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Janssen Pharmaceutica N.V. v. Teva Pharm. USA, Inc. (In re '318 Patent Infringement Litig.) - 583 F.3d 1317 (Fed. Cir. 2009)

Rule:

The enablement requirement of 35 U.S.C.S. § 112, para. 1 requires that a specification adequately disclose to one skilled in the relevant art how to make, or in the case of a process, how to carry out, the claimed invention without undue experimentation. The utility requirement of 35 U.S.C.S. § 101 mandates that any patentable invention be useful and, accordingly, the subject matter of the claim must be operable. If a patent claim fails to meet the utility requirement because it is not useful or operative, then it also fails to meet the how-to-use aspect of the enablement requirement.

Facts:

Janssen Pharmaceutica N.V., Janssen L.P., and Synaptech, Inc. ("Janssen") filed a complaint for patent infringement against a number of generic manufacturers. The subject of the patent infringement was ‘318 patent, a patent which claimed a method for treating Alzheimer’s disease with galanthamine. 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 defendants conceded infringement of claims 1 and 4 of the ‘318 patent, and a bench trial was held on the invalidity issues of anticipation, obviousness, and enablement. The district court concluded that the patent was invalid for lack of enablement on two distinct grounds: The specification did not demonstrate utility because relevant animal testing experiments were not finished by the time the patent was allowed, and the specification provided only minimal disclosure of utility. The district court alternatively found that the specification and claims did not teach one of skill in the art how to use the claimed method because the application did not provide sufficient dosage information. Janssen appealed.

Issue:

Was the ‘318 patent invalid for lack of enablement?

Answer:

Yes.

Conclusion:

The Court agreed with the district court and held that the ‘318 patent’s description of using galantamine to treat Alzheimer's disease thus did not satisfy the enablement requirement because the '318 patent's application did not establish utility. According to the Court, although a person of ordinary skill in the art would have viewed the invention as scientifically grounded, that did not demonstrate that a person of ordinary skill in the art would have recognized that the specification conveyed the required assertion of a credible utility. The specification did no more than state a hypothesis and propose testing to determine its accuracy.

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