In a recent precedential decision, a split Federal Circuit (Judges Dyk and Taranto in the majority, Judge Newman, dissenting) issued a lengthy, 53-page decision, regarding the obviousness doctrine. Judge Taranto, writing for the majority, engaged in a fact-intensive analysis to determine that a ‘blocking patent’ mooted evidence of objective indicia of non-obviousness and found the patents-in-suit invalid on obviousness grounds.
Acorda owned four patents (the “Acorda patents”) listed in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (“Orange Book”) for Ampyra®, a multiple sclerosis (“MS”) medication containing the active ingredient 4-aminopyridine (“4-AP”). Importantly, Acorda listed a fifth patent, U.S. Patent Number 5,540,938 (the “Elan patent”), in the Orange Book for Ampyra. Acorda is the exclusive licensee for the Elan Patent. The Elan patent predates the Acorda patents and broadly claims administering a sustained-release formulation of 4-AP to individuals with multiple sclerosis. The Acorda patents further claimed that such a drug must be administered (1) in a 10 mg dose twice a day (2) at that stable dose for the entire treatment period of at least two weeks (3) to achieve 4-AP serum levels of 15–35 ng/ml and (4) to improve walking. Continue Reading