Hormone Research Foundation v. GENENTECH, INC.,
| Citation | 708 F. Supp. 1096 |
| Decision Date | 04 August 1988 |
| Docket Number | No. C-86-5201 MHP.,C-86-5201 MHP. |
| Parties | HORMONE RESEARCH FOUNDATION and Hoffmann-LaRoche, Inc., Plaintiffs, v. GENENTECH, INC., Genentech Development Corporation and Genentech Clinical Partners, Ltd., Defendants. |
| Court | U.S. District Court — Northern District of California |
COPYRIGHT MATERIAL OMITTED
S. Leslie Misrock, Gidon D. Stern, Pennie & Edmonds, New York City, Stephen V. Bomse, Heller, Ehrman, White & McAuliffe, San Francisco, Cal., for plaintiffs.
Roland N. Smoot, James W. Geriak, Douglas E. Olson, Coe A. Bloomberg, Lyon & Lyon, Los Angeles, Richard Haas, Lasky, Haas, Comler & Munter, San Francisco, Cal., for defendants.
Plaintiffs Hormone Research Foundation and Hoffmann-LaRoche, Inc., filed suit against defendants Genentech, Inc., Genentech Development Corporation and Genentech Clinical Partners, Ltd. ("Genentech"), alleging that Genentech's human growth hormone product, Protropin, infringes Patent No. 3,853,833. The action is now before the court on three cross-motions for partial summary judgment, as well as plaintiffs' motion to preclude reliance upon the uncompleted deposition of Dr. Li and plaintiffs' ex parte application for a five-month extension of pretrial and trial dates. After consideration of the memoranda and supporting documents submitted by the parties and the arguments of counsel, the court grants defendants' first and third motions for summary judgment, denies defendants' second motion for summary judgment and all of plaintiffs' cross-motions, and declines to address plaintiffs' motions to preclude reliance on the deposition of Dr. Li and for a five month extension of pretrial and trial dates.
In 1971, Dr. Li thought he had identified the correct structure of and developed a process for synthesizing human growth hormone ("HGH"). He filed for and obtained, after some amendment and argument, Patent No. 3,853,833 ("the '833 patent"), claiming the method by which he synthesized the substance he thought was HGH, the substance itself and substances produced by the specified method. Li used an established protein synthesis process known as "solid phase peptide synthesis" to construct the complex amino acid structure he thought was HGH. It was later discovered that the structure Li identified as HGH in Figure 2 of the '833 patent ("Fig. 2") differed from the natural structure in several respects.
Genentech produces an HGH product which it calls Protropin. Because of the differences between natural HGH and Fig. 2, Protropin differs from the structure identified in Li's Fig. 2 in that it contains two additional proteins (192 instead of 190) and has slightly different proteins in the positions corresponding to positions 73 (glutamic acid rather than glutamine), 106 (aspartic acid rather than asparagine) and 108 (asparagine rather than aspartic acid) of the protein sequence shown in Fig. 2.1 See Meier Dec.Ex. A, '833 Patent at Fig. 2; Ex. B, Meier Dec.Ex. B, Defendants' Responses to Plaintiffs' Interrogatories Nos. 1 through 39 at 2; Meier Dec.Ex. D, Direct expression in Escherichia coli of a DNA sequence coding for human growth hormone at 3.
In addition, the development of recombinant DNA techniques for synthesizing proteins made it possible to produce and isolate HGH in marketable quantities for use in the treatment of humans with growth deficiencies. Protropin is produced by the recombinant DNA process rather than the solid phase peptide synthesis method used by Li and described in the specification of his patent.
Plaintiffs Hormone Research Foundation, the owner of the Li patent, and Hoffman-LaRoche, the exclusive licensee under the Li patent, filed this action against Genentech claiming that Genentech is infringing the Li patent by conducting clinical trials on, seeking federal approval for, and making, using and selling Protropin. Plaintiffs seek both injunctive and monetary relief. In response to Defendants' Interrogatory No. 22, plaintiffs identified eight claims of the Li Patent which they contend are infringed by Genentech: claims 1, 3, 11, 12, 17, 18, 20 and 25.
The eight patent claims allegedly infringed by Genentech may be described as follows:
Claim 1 claims a "method of producing synthetic human pituitary growth hormone which comprises" three general steps, the first of which involves forming an amino acid chain "in the sequence of natural human pituitary growth hormone";
Claim 3 claims a "method of producing a substance having growth-promoting activity which comprises" the same three steps as in claim 1 except the first step requires that the chain be formed ;
Claim 11 is identical to claim 3 except the first step requires forming a chain ;
Claim 12 claims a ;
Claim 17 is identical to claim 12 except the structure must correspond to ;
Claim 18 claims a "composition of matter produced in accordance with the method of claim 1";
Claim 20 claims a "composition of matter produced in accordance with the method of claim 3";
Claim 25 claims a "composition of matter produced in accordance with the method of claim 11."
Meier Dec.Ex. A, '833 Patent at cols. 11-14.
Under Federal Rule of Civil Procedure 56, summary judgment shall be granted "against a party who fails to make a showing sufficient to establish the existence of an element essential to that party's case, and on which that party will bear the burden of proof at trial ... since a complete failure of proof concerning an essential element of the nonmoving party's case necessarily renders all other facts immaterial." Celotex Corp. v. Catrett, 477 U.S. 317, 322, 106 S.Ct. 2548, 2552, 91 L.Ed.2d 265 (1986). See also T.W. Elec. Serv. Inc. v. Pacific Elec. Contractors Ass'n, 809 F.2d 626, 630 (9th Cir.1987) (); Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 250, 106 S.Ct. 2505, 2511, 91 L.Ed.2d 202 (1986) (). The inferences to be drawn from the facts must be viewed in a light most favorable to the party opposing the motion. T.W. Elec. Serv., 809 F.2d at 631.
Summary judgment is appropriate in a patent case, as in any other case, where no genuine issue of material fact exists and the moving party is entitled to judgment as a matter of law. Townsend Engineering Co. v. Hitec Co., 829 F.2d 1086, 1089 (Fed. Cir.1987). Because infringement is a question of fact, however, the court should approach a motion for summary judgment as to infringement "with a care proportioned to the likelihood of its being inappropriate." D.M.I., Inc. v. Deere & Co., 755 F.2d 1570, 1573 (Fed.Cir.1985).
The parties have filed three cross-motions for partial summary judgment on the issues of (1) whether Genentech has infringed the claims in the Li patent that refer specifically to Fig. 2; (2) whether Genentech has infringed the claims in the Li patent that refer to the synthesis method used; and (3) whether the claims in the Li patent allegedly infringed by Genentech are invalid because they do not enable the making and using of the claimed invention. In addition, plaintiffs have filed a motion to preclude reliance upon the uncompleted deposition of Dr. Li and an ex parte application for a five-month extension of pretrial and trial dates.
Genentech's first motion for partial summary judgment seeks a determination that defendants do not infringe claims 3, 11, 12, 17, 20 and 25 ("the Fig. 2 claims") of the Li patent because Protropin does not contain a compound having the structure of Fig. 2 in the Li patent or of a fragment of Fig. 2 as described in claims 11 and 17. Independent claims 3, 11, 12 and 17 refer specifically to Fig. 2, and claims 20 and 25 depend from claims 3 and 11, respectively, which refer to Fig. 2. Plaintiffs' cross-motion seeks a determination that the scope of the Fig. 2 claims is not limited, either by the language of the claims or the prosecution history of the patent, to structures identical to Fig. 2.
Literal infringement is found when "properly interpreted claims read on the accused product or method." Moleculon Research Corp. v. CBS, Inc., 793 F.2d 1261, 1269-70 (Fed.Cir.1986). While literal infringement itself is an issue of fact, the preliminary step of claim interpretation is a matter of law. Id. at 1270. Defendants argue that the Fig. 2 claims, properly interpreted, cannot as a matter of law be found literally to encompass defendants' HGH products because those products do not contain any substance having the exact structure of Fig. 2 or of the portion of Fig. 2 from positions 86 to 190.
The structure of Genentech's synthetic HGH is identical to neither the entire Fig. 2 structure nor a structure described by claims 11 and 17 consisting of the active portion of Fig. 2 (positions 86-190) combined with any fraction of the remaining, inactive portion of Fig. 2 (positions 85-1). Instead, Genentech's synthetic HGH is lengthier than the structure described by Fig. 2, containing two additional amino acids (in the case of Protropin II, one...
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