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A district court judge “clearly erred” in concluding that inventors withheld material information and made affirmative misrepresentations during prosecution of two biotechnology patents, the U.S. Court of Appeals for the Federal Circuit ruled Sept. 21 ( Life Technologies Inc. v. Clontech Laboratories Inc., No. 99-1550, Fed. Cir.). The panel reversed a ruling by U.S. Judge Alexander Williams Jr. of the District of Maryland finding U.S. Patents No. 5,244,797 and No. 5,668,005, owned by Life Technologies Inc. (LTI), unenforceable for inequitable conduct. The inventors of the patents, Dr. Michael Kotewicz and Dr. Gary Gerard, sought to develop a genetically engineered reverse transcriptase (RT) enzyme that exhibited DNA polymerase activity but did not substantially exhibit RNase H activity. However, they had difficulty locating and deleting the RNase H activity from the RT molecule until the 1986 publication of an article by M.S. Johnson which suggested that the RNase H activity of the RT enzyme resided at the carboxyl terminal end of the molecule. EXPERIMENTS The inventors conducted experiments at the carboxyl terminal end of the RT enzyme, hoping to disprove Johnson’s theory; however, the experiments were successful. By December 1986, they had created a mutant RT enzyme that lacked RNase H activity but retained DNA polymerase activity. A few months later, Kotewicz contacted Dr. Stephen Goff, a researcher at Columbia University, about his attempts to develop an engineered RT enzyme. During the conversation, Goff stated that he had developed “oligonucleotide insertion mutations that reduce RNase H in cloned RT.” In addition, during the summer of 1987, Gerard learned that Goff had presented his RT research at Stanford University. Gerard and Kotewicz urged LTI to allow them to publish their results as quickly as possible under the assumption that Goff would be publishing soon. They also submitted forms to management at LTI initiating the patent application process. Kotewicz and Gerard filed the patent application from which the ’797 and ’005 patents ultimately issued in January 1988. They disclosed numerous prior art references, including the Johnson article, but did not reveal their knowledge of Goff’s work because their patent attorney indicated that it was not material. PROSECUTION During prosecution, the examiner rejected the inventors’ claims as obvious over Johnson several times. In response, the inventors argued that at the time of the invention, Johnson’s teachings were contrary to teachings in the prior art and that therefore the claimed invention would not have been obvious over Johnson. The examiner accepted that argument and the ’797 patent issued in September 1993. Shortly thereafter, the inventors filed a continuation application, in which they revealed their knowledge of Goff’s work. The examiner allowed the application to issue as the ’005 patent over the information regarding Goff, finding it had “no bearing on … the instant application.” LTI sued Clontech in December 1996, alleging infringement. In response, Clontech asserted that the patents should be held unenforceable for inequitable conduct. After a bench trial, Judge Alexander concluded that the inventors withheld material information regarding the motivation they derived from the Johnson article and made material misrepresentations about the article. In addition, the court said, the inventors’ knowledge of Goff’s work was material and should have been disclosed. LTI appealed. ‘MISAPPREHENSION’ Reversing and remanding, the Federal Circuit held first that the lower court premised its factual finding regarding the Johnson article on “a misapprehension of the legal standards of patentability” by determining that the manner in which the inventors used a disclosed prior art reference is material information that must be revealed to the patent examiner. “The only inquiry is whether the teachings of the Johnson article, in combination with other relevant prior art, would have rendered the claimed invention obvious to one of ordinary skill in the art; this inquiry, as a matter of law, is independent of the motivations that led the inventors to the claimed invention,” the appeals court said. The lower court also erred, the Federal Circuit said, in finding that the inventors engaged in misrepresentation when they stated that at the time of their invention, one of ordinary skill in the art would have thought that “something more was necessary” than what was described in the Johnson article. “Because the Johnson article was contrary to established teachings and was based on a relatively new technique, the inventors argued that a reasonable expectation of success was lacking,” the panel said. “This argument is simply not a misrepresentation.” GOFF’S WORK Finally, the panel held that the lower court was incorrect in finding material the inventors’ knowledge of Goff’s work. “While the inventors knew that Goff had potentially achieved a reduction in RNase H activity in RT enzymes, the inventors were unaware of when these results were achieved, how they were achieved, the degree to which the RNase H activity was reduced, or whether DNA polymerase activity was retained,” the court said. “Knowledge of these details would have been required for the Examiner to consider whether Goff was a prior inventor. Because the inventors lacked such crucial information, the incomplete knowledge that they did have regarding Goff would not have been material to a reasonable Examiner.” Life Technologies is represented by Robert J. Koch of Fulbright & Jaworski in Washington, D.C.; Scott H. Blackman of Lyon & Lyon in Washington, D.C.; Steven M. Bauer of Testa, Hurwitz & Thibeault in Boston; and Alan W. Hammond of the company’s legal department in Rockville, Md. Clontech is represented by Marc R. Labgold of Piper Marbury Rudnick & Wolfe in Washington, D.C., and Catherine B. Richardson, Sharon E. Crane and Kevin M. Bell of Long, Aldridge & Norman in Washington, D.C. �; Copyright 2000 Mealey Publications, Inc.

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