Free Letter - District Court of Delaware - Delaware

Case 1:05-cv-00337-SLR Document 154 Filed 06/29/2007 Page 1 of 2
Moms]ames
Mary B. Matterer
$02888.6960
[email protected]
June 29, 2007
The Honorable Sue L. Robinson
United States District Court
for the District of Delaware
844 N. King Street
Wilmington, DE 19801
Re: King Pharmaceuticals Research and Development, Inc. et al. v. Sicor Inc. et al.;
Civil Action N0. 05-0337-SLR
Your Honor:
We are writing pursuant to D.Del. L.R. 7.l.2(c) to call the Court’s attention to a new
Federal Circuit opinion decided after the post-trial briefing in this matter. On June 28, 2007, the
Federal Circuit decided its first pharmaceutical patent case involving obviousness since KSR and
affirmed the district court’s determination that the generic manufacturer defendants failed to
prove by clear and convincing evidence that the asserted claims of the patent at issue were
invalid as obvious under 35 U.S.C. § 103. Takeda Chem. Indus., Ltd. v. Alvhapharm Pty., Ltd.,
No. 06-1329 (Fed. Cir. June 28, 2007).
In Takeda, the Federal Circuit stressed that the teaching, suggestion, or motivation
("TSM") test retains an important role in obviousness analyses. (See id. at 10.) The court stated
that "[a]s long as the [TSM] test is not applied as a ‘rigid and mandatory’ formula, that test can
provide ‘helpful insight’ to an obviousness inquiry. Id. at 10 (quoting KSR Int ’l C0. v. T eleflex,
Inc., 127 S. Ct. 1727, 1731 (2007)). Moreover, the Federal Circuit stated that the Court in KSR
“acknowledged the importance of identifying ‘a reason that would have prompted a person of
ordinary skill in the relevant field to combine the elements in the way the claimed new invention
does’ in an obviousness determination." Id. ln view of this understanding, the Federal Circuit
upheld the determination of the district court that the prior art taught away from the claimed
invention, and further that a person of ordinary skill in the art would not have been motivated to
make the claimed invention. See id. at 10, 13, 16.
The Federal Circuit also addressed the "obvious to try" language in KSR. Id. at 15. In
particular, the court differentiated between predictable arts, where "there are a finite number of
identified, predictable solutions," and unpredictable arts, such as pharmaceutical development.
See id. (stating "[r]ather than identify predictable solutions for antidiabetic treatment, the prior
art disclosed a broad selection of compounds any one of which could have been selected as a
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Case 1:05-cv-00337-SLR Document 154 Filed 06/29/2007 Page 2 of 2
Monis]amesLt.»
The Honorable Sue L. Robinson
June 29, 2007
Page 2
lead compound for investigation."). Moreover, the court emphasized that the lead compound
selected by the inventors in Takeda was described in the prior art as exhibiting negative
properties that would have directed one of ordinary skill in the art away from that compound.
See id at 15.
Much like this case, the defendants in Takeda argued that the holding of Pfizer directly
supported their position. Id. at 15-16 (citing Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348 (Fed. Cir.
2007)). However, the Federal Circuit reiterated that the conclusion in Pfizer was based on the
“particularized facts" of that case. Id. at 15-16. The court contrasted the situation in Pfizer,
noting in Takeda that a person of ordinary skill in the art would not have chosen a compound that
was associated with the existence of toxicity or side effects. Id. at 16.
Plaintiffs respectfully submit that the Takeda case deserves careful consideration in the
Court’s determination in this action.
Respectfully, _Q
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ary . Matteyer #2696
mmatterer@m/onisjames.com
Enclosure
cc: Karen Keller, Esq. (via email & hand delivery)
Paul Crawford, Esq. (via email & hand delivery)
Annemarie Hassett, Esq. (via email & fedex)
Jonathan Muenkel, Esq. (via email & fedex)