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Court Revises Claim Construction for Patents on Recombinant DNA Technology

April 29, 2002

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Last Month at the Federal Circuit - May 2002

Judges: Rader (author), Michel, and Schall

In Genentech, Inc. v. Amgen, Inc., No. 01-1098 (Fed. Cir. Apr. 29, 2002), the Federal Circuit vacated a district court’s SJ of noninfringement and remanded for a determination of infringement under a revised claim construction. The Court also ruled that the district court properly denied a motion for discovery relating to the accused product and did not abuse its discretion by precluding Genentech, Inc. (“Genentech”) from pursuing a theory of infringement under the DOE after Genentech had failed to explicitly include such a theory in its pretrial claimconstruction charts.

Genentech sued Amgen, Inc. (“Amgen”) for infringement of three patents based on Amgen’s production and sale of Neupogen®, a recombinant methionyl-human-granulocyte-colony-stimulating factor (“met-hGCSF”) that stimulates replication of white blood cells. The patent claims at issue concerned cloning vehicles and recombinant DNA processes for producing polypeptides in microbial cells. Amgen makes Neupogen® by producing the recombinant protein from a plasmid expressed in bacterial cells.

Genentech’s appeal centered on construction of the terms “ribosome binding site” and “control region” as used in DNA plasmid vectors that express recombinant proteins in microbial cells. The district court had construed the term “ribosome binding site” to contain effectively three parts, a “Shine- Dalgarno” (“S-D”) sequence, a start codon, and intervening linker DNA separating the two. Genentech argued that the term properly construed would encompass only the S-D sequence and the start codon. Acknowledging that none of the patents explicitly defined the term, the Federal Circuit considered arguments in the prosecution history of the patents as well as declaration testimony of expert witnesses before concluding that Genentech was correct. Neither intrinsic nor extrinsic evidence established that the linker sequence made up part of the ribosome-binding site.

Regarding the term “control region,” the Federal Circuit found that the district court had erred by failing to appreciate the difference between the content (sequence) of the control region and the manner in which it was constructed. Relying on the specification and the prosecution history, the Court held that the “control region” limitation could be met regardless of how the DNA sequence of the region was assembled. In view of its revisions to the claim construction, the Federal Circuit vacated the lower court’s SJ of noninfringement and remanded for an infringement determination based on the proper claim construction.

Genentech also appealed the district court’s denial of its motion seeking discovery of the sequence of Amgen’s entire control region and its method for assembling that region. The Federal Circuit held that the district court did not abuse its discretion by denying the motion since Genentech already had enough information about the control region to determine the issue of infringement.

The Federal Circuit also found that the district court had not abused its discretion by precluding Genentech from pursuing a theory of infringement under the DOE. Under the local rules of the Northern District of California, Genentech was required to submit a pretrial claim chart explicitly reciting its theories of infringement. Genentech contended only literal infringement. Genentech argued that it had reasonably believed that it was required by the local rule to chose between either literal infringement or infringement under the DOE in the claim charts. The Federal Circuit was not persuaded and upheld the district court’s decision, noting that the appellate court defers to lower courts’ local rules to allow those courts to properly manage the cases before them. The Court added that even though the record provided grounds for the district court to allow Genentech to amend its infringement contentions, the district court did not abuse its discretion by refusing to do so.