Eli Lilly and Co. v. Actavis Elizabeth LLC

• Citation: 676 F. Supp.2d 352
• Decision Date: 31 December 2009
• Docket Number: Civil Action No. 07-cv-3770 (DMC).
• Parties: ELI LILLY AND COMPANY, Plaintiff, v. ACTAVIS ELIZABETH LLC, Glenmark Pharmaceuticals Inc., Sun Pharmaceutical Industries Ltd., Sandoz Inc., Mylan Pharmaceuticals Inc., Apotex Inc., Aurobindo Pharma Ltd., Teva Pharmaceuticals USA, Inc., Synthon Laboratories, Inc., Zydus Pharmaceuticals, USA, Inc., Defendants.
• Court: U.S. District Court — District of New Jersey

676 F.Supp.2d 352

ELI LILLY AND COMPANY, Plaintiff, v. ACTAVIS ELIZABETH LLC, Glenmark Pharmaceuticals Inc., Sun Pharmaceutical Industries Ltd., Sandoz Inc., Mylan Pharmaceuticals Inc., Apotex Inc., Aurobindo Pharma Ltd., Teva Pharmaceuticals USA, Inc., Synthon Laboratories, Inc., Zydus Pharmaceuticals, USA, Inc., Defendants.

Civil Action No. 07-cv-3770 (DMC).

United States District Court, D. New Jersey.

December 31, 2009.

John F. Brenner, Melissa Anne Chuderewicz, Pepper Hamilton, LLP, Princeton, NJ, for Plaintiff.

Gregory D. Miller, Podvey, Meanor, Catenacci, Hildner, Cocoziello & Chattman PC, James S. Richter, Melissa Steedle Bogad, Winston & Strawn, LLP, Mayra Velez Tarantino, Michael E. Patunas, Lite, DePalma, Greenberg & Rivas, LLC, Arnold B. Calmann, Katherine Ann Escanlar, Saiber LLC, Newark, NJ, James E. Cecchi, Melissa E. Flax, Carella Byrne Bain Gilfillan Cecchi Stewart & Olstein, PC, Roseland, NJ, Brian Jeffrey Robinson, Steven J. Lee, Kenyon & Kenyon, Victoria Elizabeth Ford, Alston & Bird, LLP, Joseph Nicholas Froehlich, Locke, Lord, Bissell & Liddell, LLP, New York, NY, Eric I. Abraham, Hill Wallack, LLP, Princeton, NJ, for Defendants.

AMENDED OPINION

DENNIS M. CAVANAUGH, District Judge:

This matter comes before the Court upon motions for summary judgment by Eli Lilly & Co. ("Plaintiff"), and by Defendants Actavis Elizabeth LLC, Apotex Inc., Aurobindo, Sun Pharmaceuticals, Teva Pharmaceuticals, Sandoz Inc., and Mylan Pharmaceuticals Inc. ("Defendants"). This case concerns the validity and alleged infringement of U.S. Patent No. 5,658,590 ("the '590 Patent").

BACKGROUND

Strattera® is the commercial name for the drug tomoxetine, which is now known as atomoxetine. The '590 Patent is a method-of-use patent which claims methods of treating Attention Deficit/Hyperactivity Disorder ("ADHD") with atomoxetine. Claim 1 of the patent covers: A method of treating attention-deficit/hyperactivity disorder comprising administering to a patient in need of such treatment an effective amount of tomoxetine. Claims 2-16 cover specific treatment plans for subtypes of ADHD, and for certain groups of patients.

Plaintiff alleges that Defendants infringed the '590 Patent when they filed Abbreviated New Drug Applications ("ANDA") with the United States Food and Drug Administration ("FDA") seeking approval to market a generic version of Plaintiff's Strattera® drug products. Defendants notified Plaintiff in separate notice letters that they intended to sell generic atomoxetine capsules. In these letters, Defendants alleged that the '590 Patent was invalid, unenforceable or would not be infringed by the sale of generic atomoxetine capsules.

Plaintiff brings this action for infringement of the '590 Patent against all Defendants. Defendants respond that Plaintiff's patent is unenforceable and/or invalid based upon: inequitable conduct before the United States Patent and Trademark Office ("PTO"); anticipation; lack of enablement/utility; obviousness. Alternatively, Defendants assert that, if the '590 Patent is enforceable, they have not infringed upon the patent's claims.

STANDARD OF REVIEW

Summary judgment is granted only if all probative materials of record, viewed with all inferences in favor of the non-moving party, demonstrate that there is no genuine issue of material fact and that the movant is entitled to judgment as a matter of law. FED.R.CIV.P. 56(c); Celotex Corp. v. Catrett, 477 U.S. 317, 330, 106 S.Ct. 2548, 91 L.Ed.2d 265 (1986). The moving party bears the burden of showing either (1) there is no genuine issue of fact and it must prevail as a matter of law; or (2) that the non-moving party has not shown facts relating to an essential element of the issue for which he bears the burden. Celotex, 477 U.S. at 331, 106 S.Ct. 2548. If either showing is made then the burden shifts to the non-moving party, who must demonstrate facts that support each element for which he bears the burden and must establish the existence of genuine issues of material fact. Id. The non-moving party "may not rest upon the mere allegations or denials of his pleading" to satisfy this burden, FED.R.CIV.P. 56(e), but must produce sufficient evidence to support a jury verdict in his favor. Matsushita Elec. Indus. Co. v. Zenith Radio Corp., 475 U.S. 574, 106 S.Ct. 1348, 89 L.Ed.2d 538 (1986). The Court will consider all facts and their reasonable inferences in the light most favorable to the non-moving party. See Penn. Coal Ass'n v. Babbitt, 63 F.3d 231, 236 (3d Cir.1995).

DISCUSSION

The parties move for summary judgment on a number of grounds. Plaintiff moves for summary judgment asking this Court to find that there was no inequitable conduct before the PTO (Section I), and that the '590 Patent is not invalid based on anticipation (Sec. II). Defendants move for summary judgment asking that the '590 Patent be deemed invalid based upon lack of enablement/utility (Sec. III), and for obviousness (Sec. IV). Plaintiff and Defendants both move for summary judgment on the issue of infringement, and the Court will consider the parties' motions together (Sec. V).¹

I. PLAINTIFF'S MOTION FOR SUMMARY JUDGMENT AS TO NO INEQUITABLE CONDUCT

Defendants assert that the '590 Patent is unenforceable because Plaintiff (i.e., patent applicants) committed inequitable conduct during the prosecution of the patent. Plaintiff denies inequitable conduct, and moves for summary judgment on this issue. For the reasons stated below, Plaintiff's motion is granted in part and denied in part.

A. Applicable Law

It is well settled that "each individual associated with the filing and prosecution of a patent application has a duty of candor and good faith in dealing with the Patent Office, which includes a duty to disclose to the Office all information known to that individual to be material to patentability." McKesson Info. Solutions, Inc. v. Bridge Medical, Inc., 487 F.3d 897, 913 (Fed.Cir.2007). A breach of this duty constitutes inequitable conduct, which subjects any resulting patent to nullification. To establish inequitable conduct, a party must show that the patent applicant, "with intent to mislead or deceive the examiner, failed to disclose material information or submited material false information to the PTO during prosecution." Id. Inequitable conduct, therefore, has two elements—materiality and intent.

Information is material "when a reasonable examiner would consider it important in deciding whether to allow the application to issue as a patent." Symantec Corp. v. Computer Assocs. Int'l, Inc., 522 F.3d 1279, 1297 (Fed.Cir.2008). However, "information concealed from the PTO may be material even though it would not invalidate the patent." Li Second Family Ltd. v. Toshiba Corp., 231 F.3d 1373, 1380 (Fed.Cir.2000). An otherwise material reference is not material if it is merely cumulative to, or less relevant than, information already considered by the examiner. See Pro-Mold & Tool Co. v. Great Lakes Plastics, Inc., 75 F.3d 1568, 1577 (Fed.Cir.1996); FMC Corp. v. Manitowoc Co., 835 F.2d 1411, 1415 (Fed.Cir. 1987).

To determine whether there is intent to deceive the examiner, courts look at all the facts surrounding an applicant's overall conduct to infer culpability because "intent rarely can be, and need not be, proven by direct evidence." Cargill, Inc. v. Canbra Foods, Ltd., 476 F.3d 1359, 1364 (Fed. Cir.2007). More than an omission of material information is necessary, "clear and convincing evidence of conduct sufficient to support an inference of culpable intent is required." Northern Telecom, Inc. v. Datapoint Corp., 908 F.2d 931, 939 (Fed.Cir. 1990).

Materiality and intent are separate elements of inequitable conduct, and must each be proven by clear and convincing evidence for a patent to be rendered unenforceable. Id. Nonetheless, the showing of intent can be proportionally less when balanced against high materiality. N.V. Akzo v. E.I. DuPont de Nemours, 810 F.2d 1148, 1153 (Fed.Cir.1987). Similarly, the showing of intent must be proportionally greater when balanced against low materiality. Id.

B. Analysis

Defendants' claim of inequitable conduct is premised upon Plaintiff's failure to disclose certain documents and information during prosecution of the '590 Patent, as well as allegedly making a misrepresentation to the PTO. Specifically, Defendants allege that Plaintiff improperly failed to disclose (1) a prior art reference concerning the compound tandamine, (2) a Patent Office Board of Appeals opinion, (3) a prior art paper titled "Effects of Antidepressants on Uptake and Receptor Systems in the Brain," and (4) contradictory statements Plaintiff made to the FDA in seeking approval to market atomoxetine; Defendants also contend that (5) Plaintiff intentionally misled the PTO by deceptively drafting the '590 Patent's specification.²

This Court will discuss the materiality and intent elements of inequitable conduct with respect to each alleged act of inequitable conduct.

1. The Tandamine Reference

Defendants assert that Plaintiff improperly failed to disclose material prior art. The first reference allegedly withheld was a paper reporting the results of a depression study in 1977 concerning the drug tandamine, a tricyclic antidepressant ("the Tandamine Reference").

Defendants argue that the Tandamine Reference was material because it teaches that tandamine was a tricyclic "norepinephrine reuptake inhibitor like atomoxetine with practically no serotonin potentiation, MAO inhibition and anticholinergic activity." Thus, Defendants argue, the study reveals that tandamine shared the characteristic of selectivity with atomoxetine, the compound utilized in the '590 Patent. Defendants argue that the reference refutes Plaintiff's statements during prosecution that "atomoxetine is a highly selective and specific norepinephrine inhibitor, which is not suggested by the numerous activities of the prior art tricyclics."

Plaintiff disputes the...