Yeda Research and Development Co., Ltd. v. Abbott GmbH & Co. KG

September 20, 2016

Federal Circuit Nos. 2015-1662, 2015-1663
Author: Sarah Washburn

In Yeda Research and Development Co., Ltd. v. Abbott GmbH & Co., an interference proceeding was launched between Abbott's U.S. Patent No. 5,344,915 (the '915 patent) and a Yeda application for a patent on similar technology.  Yeda asserted that Abbott's '915 patent was invalid as anticipated.  Invalidity turned on whether the patent could claim the benefit of the filing dates of either of two German patent applications.

The application that resulted in the '915 patent was filed May 1990.  It claimed priority to the '072 application, filed May 1989, and the '089 application, filed July 1989.  The prior art at issue was the Engelmann reference published in January 1990.  Both parties agreed that the Engelmann reference did anticipate the '915 patent if the priority date was May 1990. 

Whether the '915 patent was entitled to benefit from the filing dates of either application turned on whether either application provided adequate written description support for the invention claimed in the '915 patent.

Abbott's '915 patent discloses a TNFα-binding protein known as TBP-II with "a molecular weight of about 42,000 daltons" and that 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…"  However, neither of the priority documents expressly disclose the full N-terminus sequence claimed in the '915 patent.

Abbott was able to overcome this lack of explicit disclosure using the doctrine of inherent disclosure.  The Federal Circuit first stated the relevant legal standard for the written description requirement, emphasizing that a person of ordinary skill should be able to clearly recognize that the inventor possessed the claimed subject matter at the date of filing.  The court then goes on to explain the doctrine of inherent disclosure: 

                    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 for a subsequent patent application that explicitly recites the inventions inherent properties.

Using this doctrine, the court affirmed the district court's 2015 decision that Abbott's '915 patent was supported by the written description of the '072 application.  The '072 application discloses a partial N-terminus sequence and a protocol for obtaining the protein from its biological source.  The application also discloses several biological properties of the protein including molecular weight, biological activity, and degradation characteristics.  The parties agreed that the claimed protein is the only protein with the same partial N-terminus sequence and additional biological traits as disclosed in the '072 application. 

Therefore, the court concluded, "the '072 application inherently discloses the remaining amino acids in the N-terminus sequence of TBP-II and serves as adequate written description support for the patent claiming TBP-II."  In this case, it was not necessary that the priority document disclose the protein's complete N-terminus sequence in order to be an adequate written description.  The priority application, with the additional identified biological properties of the protein, was sufficient to allow a person of ordinary skill to recognize that the inventor possessed the claimed protein.