Case Name: Novartis Pharms. Corp. v. Par Pharm., Inc., Civ. No. 11-1077-RGA, 2014 U.S. Dist. LEXIS 121699 (D. Del. Aug. 29, 2014) (Andrews, J.)

Drug Product and Patent(s)-in-Suit: Exelon® (rivastigmine); U.S. Patents Nos. 6,335,031 (“the ’031 patent”) and 6,316,023 (“the ’023 patent”)

Nature of the Case and Issue(s) Presented: The one asserted claim in the ’031 patent, claim 7, depends from non-asserted independent claim 1. Claim 7 narrows claim 1 by limiting it to a specific delivery method and requires that rivastigmine and a certain amount of an antioxidant be present. Novartis asserted that Par’s ANDA product infringes claim 7 of the ’031 patent because acetaldehyde meets claim 7’s antioxidant requirement. Thus, two issues were before the court: (i) whether an antioxidant is present; and (ii) whether the antioxidant will be present in Par’s ANDA products in the amount claimed by the ’031 patent.

Novartis argued both that acetaldehyde is an antioxidant and that it is present in the patch in sufficient quantities to infringe the ’031 patent. Par countered that acetaldehyde is not an antioxidant, and even if it were, it would not be present in the final ANDA product at sufficient levels to violate the ’031 patent. The court agreed with Par.

Why Par Prevailed: The court found that Par’s ANDA product did not infringe the asserted claim because Novartis failed to prove by preponderance of the evidence that acetaldehyde was an antioxidant. First, the court found that the mere fact that acetaldehyde is a reducing agent does not make it an antioxidant. The most that could be garnered out of Novartis’ expert’s testimony is that, as acetaldehyde is a reducing agent, it may be an antioxidant. “This is not sufficient to show, by a preponderance of the evidence, that acetaldehyde is an antioxidant.” On the other hand, relying on Par’s expert and scientific literature, the likelihood that acetaldehyde is an antioxidant is decreased because it does not form a stable radical.

The Court also rejected the testing done by Novartis’ expert because the test had never been performed prior to litigation to determine if acetaldehyde was an antioxidant. Novartis was unable to cite any literature or references where the same test was used to show that a compound was an antioxidant. Moreover, Novartis’ expert was not able to show a statistically significant difference between the experiments and the control. The t-tail test showed only a 87% confidence level, which was below the standard 90 or 95% limit used in research to show a statistically significant difference. As such, the Court rejected this testimony as supportive of Novartis’s infringement claim.