Revisiting In Re Kubin

In early 2009 the Court of Appeals for the Federal Circuit ("Federal Circuit") published their decision in In re Kubin, which at the time garnered much interest from patent practitioners, especially those working in the field of biotechnology. The initial buzz in the biotech community centered around what effectively amounted to the court's evisceration of their earlier 1995 decision in In re Deuel, where they reversed the Board of Patent Appeals and Interferences ("Board"), based in part on the notion that a known protein does not necessarily render obvious the cloning of a gene encoding that protein.

Despite being presented, some 14 years later, with a similar fact pattern as Deuel, why was the Board inclined to reject the Kubin claims as obvious? No doubt the Board was emboldened on several fronts by the 2007 decision Supreme Court ruling in KSR Int'l Co. v. Teleflex, Inc..

  • In KSR, after reiterating their long standing Graham v. John Deere factors required for engaging in a § 103(a) obviousness analysis, the Supreme Court admonished the Federal Circuit's penchant for imparting rigid (and arguably 'patentee friendly') analysis to determine patentability under § 103(a), making clear that "if a person of ordinary skill can implement a predictable variation, § 103(a) likely bars its patentability" and more so if such variation or improvement represents no more than "the predictable use of prior art elements according to their established functions," enunciating that an analysis of obviousness should not be confined to a rigid test, but instead a flexible one.
  • And the Court specifically cited Deuel to exemplify this unacceptable reliance on a 'rigid' adherence that a claimed invention is not obvious just because it may have been 'obvious to try.'

The Federal Circuit's response in a post-KSR environment was to step away from the rigidity of an obviousness analysis in Deuel in regard to biotechnology-related subject matter, and instead revisit and adapt the analytical style from their 1988 pre-Deuel decision in In re O'Farrell, which also presented an obviousness issue involving biotechnology-related subject matter. The Kubin court embraced O'Farrell as meshing with the Supreme Court edict to move away from an inflexible, formulistic analysis of § 103(a) issues. Kubin now "resurrects this court's own wisdom in O'Farrell, which predates the Deuel decision by some seven years." Stating that an obvious invention would by nature be 'obvious to try,' but the more important question to the O'Farrell court being "when is an invention that was obvious to try nonetheless nonobvious?" Two such scenarios were forwarded:

  • when a multitude of choices are available to the inventor and the prior art gives no indication as to which parameters are critical for success (referred to in Kubin as a "metaphorical darts at a board" scenario); and,
  • an area of "new technology" or a "general approach" in a promising field, with only general guidance from the prior art as how to proceed

While the latter seems tailor-made for biotechnology patent issues, it is the former approach (or rather the inverse) which the Kubin court found amenable to the issue at hand. The Federal Circuit, in affirming the Board's rejection of the Kubin claims as obvious, confirmed (i) the existence of an enabling technology within the prior at to generate the claimed subject matter, (ii) a suggestion to modify the prior art (i.e., an impetus to work from the prior art protein to the claimed isolated nucleic acid molecule), and (iii) evidence that such a modification would be successful. And such success not requiring "absolute predictability of success," but only a "reasonable expectation of success" in obtaining the claimed subject matter.

Was invoking O'Farrell in response to the Supreme Court's admonishment of a rigid §103(a) analysis limited to the facts of Kubin? Or possibly relegated, albeit not purposefully, to analysis of obviousness issues relating solely to biotechnology? Only time will tell. But early returns suggest that an O'Farrell revival of sorts is catching on, both within the Federal Circuit and the district courts.

  • Bayer Schering Pharma AG v. Barr Labs, Inc. - The Federal Circuit affirming a district court holding that claims of U.S. Patent No. 6,787,531 are invalid under § 103(a), as "the invention would be obvious to try." A KSR/O'Farrell/Kubin triumvirate is invoked to hold that a claim to an oral contraceptive composition which comprises a micronized drospirenone-based combination product was obvious. As in Kubin, the Federal Circuit agreed with the district courts analysis that a finite number of possibilities were available to the inventor, with a reasonable expectation of succeeding in the generating the claimed invention.
  • P&G v. Teva Pharms. USA, Inc. - The Federal Circuit affirming a district court holding that claims to U.S. Patent No. 5,583,122, which recite the bisphosphonate compound risedronate, the active ingredient of an osteoporosis drug, nonobvious over a prior art patent disclosing an earlier bisphosphonate compound useful in treating osteoporosis. The Federal Circuit, with the KSR directive in hand, addressed the logic of the district court by applying their own precedent to determine whether a structural similarity existed between the prior art compound and the patented compound. In doing so, the Federal Circuit rounded out this analysis by again invoking the KSR/O'Farrell/Kubin logic, finally holding that "there is not credible evidence that the structural modification was routine." In other words, as per O'Farrell, numerous choices for structural modification were available, and the prior art gave no indication as to which modifications were critical for success (i.e., the "metaphorical darts at a board" scenario).

And several district court cases are incorporating this line of reasoning into their § 103(a) analysis as well, such as Johnson & Johnson Vision Care, Inc. v. CIBA Vision Care Corp. and Seiko Epson Corp. v. Coretronic Corp. Like it or not, the 'obvious to try' standard, ala O'Farrell, looks to be back in vogue. Patent practitioners should carefully consider these post-KSR ramifications when drafting or prosecuting patent applications in the USPTO, whether based in the biotechnology arts or not. Strategies should be considered early on in the process to best head off or rebut exposure to a possible claim rejection under §103(a) as tailored from the Kubin holding.

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