Life Tech v. Clontech Lab.
| Decision Date | 21 September 2000 |
| Parties | (Fed. Cir. 2000) LIFE TECHNOLOGIES, INC., Plaintiff-Appellant, v. CLONTECH LABORATORIES, INC.,Defendant-Appellee. 99-1550 DECIDED: |
| Court | U.S. Court of Appeals — Federal Circuit |
Judge Alexander Williams, Jr. Robert J. Koch, Fulbright & Jaworski L.L.P., of Washington, DC, argued for plaintiff-appellant. With him on the brief was Scott H. Blackman, LYON & LYON L.L.P., of Washington, DC; Steven M. Bauer, Testa, Hurwitz & Thibeault, LLP, of Boston, Massachusetts; and Alan W. Hammond, Life Technologies, Inc., of Rockville, Maryland.
Marc R. Labgold, Piper Marbury Rudnick & Wolfe LLP, of Washington, DC, argued for defendant-appellee. With him on the brief were Catherine B. Richardson,Sharon E. Crane, and Kevin M. Bell, Long, Aldridge & Norman, LLP, of Washington, DC.
Before MICHEL, BRYSON, and GAJARSA, Circuit Judges.
Life Technologies, Inc. ("LTI") appeals the judgment of the United States District Court for the District of Maryland, entered after a bench trial, in which the court held that LTI's U.S. Patents Nos. 5,244,797 ("the '797 patent") and 5,668,005 ("the '005 patent") were unenforceable on the ground of inequitable conduct. Because the court premised this determination on clearly erroneous findings of fact, we reverse and remand.
Reverse transcriptase ("RT") 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 1980's, the inventors of the '797 and '005 patents, Drs. Michael Kotewicz and Gary Gerard, sought to develop a genetically engineered RT enzyme that exhibited DNA polymerase activity but did not substantially exhibit RNase H activity. Kotewicz and Gerard faced several difficulties in developing this enzyme. First, it was unknown at the time where on the RT molecule the DNA polymerase and RNase H activities resided. Further, it was unknown whether the RNase H activity could be selectively removed to produce an improved mutant RT enzyme that retained DNA polymerase activity. The inventors spent several years unsuccessfully attempting to locate and delete the RNase H activity from the RT molecule.
The breakthrough for the inventors came in 1986 with the publication of M. S. Johnson et al.,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) ("the Johnson article"). The Johnson article reported comparisons made between amino sequences of certain RT molecules and the sequence of the ribonuclease enzyme from E. coli, which exhibits RNase H activity but not DNA polymerase activity. The findings of Johnson 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 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. Additionally, the Johnson article was suspect because it utilized computer comparisons of amino acid sequences, rather than experimental data. Such computer comparisons were fairly new in the art at the time. Thus, in order 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. On April 15, 1987, Kotewicz spoke on the telephone with Goff, a researcher at Columbia University. During this conversation, Goff stated that he had developed "oligonucleotide insertion mutations that reduce RNase H in cloned [RT]." However, there is no indication in the record that Goff revealed any further details concerning his work to Kotewicz during this conversation. Additionally, during the summer of 1987, Gerard learned that Goff had presented his RT research at Stanford University. Although neither Gerard nor Kotewicz attended this presentation, they surmised, based on conversations with colleagues, that Goff demonstrated "similar results" as the inventors. Based on this information, Kotewicz and Gerard urged LTI to allow them to publish their results as quickly as possible, under the assumption that Goff would soon publish similar work. They also submitted forms to management at LTI that initiated the process for preparing a patent application for their engineered RT enzyme.
In January 1988, Kotewicz and Gerard filed the parent application from which the '797 and '005 patents ultimately issued. In general, the application claimed an engineered RT enzyme that exhibited DNA polymerase activity but did not exhibit substantial RNase H activity. As part of the duty of disclosure under 37 C.F.R. § 1.56, the inventors disclosed to the Patent and Trademark Office ("PTO") 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 leading to the claims as obvious over Johnson, often in combination with other prior art that described the RT gene sequence. According to the Examiner, because Johnson taught that the RNase H activity was located at the carboxyl terminal end, and because there was a strong motivation in the art to eliminate such activity, the claimed invention would have been obvious. In response to these rejections, the inventors argued that, at the time of the invention, there would have been no reasonable expectation that the application of Johnson's results would successfully lead to the deletion of RNase H activity. This was because the teachings of Johnson were contrary to teachings in the prior art which suggested that "something more was necessary" than a deletion at the carboxyl terminal end to eliminate RNase H activity. Thus, the inventors contended that the claimed invention would not have been obvious over Johnson. The Examiner was persuaded by these arguments, and the '797 patent issued on September 19, 1993. At no time during this prosecution did the inventors reveal to the Examiner that the Johnson article played a key role in their development of the claimed invention.
Shortly after the issuance of the '797 patent, the inventors filed the continuation application that eventually resulted in the issuance of the '005 patent. 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. ("Clontech") 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. After the trial, the court found that the inventors withheld material information regarding the motivations that they derived from the Johnson article and their reliance on it in reaching their invention. The court also found that the inventors made affirmative material misrepresentations during prosecution regarding the Johnson article. 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 these actions were done with the intent to deceive the PTO. As a result, the court held that both the '797 and '005 patent were unenforceable on the ground of inequitable conduct. This appeal followed.
Applicants for patents, including their legal representatives, have the duty to prosecute patent applications in the PTO with candor, good faith, and honesty. See Molins PLC v. Textron, Inc., 48 F.3d 1172, 1178, 33 USPQ2d 1823, 1826 (Fed. Cir. 1995); 37 C.F.R. § 1.56 (1999). When this duty is breached, the applicant has committed inequitable conduct. A determination of inequitable conduct during the prosecution of a patent application renders the subsequently issued patent unenforceable. SeeLaBounty Mfg., Inc. v. United States Int'l Trade Comm'n, 958 F.2d 1066, 1070, 22 USPQ2d 1025, 1028 (Fed. Cir. 1992).
Inequitable conduct can consist of affirmative misrepresentations of material fact, submission of false material information, or the failure to disclose known material information during the prosecution of a patent, coupled with the intent to deceive the PTO. See Molins, 48 F.3d at 1178, 33 USPQ2d at 1826. Materiality and intent to deceive are distinct factual inquiries, and each must be shown by clear and convincing evidence. See Elk Corp. v....
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