United States District Court, S.D. New York
August 3, 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
Takeda brought suit against Mylan on October 17, 2003. In
Mylan's amended answer, it asserts that the "combination use"
patents are "invalid for failing to comply with one or more of
the requirements of 35 U.S.C. §§ 101, 102, 103, and 112." On
March 17, 2005, Takeda served on Mylan interrogatories and
requests for admission seeking to learn what, if any, claim of
the "combination use" patents Mylan is challenging and the
grounds for any such challenge. Mylan's responses were due by
April 25, but for various reasons were not served until June 6, a
week after the close of fact discovery ("June 6 Responses").
By letter of June 1, Takeda had argued that Mylan should be
precluded from challenging the validity or unenforceability of
the "combination use" patents at trial due to its refusal to
disclose the bases for its attacks. At a conference on June 14,
Takeda explained how Mylan's failure to disclose its theories
until June 6, and Mylan's related delay in producing a 30(b)(6)
witness, prejudiced Takeda in the completion of fact discovery
and preparation of its defense of the "combination use" patents.
Mylan agreed to produce witnesses, and if necessary reproduce
witnesses, to cure the prejudice Takeda identified. The Court
also adjusted the schedule for Takeda's production of its expert
report on these newly defined issues.
On July 15, 2005, Mylan served an expert report of Dr. Edwin D.
Bransome that asserts new theories of invalidity and identifies
seven new alleged prior art references, in effect materially
revising and expanding the June 6 Responses. Takeda requests in a
July 28 letter that Mylan be limited at trial to the specific
bases for its invalidity challenges that were identified in the
June 6 Responses. In its letter of August 1, Mylan does not give
any explanation for the change in its position, other than to say
that the June 6 Responses reflected its formulation "at that
time" of its bases to assert the invalidity of the "combination
use" patents, and that an expert may "refine" his opinion in
preparation for trial.
Mylan's having had over nineteen months to develop its theories
for challenging the validity of the "combination use" patents,
and having failed to identify any reason why it was prevented
from setting forth a complete identification of its theories in
its June 6 Responses, it is hereby
ORDERED that Mylan's attacks on the validity of the
"combination use" patents shall be limited to those identified in
its June 6 Responses. IT IS FURTHER ORDERED that Mylan shall serve a revised expert
report for Dr. Edwin D. Bransome conforming to this Order by
August 8, 2005.
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