Ryan Chirnomas | October 27, 2016
Yeda Research and Development Co. Ltd. v. Abbott GmbH & Co. KG
September 20, 2016
Before Reyna, Wallach and Hughes. Opinion by Reyna
In a case arising out of an interference, validity of the patent in question turned on the question of whether structural features of a protein, which were newly added in the U.S. application, were inherently supported by the priority document. Here, it was found that the priority document did inherently support the claimed protein, and any structural features thereof, even if it did not disclose the specific claimed structural features. This is because there was only one protein that could possibly be described by the priority document.
Abbott is the owner of U.S. Patent No. 5,344,915, which claims priority to German applications P39 15 072 and P29 22 089. The ‘915 patent discloses a protein called TBP-II, which neutralizes TNF-α, a key protein in immunological diseases. The key claim is as follows:
1. 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.
Meanwhile, the German priority documents to which the ‘915 patent claims priority do not disclose the complete N-terminus sequence. These Germans priority documents disclosed a partial N-terminus sequence, as well as how the protein is obtained from its biological source, and several physical properties of the protein.
This case arises out of an interference between Abbott’s ‘915 patent and Yeda’s application in 1996. In 2000, the Board assigned Abbott the filing date of the ‘915 patent, not the date of the German priority applications. The Board concluded that the patent was invalidated by an intervening prior art reference (Engelmann). Engelmann disclosed the TBP-II protein and distinguished it from a similar protein, TBP-I. In 2008, Abbott appealed to district court, which indicated that one of the German priority document inherently discloses the TBP-II protein, and sufficiently supports the ‘915 patent. In 2010, the Board held that the other German priority document sufficiently discloses the TBP-II protein. Yeda then appealed to district court, which agreed with the Board, and then appealed to the CAFC.
Since Engelmann would be invalidating prior art, the question of validity of the ‘915 patent turns on whether the German priority documents provide written description support. Yeda first argued that the Board applied the wrong standard. Specifically, Yeda argued that for the priority document to support the ‘915 claims, the skilled artisan would have to understand that the partial sequence of the priority document includes the amino acids recited in the ‘915 claim. On the other hand, Abbott argued that the priority document only needs to sufficiently describe the TBP-II protein itself, and the partial sequence disclosure can be coupled with other characteristics.
The CAFC agreed with Abbott and held that the German priority document inherently supports the ‘915 claims. Citing to Kennecott v. Kyocera, 835 F.2d 1419 (Fed. Cir. 1987), the CAFC indicated that when a “specification describes an invention that has certain undisclosed yet inherent properties, that specification serves as an adequate written description to support a subsequent patent application that explicitly recites the invention’s inherent properties.” It was not disputed that TBP-II is the only protein with the partial sequence and characteristics described in the priority document. The CAFC distinguished over two cases cited by Yeda (Hyatt v. Boone, 146 F.3d 1348 (Fed. Cir. 1998) and In re Wallach, 378 F.3d 1330 (Fed. Cir. 2004)), indicating that unlike in those cases, here, it is undisputed that the invention of the earlier application is exactly the same as the invention of the later patent. Thus, the priority document sufficiently supports the claims reciting the full N-terminal sequence.
Yeda then argued that the prosecution history precludes reliance on inherent disclosure. Specifically, Yeda argued that in “the context of priority determinations, the allegedly inherent limitation cannot be material to the patentability of the invention,” relying on Hitzeman v. Rutter, 243 F.3d 1345 (Fed. Cir. 2011). Yeda argued that since Abbott relied on the amino acids in question to distinguish over Engelmann, they are material to patentability. In prosecution, the Examiner relied on cited art showing a protein with the same source, weight and function as that claimed. In response, Abbott pointed to Engelmann to show that TBP-I and TBP-II are different. Abbott also relied on Engelmann to show that TBP-II has five different amino acids than TBP-I, and that these were included in the claimed sequence. However, three out of the five TBP-II-unique amino acids disclosed in Engelmann were in fact also disclosed in the priority document. Thus, the sequence of the priority document alone was sufficient to distinguish over the art on its own. Therefore, Yeda’s argument fails.
Lastly, Yeda argued that the district court was incorrect in holding that the Board’s decision was supported by substantial evidence. However, the CAFC again reiterated that the priority document disclosed nine of the 15 amino acids of the claimed N-terminus sequence and various biological characteristics. Furthermore, it was undisputed that no other known protein besides TBP-II has this structure and characteristics. Thus, the CAFC concluded that the Board’s decision was supported by substantial evidence.
In many cases, adding a new disclosure to a US application, beyond what is disclosed in a priority application, can result in a breaking of the chain of priority. But here, because the priority document inherently disclosed the subject matter first disclosed in the US application—and only that subject matter—the claims had written description support as of the priority date. However, the outcome would have likely been different if the description of the protein in the priority document was later found to correspond multiple proteins, such as stereoisomers having different functions.
Abbott was saved by the fact that they disclosed not only the partial sequence of the protein, but also how it is obtained from its biological source, and several physical properties of the protein. Thus, in emerging technologies, it is best to try to claim the subject matter as completely as possible to insulate the applicant from written description problems in the future, and to provide the flexibility to claim the subject matter in terms newly added in a later application.