Bright Line Rule
Citing Lilly and other cases2, the Board held that the references to prior art and disclosure of specific examples provided in each partys specification, in the absence of any sequence information within the specification, did not provide adequate written descriptive support for the invention. The Board, having pronounced this bright line rule, rejected all the claims without considering the support for each claim individually.
Both parties appealed the Boards decision, and the director of the U.S. Patent and Trademark Office intervened3, thereby setting the stage for the Federal Circuit to clarify important aspects of the written description requirement of the patent statute as it relates to biotech inventions.
In an opinion authored by Judge Pauline Newman, the Federal Circuit now states plainly that a sequence need not appear in a patent specification to support a DNA-based invention provided that the state of the scientific knowledge includes such structural information.
Moreover, the Court noted that application of the written description law necessarily will vary [over time] with differences in the state of knowledge in the field and differences in the predictability of the science. This last note of varying application of the law is a key issue for biotech patenting as it may impact the allowable breadth in claims of sequence-based patents.
The Federal Circuit rejected the Boards per se sequence requirement for biotechnical inventions. Such a requirement was characterized as an inappropriate generalization that ignores the state of the scientific knowledge, as explained by both parties.
Indeed, the Boards bright line rule places form unreasonably over substance, as Judge Newman noted in writing that requiring reanalysis of the chimeric molecules detailed structure where the prior art includes the nucleotide information simply lacks descriptive substance.
Moreover, the requirement to describe ones invention for the patent right, says the Federal Circuit, does not state that every invention must be described in the same way.