Galanthamine patent is held invalid for lack of enablement.
In Re: ‘318 Patent Infringement Litigation, C.A. No. 05-356-SLR, August 27, 2008.
Robinson, J. Following a bench trial and post-trial briefing, the Court finds the patent-in-suit is invalid for lack of enablement.
Plaintiffs are the exclusive licensees of the ‘318 patent claiming the treatment of Alzheimer’s disease with galanthamine and the holders of the approved NDA for galanthamine hydrobromide tablets sold under the trade name Razadyne. In 2005, several generic drug manufacturers filed with the FDA certain ANDAs containing paragraph IV certifications for generic galanthamine hydrobromide. Defendants’ argument on anticipation is based on a 1974 article published by Dr. Bhasker which defendants contend discloses the use of galanthamine to treat AD or related dementias as defined by the Court. The Court disagrees and finds that claims 1 and 4 are not invalid due to anticipation. As to obviousness, defendants contend that Bhasker, alone or in combination with a variety of prior art references disclosed all of the limitations of claim 1 of the ‘318 patent. Defendants assert that galanthamine would have been obvious to try for AD insofar as there was a finite number of identified, predictable solutions for treating AD during the time in question, and galanthamine’s central cholinergic effects were well-known. They also claim that a person of ordinary skill in the art would have been led directly to galanthamine because success in improving cognitive function had been reported with use of compounds in the same class, and prior art disclosed that galanthamine had a better side effect profile and longer duration of action. The Court finds defendants’ evidence, though not insubstantial, does not rise to level of clear and convincing required to invalidate the ‘318 patent. Next, applying Genetech, Inc. v. Novo Nordisk A/S, the Court notes that to satisfy the enablement requirement, a specification must teach those skilled in the art how to make and to use the full scope of the claimed invention without undue experimentation. Defendants assert, in view of the minimal disclosure of the specifications, that the ‘318 patent cannot be both non-obvious and enabled. The Court agrees. Therefore, given that the ‘318 patent only surmises how the claimed method could be used, rather than teach one of skill in the art how to use the claimed method, the Court finds that the ‘318 patent is invalid for lack of enablement.
