By Kevin E. Noonan --
On the same day the Federal Circuit rendered its opinion in AMP v. USPTO (the Myriad case), the Court also handed down its opinion in Eli Lilly & Co. v. Activis Elizabeth LLC. In an opinion by Judge Newman, joined by Judge Lourie (Judge Friedman was on the panel, but died before the court reached its decision), the Federal Circuit reversed a District Court finding of invalidity based on the patentee's failure to satisfy the utility aspect of the enablement requirement of § 112, 1st paragraph ("The specification shall contain a written description of the invention . . . in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same. . ."), reversed the District Court's holding that, if held valid, defendants would be liable for inducing infringement but not contributory infringement, and affirmed in all other respects.
The defendants (Actavis Elizabeth LLC, Sun Pharmaceuticals Ltd., Sandoz Inc., Mylan Pharmaceuticals Inc., Apotex, Inc., Aurobindo Pharma, Ltd., and Teva Pharmaceuticals USA Inc.) each filed an Abbreviated New Drug Application (ANDA) on atomoxetine ((R)-(–)-N-methyl-3- (2-methylphenoxy)-3-phenylpropylamine), sold by Eli Lilly as Strattera® to treat attention deficit/hyperactivity disorder (ADHD). The patent-in-suit was U.S. Patent No. 5,658,590; specifically at issue was claim 1:
A method of treating attention- deficit/hyperactivity disorder comprising administering to a patient in need of such treatment an effective amount of tomoxetine.
Atomoxetine itself was known and patented by Eli Lilly & Co. in U.S. Patent No. 4,314,081, which expired in 1999. That patent disclosed urinary incontinence and depression as two uses for the drug; it was only in 1993 that Eli Lilly scientists suggested that atomoxetine could be used to treat ADHD. In this regard, the District Court found that "occurrence of ADHD is wide, the cause is unknown, and the mechanism of drug treatment unclear," all of which is exacerbated by the lack of an animal model. In addition, the '590 patent specification taught that treatments current at the time the invention was made were inadequate and "exhibited deficiencies" (including sudden death in children). Despite these deficiencies, testimony established that the Lilly scientists' suggestion that the drug be used to treat ADHD was "met with skepticism" and FDA approval took approximately 7 years.
The ANDAs filed by the defendants contained Paragraph IV certifications of invalidity (for obviousness, and lack of enablement based on scope and utility), unenforceability, and non-infringement (under both inducement to infringe and contributory infringement). The District Court held that none of the defendants had established invalidity for obviousness or lack of enablement based on scope, but that claim 1 of the '590 patent was invalid for failure to provide evidence that the claim was operable, i.e., the specification failed to satisfy the utility aspect of the enablement requirement. The basis for the District Court's decision was that the "utility [of the claimed method] was not established because experimental data showing the results of treatment of ADHD were not included in the specification." The question addressed by the Federal Circuit was the extent of disclosure required to satisfy this requirement of the statute. Lilly contended that disclosing the use of atomoxetine to treat ADHD was enough, while defendants contended (and the District Court agreed) that the claimed utility must be established by experimental evidence in the application as filed.
The Federal Circuit reversed, based on its determination that the District Court's finding that experimental data was required to be in the application as filed was error. Provided priority between inventors is not involved, the Court's opinion said that applicants are able to submit data "either before or after the patent application was filed," where after-filed evidence "can be used to substantiate any doubts as to the asserted utility since this pertains to the accuracy of a statement already in the specification." The Court's opinion reversing the District Court's finding of invalidity was based on the requirement that an assertion of utility must be accepted as sufficient to satisfy the utility requirement unless there is "some reason" for the skilled worker to question the "objective truth" of the asserted utility, citing In re Langer, 503 F.2d 1380, 1391 (CCPA 1974), In re Brana, 51 F.3d 1560 (Fed. Cir. 1995), and In re Marzocchi, 439 F.2d 220, 223 (CCPA 1971). From Brana, the Court quoted the requirement that "[o]nly after the PTO provides evidence showing that one of ordinary skill in the art would reasonably doubt the asserted utility does the burden shift to the applicant to provide rebuttal evidence sufficient to convince such a person of the invention's asserted utility," citing In re Bundy, 642 F.2d 430, 433 (CCPA 1981).
The Federal Circuit noted that the accuracy of the disclosed utility had not been questioned by the defendants, and that it was also undisputed that Lilly performed successful clinical trials after the patent application that resulted from the '590 patent was filed. And during prosecution, the examiner "did not require the submission of data" that ADHD could be treated with atomoxetine.
In assessing the adequacy of the disclosure of in the specification, the Federal Circuit opinion also noted that "[t]he utility of this product to treat ADHD is not so incredible as to warrant the special procedures that are authorized for use when the examiner doubts the described utility" or "for subject matter in once notoriously intractable areas such as cures for baldness or cancer." Here, "deference is owed to the 'qualified agency presumed to have done its job,'" citing Am. Hoist & Derrick Co. v. Sowa & Sons, Inc., 725 F.2d 1350, 1359 (Fed. Cir. 1984).
The opinion appears to restore to its traditional moorings the requirements for enablement that were called into question by the Court's decision in Janssen Pharmaceutica N.V. v. Teva Pharmaceuticals USA, Inc., 583 F.3d 1317 (Fed. Cir. 2009) (aka In re '318 Patent Litigation). In that case, the teachings that a specific compound, galantamine, could be used to treat Alzheimer's disease were found insufficient because "animal tests were 'not finished . . . by the time the '318 patent was allowed.'" The panel here distinguished the purported lack of an enabling disclosure in Janssen with the instant case, where the specification "contained a full description of the utility, experimental verification had been obtained before the patent was granted, and the examiner had not requested additional information." Here, the Court's opinion seems to be based on the existence of after-filing evidence sufficient for Lilly to rebut an assertion that the "objective truth of the asserted utility" would be doubted by the skilled worker.
Regarding the other asserted grounds of invalidity, the Federal Circuit affirmed the District Court finding that defendants had not established that the claimed invention was obvious. Defendants' obviousness argument was based on prior art that another compound -- desipramine, a norepinephrine inhibitor -- was used to treat ADHD and that atomoxetine was also to be a norepinephrine inhibitor. Thus, defendants argued that it would have been obvious to test atomoxetine for the treatment of ADHD. The District Court found this argument to be insufficient, because it is not permissible to "pick and choose" from references to find evidence supporting obviousness, while excluding other evidence (including serious side-effects from despiramine use) that would be necessary to appreciate what a reference "fairly suggests," citing In re Wesslau, 353 F.2d 238, 241 (CCPA 1965). The District Court also rejected defendants' argument that atomaxetine would have been "obvious to try" for treating ADHD; this determination was based on the Supreme Court's decision in KSR Int'l Co. v. Teleflex Inc. to the effect that "there was no evidence . . . the exercise of common sense would have led a person of ordinary skill to test atomoxetine for treatment of ADHD" (a conclusion supported by testimony from experts on both sides).
Defendants also argued that the specification did not enable the claimed method throughout its full scope, relating to the claim limitation directed to "administering to the patient an effective amount" of the drug for treating ADHD, because this limitation was not directed to the expressly disclosed formulations. Defendants presented expert testimony that undue experimentation would be required to determine particular formulations and effective amounts to be administered. The specification disclosed that oral formulations were preferred and contained generic disclosure of oral formulations, as well as ranges of preferred doses. Applying the rubrics of In re Wands, the District Court found that a person skilled in the art would be able to make formulations throughout the full scope of the claimed limitation through the exercise of no more than routine experimentation. In affirming this result, the Federal Circuit rejected defendants' argument based on ALZA Corp. v. Andrx Pharmaceuticals, LLC, 603 F.3d 935 (Fed. Cir. 2010) (where the claimed formulations were "a breakaway from the prior art"), and asserted the principle from Spectra-Physics, Inc. v. Coherent, Inc., 827 F.2d 1524, 1534 (Fed. Cir. 1987) that "a patent need not teach, and preferably omits, what is well known in the art."
Finally, the Federal Circuit reversed the District Court's finding that if claim 1 of the '590 patent was valid, the defendants were liable for inducing infringement under 35 U.S.C. § 271(b), but not contributory infringement under § 271(c). According to the Court, the possibility of "off-label" uses were irrelevant to the issue, since each defendant would be selling the generic product with an FDA-approved label directed to Lilly's claimed method. Moreover, since the only use for which the ANDA filers could sell the drug was the FDA-approved use, atomoxetine had no "substantial non-infringing use" and thus its sale also constituted contributory infringement under § 271(c).
Eli Lilly & Co. v. Actavis Elizabeth LLC (Fed. Cir. 2011)
Panel: Circuit Judges Newman, Friedman, and Lourie
Opinion by Circuit Judge Newman
(The opinion notes that Circuit Judge Friedman heard oral argument in the appeal, but died on July 6, 2011, and did not participate in the final decision. The case was decided by the remaining judges on the panel, in accordance with Fed. Cir. Rule 47.11.)