Case 1:14-cv-02758-PAC Document 29 Filed 10/10/14 Page 1 of 3
`ED\A'\RDS
`EDWARDS WILDMAN PALMER LLP
`III HUNTINGTONAVENUE
`BOSTON, MA 02I99
`WILDAAAN
`+l 617 239 0 I 00 moin +l 617 227 4420 Íox
`edwordswildmon com
`
`David G. Conlin
`P artn er
`+l 617 517 5515
`/ax +1 888 325 9129
`dconl in@edwardswi ldman com
`
`October 10,2014
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`VIA ECF AND U.S. MAIL
`
`Hon. Paul A. Crotty, United States District Judge
`United States Courthouse
`500 Pearl Street, Room 735
`New York, NY 10007
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`Re
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`Kowa Company Ltd., et al. v. Aurobindo Pharmq Ltd., et al., and related cases
`C.A. No. l4-cv -2497, -27 58, -2647, -27 60, -27 59, -557 5 (S.D.N.Y.) (PAC)
`Letter Brief on Indefiniteness Defense
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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-captioned litigation. Pursuant to this
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`Court's Order from the October 6,2014 Conference, we respectfully submit this letter brief in
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`opposition to Defendants' request that the Court include a disposition of Defendants' yet-
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`unspecified indefiniteness defense(s) as part of any Markman proceeding. Defendants are
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`essentially trying to create an opportunity to seek a premature final determination of an
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`indefiniteness defense(s) before the factual and expert evidence on the issues are obtained.
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`"[T]he weight of the jurisprudence disfavors indefiniteness determinations at the
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`Markman stage of patent litigation." CSB-System Intern. Inc. v. SAP America, Inc., No. 10-
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`2156,201 1 V/L 3240838, at *19 n. 16 (8.D. Pa. Jul. 28,2011)). This District has "refrainfed]
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`from ruling on this issue of indefiniteness prior to trial." In re OxyContin Antitrust Litig., 04
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`MD. 1603 SHS, 2014 WL2198590, at*4 (S.D.N.Y. i|/.ay 27,2014) (citing In re OxyContin
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`Antitrust Litig.,965 F. Supp. 2d 420, 432 n.3 (S.D.N.Y. 2013); Alcon Research, Ltd. v. Barr
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`Labs. Inc.,No. 09-cv-0318, 2011 WL 3901878, at*16 (D. Del. Sept. 6, 20ll). Similarly, in
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`Case 1:14-cv-02758-PAC Document 29 Filed 10/10/14 Page 2 of 3
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`EwlPage
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`Alcon Research, Ltd., an ANDA case relied on by this District in the In re OxyContin Antitrust
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`Litig, suprq, the District of Delaware concluded that "the indefiniteness issue is best decided at
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`trial and [we] defer consideration on it until that time." 2011 WL 3901878, at*76 (collecting
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`cases). "[S]everal well-settled principles tend to discourage such rulings at the Markman stage."
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`CSB-System Intern. Inc., 2071 WL 3240838, at * 77 . First, "there is a high burden of proof on a
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`party challenging [a] patent based on indefiniteness, which is difficult to meet at the early stages
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`of litigation." 1d Second, "unlike a Markman proceeding that gives meaning to patent claims,
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`indefiniteness invalidates claims entirely." Id. at*18; accord, Koninklijke Philips Electronics
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`N.V. v. Zoll Med. Corp.,9l4F. Supp.2d89,101 (D. Mass.2012).
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`Moreover, issues of indehniteness are often the subject of a "'largely factual' inquiry";
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`thus, the ensuing "'battle of the expefts' is not, therefore, properly resolved at the claim
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`constructionphase. Koninklijke Philips Elect. N.V.,914 F. Supp.2dat101(quoting Takeda
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`Pharm. Co. v. Handa Pharms.,LLC,20|2WL 1243109, at *16 G\f.D. Cal. Apr. ll,2012).
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`While "[i]t may be true that determining the indefiniteness of claim language is a question of law
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`'that is drawn from the courl's performance of its duty as the construer of patent claims,'which
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`is the same duty that gives rise to lhe Marlvnanheaúng. . . this does not outweigh the ...
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`practical considerations that militate against determining indefiniteness prior to the end of fact or
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`expert discovery." C,SB-,S/stem Intern. Inc.,2011 WL 3240838, at*17-I9 (quoting Exxon
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`Research&Eng'gCo. v. {1S.,265F.3dI37I,1375 (Fed.Cir.200l);[MaddingtonN.Am., Inc.v.
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`Sabert Corp., No. CIV.A.09-4883, 2010 WL 4363137, at *3 (D.N.J. Oct. 27,2010)); see also
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`Computer Stores Nw., Inc. v. Dunwell Tech, Inc.,CY-I0-284-H2,20I1 WL 2160931, at *38 (D.
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`Or. May 31,2011) ("[A]ny argument regarding invalidity of the claim for . . . indefiniteness of
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`Case 1:14-cv-02758-PAC Document 29 Filed 10/10/14 Page 3 of 3
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`the claim is 'neither appropriate nor acceptable at the claim construction stage.")
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`Finally, while the U.S. Supreme Court recently clarihed the standard for indefiniteness
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`under 35 U.S.C. S 1 12, l2 in Nautilus, Inc. v. Biosig Instruments, Inc., 134 S. Ct. 2120,189 L.
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`Ed. 2d 37 (2014), nothing in that opinion negates the weight of authority finding that
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`indefiniteness should be addressed after Markman.t If anything, the clarified standard of the
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`Nautilus case heightens the importance of obtaining the factual and expert evidence on the issue
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`before ruling on indefiniteness. As with any invalidity defense, the presumption is that the
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`claims are valid, and invalidity must be proven by clear and convincing evidence.
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`This Court should, therefore, deny defendants' request to deviate from the "weight of the
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`jurisprudence disfavor[ing] indefiniteness determinations at the Markman stage of patent
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`litigation," CSB-System Intern. únc.,2071 WL 3240838, at *19 n.16. Consistent with practice in
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`this District, the Court should "refrain[] from ruling on this issue of indefiniteness prior to trial."
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`In re OxyContin Antitrust Litig.,2014 WL 2198590, at *4.
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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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`David
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`Conlin
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`I Contrary to defense counsel's representation at the October 6,2014 Conference, the Supreme
`Court's decision in Nautilus did not isolate the analysis of indefiniteness from the subsidiary fact
`findings historically underpinning that determination. 134 S. Ct. 2129, n.10. To the contrary,
`the Court noted that no party raised "any contested factual matter," and specifically declined to
`address the evidentiary burden pertaining to such fact issues, noting, "[w]e leave these questions
`for another day." Id.
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