Acorda Therapeutics, Inc. / Alkermes Pharma v. Roxane / Mylan / Teva (“Defendants”)

Docket No. 2017-2078, -2134

September 10, 2018

Brief summary: DC invalidation of four Orange Book (“OB”) patents relating to Acorda’s Ampyra® product for obviousness affirmed.

Summary: Acorda appealed DC finding that the claims of its four Orange Book (“OB”) patents relating to its Ampyra® product and methods of treatment using the same (10 mg 4-aminopyridine (4-AP) sustained-release tablets for twice-daily administration; U.S. Pat. Nos. 8007826, 8354437, 8440703, and 8663685) invalid for obviousness. Roxane appealed DC finding that the OB “Elan patent” (US 5540938, originally assigned to Elan whose successor in interest is Alkermes) directed to methods of treatment using 4-AP is not invalid for obviousness, and its injunction until after the Elan patent expires. Acorda’s US 9918973 is also listed on the OB for Ampyra® but not included here. The FC opinion explains that 4-AP is a potassium channel blocker and is “also called ‘dalfampridine’ and ‘fampridine’, first identified in 1902”, “was first used in human studies in the 1970s to investigate its effect on neurological diseases resulting in muscle weakness”, “has been the focus of research regarding the treatment of multiple sclerosis in particular”, and summarizes some of that research (including Acorda’s multiple sclerosis studies (MS-F202 and Phase III studies that do not “constitute[] publicly available prior art to the Acorda patents in this case”)). Accorda argued that one of the references relied on in the DC’s obviousness analysis “teaches away from the claimed invention”, “that the prior art teaches the administration of sustained-release 4-AP in a titrated-dosing regimen rather than a stable-dosing regimen”, and that the prior art “collectively” does not “teach[] the efficacy of a stable 10 mg twice-daily dose or indicates that such a dose is among the small number of options that a skilled artisan would have been motivated to test with a reasonable expectation of success to improve walking”, but the FC panel rejected those arguments (e.g., “Schwid supports a motivation to test, with a reasonable expectation of success, a 10 mg twice-daily dose”, “Acorda overstates the significance of” Schwid’s data “to the issue of a reasonable expectation of success for walking improvement”, and “has pointed to nothing…declaring that doses lower than 17.5 mg twice-daily wold not be effective”). Regarding Acorda’s teaching away arguments, the FC panel explained that “[e]ven if many earlier studies used a titrating-dosing scheme to avoid adverse effects…those studies do not, as the [DC] found, undermine the other evidence” of a reasonable expectation of success. The FC panel found the DC’s “findings not only have adequate evidentiary support but comport with the guidance of KSR to “take account of the inferences and creative steps that a person of ordinary skill in the art would employ’” (Hoffman-La Roche, FC 2014 (no requirement for a “[c]onclusive proof of efficacy”); PharmaStem, FC 2007; Pfizer, FC 2007 (“the expectation of success need only be reasonable, not absolute”); Santarus, FC 2012 (“an obvious formulation cannot become nonobvious simply by administering it to a patient and claiming the resulting serum concentrations”)). Acorda also argued that the DC improperly relied “on the Elan patent as a blocking patent for the Acorda patents’ claimed inventions” to determine “that commercial success, failure of others, and long-felt but unmet need did not ‘support’ or ‘militate in favor of’ nonobviousness”, but the FC panel disagreed (the DC’s “opinion is best read not as invoking a categorical rule, but as drawings conclusions on a limited factual record” (Merck I, FC 2005, in which evidence of commercial success was not persuasive since an “earlier patent and FDA regulatory approval depressed incentives for others to invent the weekly-dosing scheme” for Fosamax); Galderma, FC 2013; Merck II, FC 2017 (“exclusive license to a blocking patent did not, all by itself, justify discounting evidence of commercial success”); § 271(e)(1) “safe harbor is certainly relevant, but it does not eliminate infringement liability”; the DC “did not err in viewing the Elan patent, among other evidence, as evidence that discounted the weight of Acorda’s evidence”). The Defendant’s cross-appeal regarding the Elan patent was not considered since that patent expired on July 30, 2018 and the injunction was therefore terminated. The DC decision was therefore affirmed.

This entry was posted in Generics / ANDA, Obviousness, Obviousness-Teaching Away. Bookmark the permalink.

Leave a Reply

Fill in your details below or click an icon to log in: Logo

You are commenting using your account. Log Out /  Change )

Google photo

You are commenting using your Google account. Log Out /  Change )

Twitter picture

You are commenting using your Twitter account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )

Connecting to %s

This site uses Akismet to reduce spam. Learn how your comment data is processed.