Dalfampridine – USA

Dalfampridine – USA

On Mar 31, 2017, Delaware court issued Memorandum Opinion in Dalfampridine (AMPYRA) case.
Acorda Therapeutics, Inc. and Alkermes Pharma Ireland Limited (“Plaintiffs”) allege that Apotex Corp., Apotex Inc., Mylan Pharmaceuticals Inc., Roxane Laboratories, Inc., and Teva Pharmaceuticals, USA, Inc. (“Defendants”) infringe several United States Patents. Patent No. 5,540,938 (the ‘”938 patent” or the “Elan Patent”) relates to the use of a sustained-release formulation of 4-AP, administered once or twice daily, to treat neurological diseases including multiple sclerosis (“MS”). Patent 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”) (collectively, the “Acorda Patents”) relate to the use of 10 mg sustained-release formulations of 4-AP to treat walking impairments in individuals with MS.
The asserted claims of the Acorda Patents are directed to a method of improving walking in a human with multiple sclerosis by administering a 10 milligram dose of 4-AP twice per day, for either two weeks or twelve weeks. Certain claims also require that this dosage regimen produce particular pharmacokinetic results. Certain claims further mandate that there be no titration before or after administration of the 10 mg/twice-daily dose. Defendants argue that all of these claims are obvious because the prior art would have given a POSA a reasonable expectation of success in combining these limitations.
The Court concludes that Defendants have shown that the prior art taught the four disputed limitations: the use of 4-AP to improve walking; the use of a 10 mg/twice-daily dosage; the use of stable dosing; and the inherent pharmacokinetic limitations. The Court finds that a POSA would have been motivated to combine these limitations with a reasonable expectation of success. The Court also agrees with Defendants that the secondary indicia do not support a finding of non-obviousness with respect to any claim. As such, the asserted claims of the Acorda Patents are invalid.
Defendants have failed to prove by clear and convincing evidence that claims 3 and 8 of the Elan Patent are invalid due to obviousness. Defendants have proven by clear and convincing evidence that claims 1, 7, 38, and 39 of the ‘826 patent; claims 3 and 5 of the ‘685 patent; claims 1, 2, 5, 22, 32, 36, and 37 of the ‘437 patent; and claims 36, 38, and 45 of the ‘703 patent are invalid due to obviousness.
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