Merck & CIE v. Gnosis S.P.A. et al.

Docket Nos. 2014-1779

December 17, 2015

Brief Summary: PTAB decision of obviousness affirmed (motivation derived from prior art, no nexus shown). Judge Newman’s dissent argues post-grant review improperly allows “the petitioner [to] provide invalidity by no more than a preponderance of the evidence” and that the obviousness conclusions are based on hindsight (“Only hindsight provides such prophesy.”).

Summary: Merck appealed PTAB decision (IPR2013-00117) that the disputed claims of its US 6,011,040 relating to methods for “preventing or treating disease associated with increased levels of homocysteine…comprising administering at least one tetrahydrofolate [THF] in natural stereoisomeric form”, the THF being 5-methyl-(6R) tetrahydrofolic acid (L-5-MTHF) in humans invalid for obviousness in view of an EP patent (Serfontein), a US patent (Marazza) and a scientific publication (Ubbink). Serfontein discloses using “folate or a suitable active metabolite of folate” (without identifying a “suitable active metabolite”) “for lowering levels of homocysteine…in a patient”. Marazza was found to identify “L-5-MTHF as a ‘natural metabolite’ that may be used ‘as at least one active compound’ in a treatment for folate deficiency” and a process for separating “5-MTHF into pure L-5-MTHF and D-5-MTHF forms”. Ubbink is described as affirming “[n]umerous studies [indicating] that elevated plasma homocysteine concentrations are associated with increased risk for premature vascular disease” and “positive results of treating these conditions with a vitamin supplement containing folic acid.” The Board found the claims obvious, concluding a person of skill would have been motivated to combine the references and finding no “adequate nexus between the novel features of the ‘040 patent and the evidence of commercial success, licensing, copying, and industry praise.” The FC panel agreed with the Board’s conclusion of obviousness because, e.g., “a person of ordinary skill viewing Serfontein and Marazza would have been motivated to use L-5-MTHF as the ‘suitable active metabolite of folate’ called for by the method disclosed in Serfontein” and/or Ubbink. It disagreed with Merck’s teaching away arguments, finding “[t]he prior art does not unambiguously teach that administration of 5-MTHF would increase homocysteine levels” (“although [Merck’s prior art showed] switching to 5-MTHF may have correlated with a slight increase…the net effect is still a reduction”). The FC panel also disagreed that “a person of ordinary skill would have thought 5-MTHF was too unstable for therapeutic use”, even though “[t]he Harper references” state “[a]lthough [5-MTHF] would be desirable for use in therapy, it is probably too unstable” and “had to be withdrawn because of its instability”, because a later prior art (including Marazza) disclosed “[a] new and stable preparation of MTHF” (“the prior art must be considered as a whole”). Merck also argued “the Board never made an express finding [of] a reasonable expectation of success” but the FC panel wrote that while KSR explains “a factfinder’s analysis of a reason to combine known elements in the art ‘should be made explicit’”, it “does not require an explicit statement of a reasonable expectation of success in every case” (“cautioning against confining the obviousness analysis using formalistic rules”) and the Board addressed this point “in the context of its teaching away arguments.” The FC panel also agreed with the Board’s nexus-related conclusions (e.g., “the ‘mixed’ products…have material features beyond those disclosed and claimed in the ‘040 patent”).

Judge Newman’s dissent argued post-grant review improperly allows “the petitioner [to] provide invalidity by no more than a preponderance of the evidence” and “it is incorrect for this court, as the only reviewing tribunal, to review the PTAB decision under the highly deferential ‘substantial evidence’ standard” (“whether the decision could reasonably have been made, not whether it was correctly made”). The dissent also criticized the the conclusions of obviousness (e.g., “Marazza does not teach that L-5-MTHF is suitable to treat elevated homocysteine, but only that is an ‘active’ folate for treating folate deficiency. Amid the uncertain predictability of biological response, this background does not provide a reasonably likelihood of successful treatment with any selected stereoisomer. Only hindsight provides such prophesy…A prima facie case cannot be based on the inventors successful investigations…there is no suggestion to select and make such combination with a reasonable expectation of success in treating elevated homocysteine. The only source of this concept is hindsight reconstruction using the teachings of these inventors…Whether or not these inconsistent teachings are viewed as ‘teaching away’ they do not teach toward a reasonable likelihood of success. The panel majority errs in law, in stating that ‘the PTAB impliedly found a reasonable expectation of success’ based on the PTAB’s finding of no ‘teaching away’. Such ‘implication’ resides only the backward-looking eye of the beholder.”)

This entry was posted in America Invents Act, Inter Parties Review (IPR), Obviousness, Post-grant review. Bookmark the permalink.

Leave a Reply

Fill in your details below or click an icon to log in: Logo

You are commenting using your account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )

Connecting to %s

This site uses Akismet to reduce spam. Learn how your comment data is processed.