One of the requirements for obtaining a patent is enablement. As set forth in 35 U.S.C. §112, ¶1, the specification of the patent must teach a person skilled in the art how to make and use the invention without undue experimentation. The enablement requirement must be satisfied at the time the patent application is filed for each claim. If a claim in a patent is not enabled, it is invalid.
In In re ‘318 Patent Infringement Litigation (Janssen Pharmaceutica N.V. v. Teva Pharmaceuticals USA, Inc. and related cases) (2009 U.S. App. LEXIS 21166, September 25, 2009), the Federal Circuit Court of Appeals addressed the issue of enablement. Janssen’s patent covered a method to treat Alzheimer’s disease with a chemical compound called galanthamine. Claim 1 of the patent was:
“A method of treating Alzheimer’s disease and related dementias which comprises administering to a patient suffering from such a disease a therapeutically effective amount of galanthamine or a pharmaceutically-acceptable acid addition salt thereof.”
The patent application was filed on 1986. The specification was slightly longer than one page and contained brief summaries of six scientific articles which discussed the use of galanthamine on humans or animals for various purposes. None of the six articles addressed the treatment of Alzheimer’s or dementia or the potential of galanthamine to treat those diseases.
The PTO examiner rejected the original claims on the grounds of indefiniteness and obviousness. The claims were found to be indefinite because they covered a method of “treating and diagnosing” Alzheimer’s and the examiner stated that diagnosis was not related to treatment. The obviousness rejection was based on several of the scientific articles disclosed in the specification which addressed the treatment of memory loss in animals.
In response to the office action, the inventor deleted the word “diagnosis” so that the claims covered only the treatment of Alzheimer’s, which overcame the indefiniteness rejection. The inventor overcame the obviousness rejection by asserting that the scientific studies on memory loss had no relevance to Alzheimer’s because they were conducted under unrelated circumstances. The inventor also stated that experiments on animal models related to Alzheimer’s had begun.
The patent was allowed and issued in 1987. The research on the animal models was not completed by the time the patent issued and was not provided to the PTO.
The inventor later licensed the patent to Janssen. Janssen then obtained FDA approval to treat Alzheimer’s with galanthamine. Shortly thereafter, several drug companies filed abbreviated new drug applications for generic versions of galanthamine. Janssen sued these companies for patent infringement.
At a bench trial, the defendants admitted infringement, but asserted that the patent was invalid as anticipated, obvious, and not enabled. The district court found that the patent was not anticipated or obvious but was invalid on the grounds that it was not enabled. The court held that the specification lacked utility, as the animal tests were not done, and that it was not enabled because it did not describe the dosage to be used.
Janssen appealed. The Federal Circuit Court of Appeals affirmed the trial court’s decision.
The Court of Appeals discussed both the enablement and utility requirements:
“The utility requirement prevents mere ideas from being patented. As we noted in Genentech, Inc. v. Novo Nordisk A/S, 108 F.3d 1361, 1366 (Fed. Cir. 1997), ‘patent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable…Tossing out the mere germ of an idea does not constitute enabling disclosure.’”
The court further stated:
“The utility requirement also prevents the patenting of a mere research proposal or an invention that is simply an object of research. Again as the Supreme Court stated in Brenner ‘a patent is not a hunting license. It is not a reward for the search, for compensation for its successful conclusion.’ [Citation omitted.] A process or product ‘which either has no known use or is useful only in the sense that it may be an object of scientific research’ is not patentable. [Citation omitted.] As we observed in Fisher, inventions do not meet the utility requirement if they are ‘objects upon which scientific research could be performed with no assurance that anything useful will be discovered in the end.’”
The court explained that patent applications for methods of treating diseases usually include test results to satisfy the utility requirement. The test results need not be Phase II (human trials), but rather may be from animal tests or in vitro research.
The court found that the patent application, however, did not include any test results. The six scientific articles clearly did not provide evidence of utility because the inventor had stated during the prosecution of the patent that those references did not relate to the method of the invention and did not render it obvious.
Janssen argued that utility was demonstrated by analytic reasoning and that test results were not necessary. The court noted that Janssen’s suggested reasoning was not included in the specification and was therefore irrelevant.
The court concluded:
“Thus, at the end of the day, 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. That is not sufficient. [Citation omitted.] ‘If mere plausibility were the test for enablement under §112, applicants could obtain patent rights to “inventions” consisting of little more than respectable guesses as to the likelihood of their success. When one of the guesses later proved true, the “inventor” would be rewarded the spoils instead of the party who demonstrated that the method actually worked.’”