Genentech, Inc. v. Novo Nordisk A/S

• Citation: 42 USPQ2d 1001,108 F.3d 1361
• Decision Date: 13 March 1997
• Docket Number: No. 96-1440,96-1440
• Parties: GENENTECH, INC., Plaintiff-Appellee, v. NOVO NORDISK, A/S, Novo Nordisk Of North America, Inc. and Novo Nordisk Pharmaceuticals, Inc., Defendants-Appellants.
• Court: United States Courts of Appeals. United States Court of Appeals for the Federal Circuit

Page 1361

108 F.3d 1361

42 U.S.P.Q.2d 1001

GENENTECH, INC., Plaintiff-Appellee, v. NOVO NORDISK, A/S, Novo Nordisk Of North America, Inc. and Novo Nordisk Pharmaceuticals, Inc., Defendants-Appellants.

No. 96-1440.

United States Court of Appeals Federal Circuit.

March 13, 1997.

Rehearing Denied; Suggestion for Rehearing In Banc

Declined May 12, 1997.

Leora Ben-Ami, Rogers & Wells, New York City, argued, for plaintiff-appellee. With her on the brief were John E. Kidd, Nicholas L. Coch, Joseph Ferraro, Philip E. Roux, and Gerard P. Norton. Of counsel was Ryan Trainer, Rogers & Wells, Washington, D.C.

Albert L. Jacobs, Jr., Graham & James LLP, New York City, argued, for defendant-appellants. With him on the brief were Jesse D. Reingold, Gerard F. Diebner, and Daniel A. Ladow. Of counsel on the brief were John C. Vassil, Kurt E. Richter and Kenneth H. Sonnenfeld, Morgan & Finnegan, LLP, New York City. Of counsel were Brad S. Needleman and Andrew T. Solomon, Graham & James.

Before ARCHER, Chief Judge, LOURIE, and BRYSON, Circuit Judges.

LOURIE, Circuit Judge.

Novo Nordisk A/S, Novo Nordisk of North America, Inc., and Novo Nordisk Pharmaceuticals, Inc. (collectively "Novo") appeal from the order of the United States District Court for the Southern District of New York, issuing a preliminary injunction in favor of Genentech, Inc., enjoining Novo from importing, marketing, using, selling, offering for sale or distributing its Norditropin TM-brand recombinant human growth hormone (hGH) product. Genentech, Inc. v. Novo Nordisk A/S, 935 F.Supp. 260 (S.D.N.Y.1996). Because the district court's conclusion that Genentech had demonstrated a likelihood of success on the merits was based on an error of law and because its remaining findings were premised on this error, we vacate the injunction.

BACKGROUND

This consolidated patent infringement action was first brought in the United States District Court for the Southern District of New York on November 30, 1994. On May 12, 1995, Genentech moved for a preliminary injunction under U.S. Patent 4,601,980 to prevent Novo from importing, marketing, using, selling, offering for sale or distributing in the United States its Norditropin TM-brand recombinant hGH product. The district court granted Genentech's motion and issued an injunction. Novo Nordisk of North Am., Inc. v. Genentech, Inc., No. 94 Civ. 8634(CBM), 1995 WL 512171, 1995 U.S. Dist. LEXIS 12588 (S.D.N.Y. Aug. 28, 1995).

On appeal this court vacated the injunction. Novo Nordisk of North Am., Inc. v. Genentech, Inc., 77 F.3d 1364, 37 USPQ2d 1773 (Fed.Cir.1996). We held that the district court clearly erred in finding that Genentech established a likelihood of proving infringement of the '980 patent because that finding was based on an improper construction of claim 2 of the patent. Based upon the specification and prosecution history, we concluded that because the claim used the phrase "human growth hormone unaccompanied by ... other extraneous protein," it was limited to processes for directly expressing either hGH or met-hGH. Id. at 1371, 37 USPQ2d at 1779. Because the parties agreed that Novo did not use direct expression to produce these proteins, we concluded that Novo did not infringe the patent. Id.

Upon returning to the district court, Genentech asserted its newly issued U.S. Patent 5,424,199. The '199 patent has the same specification as the '980 patent and contains a single claim directed to:

[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.

This claim differs from the claim adjudicated in the prior case in reciting that the encoded protein has an additional amino acid sequence and includes the step of cleaving this conjugate protein. This process of expressing a DNA encoding a conjugate protein and using an enzyme to cleave off an undesired portion of that protein is generally known as cleavable fusion expression. The parties agree that Novo uses cleavable fusion expression to produce hGH. Id.

On June 27, 1996, after conducting a twelve-day evidentiary hearing, the district court again issued a preliminary injunction, this time based upon the '199 patent, enjoining Novo from importing, marketing, using, selling, offering for sale, or distributing in the United States its Norditropin TM-brand recombinant hGH product. Genentech v. Novo Nordisk A/S, 935 F.Supp. 260 (S.D.N.Y.1996). The district court based its decision upon, inter alia, a finding that Genentech would likely overcome Novo's defense that the '199 patent was invalid for lack of an enabling disclosure under 35 U.S.C. § 112, p 1 (1994).

Novo appeals to this court, challenging the grant of the preliminary injunction. ¹ We have jurisdiction pursuant to 28 U.S.C. § 1292(c) (1994).

DISCUSSION

The grant or denial of a preliminary injunction pursuant to 35 U.S.C. § 283 is within the discretion of a district court. We Care, Inc. v. Ultra-Mark Int'l Corp., 930 F.2d 1567, 1570, 18 USPQ2d 1562, 1564 (Fed.Cir.1991). Accordingly, a trial court's decision granting a preliminary injunction will be overturned on appeal only upon a showing that the court abused its discretion. Joy Techs., Inc. v. Flakt, Inc., 6 F.3d 770, 772, 28 USPQ2d 1378, 1380 (Fed.Cir.1993). Such an abuse of discretion may be established by showing that the court made a clear error of judgment in weighing relevant factors or exercised its discretion based upon an error of law or clearly erroneous factual findings. Id.

As the moving party, Genentech had to establish its right to a preliminary injunction in light of four factors: (1) a reasonable likelihood of success on the merits; (2) irreparable harm if the injunction were not granted; (3) the balance of the hardships; and (4) the impact of the injunction on the public interest. Nutrition 21 v. United States, 930 F.2d 867, 869, 18 USPQ2d 1347, 1348-49 (Fed.Cir.1991); Hybritech Inc. v. Abbott Labs., 849 F.2d 1446, 1451, 7 USPQ2d 1191, 1195 (Fed.Cir.1988).

A. Likelihood of Success on the Merits

In order to demonstrate that it has a likelihood of success, Genentech must show that, in light of the presumptions and burdens that will inhere at trial on the merits, (1) it will likely prove that Novo infringes the '199 patent and (2) its infringement claim will likely withstand Novo's challenges to the validity and enforceability of the '199 patent. See New England Braiding Co. v. A.W. Chesterton Co., 970 F.2d 878, 882-83, 23 USPQ2d 1622, 1625-26 (Fed.Cir.1992). ² In other words, if Novo raises a "substantial question" concerning validity, enforceability, or infringement (i.e., asserts a defense that Genentech cannot show "lacks substantial merit") the preliminary injunction should not issue. Id. More specifically, with regard to Novo's validity defenses, the question on appeal is whether there is substantial merit to Novo's assertion that the '199 patent claim fails to meet the requirements of 35 U.S.C. § 112, p 1 (1994).

Novo argues that the district court's findings regarding validity under § 112, p 1, are clearly erroneous because it presented clear and convincing evidence that the patent specification would not have enabled a person of ordinary skill in the art to practice the claimed invention without undue experimentation. Novo also argues that the specification fails to contain a written description of the claimed invention. Regarding enablement, Novo argues that the patent is invalid because it does not contain sufficient detail concerning the practice of the claimed method. Novo argues that the mere generic statement of the possibility of cleavable fusion expression, along with the DNA sequence encoding hGH, a single enzyme (trypsin) for cleaving undisclosed conjugate proteins, and a statement of that enzyme's cleavage sites as being potential amino acid extensions conjugated to hGH is not an enabling disclosure commensurate in scope with the claim. Genentech responds that all of the district court's factual findings regarding enablement are supported by the record. More specifically, Genentech argues that those skilled in the art of recombinant protein expression and purification at the time of filing, July 5, 1979, would have been able to use cleavable fusion expression to produce hGH without undue experimentation by using the teachings of the specification along with methods and tools well known in the art. We conclude that Novo has raised more than a substantial question concerning the validity of the '199 patent. In fact, it has shown that the patent is invalid.

Section § 112, p 1, provides, in relevant part that:

[t]he specification shall contain a written description of the invention, and the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same....

"[T]o be enabling, the specification of a patent must teach those skilled in the art how to make and use the full scope of the claimed invention without 'undue experimentation.' " In re Wright, 999 F.2d 1557, 1561, 27 USPQ2d 1510, 1513 (Fed.Cir.1993); see also Amgen, Inc. v. Chugai Pharm. Co., 927 F.2d 1200, 1212, 18 USPQ2d 1016, 1026 (Fed.Cir.1991); In re Fisher, 57 C.C.P.A. 1099, 427 F.2d 833, 839, 166 USPQ 18, 24 (1970) ("[T]he scope of the claims must...