Ariad v. Eli Lilly (08-1248.pdf, Fed. Cir. 2009) (Judge Moore; Concurring opinion by Judge Linn)
Ariad sued Lilly for infringing its patent that claims a method of reducing NF-κB ("en eff kappa be") activity. The listed inventors of the patent include, inter alia, two Nobel Laureates, and the original assignees include Harvard, MIT, and the Whitehead Institute. A jury found that both Evista and Xigris infringe, and the judge denied Lilly's JMOL motion on invalidity. The resulting judgment was for $65 million in past damages and an ongoing royalty of 2.3% of sales.
On appeal, the Federal Circuit reversed the lower court's decision - finding the asserted claims invalid for lack of written description. The written description requirement is intended to ensure that the inventors "disclose the technologic knowledge upon which the patent is based [and] demonstrate that the patentee was in possession of the invention that is claimed." (Quoting Capon). Consequently, the disclosure in the patent document "must clearly allow persons of ordinary skill in the art to recognize that he or she invented what is claimed” and was in "possession" of the invention at the time of filing including "all elements and limitations." In other words, Ariad "must describe some way of performing the claimed methods." The actual level of disclosure depends upon several factors such as the extent of prior art, maturity of the science, and the "predictability of the aspects at issue."
Here, it was clear that the invention was "extraordinarily creative" in a highly unpredictable field with little prior art available. Ariad's expert even testified that the invention necessitated the development of a new vocabulary. All these factors indicate that the written description bar will be set high.
Here, Ariad's description was scant on real examples
The ’516 patent discloses no working or even prophetic examples of methods that reduce NF-κB activity, and no completed syntheses of any of the molecules prophesized to be capable of reducing NF-κB activity.
Without specific examples, Ariad attempted to show that its description was sufficient by bolstering the skill of a PHOSITA. Unfortunately for the Patentee, the Jury found an early effective filing date and much of Ariad's evidence showed skill in the art after that 1989 date.
Because written description is determined as of the filing date—April 21, 1989 in this case—evidence of what one of ordinary skill in the art knew in 1990 or 1991 cannot provide substantial evidence to the jury that the asserted claims were supported by adequate written description.
Although important, these small date issues probably made no difference because the description was so lacking and the prior art so sparse.
The state of the art at the time of filing was primitive and uncertain, leaving Ariad with an insufficient supply of prior art knowledge with which to fill the gaping holes in its disclosure.
"We therefore conclude that the jury lacked substantial evidence for its verdict that the asserted claims were supported by adequate written description, and thus hold the asserted claims invalid."
Caveat Vindicor: In its conclusion, the court noted that this result likely turned on clam construction. If Ariad had agreed to a narrower construction in litigation or narrower claim language during prosecution, then the written description requirement might have been satisfied. Of course, if it had pursued that strategy, infringement would have likely been lost.
Although Judge Linn concurred in the opinion, he wrote separately to remind readers of his belief that the written description requirement should be eliminated and enablement be allowed to do its job.
- Pioneering inventions are less likely to be found obvious or anticipated. However, one problematic result highlighted by this decision is that those pioneer patents are more likely to be trapped by the formalities of the patent system.