Genentech, Inc. v. Novo Nordisk

• Decision Date: 22 August 1996
• Docket Number: Civil Action No. 95 Civ. 3474 (CBM),95 Civ. 0110 and 96 Civ. 1755.,94 Civ. 8634
• Citation: 935 F. Supp. 260
• Parties: GENENTECH, INC., Plaintiff, v. NOVO NORDISK A/S, Novo Nordisk of North America, Inc., and Novo Nordisk Pharmaceuticals, Inc., Defendants.
• Court: U.S. District Court — Southern District of New York

935 F. Supp. 260

GENENTECH, INC., Plaintiff, v. NOVO NORDISK A/S, Novo Nordisk of North America, Inc., and Novo Nordisk Pharmaceuticals, Inc., Defendants.

Civil Action Nos. 95 Civ. 3474 (CBM), 94 Civ. 8634, 95 Civ. 0110 and 96 Civ. 1755.

United States District Court, S.D. New York.

June 27, 1996.

Public Version Filed August 22, 1996.

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Rogers & Wells (by Leora Ben-Ami, John E. Kidd, Nicholas L. Coch, Joseph Ferraro, Philip E. Roux, Gerard P. Norton), New York City, for Plaintiff Genentech, Inc.

Graham & James (by Albert L. Jacobs, Jr., Jesse D. Reingold, Donald M. Currie, Gerard F. Diebner, Daniel A. Ladow), Morgan & Finnegan (by John C. Vassil, Kurt E. Richter, Kenneth H. Sonnenfeld), New York City, for Defendants Novo Nordisk A/S, Novo Nordisk of North America, Inc., and Novo Nordisk Pharmaceuticals, Inc.

ORDER

MOTLEY, District Judge.

Upon consent of the parties, the accompanying Opinion and Order shall be filed as the public version of the Opinion and Order originally filed under seal on June 27, 1996, which granted Genentech, Inc.'s motion for a preliminary injunction in the above-captioned case.

SO ORDERED.

OPINION

FINDINGS OF FACT AND CONCLUSIONS OF LAW

I. PRIOR PROCEEDINGS

1. This consolidated action began on November 30, 1994. On May 12, 1995, Genentech Inc. ("Genentech") moved for a temporary restraining order and a preliminary injunction to enjoin Novo Nordisk A/S, Novo Nordisk of North America, Inc., and Novo Nordisk Pharmaceuticals Inc.'s (collectively, "Novo"'s) importation, marketing and sale of Norditropin® in the United States based on Genentech's U.S. Patent No. 4,601,980 ("the '980 patent"). An evidentiary hearing was held before this court from May 22, 1995 until June 14, 1995.

2. On June 14, 1995, this court issued a temporary restraining order to preserve the status quo pending the Court's ruling on Genentech's motion for a preliminary injunction. On June 28, 1995, this motion was granted.¹

3. Then, on February 26, 1996, the Federal Circuit issued its decision vacating the preliminary injunction and remanding the action to this court. See Novo Nordisk of North America, Inc. v. Genentech, Inc., 77 F.3d 1364 (Fed.Cir.1996). The Federal Circuit found that this court had applied an erroneous claim construction in determining that Genentech had established a likelihood of success on the merits of its patent infringement claim. Specifically, the Federal Circuit held that Claim 2 of the '980 patent, read in light of the specification, covers "only a method of directly expressing human growth hormone and does not encompass a cleavable fusion expression process." Id. at 1369.

4. The Federal Circuit did not analyze this court's findings and conclusions on the issues of validity, irreparable harm, balancing of equities, and public interest. Rather, the Federal Circuit set these conclusions aside because all were premised on an erroneous finding of infringement. Id. at 1371.

5. On March 21, 1996, Genentech again moved for a preliminary injunction prohibiting Novo from marketing and selling Norditropin® in the United States — this time based on Novo's alleged infringement of U.S. Patent No. 5,424,199 ("the '199 patent"). A hearing on this motion was held from May 8, 1996 through May 23, 1996, and included concurrent testimony and evidence on Novo's motion to dismiss in Genentech, Inc. v. Novo Nordisk A/S, et al., 96 Civ. 1755 (CBM), Genentech's separate action relating to the '199 patent. The court now addresses this motion.²

II. THE ISSUANCE AND HISTORY OF THE '199 Patent

6. The '199 patent was not before this court at the time of Genentech's original motion for a preliminary injunction because it did not issue until June 13, 1995 (GNE 200), the day the evidentiary hearing concluded, and the day before the temporary restraining order was issued.³

7. The '199 patent arises out of the same pioneering invention as, and shares the specification of the '980 patent and the other patents which issued on the basis of the original Goeddel-Heyneker application filed July 5, 1979 (FF 58; 96 Tr. 515-516, Peet). The sole '199 patent claim, however, explicitly covers a cleavable fusion expression process. Novo has conceded this. (96 Tr. 1283, Villa-Komaroff). This claim reads as follows:

1. A method of producing a protein consisting essentially of amino acids 1-191 of human growth hormone comprising: (a) expressing in a transformant bacterium, DNA coding for a human growth hormone conjugate protein, which conjugate protein consists essentially of amino acids 1-191 of human growth hormone as set forth in combined FIGS. 1 and 3 unaccompanied by the leader sequence of human growth hormone or other extraneous protein bound thereto and an additional amino acid sequence which is specifically cleavable by enzymatic action, and

(b) cleaving extracellularly said conjugate protein by enzymatic action to produce said protein consisting essentially of amino acids 1-191 of human growth hormone.

8. A patent applicant may apply for and obtain a series of patents based on the same application (96 Tr. 392, Peet). It is common practice for the applicant to obtain a series of different claims in separate patents covering different specific embodiments until satisfied that the issued claims provide coverage for the full scope of the invention disclosed in the specification (96 Tr. 392, Peet). This is what Genentech did with the '199 patent (96 Tr. 392-93, Peet).

III. LIKELIHOOD OF SUCCESS ON THE MERITS

A. Claim Interpretation — The Scope Of Claim 1 Of The '199 Patent

9. The interpretation and construction of a patent claim, which define the scope of the patentee's rights under the patent, is a matter of law to be determined exclusively by the court. Markman v. Westview Instruments, Inc., 52 F.3d 967, 970-971 (Fed.Cir.1995) (en banc), aff'd, ___ U.S. ___, 116 S.Ct. 1384, 134 L.Ed.2d 577 (1996). To determine the meaning of claims, courts look to the claim language, the specification, and the prosecution history. See, e.g., Minnesota Mining and Manufacturing Co. v. Johnson & Johnson Orthopaedics, Inc., 976 F.2d 1559, 1576-77 (Fed.Cir.1992). The prosecution history "is of primary significance in understanding the claims" because it provides an "`undisputed public record'" of the proceedings in the Patent and Trademark Office. Markman, 52 F.3d at 980. Additionally, claims should be interpreted as "those skilled in the art would interpret the claims." Id.

10. The parties agree that Claim 1 of the '199 patent covers a cleavable fusion expression process. However, Novo raised two issues regarding claim interpretation: (1) whether the term "DNA" and the reference to Figures 1 and 3 in the claim exclude the use of genomic DNA from the claim, and (2) whether the claim is a "means plus function" claim, therefore covering only the use of trypsin and the amino acid extensions recognized by trypsin and their "equivalents." For the reasons set forth below, the court finds that (1) the claim does not exclude genomic DNA and (2) enzymatic action is a generic term not limited to trypsin and its "equivalents" and the amino acid sequence is simply one which is specifically cleavable by the enzyme of choice.

1. Claim 1 Of The '199 Patent Contains No Limitation For The Source Of DNA Coding For Human Growth Hormone

11. The court rejects Novo's argument that Claim 1 of the '199 patent should be construed to contain a limitation on the source of the DNA utilized in the claimed process. No such limitation appears in the language of the claim (96 Tr. 396-397, Peet). Moreover, it is clear from the '199 patent prosecution history that both the Examiner and Genentech stated that the source of the DNA coding for human growth hormone was irrelevant and could include chemically synthesized DNA, cDNA or genomic DNA (GNE 201, pp. 83, 91). Indeed, this issue arose during prosecution of the '199 patent. The Examiner stated specifically his understanding that the DNA was generic and would include genomic DNA (GNE 201, p. 83). In response to a specific inquiry from the Examiner, Genentech stated that the source of the DNA was not critical and "need not be recited in the claims." (GNE 201, p. 91). Thus, the file history explicitly states that the claim of the '199 patent contained no limitation as to the source of the DNA, and can include genomic DNA (96 Tr. 396, Peet).

12. Novo also argues that the claim language "which conjugate protein consists essentially of amino acids 1-191 of human growth hormone as set forth in combined FIGS. 1 and 3" requires the use of semi-synthetic DNA, i.e., a combination of synthetic DNA and cDNA, because the Figures show the preferred semi-synthetic DNA. Novo's argument, however, fails as a matter of simple grammatical construction. First, the phrase is set off by a comma from the DNA portion of the claim, indicating that the phrase modifies the conjugate protein, not the DNA. Second, Figures 1 and 3 show both a DNA sequence and an amino acid sequence. The claim language requires only that the hGH component of the conjugate protein be the amino acid sequence 1-191 disclosed in the referenced Figures. It does not require the particular example of the DNA for amino acids 1-191. Thus, the reference to the Figures has no bearing on the source of the DNA. The phrase relates only to the amino acid sequence.

13. Novo also argues that because the specification does not explicitly mention it, genomic DNA cannot be within the claim's scope (96 Tr. 1139, Villa-Komaroff). This argument is without merit. First, the claim language clearly does not require a particular source of DNA, as compared, for example, to the '832 patent, which does require a particular source, namely a combination of synthetic DNA and cDNA (NN 200). Second, although the specification refers to synthetic DNA and cDNA, Novo has conceded previously that everything in the...