Eli Lilly and Company v. Aradigm Corporation, Defendant-Cross

376 F.3d 1352, 71 U.S.P.Q. 2d (BNA) 1787, 2004 U.S. App. LEXIS 15144, 2004 WL 1609112
CourtCourt of Appeals for the Federal Circuit
DecidedJuly 20, 2004
Docket03-1336, 03-1337
StatusPublished
Cited by202 cases

This text of 376 F.3d 1352 (Eli Lilly and Company v. Aradigm Corporation, Defendant-Cross) is published on Counsel Stack Legal Research, covering Court of Appeals for the Federal Circuit primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Eli Lilly and Company v. Aradigm Corporation, Defendant-Cross, 376 F.3d 1352, 71 U.S.P.Q. 2d (BNA) 1787, 2004 U.S. App. LEXIS 15144, 2004 WL 1609112 (Fed. Cir. 2004).

Opinions

Opinion for the court filed by Circuit Judge CLEVENGER. Concurring opinion filed by Circuit Judge LOURIE.

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]*1355States 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 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.

I

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®), 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 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 unclus-tered 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, 11. 17-20. In other words, “[a]lthough [lispro] exists in solution as a hexamer, it very rapidly disassociates into a virtually entirely monomeric form following subcutaneous administration ... [permitting it to be] absorbed quantitatively faster than [regular] insulin after subcutaneous administration.” '477 patent, col. 12,11.14-19.

Aradigm’s business focuses on drug delivery through the inhalation of aerosols. In January 1997, a number of Aradigm scientists filed a patent application that, in March 1999, issued as the '477 patent. Titled “Use of Monomeric Insulin as a Means for Improving the Bioavailability of Inhaled Insulin,” Aradigm’s '477 patent claims methods of aerosolized administration of lispro, among other monomeric insulin analogs, in which the lispro “quickly enters the circulatory system after being inhaled into the lung.” Id. at col. 3,11. 9-10. One difficulty with administering regular insulin in aerosolized form is believed to be that inhaled insulin “is sequestered in the lung to a significant degree” and therefore does not rapidly or predictably enter the bloodstream where insulin must be located to have its therapeutic effect. Id. at col. 13, 1. 8. When filing the '477 patent, Aradigm believed that inhalation of lispro instead of regular insulin would reduce the tendency of insulin to remain in [1356]*1356the lungs because, “as with subcutaneous delivery, the disassociation of insulin from hexameric to monomeric form is an important first step prior to the absorption of insulin into the blood stream,” and because lispro dissociates more rapidly than regular insulin does. Id. at col. 13, 11. 15-18.

As relevant to this appeal, the '477 patent contains the following method claims:

5. A method of improving the bioa-vailability of insulin delivered via the lung, comprising:
aerosolizing a formulation of an insulin analog which analog rapidly disassociates into monomeric form; inhaling the aerosolized formulation of the insulin analog into the lungs in a manner which allows the particles of the insulin analog to deposit on the lung tissue.
6. The method of claim 5, wherein the inhaled insulin analog is insulin lis-pro which rapidly disassociates in a monomeric form producing a relative bioa-vailability greater than twice that seen after the inhalation of a similar amount of recombinant human insulin.
15. A method of reproducibly effecting a serum glucose level, comprising: aerosolizing a formulation comprising monomeric insulin;
administering the aerosolized formulation.
17. The method of claim 15, wherein the monomeric insulin is insulin lispro.

Id. at col. 49, 1. 65 to col. 50, 1. 10; col. 50, 11. 38-42, 48-49.

II

All of Lilly’s allegations reduce to a single alleged wrong: that Aradigm improperly appropriated information about the advantages of pulmonary delivery of lispro from Lilly and incorrectly claimed the invention in the '477 patent as exclusively its own. In 1995 and 1996, Lilly and Aradigm held four meetings to discuss a possible collaboration that would take advantage of Lilly’s expertise in insulin compounds and Aradigm’s expertise in aerosolized drug delivery. Several scientists from Lilly were involved in the four meetings with Aradigm scientists: In June and November of 1995, Dr. Harrison from Lilly attended; in June 1996, Dr. Roeder from Lilly attended; and in July 1996, Drs. DiMarchi and Wolff from Lilly, among others, attended. Lilly insists that its scientists conveyed to Aradigm during these meetings the specific advantages to be expected from using lispro instead of regular insulin in an aerosol delivery device.

In the district court, Lilly brought a claim under 35 U.S.C. § 256 to address the alleged omission of Drs. Harrison and DiMarchi from the list of inventors on the '477 patent,1 arguing to the jury that both [1357]*1357were joint inventors of the inventions in dependent claims 6 and 17. The verdict form instructed the jury to answer whether or not Lilly had proved by clear and convincing evidence that either Dr. Harrison or Dr.

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376 F.3d 1352, 71 U.S.P.Q. 2d (BNA) 1787, 2004 U.S. App. LEXIS 15144, 2004 WL 1609112, Counsel Stack Legal Research, https://law.counselstack.com/opinion/eli-lilly-and-company-v-aradigm-corporation-defendant-cross-cafc-2004.