Rasmussen v. SmithKline Beecham Corp., 413 F.3d 1318 (Fed. Cir. 2005) (link below) was a truly scary decision that many of us practitioners hoped would be ignored by future Fed. Cir. panels as an aberration brought on by over-extensive prosecution, a litigation setting, and good lawyering. In that decision a Merck application filed early in a chain of nine applications was held to be non-enabled, and Merck’s priority claim was denied. The application, as I recall, claimed the use of a known compound to treat prostate cancer. Clearly, it worked or at least showed promise, or the interference would not have advanced so far. However, the court held that Merck’s early applications were non-enabled, affirming the Board’s finding that Merck provided no experimental data confirming the alleged anti-cancer activity and “no reasonable scientific basis for [the art worker] to conclude that method would [work].” Citing In re Novak (CCPA 1962). The court reasoned:
“If mere plausibility were the test for enablement…applicants could obtain patents rights to ‘inventions’ consisting of little more than respectable guesses as to the likelihood of success. When one of the guesses later proved true, the ‘inventor’ would be rewarded…instead of the party who demonstrated that the invention actually works.”
In 2005, while I noted that the early applications had no experimental data at all, even in vitro tests, I also noted that the court recognized that the applications did have a discussion of the scientific basis of the method of treatment. I closed a slideshow on this decision by noting that “Merck ‘guessed right’–the method of treatment worked and for the reason Merck said it did…. Merck met most of the Wands factors (except working examples, which are not required to meet s. 112)…We want early disclosures of drugs and medical treatments.”
Apparently not so much. In Janssen Pharmaceutica v Teva, appeal no. 2008-1594, 2009-1070 (Fed. Cir. Sept. 25, 2009) a split panel affirmed the invalidation of U.S. Pat. No. 4663318, claiming the use of a known compound, galanthamine, to treat the symptoms of Alzheimer’s disease, on the basis that the specification “does not satisfy the enablement requirement because [the specification] did not establish utility.” Yes, the specification was short, there was no experimental test data (even in vitro) and the inventor offered little in the way of explanation for the mechanism of action (e.g., did not say “While not intending to be bound by any theory of action, it is believed that…”), but honorable jurists, HE GUESSED RIGHT! Subsequent animal model tests were positive and, as the majority noted without comment: “In February 2001 [the inventor] received approval from the [FDA] for using galantamine to treat mild to moderate Alzheimer’s disease.”
The majority cites In re Fisher, which held that ESTs lacked practical utility, but that is a far cry from denying a patent on a new use for an old compound, when that new use is far from incredible on its face and of great social importance. While stopping just short of requiring in vitro testing that can be correlated to efficacy (something the PTO longed for in the 90′s), the majority left little hope for those inventors who cannot come up with test results during prosecution (even if the Examiner does not require it): “Thus at the end of the day, the specification, even read in the light of the knowledge of those skilled in the art, does no more than state a hypothesis and propose testing to determine the accuracy of that hypothesis. That is not sufficient. See Rasmusson…. ” Janssen had argued that “analytic reasoning” should be sufficient to establish utility. While finding no case law contradicting this position, the majority simply found that “[t]hese insights are nowhere described in the specification.”
Read Judge Gajarsa’s dissent first; it will amplify your stress/distress level at Judge Dyk’s and Judge Mayer’s stern opinion, that comes perilously close to moralizing. Judge Gajarsa reminds the majority that it is the defendants’ burden to invalidate the patent by showing that “its model for Alzheimer’s therapy, is not sufficient for a skilled artisan to believe the invention’s utility.” He closes by stating that “[the panel] cannot defer to the district court’s legal conclusion or [deficient] fact-findings, and thus, it is particularly problematic for the majority to require Janssen to demonstrate on appeal that its patent is valid.” Unfortunately, this is a dissent and, as the patentee learned with a vengeance: No flash of genius goes unpunished.