Case 1:14-cv-05575-PAC Document 38 Filed 10/17/14 Page 1 of 3
`Case 1:14-cv-05575-PAC Document 38 Filed 10/17/14 Page 1 of 3
`Case 1:14—Cv-02759—PAC Document 35 Filed lOllOl14 Page 1 of 3
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`Séiber
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`117051 NEVS n1 LAW
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`October 10, 2014
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`Jakob B. Halpern
`(973) 622-8394
`jhalpern@saiber.com
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`BY ECF & EMAIL
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`lion. Paul A. Crotty
`United States District Judge
`500 Pearl Street, Room 735
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`United States Courthouse
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`New York, NY 10007
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`Re: Kowa Company, Ltd. at at. v Aurobindo Pharma Limited at at, and related cases, l4-cv-
`2497-PAC, 14-cv-2647-PAC, 14-cv—2758, 14—cv—2759, l4—cv-2760-PAC, and l4—cv-557‘5-PAC.
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`Dear Judge Crotty,
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`Our firm, with Rakoczy Molino Mazzochi Siwik LLP, represents the Mylan Defendants
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`in this matter. We submit the within letter brief on behalf of all Defendants in the related
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`matters. This brief addresses the guestion of whether the burden is on Plaintiffs to come forward
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`first with expert opinions on secondary considerations in their expert reports, with Defendants
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`responding in a subseguent round.1
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`Argument:
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`Plaintiffs have the initial burden of production to identify any allegedly
`relevant secondary considerations they intend to present at trial.
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`Under the Supreme Court’s decision in Graham v. John Deere Ca, 383 US. 1, 17—18
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`(1966), an analysis of obviousness requires the Court
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`to consider any allegedly relevant
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`“secondary” considerations (sometimes called “objective evidence”) suggesting that a challenged
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`invention is non-obvious. Such secondary considerations may include, but are not limited to,
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`commercial success, long-felt but unsolved need, failure of others and copying. KSR Int’l Co. v.
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`1 For the convenience of the Court, Defendants sought to include a placeholder in the case
`schedule submitted today identifying those topics on which the Court had ordered letter briefing.
`Plaintiffs refused to include this. Thus, the non—inclusion of the issue in the proposed schedule
`should not be construed as a waiver by Defendants on the issue.
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`

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`Case 1:14-cv-05575-PAC Document 38 Filed 10/17/14 Page 2 of 3
`Case 1:14-cv-05575-PAC Document 38 Filed 10/17/14 Page 2 of 3
`Case 1:14«cv~02759-PAC Document 35 Filed 10/10/14 Page 2 of 3
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`Hon. Paul A. Crotty, U.S.D.J.
`October 10, 2014
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`Teleflex Inc, 550 U.S. 398, 406, 415 (2007); see also Ecolochem, Inc. v. S. Cal. Edison Co, 227
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`F.3d 1361, 1376 (Fed. Cir. 2000).
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`Although the accused infringer bears the ultimate burden of proof as to obviousness, the
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`patentee bears the burden of production with regard to secondary consideration evidence. See
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`Crocs, Inc. v. Int’l Trade Comm ‘n, 598 F.3d 1294, 1310-11 (Fed. Cir. 2010) (requiring that the
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`patentee “shows both that there is commercial success” and nexus before “the burden of coming
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`forward with evidence in rebuttal shifts to the challenger”); Ecolochem, 227 F.3d at 1376
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`(producing evidence of secondary considerations was plaintiff’s burden); Demaco Corp. v. F.
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`Van LangsdorjfLicensing Ltd, 851 F.2d 1387, 1392-93 (Fed. Cir. 1988) (patentee has burden of
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`coming forward with evidence of secondary considerations and their nexus to the patented
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`invention); see also In re Cyclobenzaprtne Hydrochloride Extended-Release Capsufe Patent
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`Ling, 676 F.3d 1063, 1075, 1078-79, 11. 5 (Fed. Cir. 2012). This rule makes common sense, as
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`defendants typically have no way of anticipating which,
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`if any, of the several categories of
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`secondary evidence the patentee will seek to rely on at trial.
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`Accordingly, Defendants respectfully submit that Plaintiffs should be required to disclose
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`their opinions and evidence of secondary considerations before Defendants are obligated to
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`provide any rebuttal evidence.
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`In particular, Defendants request that Plaintiffs be required to
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`identify any allegedly relevant secondary considerations and related opinions in their opening
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`expert reports due on December 15, 2015.2 This will afford Defendants an opportunity to rebut
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`Plaintiffs’ evidence of secondary considerations of non—obviousness rather than guess as to what
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`Plaintiffs’ may be. To do otherwise would be prejudicial and unjust to Defendants.
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`2 At the very least, such disclosure certainly should not be delayed past the second round of
`expert reports, due on January 29, 2016, so that Defendants have the opportunity to respond in
`the final round of expert reports.
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`2
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`

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`Case 1:14-cv-05575-PAC Document 38 Filed 10/17/14 Page 3 of 3
`Case 1:14-cv-05575-PAC Document 38 Filed 10/17/14 Page 3 of 3
`Case 1:14—Cv—02759-PAC Document 35 Filed 10i10/14 Page 3 0f 3
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`Hon. Paul A. Crotty, U.S.D.J.
`October 10, 2014
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`Accordingly, Defendants respectfully request that this Court order the following:
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`Defendants are not obligated to address secondary considerations in their opening round
`of expert
`reports.
`Plaintiffs
`shall provide their expert opinions on secondary
`considerations no later than December 15, 201 5.
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`Respectfully submitted,
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`fs Jakob B. Halpern
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`Jakob B. Halpern
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`cc:
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`All counsel of record (by ECF & email)
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