Acorda Therapeutics, Inc. v. Roxane Labs., Inc.

Case Name: Acorda Therapeutics, Inc. v. Roxane Labs., Inc., Fed. Cir. Nos. 2017-2078, -2134, 2018 U.S. App. LEXIS 25536 (Fed. Cir. Sept. 10, 2018) (Circuit Judges Newman, Dyk, and Taranto presiding; Opinion by Taranto, J.; Dissent by Newman, J.) (Appeal from D. Del., Stark, C.J.)

Drug Product and Patent(s)-in-Suit: Ampyra® (dalfampridine); U.S. Patents Nos. 8,007,826 (“the ’826 patent”), 8,663,685 (“the ’685 patent”), 8,354,437 (“the ’437 patent”), and 8,440,703 (“the ’703 patent”)

Nature of the Case and Issue(s) Presented: The patents-in-suit claim the administration of a medication containing the active ingredient 4-aminopyridine (4-AP) to improve walking in individuals with multiple sclerosis. Defendants filed ANDAs to market a generic version of the drug and then stipulated to infringement of the asserted patents. Defendants, however, argued that the asserted patents were invalid as obvious in light of the prior art. After a bench trial, the District Court for the District of Delaware agreed with Defendants and held that the asserted patents were obvious. On appeal, the Federal Circuit affirmed the lower court’s ruling, invalidating the patents-in-suit.

Why Defendants Prevailed: Plaintiff Acorda presented three arguments on appeal. First, Acorda argued that a POSA would not be motivated to combine the prior art to invalidate the asserted patents. Acorda claimed that the prior art taught only high serum levels of 4-AP and, therefore, taught away from the lower serum levels claimed in the asserted patents. The prior art, however, simply stood for the proposition that high serum levels of 4-AP evinced an effective treatment—it did not teach that lower serum levels of 4-AP would be ineffective. Additionally, the prior art taught that it was desirable to achieve a stable-dosing regimen for administering the 4-AP formulation. Defendants’ expert testimony was consistent with all of these findings, and thus the Federal Circuit found no error.

Second, Acorda argued that the district court improperly determined that the pharmacokinetic claims of the asserted patents were inherent to the invention, and thus obvious. Acorda argued that a POSA would not expect that the pharmacokinetic profile for a spinal cord injury (taught in the prior art) to be the same as the pharmacokinetic profile for multiple sclerosis. Acorda’s argument was undermined by the clear disclosure of the prior art, which stated that 4-AP was an effective treatment for patients with spinal cord injuries, as well as other demyelinating disorders such as multiple sclerosis. Thus, a POSA would expect a similar pharmacokinetic profile in both scenarios and would apply the teachings of the prior art to multiple sclerosis.

Finally, Acorda argued that the district court improperly discounted objective indicia of commercial success. Specifically, Acorda argued that the district court erred by applying an improper categorical rule that the existence of a blocking patent overrode objective indicia of non-obviousness. The Federal Circuit disagreed, and concluded that the district court applied a specific, fact-based analysis, and not a categorical rule.

In her dissent, Judge Newman notes that Acorda’s new treatment for multiple sclerosis was “achieved after decades of failed research” and that the district court discounted the weight of the objective indicia of non-obvious before it on the theory that the patentee had a “blocking” patent. She did not believe that defendants met their burden of proving obviousness.