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University of Utah v. Max-Planck-Gesellschaft

United States Court of Appeals, Federal Circuit

March 23, 2017

UNIVERSITY OF UTAH, Plaintiff-Appellee
v.
MAX-PLANCK-GESELLSCHAFT ZUR FOERDERUNG DER WISSENSCHAFTEN E.V., A CORPORATION ORGANIZED UNDER THELAWS OF GERMANY, MAX-PLANCK-INNOVATIONGMBH, A CORPORATION ORGANIZED UNDER THE LAWS OF GERMANY, WHITEHEAD INSTITUTE FOR BIOMEDICAL RESEARCH, A DELAWARE CORPORATION, MASSACHUSETTS INSTITUTE OF TECHNOLOGY, A MASSACHUSETTS CORPORATION, ALNYLAM PHARMACEUTICALS, INC., A DELAWARE CORPORATION, ROBERT L. CARET, PRESIDENT OF THE UNIVERSITY OF MASSACHUSETTS IN HIS OFFICIAL CAPACITY, JAMES R. JULIAN, JR., CHRISTINE M. WILDA, SENIOR VICE PRESIDENTFOR ADMINISTRATION & FINANCE AND UNIVERSITY TREASURER OF THE UNIVERSITY OF MASSACHUSETTS, IN HIS OFFICIAL CAPACITY, JAMES P. MCNAMARA, EXECUTIVE DIRECTOR, OFFICE OF TECHNOLOGY MANAGEMENT OF THE UNIVERSITY OF MASSACHUSETTS, IN HIS OFFICIAL CAPACITY, THEIR PREDECESSORS AND SUCCESSORS IN OFFICE, Defendants-Appellants UNIVERSITY OF MASSACHUSETTS, A MASSACHUSETTS CORPORATION, DAVID J.GRAY, Defendants

         Appeal from the United States District Court for the District of Massachusetts in No. 1:11-cv-10484-PBS, Judge Patti B. Saris.

          Mark Carlson, Hagens, Berman, Sobol, Shapiro LLP, Seattle, WA, argued for plaintiff-appellee. Also represented by Steve Berman.

          Morgan Chu, Irell & Manella LLP, Los Angeles, CA, argued for defendants-appellants. Also represented by David Isaac Gindler, Alan J. Heinrich; Sandra Haberny, Newport Beach, CA.

          Before O'MALLEY, Reyna, and WALLACH, Circuit Judges.

          Reyna, Circuit Judge.

         Defendants-Appellants ("Max Planck") appeal a decision of the United States District Court for the District of Massachusetts, which found that this case was not "exceptional" within the meaning of 35 U.S.C. § 285 and thus denied Max Planck's motion for attorney fees. The district court did not abuse its discretion. We therefore affirm.

         Background

         A. Discovery of the Patented Invention

         The underlying dispute concerns inventorship of the Tuschl II patents, [1] which relate to the field of RNA interference ("RNAi"). RNAi is a process for "silencing" certain genes from expressing the proteins they encode, which may be useful in treating a variety of diseases, particularly those associated with overactive or mutated genes.

         In March 2000, well before the Tuschl II invention was reduced to practice, Dr. Thomas Tuschl and his colleagues published an article describing their various discoveries in the field of RNAi. Less than a month later, Dr. Brenda Bass, of the University of Utah ("UUtah"), published a mini-review in Cell magazine that summarized the state of RNAi research, focusing on Dr. Tuschl's article. In addition to summarizing current research, Dr. Bass' mini-review included several of her own hypotheses about enzymatic processes that may be responsible for the RNAi activity reported in Dr. Tuschl's article. One of those hypotheses involved molecules that have a feature called "3' overhangs, " which are certain double-stranded RNA ("dsRNA") molecules with a nucleotide overhang on the 3' ends of dsRNA.

         After publishing his article, Dr. Tuschl transitioned to a new line of research that would result in the patented Tuschl II invention. Dr. Tuschl and his colleagues focused on design and testing of candidate molecules to advance their goal of developing synthetic drugs that could trigger RNAi in mammals and be used for therapeutic purposes. It is undisputed that Dr. Tuschl read Dr. Bass' mini-review, recognized her hypothesis that 3' overhangs may be relevant to RNAi, and tested that hypothesis. Those tests were successful; data from cloning and sequencing revealed that species with 3' overhangs were prevalent in active RNAi systems. See, e.g., '704 patent col. 18 1. 14-col. 19 1. 25. Based on these data, the Tuschl II inventors chemically synthesized candidate molecules with and without 3' overhangs and tested for RNAi activity. See id. They determined that small synthetic dsRNA with 3' overhangs (dubbed "siRNA") can be more effective at inducing RNAi than dsRNAs without 3' overhangs. See id. The Tuschl II inventors demonstrated that their synthetic siRNAs could trigger RNAi for therapeutic purposes in mammals, including humans. See id. at col. 211. 27-col. 231. 67.

         Max Planck filed a patent application for the discovery. Dr. Bass' mini-review was cited as prior art during prosecution of all ten of the Tuschl II patents, each of which issued. After the patent applications were filed, the Tuschl II inventors published two articles reporting their findings. Dr. Bass was a journal referee for both articles, and she recommended publication.

         B. Inventorship Challenge

         UUtah, on behalf of Dr. Bass, sued Max Planck for correction of ownership, claiming that Dr. Bass should be named as either a sole or joint inventor of the Tuschl II patents. UUtah's claim of sole inventorship turned on allegations that Dr. Bass reduced to practice the concept that molecules with 3' overhangs would be integral to RNAi, focusing primarily on Dr. Bass' mini-review in Cell magazine. Its claim of joint inventorship turned on alleged collaboration ...


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