Pharmaceutical Patents (Intellectual Property Law Series)

THIS CASEBOOK contains a selection of 136 decisions the U. S. Court of Appeals that discuss and analyze patent law issues related to the pharmaceutical industry. The selection of decisions spans from 2005 to the date of publication.


Proving Lack of Enablement: The Challenger's Burden

To prove that a claim is invalid for lack of enablement, a challenger must show by clear and convincing evidence that a person of ordinary skill in the art would not be able to practice the claimed invention without "undue experimentation." In re Wands, 858 F.2d 731, 736-37 (Fed. Cir. 1988); see also Johns Hopkins Univ. v. CellPro, Inc., 152 F.3d 1342, 1360 (Fed. Cir. 1998) ("[I]t is imperative when attempting to prove lack of enablement to show that one of ordinary skill in the art would be unable to [practice] the claimed invention without undue experimentation.") (emphasis omitted). After the challenger has put forward evidence that some experimentation is needed to practice the patented claim, the factors set forth in Wands then provide the factual considerations that a court may consider when determining whether the amount of that experimentation is either "undue" or sufficiently routine such that an ordinarily skilled artisan would reasonably be expected to carry it out. Wands, 858 F.2d at 737. Alcon Research Ltd. v. Barr Laboratories, Inc.,(Fed. Cir. 2014)


The Invention Does not Need to Work

Furthermore, a patent does not need to guarantee that the invention works for a claim to be enabled. It is well settled that an invention may be patented before it is actually reduced to practice. Pfaff v. Wells Elecs., Inc., 525 U.S. 55, 61 (1998). Similarly, a patentee is not required to provide actual working examples; [the court has] rejected enablement challenges based on the theory that there can be no guarantee that prophetic examples actually work, as "[t]he burden is on one challenging validity to show by clear and convincing evidence that the prophetic examples together with other parts of the specification are not enabling." Atlas Powder Co. v. E.I. du Pont de Nemours & Co., 750 F.2d 1569, 1577 (Fed. Cir. 1984). Nor is it "a requirement of patentability that an inventor correctly set forth, or even know, how or why the invention works." Newman v. Quigg, 877 F.2d 1575, 1581-82 (Fed. Cir. 1989) (citing Diamond Rubber Co. v. Consol. Rubber Tire Co., 220 U.S. 428, 435-36 (1911)). Alcon Research Ltd. v. Barr Laboratories, Inc., ibid.