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Reversing and remanding a ruling that made patents unenforceable because of inequitable conduct, the U.S. Court of Appeals for the Federal Circuit held Sept. 21 that the manner in which inventors used a disclosed prior art reference is not material information that must be revealed to the PTO. Life Technologies Inc. v. Clontech Laboratories Inc., No. 99-1550 (Fed. Cir. 9/21/00). Reverse transcriptase is a naturally occurring enzyme that exhibits DNA polymerase activity. DNA polymerase activity enables the RT enzyme to utilize a messenger RNA (mRNA) molecule as a template to synthesize a complementary strand of DNA (cDNA). This reaction results in a DNA/RNA hybrid molecule. In addition to DNA polymerase activity, naturally occurring RT, known as “wild-type” RT, also exhibits RNase H activity. RNase H activity degrades the original mRNA template as the cDNA molecule is made. RNase H activity is undesirable because this degradation of the mRNA template negatively affects the ability and efficiency of the RT to make cDNA. Beginning in the early 1980s, Dr. Michael Kotewicz and Dr. Gary Gerard, the inventors of the patents that are the subject of this action, sought to develop a genetically engineered RT enzyme that exhibited DNA polymerase activity but did not substantially exhibit RNase H activity. Their breakthrough came in 1986 with the publication of “Computer Analysis of Retroviral Pol Genes: Assignment of Enzymatic Functions to Specific Sequences and Homologies with Nonviral Enzymes,” 83 Proceedings of the Nat’l. Acad. of Sci. 7648 (1986), by, among other people, M. S. Johnson. Johnson’s findings suggested to the inventors that the RNase H activity of the RT enzyme resided at the carboxyl terminal end of the molecule. The inventors, however, were skeptical of Mr. Johnson’s results because the literature existing at the time suggested that the location of the RNase H activity was at the front end of the RT molecule. To “exclude the possibility” that Johnson was correct, Kotewicz and Gerard decided to conduct experiments at the carboxyl terminal end of the RT enzyme. Contrary to expectations, these experiments were successful and, by December 1986, the inventors had created a mutant RT enzyme that lacked RNase H activity but retained DNA polymerase activity. A few months after confirming their discovery, Kotewicz and Gerard learned that another researcher, Dr. Stephen Goff, was working to develop an engineered RT enzyme. Based on research about Goff’s work — including a phone call to Goff — Kotewicz and Gerard urged Life Technologies Inc. to allow them to publish their results as quickly as possible, under the assumption that Goff soon would publish similar work. They also submitted forms to management at LTI that initiated the process of preparing a patent application for their engineered RT enzyme. As part of the duty of disclosure under 37 C.F.R. � 1.56, the inventors disclosed to the USPTO numerous prior art references, including the Johnson article. However, the inventors did not reveal their knowledge of Goff’s work because their patent attorney indicated that such limited and incomplete information would not be material. During the prosecution of the patent, U.S. Patent No. 5,244,797, the examiner rejected the inventors’ claims as obvious in light of the Johnson work. The inventors argued that, at the time of their invention, there would have been no reasonable expectation that the application of Johnson’s results would lead to the deletion of RNase H activity. This was because Johnson’s teachings were contrary to teachings in the prior art, suggesting that “something more was necessary” than a deletion at the carboxyl terminal end to eliminate RNase H activity. The examiner was persuaded by these arguments, and the ’797 patent issued on Sept. 19, 1993. Shortly afterwards, the inventors filed the continuation application that eventually resulted in the issuance of the U.S. Patent No. 5,668,005. During the prosecution of this application, the inventors revealed their knowledge of Goff’s work. The examiner allowed the application to issue over the newly revealed information regarding Goff, stating that the new information had “no bearing on … the instant application.” In December 1996, LTI sued Clontech Laboratories Inc. for infringement of the ’797 and ’005 patents. In response, Clontech asserted various affirmative defenses, including an allegation that the patents should be held unenforceable due to inequitable conduct. A bench trial on the inequitable conduct issue ensued. The U.S. District Court for the District of Maryland found that the inventors withheld material information regarding their motivations for reading the Johnson article and their reliance on it to create their invention. The court also found that the inventors made affirmative material misrepresentations regarding the Johnson article during the patents’ prosecution. Further, the court found that the inventors’ knowledge of Goff’s work was material and should have been revealed to the PTO during the prosecution of the ’797 patent. Finally, the court determined that the inventors committed these actions with the intent to deceive the PTO. As a result, the district court declared both the ’797 and ’005 patents unenforceable on the ground of inequitable conduct. LTI appealed. Citing Standard Oil Co. v. American Cynamid Co., 774 F.2d 448 (Fed. Cir. 1985), the Federal Circuit held that, because patentability is assessed from the perspective of the hypothetical person of ordinary skill in the art, information regarding the subjective motivations of inventors is not material. Citing 35 U.S.C.S. � 103(a), the court of appeals further held that the path that leads an inventor to the invention is expressly made irrelevant to patentability by statute. The court wrote: Thus, the inventors’ reliance on the Johnson article and the motivations that they derived from it have no bearing on the issue of patentability. It does not matter whether the inventors reached their invention after an exhaustive study of the prior art, or developed their RT enzymes in complete isolation. 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. Therefore, the district court clearly erred by finding that the inventors’ reliance on Johnson was material. Agreeing with the inventors’ argument that there would have been no reasonable expectation of success in applying Johnson’s teachings, the court of appeals held that “the inventors’ non-obviousness arguments were not affirmative misrepresentations and cannot give rise to a determination of inequitable conduct. Thus, the district court committed clear error.” Regarding the district court’s holding that the inventors withheld knowledge of Goff’s work, the court of appeals found that the inventors were in possession of, at most, very limited information about Goff’s work. The court of appeals therefore reversed the district court’s determination that the inventors engaged in inequitable conduct and remanded the case for further proceedings.

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