Yeda Research and Development Co. v. Abbott GmbH & Co. (Fed. Cir. 2016)

By Kevin E. Noonan --

Before the Supreme Court's recent forays into the topic of subject matter eligibility in patent law, the most contentious line of cases (from the Federal Circuit) concerned the written description requirement of Section 112.  Indeed, some (like former Chief Judge Rader) believed that the statute does not contain a separate written description requirement, an opinion firmly shut down by the Court's en banc decision in Ariad v. Eli Lilly & Co.  That case established not only the existence of a requirement separate from enablement that a specification provide an adequate written description, but affirmed the decision from Regents of the University of California v. Eli Lilly & Co. that the requirement was satisfied if the person of ordinary skill in the art would have understood the inventor to have possessed the invention throughout its full scope when the application was filed.

Although the principles seem to be settled (a dangerous assumption with this or perhaps any Supreme Court decision) the application of the law still leaves room for surprise.  One such surprise was enunciated by the Federal Circuit in its decision upholding a district court's finding that disclosure and possession can be satisfied inherently, in Yeda Research and Development Co. v. Abbott GmbH & Co.  The case came to the Court after two adverse decisions before the District Court (for the District of Columbia) and the U.S. Patent and Trademark Office's Patent Trial and Appeal Board (PTAB).  Yeda and Abbott were in an interference involving Abbott's U.S. Patent No. 5,344,915 in which Yeda originally prevailed.  The basis for the initial PTAB decision was that the '915 patent was not entitled to an earlier priority date based on a German patent application.  Without that priority claim, it was undisputed that an intervening prior art reference (Engelmann) anticipated the claims.  The question was whether the original German patent, which disclosed isolation but not amino acid sequence characterization of a tumor necrosis factor binding protein, named TBP-II, inherently disclosed the amino acid sequence of the amino terminus, as recited in representative claim 1 of the '915 patent:

A purified and isolated TNFα-binding protein which has a molecular weight of about 42,000 daltons and has at the N terminus the amino acid sequence
    Xaa Thr Pro Tyr Ala Pro Glu Pro Gly Set Thr Cys Arg Leu Arg Glu
    where Xaa is hydrogen, a phenylalanine residue (Phe), or the amino acid sequences Ala Phe, Val Ala Phe, Gln Val Ala Phe, Ala Gln Val Ala Phe, Pro Ala Gln Val Ala Phe or Leu Pro Ala Gln Val Ala Phe.

The disclosure of the priority applications was limited to "a partial N-terminus sequence, a protocol for obtaining the protein from its biological source, and additional properties of the protein, such as molecular weight, biological activity, and degradation characteristics when exposed to trypsin."  The parties also agreed, according to the Federal Circuit opinion, that the (partial) N-terminal amino acid sequence set out in the priority document(s) were only present in TBP-II, the same protein disclosed and claimed in the '915 patent.

The PTAB found the '915 patent to be invalid for anticipation buy the Engelmann reference in original interference (No. 103,625) and Abbott brought suit in district court challenging that decision.  The District Court granted summary judgment for Abbott, agreeing that the priority application "inherently discloses the TBP-II protein and provides an adequate written description of the invention claimed in the '915 application" and remanded to the PTAB.  The PTAB found on remand that the '915 specification satisfied the written description requirement and Yeda filed its own district court action challenging that result.  Again, the District Court found that the '915 specification satisfied the written description requirement and granted summary judgment to Abbott.  This appeal followed.

The Federal Circuit affirmed, in an opinion by Judge Reyna joined by Judges Wallach and Hughes.  Relevant to its decision, the panel noted that it was undisputed that the protein disclosed in the priority applications was the same protein disclosed in the '915 patent and in the Engelmann reference, and that this is the only protein having that amino acid sequence.  Under the doctrine of inherent disclosure," when a specification describes an invention that has certain undisclosed yet inherent properties, that specification serves as adequate written description to support a subsequent patent application that explicitly recites the invention's inherent properties" according to the opinion, citing Kennecott Corp. v. Kyocera Int'l, Inc., 835 F.2d 1419, 1421 (Fed. Cir. 1987) (a pre-Ariad case now seeming to have the imprimatur of the Federal Circuit as remaining good law).  Here, under the circumstances of this case, the Federal Circuit held that the priority application inherently disclosed the N-terminal amino acid sequence of TBP-II.  Specifically, the Court said that "[i]t is not necessary for an application to disclose a protein's complete N-terminus sequence in order to provide an adequate written description of that protein."  In distinguishing this case from precedent cited by Yeda (Hyatt v. Boone, 146 F.3d 1348 (Fed. Cir. 1998) and In re Wallach, 378 F.3d 1330 (Fed. Cir. 2004)), the importance of the circumstances is clear:  "[n]either Hyatt nor Wallach involved the situation present in this case, where it is undisputed that the invention described in an earlier application was the exact invention claimed by the later patent."

The opinion also rejected Yeda's argument that inherent limitations cannot be relied upon in a priority determination if the limitations are material to patentability, citing Hitzeman v. Rutter, 243 F.3d 1345, 1355 (Fed. Cir. 2001).  Yeda supported its position that the specific amino acid sequences were material on the basis that Abbott had distinguished its claims from prior art "that disclosed a protein with the same source, weight, and function as the protein claimed in the '915 patent."  In the panel's view, the prosecution history did not corroborate Yeda's reading of the prior art disclosure, stating that "the cited art concerned only TBP-I, and that TBP-II includes a sequence of five amino acids not present in TBP-I that match the chain recited in the '915 patent claims."  And 3 of the 5 distinguishing amino acids disclosed in the Engelmann reference were also disclosed in the priority applications for the '915 patents and "were themselves sufficient to distinguish TBP-I from TBP-II."

The apparent liberality applied by the Court in finding that the disclosure of the priority applications satisfied the written description requirement is in stark contrast to how stringently the requirement has been applied over the past twenty years in the USPTO, particularly in a variety of Guidances and Training Materials promulgated during that time.  But while certainly constrained by the particular facts set forth in the opinion, in some ways perhaps how the Court applied the requirement is consistent with Judge Lourie's formulation of how Section 112 should be interpreted in the Lilly case that in many ways was the beginning of modern written description jurisprudence:

A description of a genus of cDNAs may be achieved by means of a recitation of a representative number of cDNAs, defined by nucleotide sequence, falling within the scope of the genus or of a recitation of structural features common to the members of the genus, which features constitute a substantial portion of the genus.

Here, the "members of the genus" was in fact TBP-II itself, and the "structural features" comprised the partial amino acid sequence disclosed plus the protein itself from which the remaining amino acids comprising the N-terminus of the protein could be determined.  The situation here in many ways was the opposite of what Judge Lourie prescribed against:  not a broad genus defined purely by function, but a particular protein that inherently had an N-terminal amino acid sequence that need not be expressly recited in order to support a priority claim.

Yeda Research and Development Co. v. Abbott GmbH & Co. (Fed. Cir. 2016)
Panel: Circuit Judges Reyna, Wallach, and Hughes
Opinion by Circuit Judge Reyna

Comments

[Dave Goldsmith]

Only one problem. In addition to some correct amino acids, the German priority document disclosed at least one wrong amino acid and in addition, because they could not be determined, hundreds of thousands of possibilities for the remaining amino acids of the N-terminal sequence in the '915. But what is worst, none of the three judges had any significant patent experience, nor any scientific experience necessary for a complicated protein case. This was clear when one of the judges referred to a decision by the CAFC by explaining that the decision said XYZ, while in reality the decision was exactly the opposite of what the judge said. There used to be a time where the CAFC got it right most of the times. Not anymore!