The Medicines Company v. Mylan Inc. et al

Filing 410

MEMORANDUM Opinion and Order Signed by the Honorable Amy J. St. Eve on 3/27/2014:Mailed notice(kef, )

IN THE UNITED STATES DISTRICT COURT
NORTHERN DISTRICT OF ILLINOIS
EASTERN DIVISION
THE MEDICINES COMPANY,
Plaintiff,
v.
MYLAN INC., MYLAN
PHARMACEUTICALS INC., and
BIONICHE PHARMA USA, LLC,
Defendants.

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No. 11-cv-1285

MEMORANDUM OPINION AND ORDER
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”),1 a product patent. TMC
has moved to preclude Mylan’s expert, Ivan T. Hofmann, from offering opinions regarding the
legal requirements for commercial success, including his interpretation of relevant case law. For
the reasons set forth below, the Court denies the motion.
I.

Background

This action arises out of a patent infringement case involving the ’727 Patent. The ’727
patent “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 Angiomax®, which is an
anticoagulant drug used in patients with unstable angina who are undergoing percutaneous
transluminal coronary angioplasty. (R. 1, Comp. at ¶¶ 11, 13.) TMC markets Angiomax®. (Id.
¶ 13.)
In this case, TMC alleges that Mylan, before the expiration of the patent-in-suit,
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 its generic Angiomax® product. TMC contends that
Mylan’s ANDA No. 202471 infringes certain claims of the ’727 patent. Specifically, TMC
asserts that Mylan has infringed 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:
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The Court previously granted Mylan’s summary judgment motion as to United States Patent
No. 7,598,343 (the “’343 patent”). (R. 309.)

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 Asp9bivalirudin that does not exceed about 0.6% as measured by HPLC.
Each asserted claim in the ’727 patent 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%.” No claims in the ’727 patent explicitly refer to “efficient mixing” or any other steps in
the bivalirudin compounding process.
As a defense to this infringement action, Mylan has asserted that the ‘727 patent is
obvious and thus invalid under 35 U.S.C. § 103. “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 burden of establishing
invalidity of a patent or any claim thereof shall rest on the party asserting such invalidity.”
Microsoft Corp. v. i4i Ltd. P’ship, __ U.S. __, 131 S. Ct. 2238, 2245, 180 L. Ed. 2d 131 (2011)
(citing 35 U.S.C. § 282).
Mylan disclosed Mr. Hofmann to opine on the lack of commercial success of the ’727
patent. TMC seeks to exclude certain of Mr. Hofmann’s opinions on the grounds that he is
giving legal opinions.
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II.

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[,] . . . 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); United States v. Pansier, 576 F.3d 726, 737 (7th Cir. 2009) (“To
determine reliability, the court should consider the proposed expert’s full range of experience
2

The Court previously struck the testimony of TMC’s expert on commercial success, Mr.
Anthony Flammia. (R. 406.)
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and training, as well as the methodology used to arrive [at] a particular conclusion.”). 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 facts
of the case.” Lees v. Carthage College, 714 F.3d 516, 521-22 (7th Cir. 2013); see also Stollings
v. Ryobi Tech., Inc., 725 F.3d 753, 765 (7th Cir. 2013); Power Integrations, 711 F.3d at 1373;
Pansier, 576 F.3d at 737. Mylan bears the burden of establishing that Mr. Hofmann’s testimony
satisfies the mandates of Daubert and Rule 702. Lewis v. CITGO Petroleum Corp., 561 F.3d
698, 705 (7th Cir. 2009).
III.

Analysis

Mylan disclosed Mr. Hofmann as its commercial success expert to opine on the lack of
commercial success of the ’727 patent. Mr. Hofmann has a bachelor degree in business
administration with a double major in accounting and economics from the University of Notre
Dame. He is a certified public accountant and a certified licensing professional. He is not a
legal or technical expert.
In the course of offering his opinions on commercial success, Mr. Hofmann references
the legal standard upon which he bases his economic analysis and opinions. Contrary to TMC’s
assertions, Mr. Hoffman is not offering an impermissible legal opinion. Instead, he is merely
setting forth his understanding of the legal standards upon which he relies for his opinions. This
reference is appropriate and puts his testimony in context. See A.E. ex rel. Evans v. Indep. Sch.
Dist. No. 25, 936 F.2d 472, 476 (10th Cir. 1991).
Moreover, the trial in this case is a bench trial. The Court is fully aware of the law of
obviousness and commercial success. The Court, as the trier of fact in this case, will not
construe Mr. Hoffman’s comments or his understanding of the law on which he bases his
commercial success opinions as any type of expert opinion on the law. Metavante Corp. v.
Emigrant Sav. Bank, 619 F.3d 748, 760 (7th Cir. 2010) (observing that “the court in a bench
trial need not make reliability determinations before evidence is presented” because “the usual
concerns of the rule – keeping unreliable expert testimony from the jury – are not present in such
a setting”); United States v. Brown, 415 F.3d 1257, 1269 (11th Cir. 2005) (“There is less need
for the gatekeeper to keep the gate when the gatekeeper is keeping the gate only for himself.”).
Accordingly, TMC’s motion is denied.
Date: March 27, 2014
AMY J. ST. EVE
United States District Court Judge

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