Hormone Research Foundation, Inc. v. Genentech, Inc.
| Citation | 15 USPQ2d 1039,904 F.2d 1558 |
| Decision Date | 05 June 1990 |
| Docket Number | Nos. 89-1082,89-1111,s. 89-1082 |
| Parties | HORMONE RESEARCH FOUNDATION, INC. and Hoffmann-LaRoche, Inc., Plaintiffs-Appellants, v. GENENTECH, INC., Genentech Development Corporation and Genentech Clinical Partners, Ltd., Defendants/Cross-Appellants. |
| Court | United States Courts of Appeals. United States Court of Appeals for the Federal Circuit |
S. Leslie Misrock of Pennie & Edmonds, New York City, argued for plaintiffs-appellants. Of counsel were Gidon D. Stern, Stephen J. Harbulak, Thomas E. Friebel, and Jennifer Gordon, of Pennie & Edmonds.
Coe A. Bloomberg of Lyon & Lyon, Los Angeles, Cal., argued for defendants/cross-appellants. Of counsel were Roland N. Smoot, James W. Geriak, Paul H. Meier, and Thomas J. Morgan, of Lyon & Lyon.
Before ARCHER, Circuit Judge, COWEN, Senior Circuit Judge, and MICHEL, Circuit Judge.
Hormone Research Foundation and Hoffmann-LaRoche, Inc. (collectively HRF) appeal from the summary judgment of the United States District Court for the Northern District of California, Hormone Research Found. v. Genentech, Inc., 708 F.Supp. 1096, 8 USPQ2d 1377 (N.D.Cal.1988), holding (1) that Genentech, Inc., Genentech Development Corporation, and Genentech Clinical Partners, Ltd. (collectively Genentech) did not infringe claims 3, 11, 12, 17, 20, and 25 of U.S. Patent No. 3,853,833 ('833 patent), and (2) that claims 1, 3, 11, 12, 17, 18, 20, and 25 of that patent, which constitute all the claims in the suit, are invalid under 35 U.S.C. Sec. 112, first paragraph, for lack of enablement. Genentech cross-appeals from the denial of attorney fees and costs under 35 U.S.C. Sec. 285. We affirm-in-part, vacate-in-part and remand.
The facts underlying this appeal are set forth in the district court's opinion, id., and familiarity with that opinion is presumed. The facts may be summarized as follows.
In April, 1971, Dr. Chao Hao Li filed a patent application describing the production, via a process known as "solid phase peptide synthesis," of a synthetic, 188 amino acid sequence exhibiting growth promoting properties. According to the application, Dr. Li indicated that he had identified the structure of the natural human growth hormone (HGH). 1 However, in a continuation-in-part application that eventually matured into the '833 patent, Dr. Li conceded error in that regard and proposed a different version of the sequence of HGH, which is shown in Figure 2 of the '833 patent appended hereto. It is a 190 amino acid sequence.
It was later discovered and is admitted by HRF that the structure in Figure 2 of the '833 patent actually differs from natural HGH in two respects:
(1) HGH has one additional amino acid in the chain. (, glutamine is included at a position after the 68th amino acid.); and
(2) HGH has slightly different amino acids in positions 73, 106, and 108. (, there is glutamic acid instead of glutamine at position 73, aspartic acid instead of asparagine at 106, and asparagine instead of aspartic acid at 108.)
Hormone Research Foundation is the current owner of the '833 patent and Hoffman-LaRoche has an exclusive license thereunder. Genentech produces, by a recombinant DNA method, a human growth hormone product it calls Protropin. The structure of Protropin differs from the structure identified in Figure 2 of the '833 patent in that Protropin contains 192 amino acids instead of 190. Specifically, Protropin has an additional methionine at the amino end of the sequence and, like natural HGH, it has an additional glutamine after position 68 and slightly different proteins in the positions corresponding to position 73 (glutamic acid rather than glutamine), 106 (aspartic acid instead of asparagine) and 108 (asparagine instead of aspartic acid).
Genentech has also produced Protropin II, which apparently has not yet been approved for marketing by the Federal Drug Administration. The parties do not dispute that Protropin II has a structure identical to that of natural HGH.
Believing that Genentech's activities relating to Protropin and Protropin II are in violation of its rights under the '833 patent, HRF filed suit against Genentech seeking both injunctive and monetary relief. The eight claims of the '833 patent asserted by HRF are:
1. A method of producing synthetic human pituitary growth hormone which comprises:
a. forming an unbridged polypeptide chain of amino acid residues in the sequence of natural human pituitary growth hormone;
b. generating sulfhydryl groups on the cysteine residues in said polypeptide chain;
c. oxidizing said sulfhydryl groups under conditions effective to form disulfide bridges between said cysteine residues, thereby forming two intramolecular rings in the polypeptide chain.
3. A method of producing a substance having growth-promoting activity which comprises:
a. forming an unbridged polypeptide chain of amino acid residues in a sequence corresponding to FIG. 2 or 3 of the accompanying drawing;
b. generating sulfhydryl groups on the cysteine residues in said polypeptide chain;
c. oxidizing said sulfhydryl groups under conditions effective to form disulfide bridges between said cysteine residues, thereby forming two intramolecular rings in the polypeptide chain.
11. A method of producing a substance having growth-promoting activity which comprises:
a. forming an unbridged polypeptide chain of amino acid residues in a sequence corresponding to (i) the portion of the sequence of FIG. 2 of the drawing from positions 86 to 190 or (ii) the said portion (i) combined with any fraction of the remaining portion from position 85 to position 1;
b. generating sulfhydryl groups on the cysteine residues in said polypeptide chain;
c. oxidizing said sulfhydryl groups under conditions effective to form a disulfide bridge between said cysteine residues across positions 181 and 188; thereby forming an intra-molecular ring in the polypeptide chain.
12. A composition of matter consisting essentially of a synthetic, biologically active substance which has a structure corresponding to FIG. 2 of the accompanying drawing.
17. A composition of matter consisting essentially of a synthetic, biologically active substance which has a structure corresponding to (a) the portion of the structure of FIG. 2 of the drawings from positions 86 to 190 or (b) the said portion (a) combined with any fraction of the remaining portion from position 85 to position 1.
18. A composition of matter produced in accordance with the method of claim 1.
20. A composition of matter produced in accordance with the method of claim 3.
25. A composition of matter produced in accordance with the method of claim 11.
Before the district court, Genentech filed three motions for summary judgment. 2 In its first motion, Genentech alleged that it had not infringed claims 3, 11, 12, 17, 20, and 25 of the '833 patent (the Figure 2 claims) because its Protropin products do not contain a compound having the structure of Figure 2. 3 In its second motion, Genentech alleged that its products do not infringe claims 1, 3, 11, 18, 20, and 25 because they are produced by a recombinant DNA technique which differs from the solid-phase peptide process covered by these claims. In its final motion, Genentech asserted that the '833 patent claims at issue were invalid because the specification failed to satisfy the enablement requirement of 35 U.S.C. Sec. 112, first paragraph. 4 The district court granted Genentech's first and third motions, but denied the second.
With regard to Genentech's first motion, the district court found that the Figure 2 claims were not literally infringed because Genentech's products do not "correspond" to the structure of Figure 2. The district court also concluded that prosecution history estoppel precludes HRF from recovering for infringement under the doctrine of equivalents. On the enablement motion, the district court held that the specification would not have enabled a person skilled in the art to make and use either HGH (claims 1 and 18) or the structure of Figure 2 (claims 3, 11, 12, 17, 20, and 25) because, in its view, the synthesis process disclosed in the specification would not produce the identical polypeptide sequences called for in these claims.
Genentech also filed a motion for attorney fees and costs under 35 U.S.C. Sec. 285, which the district court denied on the basis that Genentech had not shown that such an award was warranted. 5
In this appeal, HRF contends that:
(1) The district court erred in concluding on summary judgment that there (2) The district court erred in concluding on summary judgment that prosecution history estoppel precludes a finding of infringement of the Figure 2 claims under the doctrine of equivalents.
was no literal infringement of claims 3, 11, 12, 17, 20, and 25 of the '833 patent.
(3) The district court erred in concluding on summary judgment that claims 1, 3, 11, 12, 17, 18, 20, and 25 of the '833 patent were invalid under 35 U.S.C. Sec. 112, first paragraph, for lack of enablement. 6
In its cross appeal, Genentech asserts that:
(4) The district court erred in denying it an award of attorney fees and costs under 35 U.S.C. Sec. 285.
OPINIONUnder Rule 56(c) of the Federal Rules of Civil Procedure, summary judgment "shall be rendered if the pleadings, depositions, answers to interrogatories, and admissions on file, together with the affidavits, if any, show there is no genuine issue of material fact and the moving party is entitled to a judgment as a matter of law." See Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 247, 106 S.Ct. 2505, 2509, 91 L.Ed.2d 202 (1986). "In reviewing a district court's grant of summary judgment in a patent case, this court must ... determine for itself whether the evidence is genuinely conflicting on the material issues of fact and, if not, whether the movant is entitled to judgment on those facts." Avia Group Int'l, Inc. v. L.A. Gear Cal., 853 F.2d 1557, 1561, 7...
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