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Court Reads Specification as Disavowing Certain Lipophilic Component

July 08, 2004

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Last Month at the Federal Circuit - August 2004

Judges: Prost (author), Gajarsa, and Bryson (dissenting)

In Novartis Pharmaceuticals Corp. AG v. Abbott Laboratories, No. 03-1367 (Fed. Cir. July 8, 2004), the Federal Circuit reversed the district court’s claim construction of the phrase “lipophilic component” but, nonetheless, affirmed the district court’s JMOL for noninfringement.

Novartis Pharmaceuticals Corporation AG (“Novartis”) is the assignee of two patents directed to pharmaceutical compositions of cyclosporin, U.S. Patent Nos. 5,342,625 (“the ‘625 patent”)and 6,007,840 (“the ‘840 patent”). The two patents describe compositions that facilitate human absorption of the highly hydrophobic cyclosporin by use of a microemulsion. Cyclosporin helps to prevent organ rejection in transplant patients. Novartis sued Abbott Laboratories (“Abbott”) for allegedly infringing these two patents with its product Gengraf, a cyclosporin formulation.

The district court construed the phrase “lipophilic phase component” to require at least one excipient that (1) is a pharmaceutically acceptable solvent in which cyclosporin is soluble, (2) is immiscible with both water and the hydrophilic-phase components (without a surfactant), and (3) is not a surfactant. Although they did not agree on the meaning of the phrases, both parties agreed that “lipophilic phase component” means the same thing as “lipophilic component.”

The parties disputed whether Gengraf contains a “lipophilic phase component.” Abbott asserted that Gengraf contains only hydrophilic excipients and surfactants. The jury returned a verdict that Abbott did not infringe claims of the ‘625 patent but did infringe claims of the ‘840 patent. The district court granted Abbott’s motion for a JMOL with respect to infringement of the ‘840 patent, noting that under its claim construction, the “lipophilic phase component” cannot be a surfactant.

In construing the phrase “lipophilic component,” the Federal Circuit noted that neither party had been able to demonstrate convincingly that the term “lipophilic component” had a well-defined meaning to those of ordinary skill in the art. Novartis pointed to passages of the specification that indicate that a surfactant or a mixture of surfactants could form a part of the lipophilic phase that dissolves the cyclosporin, provided that this surfactant or mixture of surfactants was an effective solvent for the cyclosporin. The Federal Circuit agreed with Novartis that the district court had erred in concluding that a surfactant can form no part of the “lipophilic component.”

Novartis further argued that surfactants could constitute the whole of the lipophilic phase. The Federal Circuit did not agree with Novartis on this point, however, and noted that the specification of the ‘840 patent discloses that if a surfactant forms a part of the lipophilic phase, it does so as a cosolvent. The Federal Circuit consulted a dictionary in defining “co-solvent” as a solvent that can dissolve a solute in conjunction with another solvent and defining “part” as something less than whole.

The Federal Circuit further noted the specification’s teaching that in the lipophilic phase, if mixtures of surfactants were used as solvents to dissolve the cyclosporin, the other solvent could not be another surfactant. Rather, the other solvent had to be a pharmaceutically acceptable nonsurfactant lipophilic excipient capable of dissolving cyclosporin. The Federal Circuit concluded that the “lipophilic component” can contain a surfactant but cannot be composed entirely of surfactants. Furthermore, the “lipophilic component” must contain, at a minimum, a nonsurfactant excipient that is a pharmaceutically acceptable lipophilic substance capable of dissolving cyclosporin.

Novartis also disagreed with the district court’s requirement that the “lipophilic phase component” must be immiscible with the hydrophilic phase in the absence of surfactants. The Federal Circuit agreed with Novartis and concluded that the specification, contrary to the district court’s reading, does not teach that the entire lipophilic phase must be immiscible with the hydrophilic phase, but rather only components, i.e., parts, of the phase should be immiscible.

Having determined that the district court had incorrectly construed the phrase “lipophilic component,” the Federal Circuit turned to the issue of whether the district court had erred in granting the JMOL of noninfringement of the ‘840 patent. The district court, having construed “lipophilic component” to exclude surfactants, found that the specific exclusion principle precluded it, as a matter of law, from treating the surfactant as an element forming the lipophilic component. Therefore, no compound existed in Gengraf that corresponded to the lipophilic component, so the all-elements rule compelled the district court to find that no reasonable fact-finder could find infringement under the DOE.

On appeal, Novartis argued that Abbott equivalently infringed because one of the surfactants in Gengraf, Span 80, was equivalent to the nonsurfactant excipient required by the “lipophilic component.” The Federal Circuit rejected Novartis’s theory of infringement by equivalence as contrary to the proper construction of the term “lipophilic component” because the theory required that “lipophilic component” include a chemical composition composed entirely of surfactants.

The Federal Circuit found no basis to reverse the JMOL for noninfringement of the ‘840 patent because Novartis could not provide evidence that would allow a reasonable juror to conclude that there is a “lipophilic component,” as properly construed, in Gengraf. Accordingly, the Federal Circuit, finding no error in the district court’s grant of the JMOL, reversed the district court’s claim construction and affirmed the grant of the JMOL for noninfringement of the ‘840 patent.