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In In re '318 Patent Infringement Litigation (Fed. Cir. 2009) Slip Opinion, 2008-1594, 2009-1070, a three-judge panel of the Federal Circuit held that a drug not known at the time of filing to be effective in treating Alzheimer's disease was not patentable on its filing date of January 15, 1986, even though affirmative results from tests were available by July 1987, after the patent was issued.

Follow up:

The specification for the '318 patent was only just over one page in length, and it provided almost no basis for its stated conclusion that it was possible to administer "an effective Alzheimer's disease cognitively-enhancing amount of galanthamine." The specification provided only short summaries of six scientific papers. The district court subsequently found the patent invalid because relevant animal testing experiments by the time the '318 patent was allowed and the specification provided only minimal disclosure of utility. In the alternate, the district court found the specification and claims did not tach one of skill in the art how to use the claimed method because the application only surmised how the claimed method could be used without providing sufficient galantamine dosage information.

Under 35 U.S.C. 112, enablement is determined as of the effective filing date of the patent application, and enablement is closely related to the requirement for utility. Inventions must have substantial utility and specific benefit existing in currently available form. The utility requirement prevents mere ideas from being patented, as merely tossing out the mere germ of an idea does not constitute an enabling disclosure. The utility requirement also prevents the patenting of a mere research proposal or an invention that is simply an object of research. The patent is not a reward for a search, but rather compensation for its successful conclusion.

Neither in vitro tests results nor animal test results involving the use of galantamine to treat Alzheimer's-like conditions were provided. The results of the patent's proposed animal tests were not available at the time of the application. Therefore, the results could not be used to establish enablement.

Expert witness were called to testify in support of the inventor and an alleged infringer. Both agreed that the utility of the invention could not be inferred from the prior art testing described in the application. The inventor had responded earlier to an obviousness rejection by an examiner that "nothing in this teaching leads to an expectation of utility against Alzheimer's disease. According to the PTO's Manual of Patent Examining Procedure ("MPEP"), arguments or reasoning may be used to establish an invention's therapeutic appeal. Although the inventor asserted that analytical reasoning supported the utility of the invention, his insights were not described in the application and there was no evidence to suggest that someone skilled in the art would infer galantamine's utility from the specification, even if such inferences could substitute for an explicit declaration of utility.

Thus, the 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, which is not enough to obtain patent rights to the invention. The Federal Circuit affirmed the decision of the district court.