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 support of its reasoning, the Court quoted the statement from In re Brana, 51 F.3d 1560, 1566 (Fed. Cir. 1995) that "one who has taught the public that a compound exhibits some desirable pharmaceutical property in a standard experimental animal has made a significant and useful contribution to the art, even though it may eventually appear that the compound is without value in the treatment in humans." Id.

Applying these somewhat permissive legal standards, the Federal Circuit upheld validity based on the patented device having been successfully implanted in pigs in accordance with the procedure described in the patent and evidence that pigs were a "standard experimental model." Id.

We observe that this decision follows in the footsteps of Judge Newman's prior nonprecedential (though still cite-able per Fed. Cir. R. 32.1) opinion in Eli Lilly & Co. v. Actavis Elizabeth LLC, 2011 WL 3235718 (Fed. Cir. July 29, 2011), where the Court reversed a finding of invalidity for lack of enablement/utility of a method of treatment claim. In Lilly, the defendants had argued that utility was not established because the patent specification did not contain experimental data justifying the claimed treatment method. Id. at *5. The Court explained that the patent specification did in fact satisfy the utility requirement for treatment with the drug product, though experimental data was not included in the specification and was obtained after the application had been filed. Id. at *6-8. As the Court stated:

The only relevant concern of the Patent Office under these circumstances should be over the truth of any such assertion. The first paragraph of § 112 requires nothing more than objective enablement. How such a teaching is set forth, either by the use of illustrative examples or by broad terminology, is of no importance.

Id. at *8 (quoting In re Marzocchi, 439 F.2d 220 (CCPA 1971)).

In sum, Edwards now adds to the armamentarium of potentially helpful decisions for innovator companies in responding to allegations that their patents are invalid for not including adequate experimental data. We do caution, however, that there is a significant body of case law addressing these issues, and we would advise careful review in individual circumstances based on the facts of the particular case.

The content of this article does not constitute legal advice and should not be relied on in that way. Specific advice should be sought about your specific circumstances.