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RORER AND GENENTECH TO MEET ON FACTOR VIII PATENT DISPUTE

Executive Summary

RORER AND GENENTECH TO MEET ON FACTOR VIII PATENT DISPUTE following a federal judge's July 20 ruling. "The parties are directed to meet and confer with respect to further proceedings, including the possibility of settlement," San Francisco Federal Court Judge William Schwarzer ruled. Counsel from both sides have been directed to appear at a Sept. 11 status conference. While the court held that Genentech had infringed on certain claims of the Rorer patent, it did not rule on the patent's validity, noting instead that Genentech had offered evidence "sufficient at least to raise genuine issues as to validity." Rorer licenses the patent from the Scripps Clinic and is seeking to block other firms from developing highly purified Factor VIII products. "Although Scripps is entitled to partial summary judgment on the issue of infringement, Genentech's challange to the validity of the . . . patent remains unresolved," the memorandum states. "Because the parties have not yet had an opportunity to conduct relevant discovery on these issues, the court is not in a position to determine whether a sufficiently clear showing of validity has been made to sustain a finding of a likelihood of success." Originally issued in 1982, the Scripps product and process patent was reissued in 1985 to include claims for preparations with specific characteristics relating to purity and concentration. "Scripps has produced uncontroverted evidence that Genentech's recombinant Factor VIII:C had potencies in the range of 134 to 1172 u/ml, fold purifications of at least 160,000, and specific activities greater than 2240 units/mg," the memorandum states. "Genentech's recombinant Factor VIII:C therefore infringed these claims." Rorer's process uses monoclonal antibodies to purify its Factor VIII product, Monoclate, from human and porcine plasma. An application for Monoclate is currently pending at FDA, and the company is anticipating a product launch by the fourth quarter of 1987. Through its Melloy Labs subisidary, Rorer is also working on a recombinant Factor VIII product. Genentech's Factor VIII development partner is Cutter, a division of Miles Labs. Two other biotech firms, Chiron and Genetics Institute, are also developing recombinant Factor VIII products, the latter in conjunction with Baxter Travenol. Genentech, which said that the ultimate resolution of the patent infringement litigation would "not have material effect" on the company's business, also noted that patent infringement suits have also been filed against Chiron and Baxter.
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