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`3 of 32 DOCUIVIENTS
`
`TI-IE MEDICINES CO1‘/IPANY,Pl:1intiff, V. MYLAN INC., MYLAN
`PHARNIACEUTICALS INC., and BIONICHIE‘. PHARMA USA, LLC, Defendants.
`
`No. 11-cv—12S5
`
`UNITED STATES DISTRICT COURT FOR THE NORTHERN DISTRICT OF
`ILLINOIS, EASTERN DIVISION
`
`2014 US. D551. LEXIS 40724
`
`March 27, 2014, Decided
`March 27, 2014, Filed
`
`SUBSEQUENT HISTORY: Motion granted by, in pan,
`Motion denied by, in part Meds. Co. v. Myian Inc., 2014
`US. Dist‘. LEXIS 52952 (ND. Ill, Apr. 1 7, 2014)
`
`Chicago, IL; Scott D. Eads, PRO HAC VICE, Perkins
`Coie Llp, Portland, OR; Shannon M. Bloodworth, PRO
`HAC VICE, Perkins Coie Lip, Washington, DC.
`
`PRIOR HISTORY: Meds. Co. v. Pvfylrrn lnc., 2014 US
`Dist. LEWS ~I05I4 (ND. UL, ilrfar. 27, 2014)
`
`testimony,
`expert
`bivaiiruciin,
`TERNES:
`CORE
`standard,
`subject
`pliarnracetitical, batch,
`skill,
`legal
`matter, prior art, trier of fact, offering, training, patent,
`patent
`infringement,
`legal
`opinions.
`burden
`of
`estabtisliing,
`nonobvionsness,
`anticoagulant,
`infringement,
`compounding,
`obviousness,
`reliability,
`comprising, ingredient, invalidity, gatekeeper, invention,
`impurity, patented, reiiable, I1'l2lXiI‘{ll1lI1
`
`[*1] For The Medicines Company,
`COUNSEL:
`Plaintiff: David A. Zwaliy, Porter F. Fleming, Frommer
`Lawrence & Hang LLP, New York, NY;
`John
`Bostjancich, Patricia Susan Smart, Smart & Bostjancicta,
`Chicago,
`IL; Mark P Walters, Frommer Lawrence &
`Hang LLP, Seattle, WA.
`
`For M_v1an lnc., Mylan Pharmaceuticals lnc., Bioniclte
`Pharina USA, LLC, Defendants: David E. Jones, LEAD
`ATTORNEY, PRO HAC VICE, Autumn N. Nero, David
`J. Harth, Iimiiy J. Greb, PRO HAC VICE, Perkins Coie
`Lip, Madison, WI; James B Cougltlan, Perkins Coie LLP,
`
`For Bioniche Pharrna USA, LLC, Mylan Phannaceuticals
`lnc., Mylan In-3., Counter Ciaimantsz David E. Juries,
`LEAD ATTORNEY, PRO HAC VICE, Autumn N. Nero,
`David J. Hartli, Emily J. Greb, Perkins Coie Lip,
`Madison, WI; Scott D. Eads, LEAD ATTORNEY,
`Perkins Coie Llp, Portland, OR; James B Conghlan,
`Perkins Coie LLP, Chicago, IL; Shannon M. Bioedwonh,
`Perkins Coie Lip, Washington, DC.
`
`For The Medicines Company, Counter Defendant: John
`Bostjancich, Patricia Susan Smart, Smart & Bostjaricich,
`Chicago,
`IL; Mark P Walters, Frommer Lawrence &
`Hang LLP, Seattle,
`[*2] WA; Porter F. Fleming,
`Frommer Lawrence & Hang LLP, New York, NY.
`
`JUDGES: AMY J. ST. EVE, United States Disljicl
`Court Judge.
`
`0i’IN[ON BY: AMY J. ST. EVE
`
`OPINION
`
`MEM RAND M }’INI NAND RDER
`
`SENJU EXI-IIBIT 2337
`Lupin v Scnju.
`IPR20 I5-91097, II’R2Dl5~0l099,
`IPR2015-mmn K: tPR‘)n1«:_m1n::
`
`

`
`2014 U.S. Dist. LEXIS 40724, *2
`
`Page 2
`
`infringement action by The
`a patent
`is
`This
`Medicines Company ("TMC") against Defendants Mylan,
`inc., Mylan Pharmaceuticals Inc. and Bionclie Phanna
`USA, LLC alleging infringement of United States Patent
`No. 7,582,727 (the ‘"727 parem"),1 a product patent.
`TMC has moved to preclude Mylan's expert, Ivan T.
`Hofniann,
`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.
`
`The Court previously granted Mylan‘s
`1
`sunmiary judgment motion as to Unitecl States
`Patent No. 7,598,343 (the ‘"343 patent").
`(R.
`309.)
`
`I. Baekgrountl
`
`This action arises out of a patent infringement case
`involving the '72? Parent, The 272? patent "relates to a
`compounding process for preparing a pharmaceutical
`batcl1(es) of a drug product or
`a pliarinaceutical
`forn1ulation(s)
`comprising bivaiirudin as an active
`ingredient." ('7.?7patem‘ at col. 2 ll. 29-32) Bivalirudin is
`the active ingredient
`in Angiornax®, which is an
`anticoagulant drug [*3] used in patients with unstable
`angina who are undergoing percutaneous transluminal
`coronary angioplasty. (R. 1, Comp. at Ԥ]'1] 11, 13.) 'EMC
`markets Angiorna.\'®. (Id. it 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 coirunercial manufacture, use,
`sale, offer for sale, andfor importation of its generic
`Angiomax® product. TMC contends that Mylan‘s ANDA
`No. 202471 infringes certain claims of the '727 patent.
`Specifically,
`’lMC asserts that Mylan has infringed
`claims 1-3. 7-10 and i7 of the '72? parent. 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 blvalimdin (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 inaxiinum impurity level of
`Asp9-bivalirudin 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
`[*4] maximum impurity
`level
`of
`Asp9-bivalirudin that does not exceed about 0.6%." No
`claims in the '72? patent explicitly refer to "efficient
`mixing"
`or
`any
`other
`steps
`in
`the
`bivalirudtn
`compounding process.
`
`As a defense to this infringement action, Mylan has
`asserted that the '72? parent is obvious and t.hus 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 an to which said subject matter pertains.” In re
`Cyciobenzaprirre
`Hydr'ocfn'oride
`Extena‘ea‘—ReIease
`Capstrie Patent Lr'tr'g., 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 an;
`(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
`[*5} burden of
`establishing invalidity of a patent or any claim thereof
`shall
`rest on the party asserting such invalidity."
`A-ficrosofl Corp. v. Hi Ltd. Pishtp,
`U.S.
`, 13] S. Ct.
`2238, 2245, 180 L. Ed. 20‘ 131 (2011) (citing 35 U.S.C. §
`232).
`
`Mylan disclosed Mr. Hofmann to opine on the lack
`of commercial success of the 727' pal‘r:'m‘.2 TMC seeks to
`exclude certain of Mr.
`I-lot"mann's opinions on the
`grounds that lie is giving legal opinions.
`
`2 The Court previously struck the testimony of
`Th/.[C's
`expert on commercial
`success, Mr.
`Anthony Flannnia. (R. 406.)
`
`II. Legal Stantlartl
`
`"The admissibility of expert testimony is governed
`by Federal Rule of Eviderrce 702 and the Supreme
`Court's
`opinion
`in Daubert
`v. Merrell Dow
`PI1ar'rrmcerrticar!.s', 1116., 509 US. 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
`
`

`
`2014 l}.S. Dist. LEXIS 40724, *5
`
`Page 3
`
`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 Hopper’ v.
`Wnirrrart Stores, Inc., 602 F.3d 820, 824 (701 Cir. 2010).
`
`Under {*6} the expert-testirnony framework, courts
`perfonn the gatekeeping function of determining whether
`the expert testimony is both relevant and reliable prior to
`its admission at trial. See r'a‘.; Power Inregmtiorrs, Inc. B
`FairchiidSemiconductor1m"I., Inc, 711 F.3d 1348, 1373
`(Fed. Cir. 2013); United States v. Prmsier, 576 F.3d 726,
`737 (7th Cir. 2009) ("To determine reliability, the court
`should consider
`the proposed expert's full
`range of
`experience 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 lestirnon_v: first, the expert must be qualified as an
`expert by knowledge,
`skill, experience,
`training, or
`education; second,
`the proposed e.\pert must assist the
`trier of fact in detcrrniuirrg 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 ntust have reliably
`applied the principles and methods to the facts of the
`case." Lees v. Carthage College, 7}-if F.3d 5J6, 52]-22
`(7:11 Cir. 2013); see also Stoffirrgs v. Ryobi Teclrs, 1216.,
`725 F.3d 753, 765 (701 Cir. 2013); Power Im‘egrrItioIt.3‘.
`711 F.3c!at 1373; {*7] Pansier, 576 F.3d at 737. Mylan
`bears the burden of establishing that Mr. Hof1nann's
`testimony satisfies the mandates of Danbert and Rule
`702. Lewis v. CITGO Petroiermr Corp, 561 F.3d 698,
`705 (7th Cir. 2009).
`
`II}. Analysis
`
`Mylan disclosed Mr. Hofmann as its commercial
`success expert to opine on the lack of commercial success
`of the '72? patent. Mr. Hofnrarur 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. Hofrnann references the legal standard upon
`which he bases his economic analysis and opinions.
`Contrary to TMC's assertions, Mr. Hoffman is not
`offering an irnpertnissible legal opinion. Instead, he is
`merely setting forth his understanding of the legal
`standards upon which Ire relies for his opinions. This
`reference is appropriate and puts his testimony in context.
`See .Il.E ex rel. Evans 1:. Irrdep. Sch. Dist. No. 25, 936
`F.2d 472, 476 (10th Cir. 199}).
`
`Moreover, the trial in this case is a bench trial. The
`Court is fully aware of [*8] the law of obviousness and
`commercial success. The Court, as the trier of fact in this
`case, will not construe Mr. HoITrnan's corrtments or his
`understanding of
`the law on which he bases his
`cornmercial success opinions as any type of expert
`opinion on the law. Metavame Corp. v. Emigrant Sav.
`Bank, 619 F.3d 748, 760 (70: 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 »-
`iceeping unreliable
`expert testimony from the jury -- are not present in such a
`setting"); Urtired States v. Brown, 415 F'.3(I I25 7, 1269
`(11117 Cir. 2005) ("There is less need for the gatekeeper to
`keep the gate when the gatekeeper is keeping the gate
`only for hirn5ell'."). Accordingly, TMC's motion is
`denied.
`
`Date: March 27, 2014
`
`Is! Alli)’ J. St. Eve
`
`AMY J. ST. EVE
`
`United States District Court Judge
`
`

`
`+**+++++++ print Completed +******++*
`
`Time of Request: Saturday, April 30, 2016
`
`14:08:14 EST
`
`1825:559887235
`Print Number:
`Number of Lines: 148
`Number of Pages: 3
`
`107X5T
`
`Send TO:
`
`JUSTIN
`
`HASFORD,
`FINNEGAN
`901 NEW YORK AVE NW
`WASHINGTON, DC 20001-4413