The claims of the ’209 Patent were challenged in three petitions for inter partes review (IPR), but in each case the Board concluded that there was no motivation to combine the asserted prior art and that “skepticism of others,” namely the FDA, supported a finding of nonobviousness. On appeal, the Federal Circuit held that the Board’s findings were supported by the evidence and affirmed the Board’s final written decisions.
As to motivation to combine, the Federal Circuit agreed with the Board that one of the prior art references was limited to cardiovascular concerns and only generally mentioned cancer. As such, there was no motivation to combine references across fields of treatment. With respect to the Board’s findings regarding “skepticism of others,” the patent challengers argued on appeal that the FDA’s concern regarding the claimed treatment was insufficient because the FDA had allowed the patent owner to go forward with clinical trials. The Federal Circuit disagreed and noted that there is a range as to what constitutes skepticism—from a belief an invention is impossible to a belief that it is unlikely. In this case, the Federal Circuit found that the FDA’s concerns expressed during the clinical trials amounted to skepticism.
Finally, on appeal the patent challengers argued that the claims of the ’209 Patent were not directed to patentable subject matter and that, because patent eligibility is a question of law, this was an issue that could be raised properly on appeal. The Federal Circuit disagreed stating that Congress expressly limited IPRs to grounds that can be raised under 35 U.S.C. §§ 102 and 103. Thus, because patent eligibility arises under § 101, the Federal Circuit held that it cannot be addressed on appeal of an IPR.
Practice Tip: In an IPR, a petitioner should explain thoroughly the motivation to combine the prior art references, especially when those references may be viewed as relating to different fields, even if those fields seem closely related. Moreover, “skepticism of others”—as a secondary consideration of nonobviousness—may not require evidence of technical impossibility, but a simple showing of concern or surprise may suffice.
Neptune Generics, LLC v. Eli Lilly & Company, 2018-1257, 2018-1258 (Fed. Cir. Apr. 26, 2019); Mylan Laboratories Limited, et al. v. Eli Lilly & Company, 2018-1288, 2018-1290 (Fed. Cir. Apr. 26, 2019).