Friday, September 25, 2009

In Re ‘318 Patent Infringement Litigation

The ’318 patent “claims a method for treating Alzheimer’s disease with galanthamine.” The district court found that the claims were not enabled and the Federal Circuit affirmed. The court discussed the law of enablement and the policies behind it at some length, making the following general points before reaching the facts of the case at hand:

  • “Enablement is closely related to the requirement for utility.” (p. 9.)
  • “The utility requirement prevents mere ideas from being patented.” (p. 10.)
  • “The utility requirement also prevents the patenting of a mere research proposal or an invention that is simply an object of research.” (p. 10.)
  • The above is so because: “Allowing ideas, research proposals, or objects only of research to be patented has the potential to give priority to the wrong party and to confer power to block off whole areas of scientific development, without compensating benefit to the public.” (p. 11.)
  • Methods of treatment are usually supported by tests, but the inventor need not conduct those tests. (p. 11.)

In this case, testing was not available as of the priority date. The patentee argued “that utility may be established by analytic reasoning” in lieu of testing. (p. 14.) The court accepted this as a possibility, but found that the specification in this instance failed to provide such reasoning. “[T]he specification, even read in the light of the knowledge of those skilled in the art, does no more than state a hypothesis and propose testing to determine the accuracy of that hypothesis. That is not sufficient.” (p. 16.)

This case was decided based on enablement although the entire discussion concerned utility. See generally In re Swartz, 232 F.3d 862, 864 (Fed. Cir. 2000) (“Lack of utility is a question of fact and the absence of enablement is a legal conclusion based on underlying factual inquiries.”) (citations omitted).