Federal Circuit Clarifies Doctrine of Inherent Disclosure

Yeda Research and Development v. Abbott GmbH & Co. KG , No. 2015-1662, 2016 U.S. App. LEXIS 17133 (Fed. Cir. Sep. 20, 2016) (Before Reyna, Wallach and Hughes, J.) (Opinion for the Court, Reyna, J.).

Abbott owns a patent (the ‘915 patent) that discloses a protein referred to as TBP-II. This protein binds to and neutralizes another protein, called Tumor Necrosis Factor ? (“TNF ?”), which is associated with various immunological diseases. The ‘915 patent claimed priority to two applications for a “novel protein,” the ‘072 application ( May 9, 1989) and the ‘089 application (July 5, 1989). The Board of Patent Appeals and Interferences (“Board”) declared an interference between Abbott’s ‘915 patent and an application owned by Yeda. The Board denied Abbot’s priority claims, assigned a May 1990 filing date to the ‘915 patent, and concluded the patent was anticipated by a January 1990 prior art reference. The parties did not dispute that the reference anticipated the ‘915 claims, if the ‘915 patent’s earliest effective filing date was May 1990.

On appeal from the Board, the district court held that the ‘089 patent inherently discloses the TBP-II protein and provides an adequate written description of the invention claimed in Abbott’s ‘915 application. The Court granted Abbott’s motion for summary judgment, vacated the Board’s decision, and remanded. The Board responded that the ‘072 application sufficiently discloses TBP-II, and it gave the ‘915 patent the benefit of the ‘072 filing date. Therefore, the ‘915 patent was not anticipated by the January 1990 prior art reference. The district court affirmed and granted Abbott summary judgment.

On appeal to the Federal Circuit, Yeda argued that the district court did not apply the correct test for determining the sufficiency of the written description. Yeda claimed that “Abbott must show that at the time the ‘072 application was filed, a person of ordinary skill in the art would have understood that the partial N-terminus sequence in the ‘072 application included the additional amino acids identified in the ‘915 patent claims at issue.” The Court rejected this argument. Under the doctrine of inherent disclosure, when a specification describes an invention that has certain undisclosed yet inherent properties, it serves as adequate written description to support a later patent application that clearly recites the invention’s inherent properties. The Court held that the ‘072 application inherently disclosed the remaining amino acids in the N-terminus sequence of the TBP-II, and is an adequate written description to support for the ‘915 patent. The Court noted that it is “not necessary” for an application to disclose the entire sequence to provide an adequate written description.

Yeda argued that in “the context of priority determinations, the allegedly inherent limitation cannot be material to the patentability of the invention.” Yeda asserted that the amino acids missing from the literal disclosure in the ‘072 patent were material to patentability because Abbott relied upon their absence to distinguish the prior art during prosecution of Abbott’s ‘915 patent. The Court disagreed and held that Abbott did not rely solely on amino acids missing from the priority applications.

Finally, Yeda asserted that the district court erred in finding that the Board’s findings were supported by substantial evidence. The Court again rejected Yeda’s argument, holding that the Board’s decision rested on the fact that the ‘072 application identified nine of the fifteen amino acids of the N-terminus sequences recited in the relevant claim.

Under the doctrine of inherent disclosure, it is not necessary for an earlier application to explicitly describe the later patent. There is adequate written description to support a later patent where it is undisputed that the invention inherently described in an earlier application was the same subject matter included in the claims of the later patent.

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