Federal Circuit Ruling Strengthens Defenses Against Enablement Attacks On Drug And Medical Device Patents

In a decision issued earlier this week, the Federal Circuit rejected an assertion of invalidity of a patent for lack of enablement under 35 U.S.C. § 112, holding that human testing at the time the patent application was filed was not required. Edwards Lifesciences AG v. CoreValve, Inc., 2012 WL 5476839 (Fed. Cir. Nov. 13, 2012). Importantly, the Court's reasoning in doing so should be an additional source of help in fending off the growing trend of generic attacks on drug patents under § 112.

The patent in suit was directed to a prosthetic device called a "transcatheter heart valve." At the district court level, a jury found the patent to be not invalid for lack of enablement and willfully infringed. Defendant CoreValve contended that the patent was invalid for lack of enablement based on "the undisputed fact that at the time the . . . patent application was filed the stent/valve prosthesis had been implanted only in pigs." Id. at *2. Moreover, the experimental uses in pigs "were not always successful," "design changes were made after the patent application was filed," and "more developmental work was required." Id. An inventor's contemporaneous report admitted that "much more work had to be done before anybody ever even contemplated using this for a human," and the patentee's expert witness admitted that the device described in the patent application was "not a device to moving in and treat patients." Id.

In affirming the validity of the patent on these facts, the Federal Circuit made the following pronouncements which may become helpful in other § 112 cases:

The Federal Circuit endorsed as a "correct statement of the law" the district court's jury instruction which stated, inter alia, that the patent application does not necessarily need a working example: "The patent need not contain a working example if the invention is otherwise disclosed in such a manner that one skilled in the art to which the invention pertains will be able to practice it without an undue amount of experimentation." Id. The Court recognized that patents relating to drugs and medical devices are generally filed before FDA approval such that the outcome of human testing would not be available in any event: "[I]t has long been recognized that when experimentation on human subjects is inappropriate, as in the testing and development of drugs and medical devices, the enablement requirement may be met by animal tests or in vitro data." Id. at *3 (emphasis added). In...