In Merck & Cie v. Gnosis S.p.A., Appeal No. 2014-1779, the Federal Circuit affirmed a PTAB IPR decision finding that the instituted claims were invalid as obvious.

The PTAB instituted an IPR of patent claims directed toward methods of using folates to lower levels of homocysteine in the human body.  The method comprised administering L-5-MTHF.  The PTAB concluded that the claims of the patent were obvious because one would have been motivated to combine the prior art references due to their “close similarity of purpose” and that all of the claim limitations were taught in the references. 

The Federal Circuit affirmed, finding that the Board’s factual findings were supported by substantial evidence. 

In a dissenting opinion, Judge Newman disagreed with the standard of review adopted by the Federal Circuit.  She argued that the court applied the deferential “substantial evidence” standard commonly used in review of administrative decisions, but should have applied the “preponderance of the evidence” standard.  Newman argued that Congress intended the Federal Circuit to play a more active role in making sure that PTAB IPR rulings are correct in law and supported by a preponderance of the evidence.  Under the preponderance of the evidence standard, Newman would have found the claims nonobvious.