Chief Judge Stark Invalidates Patents as Obvious

May 3, 2017

Publication| Intellectual Property

In Acorda Therapeutics, Inc. v. Roxane Laboratories, Inc., C.A. No. 14-882-LPS (D. Del. Mar. 31, 2017), a post-trial decision, Chief Judge Stark held that the asserted claims of four of the asserted patents (referred to in the decision as the “Acorda” patents) relating to sustained-release drugs used to treat multiple sclerosis were invalid for obviousness, but that the defendants, Apotex Corp., Apotex, Inc., Teva Pharmaceuticals USA Inc., Roxane Laboratories, Inc., and Mylan Pharmaceuticals Inc., failed to prove by clear and convincing evidence that the asserted claims of the fifth asserted patent (referred to as the “Elan” patent) were obvious.

The Court held that although a person of ordinary skill in the art may have had a reasonable expectation of success in using the active ingredient to treat multiple sclerosis, the defendants failed to show by clear and convincing evidence that, based on the asserted prior art, this same person would have had a similar expectation regarding a sustained-release formulation of the drug. The defendants’ defenses of lack of enablement and lack of written description hinged on the Court’s acceptance of certain positions taken (according to the defendants) by the plaintiffs; because Chief Judge Stark did not adopt those positions, the Court found that the defendants failed to prove these defenses as well. Chief Judge Stark thus found the Elan patent not invalid, a finding bolstered by evidence of commercial success.

By contrast, Chief Judge Stark found the Acorda patents obvious, notwithstanding some “valid concerns” raised by the plaintiffs. Specifically, the Court found that a person of ordinary skill in the art, examining and interpreting the prior art “holistically and cautiously,” would have been motivated to combine the four limitations taught by the prior art with a reasonable expectation of success. The evidence of secondary considerations was insufficient to overcome the finding of invalidity (for instance, although the reference drug was found to be a commercial success, a blocking patent negated its value as evidence of non-obviousness).

Key Points: Although the patents invalidated in this decision survived inter partes review several months earlier, Chief Judge Stark noted that two of the prior art references in that proceeding were not asserted at trial in the litigation.

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