Chiron Corp. v. Genentech, Inc.

• Decision Date: 24 June 2002
• Docket Number: No. CIV.S-00-1252 WBS GG.,CIV.S-00-1252 WBS GG.
• Citation: 268 F.Supp.2d 1148
• Parties: CHIRON CORPORATION Plaintiff, v. GENENTECH, INC. Defendant.
• Court: U.S. District Court — Eastern District of California

268 F.Supp.2d 1148

CHIRON CORPORATION Plaintiff, v. GENENTECH, INC. Defendant.

No. CIV.S-00-1252 WBS GG.

United States District Court, E.D. California.

June 24, 2002.

COPYRIGHT MATERIAL OMITTED

Paul Joseph Riley, Morrison and Foerster LLP, San Francisco, CA, Eric S. Walters, Morrison and Foerster, Palo Alto, CA, for Plaintiff.

Jack Vivian Lovell, Hunter Richey Di-Benedetto and Eisenbeis, Sacramento, CA, James M. Emery, Michael David Celio, Keker and Van Nest, San Francisco, CA, for Defendant.

James M. Emery, Keker and Van Nest, Henry C. Bunsow, Howrey Simon Arnold and White, San Francisco, CA, for Counter-Claimant.

Rachel Krevans, Morrison and Foerster LLP, San Francisco, CA, for Counter-Defendant.

MEMORANDUM AND ORDER RE: PRIORITY, ANTICIPATION, WRITTEN DESCRIPTION, EABLEMENT, BEST MODE, UTILTY

SHUBB, District Judge.

In a separate order, the court has determined that Genentech's product, Herceptin, infringes Chiron's U.S. Patent No. 6,054,561 ("'561 patent"). Chiron and Genentech now bring cross motions for summary judgment on Genentech's anticipation, written description and enablement defenses under 35 U.S.C. §§ 102, 112. These cross motions address the central question of whether the '561 patent is entitled to the benefit of the 1984, 1985, and/or 1986 filing dates of three patent applications in the '561 patent family. Chiron also moves for summary judgment on Genentech's best mode and utility defenses under 35 U.S.C. § 112.

I. Factual and Procedural Background

On February 8, 1984, Chiron's predecessor in interest, Cetus, filed the first in what was to become a long line of patent applications that led to the issuance of the '561 patent. The 1984 application discusses monoclonal antibodies that bind to human breast cancer,¹ and identifies several such antibodies, including one known as 454 C11. The specification of the 1984 application describes how the antibodies were produced using the hybridoma method developed by Kohler and Millstein, and then screened for certain binding properties. As set forth in the 1984 application, the hybridomas that produce the claimed antibodies are on deposit with the American Type Culture Collection ("ATCC"), a cell and tissue bank accessible to the public. (See 1984 Application at 27.) In addition to discussing how the antibodies were made, the 1984 application proposes various uses for the antibodies. It states that the monoclonal antibodies of the invention can be used in cancer diagnosis and in immunoassays, and also discusses how the antibodies can be conjugated or joined with a toxin so that they can be used in cancer treatment to kill breast cancer cells. (Id. at 1, 9, 23-25.)

On January 11, 1985, Cetus filed a continuation-in-part of the 1984 application. In addition to 454 C11, the 1985 application describes and claims the monoclonal antibody 520 C9. (1995 Application at 32.) The specification of the 1985 application essentially tracks that of the 1984 application, but adds more information about the antigen to which the claimed antibodies bind. It notes that the antigen has an approximate molecular weight of approximately 210,000 daltons, and identifies seven monoclonal antibodies (including 454 Cll and 520 C9) that bind to that antigen. (Id. at 30.)

In 1986, Cetus filed another continuation application. The specification of the 1986 application is similar to the 1985 application, but it names a total of thirteen monoclonal antibodies that bind to the antigen of interest, and states that the molecular weight of the antigen is approximately 200,000 daltons. (1986 Application at 30.) The 1986 application also describes and claims other antibodies that bind to a "high molecular weight" antigen. (See id. at 36, claim 3.)

The inventors of these monoclonal antibodies, Cetus scientists Drs. David Ring and Arthur Frankel, dubbed the approximately 200,000 dalton antigen they discovered "BCA200" (i.e. "Breast Cancer Antigen 200"). In the late 1980s, Dr. Ring conducted a number of experiments comparing BCA200 to other antigens of similar molecular weight known in the art. One of these antigens was a 185,000 dalton antigen known as c-erbB-2 (later known as HER2).² Dr. Ring noted similarities between BCA200 and c-erbB-2, but concluded that BCA200 might be distinct from c-erbB-2, and published a paper to that effect in 1989. (Durie Decl. Ex. J.) Two years later, in 1991, Dr. Ring published another paper noting problems with the experiment discussed in the 1989 publication, and stating that new studies had shown that BCA200 was in fact the same antigen as c-erbB-2. (Durie Decl. Ex. F.)

In 1995, Chiron filed another continuation application that ultimately issued as the '561 patent. The '561 patent broadly claims all monoclonal antibodies that bind to c-erbB-2. Claims 1-8 and 20-25 of the '561 patent are directed toward monoclonal antibodies that "bind[ ] to a human breast cancer antigen that is also bound by monoclonal antibody 454 C11...." (See e.g., Id., claim 1). These claims rely on the 1984 parent application for priority. Claims 9-18 are directed toward monoclonal antibodies that "bind[] to a human breast cancer antigen that is also bound by monoclonal antibody 520 C9...." (See e.g., Id., claim 9). These claims assert priority based on the 1985 parent application. Claim 19 of the patent claims "a monoclonal antibody that binds to human c-erb-2 antigen," and relies on the 1984/1985 applications for priority. (Id., claim 19.) The specification of the '561 patent states that 454 C11 and 520 C9 bind to the same antigen, c-erbB-2. (Id. at 27:1-17.)

This court held a Markman Hearing and issued an order construing disputed terms in the '561 patent on April 22, 2002. As set forth in that order, the term "monoclonal antibody" as used in the patent means any homogeneous population of antibodies, and is not limited by the species or source of the antibody. (April 22, 2002 Order at 38.) Thus, the patent claims encompass monoclone antibodies derived from hybridomas, as well as "altered," "hybrid," "chimeric," and "humanized" antibodies. (Id.) A hybridoma is an immortal cell line created by fusing a B-lymphocyte cell with a myeloma cell, and is capable of producing monoclonal antibodies. (See Id. at 3.) "Altered" antibodies include antibodies conjugated with toxins. (Mar. 6, 2002 Markman Tr. at 14). "Chimeric" antibodies are antibodies having a mouse or animal variable region (the region that includes the portion cf the antibody that binds to the antigen;, and a human constant region. (Id. at 36). A chimeric antibody is an example of a "hybrid" antibody. A "humanized" antibody is a genetically engineered antibody in which the amino acid sequences in the binding site of the antibody are modeled after animal antibodies while the rest is human.

II. Discussion

The court must grant summary judgment to a moving party "if the pleadings depositions, answers to interrogatories, and admissions on file, together with the affidavits, if any, show that there is no genuine issue as to any material fact and that the moving party is entitled to judgment as a matter of law." Fed.R.Civ.P. 56(c). The party adverse to a motion for summary judgment may not simply deny generally the pleadings of the movant; the adverse party must designate "specific facts showing that there is a genuine issue for trial." Fed.R.Civ.P. 56(e); see Celotex Corp. v. Catrett, 477 U.S. 317, 106 S.Ct. 2548, 91 L.Ed.2d 265 (1986). Simply put, "a summary judgment motion cannot be defeated by relying solely on conclusory allegations unsupported by factual data." Taylor v. List, 880 F.2d 1040, 1045 (9th Cir.1989). The non-moving party must show more than a mere "metaphysical doubt" as to the material facts. Matsushita Elec. Indus. Co. v. Zenith Radio, 475 U.S. 574, 587, 106 S.Ct. 1348, 89 L.Ed.2d 538 (1986).

In addition, "the inquiry involved in a ruling on a motion for summary judgment ... necessarily implicates the substantive evidentiary standard of proof that would apply at the trial on the merits." Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 252, 106 S.Ct. 2505, 91 L.Ed.2d 202 (1986). An issued patent carries with it a presumption of validity, which can only be overcome by clear and convincing evidence to the contrary. Johns Hopkins v. CellPro, Inc., 152 F.3d 1342, 1359 (Fed.Cir. 1998); North Am. Vaccine, Inc. v. Am. Cyanamid, 1 F.3d 1571, 1579 (Fed.Cir. 1993). The court must therefore take this standard into account when ruling on the motions for summary judgment regarding Genentech's invalidity defenses.

A patent is invalid if the invention it claims was "patented or described in a printed publication . . . more than one year prior to the date of the application for patent ...." 35 U.S.C. § 102(b). In the ten year period between the filing of the 1985 application and the filing of the 1995 application, several patents and articles were published on anti-HER2 monoclonal antibodies. (Lam Decl. Ex. B (U.S. Patent No. 4,753,894, issued June, 1988); Ex. C (International Application Number PCT/US93/03080, filed April, 1993); Ex. D (Robert Hudziak, et al, p185HER2 Monoclonal Antibody Has Antiproliferative Effects In Vitro and Sensitizes Human Breast Cancer Tumor Cells to Tumor Necrosis Factor, 9 Molecular and Cellular Biology 1165-1172 (March 1989))). Chiron does not dispute that if the patent can only rely on the 1995 application for priority, these intervening references anticipate and therefore invalidate the patent. Accordingly, a threshold issue for the court is whether the '561 patent is entitled to rely on the either the 1984, 1985, or 1986 application for priority.

For a patent to get the benefit of the filing date of an earlier application, the specification of the earlier application must meet the requirements of 35 U.S.C. § 112. See 35 U.S.C. § 120 ("An application for patent for an invention disclosed in the manner provided by the first paragraph of section 112 of this title in an application...