United States District Court, S.D. New York
June 15, 2005.
TAKEDA CHEMICAL INDUSTRIES, LTD. and TAKEDA PHARMACEUTICALS, NORTH AMERICA, INC., Plaintiffs,
MYLAN LABORATORIES, INC. and UDL LABORATORIES, INC., Defendants.
The opinion of the court was delivered by: DENISE COTE, District Judge
MEMORANDUM OPINION AND ORDER
On September 8, 2003, defendant Mylan Laboratories, Inc.
("Mylan") sent a Notice of Paragraph IV certification to
plaintiff Takeda Chemical Industries, Ltd. ("Takeda"), in which
it informed Takeda that it had submitted an ANDA regarding the
sale of pioglitazone before the expiration of certain patents
("September 8 Notice"). In that notice, Mylan described its
belief that U.S. Patent No. 4,687,777 (the "`777 Patent") was
invalid on the basis of obviousness due to Compound 16 of U.S.
Patent No. 4,287,200 (the "`200 Patent"). Mylan asserted that
Compound 16 of the `200 Patent is identical to a Compound 14
identified in a prior publication of Dr. Sohda.
On March 17, 2005, Takeda served contention interrogatories on
Mylan, in which Takeda requested that Mylan detail its
contentions as to the invalidity of the `777 Patent. Mylan's
response of April 25, 2005 did not touch upon the obviousness of the `777 Patent. Instead, Mylan contended that the `777 Patent
was unenforceable on the basis that Takeda had breached its duty
of good faith and candor in applying to the PTO for the `777
Patent. Additionally, on June 2 and 3, 2005, Takeda deposed a
representative of Mylan pursuant to Rule 30(b)(6), Fed.R. Civ.
P. At that deposition, Takeda inquired as to the bases for
Mylan's contentions that the `777 Patent is invalid,
unenforceable, or not infringed, other than those disclosed in
the September 8 Notice. At several points, Mylan's counsel
objected to this line of questioning, citing the attorney-client
and work product privileges. After the close of fact discovery,
on June 6, 2005, Mylan served supplemental responses to Takeda's
interrogatories, in which it expresses that the `777 Patent is
invalid on the basis of obviousness due to a previously
unmentioned compound, Compound 57, as described in the Sohda
On June 14, Takeda wrote a letter seeking an order precluding
Mylan from introducing at trial any evidence as to invalidity of
the `777 Patent except based on obviousness as set forth in the
September 8 Notice. Pursuant to a June 15 Order, the parties
submitted additional correspondence concerning this issue. In its
submission, Mylan emphasizes Smithkline Beecham Corp. v. Apotex
Corp., No. 98 C 3952, 2000 WL 116082 (N.D. Ill. Jan. 24, 2000),
which it cites for the proposition that there is "no authority for limiting [a defendant] to the theories set
forth i[n] their notice letter."
Mylan misunderstands the law. Although as a general matter an
ANDA applicant may be able to assert theories other than those
outlined in a notification letter, "when the court has set and
the parties have agreed to a discovery period, that procedure
necessarily governs the trial. . . . [A] specific judicial
directive for the timing of discovery establishes the procedures
to which the parties are bound." ATD Corp. v. Lydall, Inc.,
159 F.3d 534, 551 (Fed. Cir. 1998). During the period of fact
discovery, Mylan never articulated any basis for the invalidity
of the `777 Patent on the ground of obviousness other than
Compound 14 of the Sohda publication. Therefore, it is hereby
ORDERED that Mylan may not offer at trial any evidence as to
invalidity of the `777 Patent except based on a theory of
obviousness set forth in the September 8 Notice.
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