The Federal Circuit has issued a decision in AbbVie v. Janssen Biotech and Centocor Biologics, which relates to patents that broadly cover antibodies which can neutralize activity of human interleukin 12 (IL-12) and have useful application in the treatment of autoimmune disorders. The patent owner, AbbVie, sued Janssen and Centocor for infringement of the patents at issue. At trial, the jury found that all of the asserted claims were invalid on the grounds of lack of written lack of description, enablement, and obviousness. AbbVie appealed the district court's decision.
On appeal, AbbVie asserted that the denial of its summary judgment was improper, because the district court erroneously held that Centocor was not collaterally estopped from raising invalidity defenses in the infringement action after the interference proceeding at the Patent and Trademark Office. Collateral estoppel or issue preclusion can be invoked when the issue sought to be precluded was involved in an earlier matter, has actually been litigated, the issue was determined by final and binding judgment, and the determination of the issue was essential to the judgment. The court here reasoned that the proceedings and judgment from the Patent and Trial Appeal Board was not final as an action for interference was still pending at the district court level. Also, §146 of the Patent statute provides in relevant part that "[a]ny party to an interference dissatisfied with the decision of the [Board] on the interference, may have remedy by civil action, if commenced within such time after decision, not less than sixty days. . . ." Further, there is language in the statute which allows the district court to make a de novo review of findings of fact in situations where new evidence is presented following the Board's review. Because procedures are provided in the patent statute that allows for additional judicial remedies if a party to an interference action is not satisfied, the court held that Centocor was not collaterally estopped in this case from raising invalidity defenses in the infringement action. However, the Federal Circuit's discussion also left open the possibility that collateral estoppel may have applied had Centocor appealed under §141 instead of bringing a civil action.
The Court also discussed the written description requirement and acknowledged that in light of Ariad this requirement is separate from the concept of enablement. While AbbVie classified its claims as a set of human antibodies, they did not disclose any structural features to indicate a commonality within the genus. The Federal Circuit found the claims to be invalid in view of Ariad's holding that "merely drawing a fence around a perceived genus is not a description of the genus" and the fact that the jury heard substantial evidence that AbbVie's patents described only one type of structurally similar antibodies which are not representative of the full variety of scope of the genus. The court also emphasized the inherent vulnerability of patents to invalidity challenges based on lack of written description, where the areas of technology are unpredictable and difficult to prove a correlation between function and structures found within the genus.
The court ultimately affirmed the district court's judgments in both the infringement action and the interference action.
The full opinion can be found here.