomax" as a non-retained expert. (Defs.' Mem. at 3, Ex.11.) Following Mylan's objection to TMC's Rule 26(a)(2) disclosure on the basis that TMC failed to disclose the opinions to which Mr. Flammia would testify at trial, TMC served an amended disclosure listing such opinions on March 21, 2013. (R. 214, Ex. 13.) On April 8, 2013-the deadline for the reply round of expert reports, - Mylan served the expert report of Ivan T. Hofmann addressing the issue of commercial success. (Defs.' Mem., Ex. 12.) Mylan had first disclosed Mr. Hofmann as an expert on February 26, 2013. (Pl.'s Mem., Ex. 4.) The parties met and conferred on March 19 and April 12 in an attempt to resolve the issue over the timing of the disclosure of Mr. Hofmann's report. TMC filed the present motion on April 17.

TMC contends that because Mylan bears the burden of proof on invalidity and obviousness, Mylan should have disclosed its expert report concerning commercial success as an indicia of nonobviousness with its initial round of experts reports on February 8 pursuant to Northern District of Illinois Local Patent Rule 5.1, which provides that within a certain time frame "each party shall make its initial expert witness disclosures required by Federal Rule of Civil Procedure 26 on issues for which it bears the burden of proof." L.P.R. 5.1. TMC additionally contends that Mylan's failure to disclose the report by the opening report deadline was willful and prejudicial. TMC seeks for the Court to strike Mr. Hofmann's opinions regarding commercial success, to preclude him from testifying about such issues at trial, and to prohibit Mylan from presenting any evidence related to commercial success. (Pl.'s Mem. 12.)

In response, Mylan argues that TMC has misinterpreted Federal Circuit precedent on the burden of production on commercial success as an indicia of non-obviousness as it relates to the order of disclosure of expert reports. Mylan further argues that TMC has played "hide-and seek" with its commercial success contentions and expert witness throughout the discovery process. Finally, Mylan asserts that any failure to timely disclose Mr. Hofmann's report was harmless pursuant to Federal Rule of Civil Procedure ("Rule") 37. (R. 219, Defs.' Mem. in Opp. to Pl.'s Mot. to Strike, at 22.)


I. Obviousness

"A patent may not issue if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains.'" In re Cyclobenzaprine Hydrochloride Extended-Release Capsule Patent Litig., 676 F.3d 1063, 1068 (Fed. Cir. 2012) (citing 35 U.S.C. § 103(a) (2006)). "Obviousness is a question of law based on underlying 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 considerations of nonobviousness." Id. Objective considerations of nonobviousness include, among other factors, the "commercial success of the patented invention." Id. at 1075. "[T]he ...

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