PTAB Trial Standard Of Review Requires Affirmance Despite Contrary Evidence

In Merck & Cie v. Gnosis S.p.A., the Federal Circuit affirmed the decision of the USPTO Patent Trial and Appeal Board (PTAB) that held the challenged claims obvious in an Inter Partes Review (IPR) proceeding. Although the court recognized evidence that undermined the obviousness finding and acknowledged objective evidence of nonobviousness, the court determined that the PTAB's factual findings were adequately supported by substantial evidence, such that the decision should be affirmed. In her dissent, Judge Newman questions whether that is the correct standard of review for a PTAB trial decision.

The Patent At Issue

At issue were claims 8, 9, 11, 12, 14, 15, and 19-22 of Merck's U.S. Patent No. 6,011,040, directed to methods of "preventing or treating disease associated with increased levels of homocysteine . . . comprising administering ... L-5-MTHF."

The PTAB found all of the contested claims obvious in view of three references:

EP 0 595 005 (Serfontein), cited for teaching the use of "folate or a suitable active metabolite of folate," along with vitamins B6 and B12 to treat high levels of homocysteine.

U.S. Patent No. 5,194,611 (Marazza), cited for "identif[ying] L-5-MTHF as a 'natural metabolite' that may be used "as at least one active compound" in a treatment for folate deficiency," and for disclosing a method of obtaining L-5-MTHF from an enantiomeric mixture.

Ubbink et al., Vitamin B-12, Vitamin B-6, and Folate Nutritional Status in Men with Hyperhomocysteinemia, 57 Am. J. Clinical Nutrition, 47, 47-53 (1993) (Ubbink), cited for reporting the association between elevated levels of homocysteine and a number of disease conditions, and treatment using a vitamin supplement containing folic acid.

As summarized by the Federal Circuit:

The Board found that, because of the close similarity of purpose and disclosure between Serfontein and Marazza, a person of ordinary skill in the art would have been motivated to combine the two references to arrive at a method of treating elevated levels of homocysteine with L-5-MTHF .... Further, the Board found a person of skill would have been motivated to use this method in the situation disclosed in Ubbink, in which the elevated homocysteine levels are associated with certain enzyme deficiencies. .... The Board also considered objective indicia of nonobviousness. The Board concluded that Merck failed to demonstrate an adequate nexus between the novel features of the '040 patent and the evidence of...