Free Letter - District Court of Delaware - Delaware

Case 1 :05-cv-00336-SLR Document 160 Filed 07/11/2007 Page 1 of 2
YOUNG CONAWAY STARGATT & TAYLOR, LLP
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kkc;]€,.@ycSE_cOm EDWARD B. MAxwEt.t, iso
July il, 2007
VIA CM/ECP
The Honorable Sue L. Robinson
United States District Court for the District of Delaware
844 N. King Street
Wilmington, DE l980i
Re: Item Devel0pr1zerztAB, et al. v. Sicor Inc., et al.
Civil Action No. 05-336~SLR
Dear Judge Robinson:
This firm, along with Goodwin Procter LLP, represents Defendants Sicor Inc. and Sicor
Pharmaceuticals, Inc. ("collectiveiy Sicor”) inthe above~captioned case. I write in response to
the June 29, 2007 submission to the Court by Plaintiffs Astellas US LLC, Astellas Pharma US,
Inc., and Item Development AB (coilectiveiy "Plair1tiffs”), which seeks to bring to the Court’s
attention a recent Federal Circuit case, Takeda Chem. Indus., Ltd. v. Alphapharm Pty., Ltd., No. _
06-1329 (P ed. Cir. June 28, 2007). Sicor disagrees that Takeda is pertinent authority here and
instead believes that Takeda is readily distinguishable on a number of grounds.
The analysis in Takeda is inapposite here because it is expressly directed to the
obviousness of claims involving structural features of a pharmaceutical compound. Claims to
chemical compounds are evaluated under a specific set of standards, as the courts have long
given speciai consideration to medicinal chemistry as an especialiy unpredictable art. See 1*).1.
159, slip op. at 9. In Takeda, the claims at issue concerned "new chemical compounds" that
resulted from “specitic molecular modification? to a "iead compound” during the
pharmaceutical development process. See, e. g., D.I. 159, slip op. at 9-i0. Takeda repeatedly
refers to a motivation to seiect a lead compound as a requirement for finding that a claimed
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Case 1:05-cv-00336-SLR Document 160 Filed 07/11/2007 Page 2 of 2
YOUNG CONAWAY STARGATT & TAYLOR, LLP
July ll, 2007
Page 2
chemical compound is obvious. See, ag., D.i. 159, slip. op. at 5. Takeda likewise emphasizes
the need to identify a reason that would have led a chemist to modify the lead compound ‘°in a
particular manner” in order to establish a prima facie case of obviousness. See, e. g., lll. 159,
slip op. at 10.
By contrast, the asserted claims in this case are directed, not to any new chemical
compound, but to methods of use of a naturally—occurring substance (adenosine) that has been
known for decades. The standards for new chemical compounds, including the selection of a
‘°lead compound," simply do not apply. The asserted claims recite only a method of use of an
old compound, involving the simple substitution ofthe direct—acting agent (adenosine) for the
indirect acting agent (dipyridamole). The guidance set forth in Takeda concerning the structural
obviousness of new chemical compounds is thus irrelevant to this case, as no compound claims
are at issue here.
n Moreover, and contrary to l?laintiffs’ suggestion, the Federal Circuit did not advocate a
broad return to the teaching, suggestion, or motivation ("TSM") test. Such a return would be
contrary to the Supreme Court’s clear directive in ICSR v. Im"! Co. v. Teleflex Inc., 127 S. Ct.
I727 (2007). ln Takeda, the Federal Circuit echoed the Supreme Court’s instruction that the
TSM test should not he applied as a "rigid and mandatory t`ormula" and carefully limited its
holding to obviousness of chemical compounds. See D.I. 159, slip op. at l0 (emphasis added).
As discussed above, the present case does not concern the narrow category of chemical
compound patents. Accordingly, the more flexible test set forth in KSR, which takes into
account "inferences and creative steps that a person of ordinary skill in the aft would employ"
should be applied. {CSR, 127 S. Ct. l'/4l.
Sicor will be prepared to discuss the distinctions between Takeda and the present case
during the oral argument to be held on July 27th.
Res ectfully submitted,
1 r , ’ F .
./ dm: /69
aren E. Keller (#4489)
cc: Clerk ofthe Court (by CM/ECF and hand delivery)
Charles E. Lipsey, Esq. (by electronic mail)
J ohn Scheibeler, Esq. (by electronic mail)
Mary B. Matterer, Esq. (by CM/ECP and electronic mail)
Annemarie Hassett, Esq. (by electronic mail)
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