BY MARK J. COHEN
On April 26, 2019, the Federal Circuit, in Neptune Generics, LLC v. Eli Lilly & Company, Appeal No. 18-257 (Fed. Cir. 2019), affirmed an inter partes review (“IPR”) decision of the Patent Trial and Appeals Board (“PTAB”) regarding the validity of claims 1-22 of US Patent No. 7,772,209. The claims are directed to the administration of folic acid and a methylmalonic acid (“MMA”) lowering agent, such as vitamin B-12, before administering pemetrexed disodium, a chemotherapy agent, in order to reduce the toxic effects of pemetrexed, an anti-folate. The PTAB concluded that the claims were non-obvious. More specifically, the PTAB found that it was known in the prior art that pretreatment with folic acid reduces the toxicity associated with administration of an anti-folate, like pemetrexed; however, when the art cited by petitioners (defendants in the appeal) were combined, there was no motivation to pretreat with vitamin B12 along with folic acid before administering pemetrexed to treat cancer. Judges Moore, Wallach and Hughes, in reviewing the record of the PTAB, found that each step of the analysis by the PTAB was supported by substantial evidence. The Neptune Generics Court found that the evidence indicated that pemetrexed-inducted toxicity correlated with folate deficiency, but not Vitamin B-12 deficiencies. The Neptune Generics Court held that there was substantial evidence in support of the finding of the PTAB that the art did not provide a motivation for a skilled artisan to administer an MMA lowering agent, such as Vitamin B-12, in addition to folic acid.
However, what was interesting about this decision was the Neptune Generics Court’s analysis regarding skepticism, one of the secondary considerations in evaluating the issue of obviousness under 35 U.S.C § 103. The legal conclusion regarding a finding that a claim is obvious is determined by the analysis of four factors set forth in Graham v. John Deere Co. of Kansas City, 363 U.S. 1, 17 (1966): (1) the scope and content of the prior art; (2) differences between the prior art and the claims at issue; (3) the level of ordinary skill in the pertinent art; and (4) evaluation of any relevant secondary factors. Skepticism by one of ordinary skill in the art is one of the secondary considerations of objective indicia of non-obviousness. The Federal Circuit has held that evidence of industry skepticism is a question of fact that weighs in favor of non-obviousness.
In Neptune Generics, the Court analyzed the PTAB’s finding of skepticism of others in the art with respect to the issue of the non-obviousness of the method claimed by Lilly. The appellants questioned the conclusion of the Board on this issue. The Neptune Generics Court noted that during Lilly’s clinical trial for pemetrexed, a number of fatalities occurred. Lilly recommended supplementation with folic acid and vitamin B12 to reduce the number of fatalities to the FDA. The FDA responded that the “medical officer does not support adding vitamins to the ongoing . . . trial.” In other communications with Lilly, the FDA stated that the information provided to it “does not appear to support the addition of vitamins,” and “the addition of vitamins . . . is risky,”
The Neptune Generics Court held that these statements by the FDA, which are considered statements by one of ordinary skill in the art, are sufficient to find skepticism. According to the Neptune Generics Court, the threshold standard for finding skepticism is not premised on whether it is “technically infeasible,” “unworkable,” or “impossible” that the claimed subject matter would work for its intended purpose. On the contrary, the Neptune Generics Court held that there is a “range of third-party opinion that can constitute skepticism, referring to an earlier case, Circuit Check Inc. v. QXQ Inc., 795 F.3d 1331, 1337 (Fed. Cir. 2015) (holding testimony that third parties were ‘worried’ or ‘surprised’ was sufficient to establish skepticism).” The Neptune Generics Court held that the FDA’s concerns in this case fell well within that range. As stated by the Neptune Generics Court:
While evidence that third parties thought the invention was impossible might be entitled to more weight, that does not mean the Board erred in giving weight to the skepticism evidence here. Accordingly, the Board did not err in finding that skepticism supported a conclusion of non-obviousness.
In addition, the Neptune Generics Court reminded appellants that an IPR and appeals to the Federal Circuit of an IPR are limited to issues of invalidity of claims under 35 U.S.C. §§102 and 103. The appellants wanted the Neptune Generics Court to consider arguments of patent eligibility under 35 U.S.C. § 101. In its argument on appeal, the appellants argued that the Administrative Procedures Act required that the reviewing Court decide all relevant questions of relevant law and not be limited to the grounds considered by the PTAB where the question is one of law. The Neptune Generics Court disagreed, stating that “Congress expressly limited the scope of inter partes review to a subset of grounds that can be raised under 35 U.S.C. §§102 & 103”, citing 35 U.S.C §311 (b), which stated that in an inter partes review, a petitioner is limited to only grounds that “could be raised under section 102 or 103.” Accordingly, the Neptune Generics Court held that it could not address an issue of patent eligibility under 35 U.S.C. §101 in this appeal of an IPR.
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