Reviewing a decision of the Board of Patent Appeals and Interferences (BPAI) finding of three patent applications directed to the pain relief formulation known as Opana® to be obvious, the U.S. Court of Appeals for the Federal Circuit affirmed the BPAI’s decision in two of the applications, but vacated and remanded the BPAI decision in the third application.   In re Kao, Case Nos. 10-1307 and -1308, and In re Ahdieh, Case No. 10-1309 (Fed. Cir. May 13, 2011) (Linn J.).

The three patent applications at issue concern controlled-release formulations of oxymorphone and are being pursued by Endo Pharmaceuticals in connection with its prescription pain tablets Opana® ER. The Court found that with respect two of three applications at issue, the BPAI’s obviousness findings were supported by substantial evidence and that Endo’s evidence of secondary consideration, namely the commercial success of Opana® ER, and showing of unexpected results were insufficient to rebut the prima facie showing of obviousness.  However, with respect to the application for the formulation of Opana®, the Court found that the BPAI did not base the factual conclusions it used to find the claims obvious on substantial evidence, and therefore vacated and remanded that application.

The Court also found that the BPAI had erred by failing to give due weight to evidence of secondary considerations of non-obviousness of the claimed formulation. The Court reminded the BPAI that evidence of a secondary consideration, such as commercial success, does not need to be across the entire claimed range in order to be reasonably commensurate with the scope of the claims. However, the Court also noted that Endo, on remand, will need to show that the proffered secondary consideration, i.e. commercial success, results from something that is both claimed and novel in the claim. With respect to unexpected results, the Court advised the BPAI to consider on remand whether there is a nexus between the unexpected results and aspects of the claimed invention not already in the prior art.

Practice Note:   The Federal Circuit considered the patentability of only one of two claims of the remanded application that it could have considered. The Federal Circuit reasoned that Endo had waived its right to have the two claims considered separately, both at the BPAI and at the Court, because Endo had failed to make separate, substantive arguments on the patentability each.  To prevent such a waiver, applicants are advised (when possible) to provide clear statements separately asserting the patentability of the appealed claims.