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Court Reverses Finding of Invalidity of Genentech’s hGH Patent

September 27, 2001

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Last Month at the Federal Circuit - October 2001

Judges: Newman (author), Clevenger, and Gajarsa

In Bio-Technology General Corp. v. Genentech, Inc., No. 00-1223 (Fed. Cir. Sept. 27, 2001), the Federal Circuit reversed a lower court decision, which held that U.S. Patent No. 4,601,980 (“the ‘980 patent”) was invalid for lack of enablement. The Court also remanded the case for further proceedings to consider the issue of infringement and dismissed an antitrust claim.

The ‘980 patent is directed to a method for producing human growth hormone (“hGH”) using the recombinant techniques of bacterial production and gene expression. In the claimed process, hGH is produced with a methionine leader amino acid, resulting in a 192-amino-acid sequence “met-hGH.” According to the ‘980 patent, the methionine sequence is  thought to be cleaved within bacteria, resulting in the native 191-amino-acid sequence, or “mature hGH.” According to evidence submitted in an ANDA to the FDA, hGH made by the process of the ‘980 patent contains 93.8 percent met-hGH and 6.2 percent mature hGH.

Claim 2 of the patent, the only claim-in-suit, states in pertinent part that “hGH is unaccompanied by the leader sequence.” Bio-Technology General Corporation (“BTG”) argued that the claim is not enabled because either the leader methionine may not be cleaved by the bacteria or the cleavage will not produce a “substantial amount” of mature hGH. Genentech, Inc. (“Genentech”) responded that the invention is enabled by met-hGH, suggesting that the methionine does not constitute a leader sequence and that the claim is enabled if any mature hGH is produced along with the met-hGH.

At the district court, a jury had found that the claim was enabled. However, the district court granted JMOL of invalidity, setting aside the jury’s ruling.

After reviewing the evidence, the Federal Circuit ruled that claim construction did not require that mature hGH would need to be produced in substantial amount or in exclusion of met-hGH for claim 2 to be enabled. Moreover, the Court found that the jury’s verdict had been supported by substantial evidence and could have been reached by a reasonable jury. As such, the Court vacated the JMOL and reinstated the jury verdict.

The Federal Circuit concluded that the record on infringement was ambiguous and remanded the issue to the district court for further consideration.

On cross appeal, BTG raised an antitrust claim, arguing that Genentech’s infringement suit and an action seeking exclusion by the ITC were “sham litigation” based on patents that Genentech knew were invalid and not infringed. The district court had dismissed these claims under Fed. R. Civ. P. 12(b)(6).

BTG argued that this dismissal was improper because the district court had relied on the initial determination of an ALJ, whose findings and opinion were not binding. The Federal Circuit ruled that in considering this issue, the district court had correctly gone beyond the ALJ’s opinion and made its judgment without discernable error. BTG also contended that the district court had abused its discretion in not granting them a request to file a second amended antitrust complaint, but the Federal Circuit affirmed the lower court’s denial of the second complaint.