Free Letter - District Court of Delaware - Delaware

Case 1 :04-cv—00968-GIVIS Document 81 Filed 05/23/2005 Page 1 of 3
FISH SL RICHARDSON P. C.
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Frederick P. Fish 19899‘1114
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May 23, 2005 fj§g‘;]g6O7
The Honorable Gregory M. Sleet Web Sire
United States District Court www‘LL‘OOm
844 King Street, Room 4324
Wilmington, DE 19801
Re: Allergan, Inc. v. Alcon Laboratories, et al.
USDC—D. Del. - Civil Action No. 04-968-GMS
® Dear Judge Sleetz
AUSTIN In the Scheduling Order (D.I. 30), the Court asked the parties to brief whether
BOSTON Allergan can assert a claim of willful infringement. Effectively conceding that
DALLAS Allergan can, [Alcon’s Letter Brief, at 2, D.I. 75], and missing that Allergan is not
EEEAWAEE required to prove its claim at this point, Alcon prematurely argues the merits in an
NW YORK attempt to justify its violation of the Court’s Scheduling Order—-clearly leading to the
SAN DIEGO conclusion that further discovery is warranted.
LLLLCON VALLEY As set forth in Allergan’s Motion to Strike (D.I. 68), Alcon, in violation of the
T“""" C"‘“ COUITLS limited pennission given in the Scheduling Order, brought summary
vMH1~¤1<>N» ¤¤ judgment on grounds not disclosed to the Court or to Allergan in either the Paragraph
IV certification or in its discovery responses. In its response to Allergan’s Letter
Brief regarding willfulness (D.I. 75), Alcon devotes several pages to justifying its
deviation from the Scheduling Order. That issue is thoroughly addressed in
Allergan’s Motion to Strike and will be addressed by the parties in additional briefing
on the issue; accordingly, it will not be addressed any f`urther here. Rather, this reply
shall remain focused on the briefing requested by the Court, whether a claim of
willful infringement is legally cognizable in an action brought under 35 U.S.C.
§ 271(e)(2)—and, as Alcon has already conceded, it is.
As is clear from Allergan’s opening letter, Alcon’s response, and the cited case law,
willful infringement is legally cognizable in a § 27l(e)(2) action; accordingly,
discovery on the topic is appropriate. As Allergan set forth in its opening letter on
willfulness, the Federal Circuit in Glaxo did g hold that there could be no
willfulness in ANDA cases. Rather, the Court left open the possibility of willfulness
in cases involving litigation misconduct and/or baseless claims in a Paragraph IV
certification. [Allergan’s Letter Br. at 4, D.I. 64]
In its response, Alcon accurately quotes the Federal Circuit’s holding in Glaxo Group
Ltd. v. Apotex, Inc., 376 F.3d 1339, 1351 (Fed. Cir. 2004), but clearly fails to
appreciate the import of the language.

Case 1 :04-cv—00968-GIVIS Document 81 Filed 05/23/2005 Page 2 of 3
FISH 8c R1cHA1r1>soN 1>.c.
The Honorable Gregory M. Sleet
May 23, 2005
Page 2
Because 35 U.S.C. § 271(e)(2) is designed to create an artyicial
act of infringement for purposes of establishing jurisdiction in the
federal courts, we hold that the district court committed clear legal
error in finding that Apotex’s mere filing of an ANDA could form
the basis of a willful infringement finding. The district court did
not find that Apotex engaged in any litigation misconduct, and
Apotex did not file a paragraph IV certification of any kind, let
alone one that made baseless accusations of invalidity such as that
filed in Yamanouchi.
Id. at 1351 (underlined emphasis added).
Notably, the Federal Circuit here is commenting on what the district court did g
base its decision of willfulness. The district court found neither that Apotex had
engaged in any litigation misconduct nor that Apotex had filed a baseless paragraph
IV certification. The obvious implication from the Federal Circuit’s language in
Glaxo is that, if the district court had found either or both of these, the Federal Circuit
would have affirmed its finding of willful infringement.
Alcon’s reliance on Aventis Pharma Deutschland GMBH v. Cobalt Pharma., Inc.,
355 F.Supp.2d 586 ( D. Mass. 2005), is misplaced. First, there was no allegation of
litigation misconduct in that case. Second, the District Court’s decision carmot trump
the Federal Circuit’s decision. As Glaxo Group states (and Alcon has conceded), at
the very least, there can be willful infringement where the defendant has filed a
baseless paragraph IV certification and there is litigation misconduct. [Alcon’s Letter
Brief, at 2, D.I. 75].
In this case, Alcon g@ file a baseless paragraph IV as evidenced by Alcon’s
constantly changing position as to what "about 0.15% (w/v)" means. Alcon’s
Paragraph IV letter was based on an untenable construction of "about 0.15% (w/v)"
that was limited to the range of0. 1499% to 0.1501%. In light of the limited
discovery taken thus far, Alcon has had to completely abandon that position and now
asserts that "about 0.15%" means 0.15% 1 0.005%. Moreover, because of fatal flaws
in its argument, Alcon chose to move for summary judgment, not on the grounds set
forth in the Paragraph IV letter for which the Court granted permission, but instead on
the ground that the ’834 Patent does not disclose "therapeutically effective
concentrations." This change in tactics is litigation misconduct, in that it: 1) violates
the scheduling order; and 2) seeks to surprise Allergan with Alcon’s true arguments,
arguments that Allergan had no opportunity to test in discovery.
Moreover, with respect to the ‘337 patent, Alcon’s claim in footnote 1 is simply
unsupported by the testimony. To the extent Alcon’s claims in its Paragraph IV letter
were based on Mr. Espino’s tests, these claims were baseless. To the extent done

Case 1 :04-cv—00968-GIVIS Document 81 Filed 05/23/2005 Page 3 of 3
Fisu ay RICHARDSON 1>.c.
The Honorable Gregory M. Sleet
May 23, 2005
Page 3
properly, these tests demonstrate that povidone acts as a solubility enhancing
component, exactly as the patent says it will. And, as has been demonstrated in the
summary judgment and claim construction briefing, Alcon’s legal arguments for
excluding povidone from the claims ofthe ‘337 patent are based on a creative
reconstruction ofthe parent file history and ignore applicable caselaw.
Accordingly, Allergan should be permitted discovery on the willful infringement
issue. Alcon has conceded that willfulness is cognizable in an § 27l(e)(2) action, and
the enumerated circumstances for making such a claim that were not present in the
Glaxo Group case are present here.
Respectfully Submitted,
William J. .
WJM/cyw `
cc: Clerk, U.S. District Court
Josy Ingersoll, Esq. (Via ECF)
Brian Coggi·o, Esq. (Via Mail)
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