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`Case 1:14-cv-02758-PAC Document 31 Filed 10/11/14 Page 1 of 3
`RDS
`EDWARDS WILDMAN PALMER LLP
`IIIHUNTINGTONAVENUE
`BOSTON, MA 02I99
`N
`+1 ó17 239 0'l 00 moin +1 ó17 227 4420 lox
`edwordswildmon cor¡
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`October I0,201.4
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`VIA ECF AND U.S. MAIL
`
`David G. Conlin
`Partn er
`+1 617 517.5515
`fax +1 888 325 91293
`dcon lin@edwardswild man. com
`
`Hon. Paul A. Crotty, United States District Judge
`United States Courthouse
`500 Pearl Street, Room 735
`New York, NY 10007
`Re: Kowa Company Ltd., et al. v. Aurobindo Pharma Ltd., et al., and related cûses
`C.A. No. l4-cv-2497, -2758, -2647, -2760, -2759, -5575 (S.D.N.Y.) (PAC)
`Letter Brief on Contention Interrogatories
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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. Pursuant to this
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`Court's Order from the October 6,2014 Conference, we respectfully submit this letter brief on
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`Defendants' request to deviate from Local Rule 33.3(c) regarding contention interrogatories
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`relating to preliminary infringement and invalidity contentions.
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`Hatch-Waxman litigation differs drastically from a typical patent litigation. Ordinary
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`infringement plaintiffs have the advantage of being able to investigate infringing products, which
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`are on the market and available prior to suit. This is not the case in Hatch-Waxman cases.
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`Hatch-Waxman plaintiffs have little information about the infringing generic drug product
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`because it is not yet available prior to FDA approval. See Eli Lilly & Co. v. Medtronic, lnc.,496
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`U.S. 661, 678 (1990); In re Fenofibrate Patent Litig.,910 F. Supp. 2dat7l4. ANDA filings are
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`confidential, and generic defendants are not required to provide patentholders with any ANDA
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`information beyond the paltry information contained in a Paragraph IV notice, "most commonly
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`the only knowledge that the pioneer company has of the ANDA." Hon. D. Folsom, E.D. Tex.
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`Case 1:14-cv-02758-PAC Document 31 Filed 10/11/14 Page 2 of 3
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`Gen. Order Il-3, at2I-22 (Mar. 15,20Il) (implementing Hatch-Waxman local patent rules).
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`ANDAs are typically extremely complicated, and voluminous.
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`Because Hatch-V/axman actions are based on artificial acts of infringement by
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`hypothetical products described in defendants' ANDAs, the ANDAs themselves are essential to
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`any infringement analysis. Medicines Co. v. Mylan Inc.,11-CV-l285,2013 WL 6633085, at*20
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`Cf.D. Il1. Dec. 16,2013) ("infringement analysis under 5271(e)(2)(A) is necessarily a
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`'hypothetical inquiry . . . properly grounded in the ANDA application and the extensive
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`materials typically submitted in its support'."); see also Ferring B.V. v. TVatson Labs., Inc.-
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`Florida,2014-1416,2014 WL 4l 16461, at *7; Abbott Labs. v. TorPharm, [nc.,300 F .3d 1367 ,
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`1373 (Fed. Cir.2002). Thus typical patent rules, such as Local Patent Rule 6, do not apply
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`reasonably to Hatch-Waxman cases. Patent Rule 6 calls for Plaintiffs to produce asserted claims
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`and infringement contentions within 45 days of the Scheduling Conference. In this case, there is
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`nothing to ensure that any of the Defendants will even produce their ANDAs within that period,
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`much less that Plaintiffs would have any significant time for analysis of any ANDAs produced.
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`Hatch-Waxman Plaintiffs should not be required to produce infringement contentions at least
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`until after all defendants have produced their complete ANDAs and Plaintiffs have had
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`reasonable time to analyze them.
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`Recognizing this difhculty, Federal District Courts including the District of New Jersey,
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`Eastern District of Texas, and Northern District of Ohio have adopted special local patent rules
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`specific to Hatch-'Waxman litigation, which require very early disclosure of the defendants'
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`ANDAs and further require the disclosure of defendants' invalidity and noninfringement
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`contentions to be made before plaintiffs' infringement contentions. S¿¿ D.N.J. L. Pat. R. 3.6;
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`Case 1:14-cv-02758-PAC Document 31 Filed 10/11/14 Page 3 of 3
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`E.D. Tex. P. R. 3-8; N. D. Ohio L. P. R. 3.9.
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`Since Local Patent Rule 6 does not reasonably apply to this Hatch-Waxman litigation,
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`and this Court has no special Hatch-Waxman rules, Plaintifß contend that Local Rule 33.3(c)
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`should apply to these contentions, as it does to other contention interrogatories.
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`In an effort to compromise the issue, plaintiff proposed a date of March 30, 2015 , which
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`should be a reasonable time after the six defendants produce their ANDAs, for Plaintiffs to
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`provide asserted claims and preliminary infringement contentions, and adate of April 30,2015
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`for Defendants to provide their preliminary invalidity contentions. Defendants have rejected
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`that compromise, and proposed that Plaintiffs should provide their asserted claims and
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`infringement contentions within 30 days of each defendant's production of its ANDA, or in any
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`event by February 2,2015. It is patently unreasonable for Defendants to unnecessarily require
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`Plaintiff to analyze six ANDAs within thirty days.1
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`Since the local patent rules do not apply well in ANDA cases, the contentions of both
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`sides should be treated as general contentions under Local Rule 33.3(c). Alternatively, this
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`Court should allow Plaintiffs' sufhcient time to analyze the ANDAs of the six defendants prior
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`to serving infringement contentions.
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`Thank you for your consideration.
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`cc
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`Counsel of record (via ECF)
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`avid G. Conlin
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`I The only reason identified by Defendants in support of their effort to force anafüftcially rushed
`deadline upon Plaintiffs is a purported concern about Markman deadlines. Plaintiffs suggested
`that the reasonable approach to address that concem would be to adjust the Markman deadlines
`correspondingly, which would not ¡affect any other deadlines.
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`