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JMOL of Noninfringement Affirmed Given Lack of Substantial Evidence

February 13, 2001

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Last Month at the Federal Circuit - March 2001

Judges: Lourie (author), Linn, and Dyk

In Forest Laboratories, Inc. v. Abbott Laboratories, No. 99-1494 (Fed. Cir. Feb. 13, 2001), the Federal Circuit affirmed a JMOL of noninfringement, following a jury verdict of infringement of U.S. Patent Nos. 4,338,301 (“the ‘301 patent”) and 4,397,839 (“the ‘839 patent”), owned by Tokyo Tanabe Co., Ltd. (“Tokyo Tanabe”).

The patents-in-suit relate to a lung surfactant composition for treating Respiratory Distress Syndrome (“RDS”) in premature babies. Abbott Laboratories (“Abbott”) developed a commercial product known as Survanta® after receiving an exclusive U.S. license to these patents from Tokyo Tanabe. ONY, Inc. (“ONY”) developed a competing product for treating RDS, which it called Infasurf®. ONY then entered into an agreement with Forest Laboratories, Inc. (“Forest”) under which Forest would develop and market Infasurf®. In 1996, ONY and Forest (collectively “ONY”) sued Abbott, seeking a DJ of noninfringement and patent invalidity. Abbott counterclaimed for infringement.

On appeal, Abbott argued that the district court had erred by construing the claim term “surface active material” as a presuspension powder because the claims were not limited to either solid or liquid form. Abbott also argued that the district court had erred in concluding that the surfaceactive material is only a part of a subset of the claimed “pharmaceutical composition.”

The Federal Circuit concluded that the district court had properly construed a “surface active material” to mean the material containing the prescribed materials in the prescribed percentages, when measured in the dried state, i.e., before being combined with a pharmaceutical carrier. However, the Court continued, the district court had erred in further construing the claim. The Court ruled that when the surface-active material is combined with a pharmaceutically acceptable carrier, it does not necessarily cease to be the claimed surface-active material, as the district court had erroneously found. The material defined in claim 1 may still be present when a pharmaceutical carrier is added to it. Thus, claim 1 does not limit its scope to a material when in dried form; it simply indicates the percentages of the compositions when measured in dried form.

Abbott also argued that the district court had erred in construing the phrase “based on the dry weight” as meaning that the weight of the lung surfactant extract material is measured before it is combined with a pharmaceutical carrier. The Federal Circuit disagreed, however, concluding that Abbott’s proposed construction impermissibly ignores certain claimed water percentages. The Court rejected extrinsic evidence as to how one skilled in the art might interpret this phrase, as it contradicted the claim language itself. Accordingly, the Court concluded, the expression “based on the dry weight” means based on the dry weight of the surface-active material before it is combined with a carrier and that this phrase does not negate the claim limitations to water.

Concerning infringement, the Court concluded that Abbott had failed to prove that the accused product meets all the claimed percentage requirements. Accordingly, the jury’s finding of infringement was not supported by substantial evidence, and therefore the JMOL was not in error. The Court rejected Abbott’s reference to ONY’s international patent application, which did describe certain water percentages, because that evidence was not with respect to the accused product.