Rivastigmine - USA

On Apr 04, 2017, Federal appeals court upheld a decision that invalidated Novartis AG's patents on the Exelon (Rivastigmine) skin patch for Alzheimer's disease, clearing the way for Noven Pharmaceuticals Inc. to launch a generic version of the drug.

The instant appeals concern inter partes reviews of U.S. Patent Nos. 6,316,023 (“the ’023 patent”) and 6,335,031 (“the ’031 patent”) (together, “the Patents-in Suit”). In two separate final written decisions, the U.S. Patent and Trademark Office’s (“USPTO”) Patent Trial and Appeal Board (“PTAB”) found that various claims of the Patents-in-Suit (“the Asserted Claims”) would have been obvious over the prior art. Novartis contest numerous aspects of the Final Written Decisions, including the PTAB’s conclusion that prior judicial opinions did not control its inquiry and the PTAB’s factual findings in support of its obviousness conclusion.

These very same patents were previously litigated and the claims were found to be nonobvious in federal district court. Novartis argued to the Federal Circuit that the arguments presented to the PTAB by Noven, as well as the prior art submitted to support those arguments, were the same as considered during litigation in federal court. The Federal Circuit disagreed, finding that the record in federal court was not identical to the record at the PTAB. But the Federal Circuit went further, saying that even if the records were identical Novartis’ argument would have to fail.

Chief Judge Prost wrote:

[E]ven if the record were the same, Novartis’s argument would fail as a matter of law. The PTAB determined that a “petitioner in an inter partes review proves unpatentability by a preponderance of the evidence (see 35 U.S.C. § 316(e)) rather than by clear and convincing evidence[] as required in district court litigation,” meaning that the PTAB properly may reach a different conclusion based on the same evidence. Noven II, 2015 WL 5782081, at *2 (italics omitted). That position comports with recent Supreme Court precedent…

CONCLUSION:

We affirm the PTAB’s conclusions that the Asserted Claims would have been unpatentable as obvious on the grounds discussed, we need not address the alternative grounds of unpatentability. (declining to address alternative grounds of unpatentability when the court upholds one such ground). Therefore, for the foregoing reasons, the Final Written Decisions of the U.S. Patent and Trademark Office’s Patent Trial and Appeal Board are AFFIRMED.