Janssen Pharmaceutica v. Teva Pharmaceuticals USA, Inc. (In re ‘318 Patent Infringement Litigation)

Bonnie Davis applied for a patent on a method of treating Alzheimer’s disease using a molecule compound called galanthamine. The patent application’s specification cited papers on animal testing that suggested positive effects of galanthamine on memory. The United States Patent and Trademark Office (PTO) initially rejected Davis’s application on the ground of obviousness in light of the animal studies. Davis responded that the cited testing was conducted on animals with normal brains—that is, under conditions with no relevance to Alzheimer’s. However, Davis added that new testing was underway that would more directly address the effects of galanthamine on Alzheimer’s. The patent (the ‘318 patent) was issued in May 1987. The testing referred to by Davis was completed in July 1987. Davis licensed the patent to Janssen Pharmaceutica (Janssen) (plaintiff) in 1995. Janssen received government approval to market galanthamine as an Alzheimer’s treatment in 2001. A few years later, Janssen sued several generic drug manufacturers for infringement of the ‘318 patent. The actions were consolidated. The federal district court held that the ’318 patent was invalid on the grounds that (1) the relevant animal testing was not complete at the time of its issuance and (2) the specification and claims failed to teach the use of the claimed method, including dosage information. Janssen appealed to the United States Court of Appeals for the Federal Circuit.