Scripps Clinic & Research Found. v. Genentech, Inc.
| Decision Date | 20 July 1987 |
| Docket Number | No. C-83-5423-WWS.,C-83-5423-WWS. |
| Parties | SCRIPPS CLINIC AND RESEARCH FOUNDATION, and Revlon, Inc., Plaintiffs and, Counterdefendants, v. GENENTECH, INC. and Miles Laboratories, Inc., Defendants. |
| Court | U.S. District Court — Northern District of California |
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Stephen V. Bomse, Heller, Ehrman, White & McAuliffe, San Francisco, Cal., and Eugene Moroz and William S. Feiler, Morgan, Finnegan, Pine, Foley & Lee, New York City, for plaintiffs and counterdefendants.
Bradford J. Duft, James W. Geriak and Douglas E. Olson, Lyon & Lyon, Los Angeles, Cal., Richard Haas and Janet Morgan, Lasky, Haas, Cohler & Munter, San Francisco, Cal., Bertram Bradley and James A. Giblin, Berkeley, Cal., and Arnold Sprung and Nathaniel D. Kramer, Sprung, Horn, Kramer & Woods, New York City, for defendants.
This action alleges infringement of a patent covering a protein known as Factor VIII:C which plays an essential part in blood clotting. Hemophiliacs commonly suffer from an absence or deficiency of this protein and as a result are exposed to the risk of hemorrhaging from even a minor wound. The patent at issue claims highly concentrated and purified Factor VIII:C and a process for deriving it from human blood plasma. The principal issue raised is whether defendant Genentech, Inc.'s production of Factor VIII:C using recombinant technology infringes plaintiffs' patent.
Plaintiffs are Scripps Clinic and Research Foundation (Scripps), the owner of the relevant patents, and Revlon, Inc., the exclusive licensee.1 They filed this action against Genentech for infringement of United States Patent No. 4,361,509 (the '509 patent) in November 1983.2 Genentech answered and cross-complained, alleging invalidity and unenforceability. The action was stayed pending Scripps's application for a reissue patent. A companion action, Scripps Clinic and Research Foundation v. Chiron Corporation, No. C-83-5424-WWS, was also stayed pending decision of this case. Genentech and several other competing biotechnology firms contested Scripps's reissue application before the Patent and Trademark Office (PTO). The PTO rejected several of Scripps's new claims and required amendments of others, but finally issued Reissue Patent No. RE 32,011 (the '011 patent) on October 22, 1985.
The parties then resumed this litigation and conducted limited discovery. On August 1, 1986 the Court denied as premature Genentech's motion for dismissal or summary judgment under 35 U.S.C. § 271(e)(1) and ordered Scripps to submit an offer of proof specifying each act alleged to be an infringement. Scripps filed its offer of proof on September 29, 1986. In October 1986, Scripps moved for a preliminary injunction and for summary judgment of infringement. In January 1987, Genentech filed motions to dismiss or for summary judgment of non-infringement and unenforceability. On March 6, 1987 the Court conducted a hearing on the motions, following which the parties filed supplemental papers and responded to the Court's request for additional information. The Court also received and has considered two declarations submitted in this action by Chiron Corporation.
The following motions are presently before the Court for decision:
(1) Scripps's motion for partial summary judgment on the issue of Genentech's infringement of the specified claims by Genentech's manufacture, use and sale of Factor VIII:C and Genentech's inducement of Cutter to make Factor VIII:C.
(2) Scripps's motion for a preliminary injunction enjoining Genentech from making, using or selling Factor VIII:C and from inducing Cutter to infringe the patent claims.
(3) Genentech's motion under 35 U.S.C. § 271(e)(1) to dismiss or for summary judgment.
(4) Genentech's motion for summary judgment of unenforceability on the ground that the patent was obtained through inequitable conduct.
(5) Scripps's counter-motion for summary judgment that the patent is not unenforceable on inequitable conduct grounds.
The following facts are undisputed.
Blood clotting, although not fully understood, may be generally described as follows. The clotting process begins when platelets in the bloodstream adhere to the site of a wound. The platelets would be dislodged, however, unless bound in place by strands of fibrin, an insoluble polymer. The formation of a network of fibrin from its soluble precursor, fibrinogen, is critical to clotting. That formation is the result of a complex series of interactions between blood proteins. Factor VIII:C is one of the agents that activate other proteins essential to this process. A deficiency in Factor VIII:C therefore prevents blood clotting.
Two Scripps scientists, Drs. Zimmerman and Fulcher, developed a process for purifying and concentrating Factor VIII:C from human and porcine blood plasma. On November 30, 1982 Scripps was issued the '509 patent claiming both the process and the product of that process, "highly purified and concentrated VIII:C." Reissue patent '011, issued October 22, 1985, added claims for human Factor VIII:C preparations with specific characteristics relating to purity and concentration.
Factor VIII:C travels in the blood stream attached to a similar protein, Factor VIII:RP, also known as von Willebrand Factor. Under the Scripps patent Factor VIII:C is obtained by pouring large quantities of human or porcine blood plasma over monoclonal antibodies to Factor VIII:RP which have been attached to a solid surface, such as small beads. Factor VIII:RP, still attached to the Factor VIII:C in the plasma, binds to these antibodies, while other particles in the plasma pass through the beads. This step of the process separates substantially pure VIII:C/VIII:RP complexes from the plasma. It is claimed to be a significant innovation over less successful techniques using either polyclonal antibodies or monoclonal antibodies to Factor VIII:C.
In the next step, the VIII:C/VIII:RP complexes are washed with a salt solution, which breaks the bonds between the Factor VIII:C and Factor VIII:RP and elutes the Factor VIII:C, leaving the Factor VIII:RP still bound to the antibodies. In the final step of the process, the Factor VIII:C is filtered through another adsorption to concentrate and purify it further.
Although the amino acid sequences of human and porcine plasma differ, Factor VIII:C derived from either human or porcine plasma will clot human blood. Factor VIII:C has also been isolated from bovine plasma but produces adverse side effects when administered to humans. Hence, the presently known plasma sources for Factor VIII:C are limited. Because Factor VIII:C exists in only minute quantities in blood, its recovery from plasma requires a large donor pool. As a result, concentrated Factor VIII:C from human sources is expensive to produce. Moreover, there is evidence (though disputed) that Factor VIII:C derived from human sources could carry impurities, including infectious agents, from the blood of donors.
Defendant Genentech researches and develops biotechnology. In 1981 a team of...
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