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Patent Lacks Priority Where Technology Did Not Yet Exist

03-1158
March 30, 2004

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Last Month at the Federal Circuit - April 2004

Judges: Rader (author), Archer, and Bryson (concurring in judgment)

In Chiron Corp. v. Genentech, Inc., No. 03-1158 (Fed. Cir. Mar. 30, 2004), the Federal Circuit affirmed a district court’s denial of Chiron Corporation’s (“Chiron”) motion for JMOL and motion for a new trial, leaving intact a jury verdict that led to the invalidity of a patent concerning monoclonal antibodies. Chiron sued Genentech, Inc. (“Genentech”) over Genentech’s sales of Herceptin®, a humanized antibody for the longterm treatment of breast cancer, alleging infringement of U.S. Patent No. 6,054,561 (“the ‘561 patent”). After a jury trial, the district court had found that all claims in the ‘561 patent, which issued from an application filed in 1995, were invalid under 35 U.S.C. § 102 because none of the claims was entitled to priority of a chain of parent applications filed in 1984, 1985, and 1986. The jury had found that none of the parent applications satisfied both the written description and enablement requirement for the claims of the ‘561 patent.

The ‘561 patent claims particular monoclonal antibodies. The district court had construed the claims of the ‘561 patent to embrace chimeric and humanized antibodies that bind to a specific protein, termed HER2. Chimeric and humanized antibodies are created by recombinant DNA technology. Based on its construction, the district court had granted Chiron’s motion for partial SJ of infringement. In addition, the parties stipulated that the ‘561 patent would be invalid under 35 U.S.C. § 102 based on intervening prior art if the ‘561 patent were denied priority to any of its parent applications.

The Federal Circuit affirmed the district court’s denial of Chiron’s motion for JMOL for two reasons. First, the Court found that neither the 1985 nor 1986 application enabled the claims of the ‘561 patent. The Federal Circuit adopted the district court’s claim construction that the claims of the ‘561 patent embraced chimeric and humanized antibodies that bind to HER2. The Court indicated that the record showed that chimeric antibodies first appeared in the literature in May 1984, four months after the filing date of Chiron’s 1984 application, and that the 1985 and 1986 applications provided no disclosure of either how to make or use chimeric antibodies. The Court determined that, since the technology was still nascent at the time of the 1986 application, undue experimentation would have been required. Thus, the Court held that the jury’s conclusion that the 1985 and 1986 applications were not enabled was amply supported. Relying on In re Hogan, 559 F.2d 595 (C.C.P.A. 1977), the Court found that the district court had erred to the extent that it created an obligation for Chiron to enable nonexistent technology as of the 1984 application’s filing date.

Second, the Court found that the 1984 application did not provide support for the new matter, chimeric antibodies claimed in the ‘561 patent. The ‘561 patent expressly defined the term “monoclonal antibody” as including chimeric and humanized antibodies, whereas the 1984 application did not. The Federal Circuit noted the term “monoclonal antibody” in 1984 apparently was not broad enough to encompass chimeric antibodies. The Court stated that Chiron could not possess and disclose the subject matter of chimeric antibodies that did not even exist at the time of the 1984 application.

The Court next turned to the district court’s denial of Chiron’s motion for a new trial, which Chiron based on errors in the jury instructions and errors in the admission of evidence. First, Chiron argued that the district court had erred by instructing the jury on Genentech’s burden of proof without adding a jury instruction on the presumption of validity of the ‘561 patent. The Federal Circuit disagreed, stating that the presumption of validity and heightened burden of proving invalidity are different expressions of the same thing. Chiron further argued that the Chiron jury instructions on the law of written description and enablement were erroneous, but the Court found no errors in these instructions. Chiron also challenged three evidentiary rulings of the district court, but the Court did not find that these alleged errors warranted reversing the district court’s denial of a new trial.

Judge Bryson concurred in the judgment, but disagreed with respect to whether the 1984 application enabled the chimeric antibodies claimed in the ’561 patent. He indicated that the proper approach was to construe the claims as they would have been understood by the skilled artisan at the time the application was filed, and not construing them to reach as-yet-undeveloped technology that the applicant did not enable. Since Chiron was not seeking to construe its claims to preserve their validity, but arguing that the claims cover technology not existing at that time, he would hold the claims as nonenabled by the 1984 application.