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Genentech, Inc. v. Novo Nordisk A/S, 108 F.3d 1361, 42 U.S.P.Q.2d 1001

Facts

The specification indicates that it purports to solve a problem. That problem is summarized at column 3, line 65, through column 4, line 8: [A] need has existed for new methods of producing hGH and other polypeptide products in quantity and that need has been particularly acute in the case of polypeptides too large to admit to organic synthesis or, for that matter, microbial expression from entirely synthetic genes.

Issue

Was the patent for the cleavable fusion expression process for producing human growth hormone (hGH) valid, and did the district court err in granting a preliminary injunction?

Was the patent for the cleavable fusion expression process for producing human growth hormone (hGH) valid, and did the district court err in granting a preliminary injunction?

Rule

The grant or denial of a preliminary injunction is within the discretion of the district court, which must consider four factors: (1) a reasonable likelihood of success on the merits; (2) irreparable harm if the injunction is not granted; (3) the balance of hardships; and (4) the impact of the injunction on the public interest. A patent is presumed valid, but the patentee must demonstrate a likelihood of success on all disputed liability issues, including validity.

Analysis

The Court of Appeals found that the district court erred in its conclusion that Genentech had demonstrated a likelihood of success on the merits. The court determined that the specification of the patent did not enable a person skilled in the art to practice the claimed invention without undue experimentation, thus rendering the patent invalid. The court emphasized that the presumption of validity does not relieve the patentee from the burden of proving that it will likely succeed on all disputed issues, including the patent's validity.

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. The specification does not describe a specific material to be cleaved or any reaction conditions under which cleavable fusion expression would work.

Conclusion

The Court of Appeals vacated the preliminary injunction and held that the patent was invalid for failure of specification to enable the practice of the claimed method.

We therefore hold that claim 1 and hence the '199 patent are invalid as a matter of law for failure of the specification to enable the practice of the claimed method.

Who won?

Novo Nordisk A/S prevailed in the appeal against Genentech, Inc. The Court of Appeals found that the district court had abused its discretion by granting the preliminary injunction based on an erroneous legal conclusion regarding the likelihood of success on the merits. The court determined that the patent was invalid due to a failure to provide an enabling disclosure, which is a fundamental requirement for patent validity.

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