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Eli Lilly & Co. v. Aradigm Corp.

United States Court of Appeals for the Federal Circuit

July 20, 2004, Decided

03-1336, 03-1337

Opinion

 [***1788]   [*1354]  CLEVENGER, Circuit Judge.

Eli Lilly and Company ("Lilly") sued Aradigm Corporation ("Aradigm") seeking, inter alia, to have two of its scientists recognized as joint inventors on Aradigm's U.S. Patent No. 5,888,477 ("the '477 patent"). Based on a jury verdict, the United  [*1355]  States District Court for the Southern District of Indiana entered final judgment in favor of Lilly insofar as it ordered the Patent and Trademark Office to add one of Lilly's scientists, Dr. DiMarchi, as an [**2]  inventor. Eli Lilly & Co. v. Aradigm Corp., No. IP 98-828-C-Y/F (S.D. Ind. Mar. 5, 2003). On the inventorship issue, Aradigm cross appeals and we reverse.

In the same district court proceedings, Lilly also sought to recover damages based on contract and unjust enrichment causes of action. The district court entered final judgment in favor of Aradigm on the unjust enrichment claim and in favor of Lilly on the contract claim, but it awarded only nominal contract damages to Lilly. Id. Lilly appeals the district court's judgment on these state law claims, and we affirm.

Lilly is a pharmaceutical company. In May 1996, U.S. Patent No. 5,514,646 ("the '646 patent") issued to Lilly. It claims among other inventions the insulin analog "lispro" (now commercially marketed by Lilly as Humalog (R)), and it lists Dr. DiMarchi as an inventor. Traditionally, regular, or natural, insulin is administered by subcutaneous injection, i.e., via a needle that deposits the insulin under the skin, to help diabetics regulate their blood glucose levels. When regular insulin molecules are in aqueous solution in the syringe, they self-associate into a stable hexamer, or six-molecule cluster. It [**3]  is believed that the approximately thirty-minute delay between the insulin's injection and the onset of its therapeutic effect can be traced to the time required for the hexamer delivered under the skin to disassociate into unclustered monomers and to diffuse away from the injection site and into the blood stream.

Lispro is a modified version of regular insulin. Like all proteins, insulin is a molecule made up of linear sequences of amino acids strung together in chains. Lispro is comprised of chains of amino acids identical to those in regular insulin except that two amino acids at one point in one of the chains are reversed in order. According to the '646 patent, this slight structural alteration makes lispro "less prone to . . . self-association" than regular insulin and endows lispro with "a comparatively more rapid onset of activity," while at the same time enabling lispro to "retain[] the biological activity of [regular] insulin." '646 patent, col. 1, ll. 17-20. In other words, "although [lispro] exists in solution as a  [***1789]  hexamer, it very rapidly disassociates into a virtually entirely monomeric form following subcutaneous administration . . . [permitting it to be] absorbed [**4]  quantitatively faster than [regular] insulin after subcutaneous administration." '477 patent, col. 12, ll. 14-19.

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376 F.3d 1352 *; 2004 U.S. App. LEXIS 15144 **; 71 U.S.P.Q.2D (BNA) 1787 ***

ELI LILLY AND COMPANY, Plaintiff-Appellant, v. ARADIGM CORPORATION, Defendant-Cross Appellant.

Prior History:  [**1]  Appealed from: United States District Court for the Southern District of Indiana. Judge Richard L. Young.

Disposition: Affirmed-in-part and reversed-in-part.

CORE TERMS

insulin, invention, patent, lispro, inventor, aerosolized, inventorship, district court, burden of proof, inhalation, subject matter, co-pending, regular, patent application, preponderance of evidence, clear and convincing evidence, argues, bioavailability, co-inventor, scientists, contributed, jury instructions, unjust enrichment, verdict form, paraphrase, monomeric, delivery, contest, lungs, communicated

Civil Procedure, Pleadings, Amendment of Pleadings, General Overview, Patent Law, Remedies, Declaratory Judgments, Originality, Correction of Inventorship Errors, Joinder of Inventors, US Patent & Trademark Office Proceedings, Examinations, Appeals, Reviewability of Lower Court Decisions, Adverse Determinations, Justiciability, Standing, Ownership, Conveyances, Joint & Sole Inventorship, Parties, Joinder of Parties, Misjoinder, Evidence, Burdens of Proof, Clear & Convincing Proof, Defenses, Inequitable Conduct, Jury Trials, Jury Instructions, Standards of Review, Infringement Actions, Claim Interpretation, Objections, Preservation for Review, Substantial Evidence, Trials, Judgment as Matter of Law, Criminal Law & Procedure, Burdens of Proof, Continuation Applications, Invention Date & Priority, Interference Proceedings, Patentability & Priority Determinations, Judgments, Relief From Judgments, Altering & Amending Judgments, Independent Actions, Newly Discovered Evidence, Abuse of Discretion, Business & Corporate Compliance, Contracts Law, Types of Contracts, Quasi Contracts