By Vincent Capuano of Sterne Kessler Goldstein & FoxAs the July issue of IP Today was going to press, the Court of Appeals
for the Federal Circuit handed down its decision and opinion in Takeda Chem. Indus., Ltd. v.
Alphapharm Pty., Ltd., No. 06-1325 (June 28, 2007). My paper in the July issue discussed
the district court’s decision and opinion in this case as it relates to whether the law of obviousness of
chemical compounds requires that the prior art motivate a person of ordinary skill to select a
"lead compound" for modification before that compound can be used to render a later-
claimed compound prima facie obvious, and whether such a requirement was consistent
with the Supreme Court’s opinion in KSR v. Teleflex. As discussed in the paper,
there is no per se "lead compound" requirement stemming from earlier
Federal Circuit precedent and such a requirement would run afoul of KSR. This
addendum addresses the Federal Circuit’s treatment of that concept in its recent decision in
Takeda v. Alphapharm.
The Federal Circuit’s holding in Takeda v. Alphapharm is neither
ground-breaking nor surprising. In fact, it is rather reasonable and straightforward. The
Court held that
in cases involving new chemical compounds, it remains necessary to identify some
reason that would have led a chemist to modify a known compound in a particular manner to establish
prima facie obviousness of a new claimed compound.
Id., Slip op., at 10.
Alphapharm argued that one of ordinary skill would begin with "compound
b" because it was the "lead compound," or as Judge Lourie put it, "the most
promising to modify in order to improve upon its antidiabetic activity and obtain a compound with
better activity." Id., Slip op., at 10-11. Because Alphapharm
chose to establish prima facie obviousness based on this "lead compound"
theory, the court specifically stated that it was "deciding the appeal as it has been
argued." Id., Slip op., at fn. 3. The court found that the prior art
did not identify "compound b" as a lead compound. In fact, the prior art singled out
"compound b" for causing considerable side effects and Alphapharm’s 30(b)(6) witness
admitted that because of its side effects it would "’presumably not’ be a suitable
candidate." Id., Slip op., at 13.
Takeda represents the Federal Circuit’s first post-
KSR decision in the chemical compound area. The Takeda
decision makes clear that in order to establish prima facie obviousness of a new
compound one must identify "some reason that would lead a chemist to modify a known
compound." It need not be established in all cases that the known compound was a
"lead compound;" such an inflexible standard would be inconsistent with
KSR.
The author is a director in the Biotechnology/Chemistry practice group of the
Washington, D.C. intellectual property law firm of Sterne, Kessler, Goldstein, & Fox P.L.L.C. This
article(presentation) reflects the present thoughts of the author, and should not be attributed to Sterne,
Kessler, Goldstein & Fox or any of its former, current, or future clients. The content is for
purposes of discussion and should not be considered legal advice. He can be reached at
vcapuano@skgf.com.