Frazer v. Schlegel, No. 06-1154 (Fed. Cir. Aug. 20, 2007)

Judges: Newman (author), Friedman, Rader

[Appealed from the Board]

In Frazer v. Schlegel, No. 06-1154 (Fed. Cir. Aug. 20, 2007), the Federal Circuit reversed the Board’s decision to award priority in an interference proceeding to Dr. C. Richard Schlegel and Dr. A. Bennett Jenson (collectively “Schlegel”), holding that Dr. Ian Frazer and Dr. Jian Zhou (collectively “Frazer”) were entitled to an earlier priority date based on an Australian filing date, representing a constructive reduction to practice of an invention whose disclosure was in compliance with the requirements of 35 U.S.C. § 112.

Dr. Frazer and Dr. Zhou, working at the University of Queensland in Australia and using procedures derived from recombinant DNA technology, succeeded in preparing what they called “papilloma virus-like particles” that had the external shape of the papilloma virus capsid, but lacked the disease-causing genetic material. Their idea was to create a vaccine from the virus-like particles. They first reported their work in a scientific article that was received by the journal Virology in California on May 21, 1991. Subsequently, they filed a patent application in Australia including the text and experimental data from that article on July 19, 1991; filed a PCT application with additional text and experimental data, and claiming priority to the Australian application on July 20, 1992; and filed an application with the PTO claiming priority to both the PCT application and the Australian application on January 19, 1994. Meanwhile, Dr. Schlegel and Dr. Jenson of Georgetown University Medical Center filed an application with the PTO directed to the same subject matter as Frazer’s application on June 25, 1992. The two applications were placed in interference and became the subject matter of the present case.

Having the earlier U.S. filing date, Schlegel was initially declared the senior party to the interference. Subsequently, Frazer was granted the benefit of the Australian filing date and was then declared the senior party. However, that benefit was later withdrawn by the patent examiner during the interference. The Board held that Frazer was not entitled to the benefit of the Australian application’s filing date because the Australian application’s disclosure was inadequate. In particular, the Board had found that Frazer’s Australian application did not provide “a described and enabled anticipation under 35 U.S.C. § 102(g) of the subject matter of the count” because, at the time the Australian application was filed, Frazer believed that both the L1 and L2 genes had to be expressed together from the same plasmid, whereas their later work, including that described in the claims of the U.S. application, showed that only the L1 protein was necessary. While recognizing the uncertainties of the science at the time Frazer’s work was done, the Board ultimately concluded that Frazer was not entitled to any date of disclosure until they had accurately and fully understood the mechanism. Thus, the Board declared Schlegel the first inventor based on Schlegel’s earlier U.S. filing date.

The Federal Circuit reversed the Board’s decision, finding that the Australian application contained complete details of the subject matter of the interference count and depicted the papilloma virus-like particle with full disclosure of how to produce it. The specification also included the DNA sequences encoding the papilloma virus L1 and L2 proteins. Although Frazer had reported expression of both the L1 protein and the L2 protein in the Australian application, and he testified at that time he believed both proteins were involved, his later discovery that either the L1 protein or both the L1 and L2 proteins led to capsid formation did not negate or contradict his earlier disclosure and constructive reduction to practice of the interference count.

The Court noted that it was not disputed that the procedures set forth in the Australian application produce the papilloma virus-like particles shown in the PCT and U.S. applications. And although Frazer testified that this was new science, the Court held that “acknowledgment of the complexities of the science does not negate the disclosure of the production of these virus-like particles.” Slip op. at 11. The Court further held that it was of no matter that Frazer had not appreciated that they had been working with a wildtype virus because, nonetheless, the description and procedures used, and the successful production of the virus-like particles there achieved and reported, disclosed and enabled a species within the counts. The Court also found that, where the claimed invention is the application of an unpredictable technology in the early stages of development, an enabling description in the specification must provide those skilled in the art with a specific and useful teaching, recognizing the stage of development of the technology. The Court concluded that the Australian application was not merely proposing an unproved hypothesis or guess, but was an enabling disclosure. Therefore, Frazer was entitled to rely upon it for the benefit of priority.