A U G U S T 2 0 0 4 Last The Federal Circuit month at Month at a Glance COURT READS SPECIFICATION AS FILING OF AN ANDA IS A “HIGHLY DISAVOWING CERTAIN LIPOPHILIC ARTIFICIAL” ACT OF INFRINGEMENT COMPONENT The mere filing of an ANDA cannot constitute Patent with lipophilic component not equiva- an act of willful infringement compensable by lently infringed by product whose only attorney’s fees under the Hatch-Waxman Act. lipophilic component was surfactant. Glaxo Group Ltd. v. Apotex, Inc. , No. 03-1575 Novartis Pharms. Corp. AG v. Abbott Labs. , (Fed. Cir. July 27, 2004) . . . . . . . . . . . . . . .6 No. 03-1367 (Fed. Cir. July 8, 2004) . . . . . .1 PAID WITNESSES LACK CREDIBILITY FOR § 271(f)(1) IS INAPPLICABLE TO PRODUCTS SUMMARY JUDGMENT OF INVALIDITY MANUFACTURED AND DISTRIBUTED Questions of fact and credibility concerning OUTSIDE THE U.S. witnesses surround determination concerning Section 271(f)(1) clearly refers to physical distribution of document at a German Trade supply of components, not simply to the sup- Show in 1986. TypeRight Keyboard Corp. v. ply of instructions or corporate oversight. Microsoft Corp. , No. 03-1197 (Fed. Cir. Pellegrini v. Analog Devices, Inc. , No. 04-1054 July 6, 2004) . . . . . . . . . . . . . . . . . . . . . . . .7 (Fed. Cir. July 8, 2004) . . . . . . . . . . . . . . . .2 SPECIFICATION CLARIFIES COMPETING Washington, DC NO BEST-MODE VIOLATION DICTIONARY DEFINITIONS OF CLAIM TERM 202.408.4000 Known ways of performing a known operation Throughout specification and in every drawing, cannot be deemed intentionally concealed patent teaches that “connecting” means Atlanta, GA absent evidence of intent to deliberately directly connecting. Searfoss v. Pioneer 404.653.6400 withhold that information. High Concrete Consol. Corp. , No. 03-1606 (Fed. Cir. July 6, Structures, Inc. v. New Enter. Stone & Lime Co., 2004) . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7 No. 03-1477 (Fed. Cir. July 29, 2004) . . . . .3 Cambridge, MA 617.452.1600 EVIDENCE SUPPORTING WALKER PROCESS LILLY SCIENTIST NOT AN INVENTOR OF CLAIM HAS NO “MEAT” ARADIGM PATENT Defendant failed to present any facts that Palo Alto, CA Court reverses a jury verdict finding that a could allow a reasonable jury to accept 650.849.6600 Lilly scientist was an inventor on an Aradigm either its proposed market definition or its patent for aerosolized administration of lispro. demonstration of antitrust immunity. Reston, VA Eli Lilly & Co. v. Aradigm Corp. , No. 03-1336 Unitherm Food Sys., Inc. v. Swift-Eckrich, Inc. , 571.203.2700 (Fed. Cir. July 20, 2004) . . . . . . . . . . . . . . .3 No. 03-1472 (Fed. Cir. July 12, 2004) . . . . .8 Brussels “CONTAINING” MEANS COMPRISING CASE REMANDED FOR THIRD TIME + 32 2 646 0353 Like the term “comprising,” the claim term Federal Circuit remands for third time, asking “containing” is open-ended. Therefore, claims the district court to develop factual record on broader than district court construed them. infringement issues. AFG Indus., Inc. v. Taipei + 886 2 2712 7001 Mars, Inc. v. H.J. Heinz Co., No. 03-1617 Cardinal IG Co., No. 03-1078 (Fed. Cir. (Fed. Cir. July 29, 2004) . . . . . . . . . . . . . . .5 July 13, 2004) . . . . . . . . . . . . . . . . . . . . . .10 Tokyo + 03 3431 6943 EDITED BY VINCE KOVALICK This publication brings you a synopsis of patent cases decided last month by the United States Court of Appeals for the Federal Circuit based on slip opinions received from the court. You can review and download the full text of each opinion by visiting our website at www.finnegan.com
L A S T M O N T H A T T H E F E D E R A L C I R C U I T Court Reads Specification as infringe claims of the ‘840 patent. The dis- trict court granted Abbott’s motion for a Disavowing Certain Lipophilic JMOL with respect to infringement of the Component ‘840 patent, noting that under its claim con- struction, the “lipophilic phase component” Sarah J. Chickos cannot be a surfactant. In construing the phrase “lipophilic com- [Judges: Prost (author), Gajarsa, and ponent,” the Federal Circuit noted that nei- Bryson (dissenting)] ther party had been able to demonstrate convincingly that the term “lipophilic com- In Novartis Pharmaceuticals Corp. AG v. ponent” had a well-defined meaning to those Abbott Laboratories , No. 03-1367 (Fed. Cir. of ordinary skill in the art. Novartis pointed July 8, 2004), the Federal Circuit reversed the to passages of the specification that indicate district court’s claim construction of the that a surfactant or a mixture of surfactants phrase “lipophilic component” but, nonethe- could form a part of the lipophilic phase that less, affirmed the district court’s JMOL for dissolves the cyclosporin, provided that this noninfringement. surfactant or mixture of surfactants was an Novartis Pharmaceuticals Corporation AG effective solvent for the cyclosporin. The (“Novartis”) is the assignee of two patents Federal Circuit agreed with Novartis that the page 01 directed to pharmaceutical compositions of district court had erred in concluding that a cyclosporin, U.S. Patent Nos. 5,342,625 (“the surfactant can form no part of the “lipophilic ‘625 patent”) and 6,007,840 (“the ‘840 component.” patent”). The two patents describe composi- Novartis further argued that surfactants tions that facilitate human absorption of the could constitute the whole of the lipophilic highly hydrophobic cyclosporin by use of a phase. The Federal Circuit did not agree microemulsion. Cyclosporin helps to prevent with Novartis on this point, however, and organ rejection in transplant patients. noted that the specification of the ‘840 Novartis sued Abbott Laboratories (“Abbott”) patent discloses that if a surfactant forms a for allegedly infringing these two patents part of the lipophilic phase, it does so as a co- with its product Gengraf, a cyclosporin for- solvent . The Federal Circuit consulted a dic- mulation. tionary in defining “co-solvent” as a solvent The district court construed the phrase that can dissolve a solute in conjunction with “lipophilic phase component” to require at another solvent and defining “part” as some- least one excipient that (1) is a pharmaceuti- thing less than whole. cally acceptable solvent in which cyclosporin The Federal Circuit further noted the is soluble, (2) is immiscible with both water specification’s teaching that in the lipophilic and the hydrophilic-phase components phase, if mixtures of surfactants were used as (without a surfactant), and (3) is not a surfac- solvents to dissolve the cyclosporin, the other tant. Although they did not agree on the solvent could not be another surfactant. meaning of the phrases, both parties agreed Rather, the other solvent had to be a phar- that “lipophilic phase component” means the maceutically acceptable nonsurfactant same thing as “lipophilic component.” lipophilic excipient capable of dissolving The parties disputed whether Gengraf cyclosporin. The Federal Circuit concluded contains a “lipophilic phase component.” that the “lipophilic component” can contain Abbott asserted that Gengraf contains only a surfactant but cannot be composed entirely hydrophilic excipients and surfactants. The of surfactants. Furthermore, the “lipophilic jury returned a verdict that Abbott did not component” must contain, at a minimum, a infringe claims of the ‘625 patent but did L L P . F I N N E G A N H E N D E R S O N F A R A B O W G A R R E T T D U N N E R
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