Takeda Chemical Indus. v. Alphapharm Pty., Ltd., No. 06-1329, slip op. (Fed. Cir. 2007).
Alphapharm sought FDA approval to a market generic version of Takeda’s drug ACTOS (U.S. Patent 4,687,777), which is used to treat diabetes. Takeda sued Alphapharm and the district court rejected Alphapharm’s obviousness attack on the patent. The Federal Circuit affirmed. It found that KSR v. Teleflex did not eliminate the prima facie obviousness requirement that a challenger, in cases involving new chemical compounds, "identify some reason that would have led a chemist to modify a known compound in a particular manner."
Takeda and KSR
Citing its Pre-KSR precedents the appellate court stated when an obviousness challenge is based on a structural similarity between the prior art and the claimed compound, the challenger must show the “prior art would have suggested making the specific molecular modifications necessary to achieve the claimed invention.” The court noted the Supreme Court’s indication in KSR that while the TSM test cannot be rigidly applied, the test is not necessarily inconsistent with the Graham analysis.
Is the Federal Circuit’s requirement that a challenger identify a reason to modify a known compound consistent with KSR’s direction that the TSM elements not be applied in a rigid and mandatory way? The Court in KSR acknowledged that "it can be important to identify 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." However the Court immediately thereafter cautioned that insights drawn by considering what reason(s) prompted the combination "need not become [a] rigid and mandatory formula."
Considering a reason that would prompt a person of ordinary skill in the art to combine the elements, is necessarily an art specific inquiry. The KSR Court recognized this by stating, "In many fields it may be that there is little discussion of obvious techniques or combinations, and it often may be the case that market demand, rather than scientific literature, will drive design trends." Will the Federal Circuit extend the Takeda requirement to other arts outside the chemical field?
Takeda’s Applicability to Software Patents
Many, including the Patent and Trademark Office Commissioner, note the particular difficulty that examiners have in finding prior art in the software field. This difficulty is part of the motivation underlying the Peer-to-Patent Pilot, which allows the public to contribute prior art relevant to software patent applicants. If Takeda is extended to software patents, it might be difficult for challengers to identify particular pieces of prior art which evidence a suggestion to combine elements. Challengers would likely argue more flexibility is necessary in showing the prima facie case of obviousness given the nature of the software art.