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Executive Summary

Recombinant Factor VIII:C products produced by Chiron and Genentech/Miles do not infringe Scripps Clinic's patent on the blood clotting factor, San Francisco Federal Court Judge William Schwarzer ruled Feb. 24. The court found that the patent claims alleged by Scripps Clinic, and its licensee Rorer, were infringed by Chiron and Genentech/Miles and are invalid. Scripps and Rorer had filed the infringement suit against Chiron and Genentech, and Genentech's licensee, Miles, in 1983. Schwarzer concluded that the Scripps/Rorer patent was unenforceable because: 1) the invention claimed in the patent was described in a paper published before the patent was granted; 2) the best mode for achieving the invention described in the patent was not adequately disclosed; and 3) the inventors of the patent did not meet legal requirements in asking for a reissuance of the patent with expanded claims in 1983. "In summary," Schwarzer ruled, "defendants' motions for summary judgment on the grounds of anticipation, inequitable conduct, and violation of the best mode requirement . . . are granted with respect to ]the disputed claims[, and the actions are dismissed." Discussing the defendants' argument that certain of the patent claims were revealed in a dissertation published in 1979, prior to issuance of the Scripps patent, the court said: "Defendants have produced clear and convincing evidence that the Harris dissertation disclosed and enabled Factor VIII:C, having the characteristics claimed in ]certain claims of the Scripps patent[." Schwarzer concluded that Scripps "has come forward with no conflicting evidence. Accordingly, defendants are entitled to summary judgment of invalidity as to ]those claims[." On the issue of disclosing the best mode for achieving the invention, which is required for a patent to be considered valid, Schwarzer ruled: "The undisputed facts establish that the method of producing purified Factor VIII:C disclosed by the patent did not work with every monoclonal antibody, that the inventors had developed a specific antibody -- identified as 2.2.9 -- which they contemplated to be the best mode to practice the invention, and that they did not disclose in the patent or otherwise the existence of that best mode, let alone its characteristics." Defendants had also argued that the Scripps patent was invalid because the patent applicants exercised "inequitable conduct" in seeking a reissuance of the original patent with expanded claims. The court ruled that there was "clear and convincing evidence of inequitable conduct by applicants" in applying for the reissuance, in part because certain information submitted about the purity of Factor VIII obtainable through the invention was not supported by fact. The court noted that "inequitable conduct makes all claims of patent unenforceable, not just those directly connected with the inequitable conduct." Rorer said it "intends to appeal vigorously" the court's ruling. The firm said it expects to file an appeal shortly. Under its agreement with Scripps, Rorer has exclusive worldwide marketing rights to recombinant Factor VIII:C covered by the patent. The firm is in the preclinical stage of development with the blood clotting concentrate. Nordisk, Chiron's licensee, is also in preclinical development with Factor VIII:C and expects to begin clinicals sometime this year. Genentech's licensee Miles began its clinical trial program in 1988. Baxter, which licenses Factor VIII:C from Genetics Institute, is reportedly the furthest along in development (Phase II/III), with a clinical trial program that has been underway for over one year.

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