E Case 1:14-cv-02758-PAC Document 28 Filed 10/10/14 Page 1 of 3
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`EDWARDS WILDMAN PALMER LLP
`II] HUNTINGTONAVENUE
`BOSTON, MA, O2199
`+l ó17 239 0l 00 moin +l 617 227 4420 Íox
`edwordswildmon cor¡
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`David G. Conlin
`P artner
`+t 6t7 5t7 5515
`/a* +l 888 325 9129
`dconli n@edwardswildman. com
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`October 10,2014
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`VIA ECF AND U.S. MAIL
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`Hon. Paul A. Crotty, United States District Judge
`United States Courthouse
`500 Pearl Street, Room 735
`New York, NY 10007
`
`Re
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`Kowa Company Ltd., et al. v. Aurobindo Pharma Ltd., et al., and related cases
`C.A. No. l4-cv-2497, -2758, -2647, -2760, -2759, -5575 (S.D.N.Y.) (PAC)
`Letter Brief on Expert Reports
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`Dear Judge Crotty:
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`We represent plaintiffs Kowa Company, Ltd., Kowa Pharmaceuticals America, Inc., and
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`Nissan Chemical Industries, Ltd. ("Plaintiffs") in the above-referenced matter. This letter sets
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`forth Plaintiffs' position regarding timing of expert reports addressing secondary considerations
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`or any obviousness opinions by Defendants' experts.
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`The Defendants in this case bear the burden of proof should they assert that any of the
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`asserted patents are invalid as obvious. Miuosoft Corp. v. i4i Ltd.,131 S. Ct.2238,2245 (2011)
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`("The burden of establishing invalidity of a patent or any claim thereof Shall rest on the party
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`asserting such invalidity."). This burden is set high - requiring proof by clear and convincing
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`evidence - and never shifts to the plaintiffs. See Novo Nordisk A/S v. Caraco Pharm. Labs. , Ltd. ,
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`719 F.3d 1346, 1353 (Fed. Cir. 2013) ("[A]s we have often held (most recently in
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`Cyclobenzaprine) . . ., this burden never shifts during the course of the litigation."); see also
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`Symbol Techs. Inc. v. Opticon 1nc., No. 86 CV 8736 KMW, 1990 V/L 58887 , at *6 (S.D.N.Y.
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`May 3,1990) ("The burden of proof is on the defendant to show invalidity by clear and
`convincing proof and that burden never shifts during the course of the litigation. *), aff'd935
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`Case 1:14-cv-02758-PAC Document 28 Filed 10/10/14 Page 2 of 3
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`F.2d 1569 (Fed. Cir. 1991). The Defendants' burden on this issue applies to each fact upon
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`which their obviousness positions are based. Symbol Techs,1990 V/L 58887 at *6 (citing
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`Carella v. Starlight Archery & Pro Line Co., 804 F .2d 13 5, 13 8 (Fed. Cir. 1986).
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`By contrast, the Plaintiffs bear no burden on the ultimate issue of obviousnes s. See
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`Orthokinetics, Inc. v. Safety Travel Chairs, Inc., 806 F .2d 1565, 1570 (Fed. Cir. 1986) ("[A]
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`patentee need submit no evidence in support of a conclusion of validity by a court or a jury.").
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`While secondary considerations have been characterized as rebuttal evidence, they must be
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`considered beþre any conclusions are drawn regarding obviousness. In re Cyclobenzaprine
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`Hydrochloride Extended-Release Capsule Patent Litig.,676F.3d1063,I075 (Fed. Cir.2012)
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`(hnding that the district court erred by reaching a "conclusion" regarding obviousness before
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`explicitly considering-and rejecting-the objective indicia evidence proffered by the patentee),
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`reh'g en banc denied (JuL.25,2012), cert. denied, 133 S. Cf. 933 (2013); see also Stratoflex, Inc.
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`v. Aeroquip Corp.,713 F .2d 1530, 1 538,218 USPQ 871, 879 (Fed. Cir. 1983) (holding that
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`"evidence rising out of the so-called 'secondary considerations' must always when present be
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`considered en route to a determination of obviousness."). To have formed a belief that apatent at
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`issue is obvious, Defendants must have accounted for secondary considerations. Se¡¿sonics, Inc.
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`v. Aerosonic Corp., 8 1 F. 3d 7566, 1071 (Fed. Cir. 1996) (finding opinion of counsel to be
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`flawed noting, "the opinion of counsel makes no mention of Aerosonic's copying and other
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`objective indicia of unobviousness, although precedent requires that these factors be
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`considered,") (citing Stratoflex).
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`Consistent with these cases and with defendants' ultimate burden, courts have required
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`that the party alleging invalidity address secondary considerations in its opening report. See e.g.,
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`Sanofi-Aventis v. Baru Labs., Lnc.,598 F. Supp.2d632,637 (D.N.J.2009) ("[A]lthough
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`Case 1:14-cv-02758-PAC Document 28 Filed 10/10/14 Page 3 of 3
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`secondary considerations may be characterized as rebuttal evidence, as a practical matter, there is
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`no compelling reason why Defendants should not address same in their opening report."); In re
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`Certain MEMS Devices and Products Containing the Same,Inv. No. 337-TA-700, 2010 ITC
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`Lexis 7123 , af * 7 (Jun. 29 , 2010) (" [R] espondents' initial expert reports addressing invalidity
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`should have, and clearly could have, included a section addressing secondary considerations").
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`In this District, Judge Cote recently reached the same conclusion (in responding to the position
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`advanced by Mylan's counsel in a different Hatch-V/axman case). SeeEx. A (Mar. 25,2013
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`Order in Case No. 12-cv-0024 (DLC) (interpreting the Federal Rules to require that initial expert
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`reports be "complete" and refusing to allow defendants to file a supplemental expert report
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`addressing secondary considerations after plaintiffs' expert report).
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`Defendants' attempt to put their heads in the sand and ignore these key obviousness
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`considerations in their expert reports addressing obviousness is a transparent attempt to facilitate
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`reaching an obviousness conclusion without considering all of the relevant evidence. Defendants
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`should not be permitted to ignore the unexpected results achieved by Livalo@, the extensive
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`commercial success of Livalo@, the number of pharmaceutical companies who are so anxious to
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`copy Livalo@ that they are willing to conduct extensive litigation in this Court, and all the other
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`secondary indicia of non-obviousness. Simply put, there is no reason for Defendants not to
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`address secondary considerations in their opening expert reports.
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`Thank you for your consideration.
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`cc: Counsel of Record (Via ECF)
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`Davicl
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