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Eli Lilly and Co. v. Elizabeth

December 29, 2009

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.



The opinion of the court was delivered by: Dennis M. Cavanaugh, U.S.D.J.

Hon. Dennis M. Cavanaugh

OPINION

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(r) 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(r) 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 (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. 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 (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).*fn1

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 "[e]ach 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, fail[ed] to disclose material information or submit[ed] 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, "[i]nformation 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 "[i]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 mislead the PTO by deceptively drafting the '590 Patent's specification.*fn2

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 "[a]tomoxetine is a highly selective and specific norepinephrine inhibitor, which is not suggested by the numerous activities of the prior art tricyclics."

Plaintiff disputes the materiality of the reference. Plaintiff argues that the reference is irrelevant because tandamine was used to treat depression, not ADHD. As such, Plaintiff asserts that the reference was not related to the patentability of the claimed method. Plaintiff also argues that, even if relevant, the study is "less relevant" than other references, and is therefore cumulative and not material. Specifically, Plaintiff suggests that the reference "would have been far less relevant to the '590 patent Examiner than information regarding other [tricyclic compounds] that had actually been used to treat ADHA, such as desipramine."

Regarding the requisite intent to deceive the examiner, Defendants assert that Plaintiff knew of the Tandamine Reference, as it appeared in a search report conducted by the European Patent Office during the prosecution of another Eli Lilly patent application. Defendants also note that the reference was disclosed in other patent applications, including the '590 Patent's corresponding Canadian application. Defendants assert, then, that Plaintiff had a policy of disclosure that was deviated from in the prosecution of '590 Patent. Under these circumstances, Defendants argue that intent to deceive can be inferred.

Plaintiff, in response, argues that disclosure of the reference to the Canadian Patent office does not show an intent to deceive the U.S. examiner. Plaintiff asserts that it only disclosed the document because the Canadian office specifically requested it (and, absent such a request, it would not have found disclosure necessary). Further, when submitting the Tandamine Reference to the European Patent office, Plaintiff explained that it did not believe that the study was material. Plaintiff contends that this fact establishes its lack of deceptive intent in failing to disclose the reference.

The Court does not find summary judgment to be appropriate here. First, the fact that the Tandamine Reference might not have rendered the patent obvious does not necessarily mean that the reference is irrelevant. A reference does not have to be potentially dispositive as to the patentability of a patent claim in order to be material for the purposes of inequitable conduct. Larson Mfg. Co. of S.D. v. Aluminart Prods., 559 F.3d 1317, 1327 (Fed. Cir. 2009) (citing Li Second Family Ltd. v. Toshiba Corp., 231 F.3d 1373, 1380 (Fed. Cir. 2000)). Even if the Tandamine Reference would not invalidate the patent for obviousness, it may have been relevant to a reasonable examiner, as it appears to have information potentially contradictory to Plaintiff's representations to the PTO.

Furthermore, at this stage this Court cannot find the reference to be cumulative. Simply because other materials provided to the examiner might have been more specific to the condition being treated by the claimed method (ADHD), it does not necessarily follow that references relating to depression are immaterial. See Regents of the Univ. of Cal. v. Eli Lilly & Co., 119 F.3d 1559, 1575 (Fed. Cir. 1997) ("What is relevant is whether [the withheld material] discloses subject matter relevant to the examination of the . . . patent application that is not taught by the [material already before the PTO]."). The Tandamine Reference's teachings, therefore, such as those related to the selectivity of tandamine (a tricyclic antidepressant), may provide information that was not already before the examiner.*fn3

A material question of fact similarly remains regarding Plaintiff's intent to deceive the examiner. Plaintiff's proffered explanation for its non-disclosure of the Tandamine Reference is partial at best. Plaintiff explains why it disclosed the reference to the Canadian Patent Office. It does not, however, explain why it disclosed the reference to the USPTO during other prosecutions, while not disclosing the study to the '590 Patent examiner. Viewing the facts in the light most favorable to the Defendants, a finder of fact could infer an intent to deceive the PTO by failing to disclose the Tandamine Reference. The Court will not resolve the issue of intent on summary judgment. See KangaROOS U.S.A., Inc. v. Caldor, Inc., 778 F.2d 1571, 1577 (Fed. Cir. 1985) (concluding that "intent to deceive or mislead is a genuine issue of material fact"; noting that "state of mind inquiries are rarely appropriate" at the summary judgment stage).

There are questions of fact as to the materiality of Tandamine Reference, and Plaintiff's intentions in failing to disclose the reference. Plaintiff's motion for summary judgment of no inequitable conduct as to the Tandamine Reference is denied.

2. The Patent Board of Appeals and Interferences

Opinion Defendants assert that Plaintiff committed inequitable conduct by failing to disclose a relevant Board of Patent Appeals and Interferences ("BPAI") decision that was issued during the prosecution of another patent ("the '985 Patent").

The '985 Patent pertains to a method of treating incontinence with tomoxetine. During the '985 prosecution, the examiner initially rejected the claims, reasoning that "tomoxetine was known in the prior art to inhibit norepinephrine uptake" and "the inhibition of norepinephrine uptake (by tricyclic antidepressants) was known in the prior art to control incontinence." Similarly, here, in the prosecution of the '590 Patent, the examiner initially rejected Plaintiff's claims because "tomoxetine was known in the prior art to inhibit norepinephrine uptake" and "the inhibition of norepinephrine uptake (by tricyclic antidepressants) was known in the prior art to treat ADHD." Defendants assert that the two patents' claims were substantially similar, and therefore a rejection by the '985 examiner would be material to the '590 examiner. Defendants' expert, Dr. John T. Goolkasian, asserted that the examiner would have considered the adverse BPAI decision to be material.*fn4

Plaintiff denies that the BPAI decision was material, and relies on the testimony of Dr. Craig W. Berridge and Dr. Floyd R. Sallee--Defendants' experts. Plaintiff asserts that, in light of the experts' testimony, the reference would not have been considered prior art for the purposes of determining the patentability of the claimed method. Further, Plaintiff argues that Dr. Goolkasian is not qualified to render an opinion on materiality, as he is not a person of ordinary skill in the art. Accordingly, Plaintiff argues, there is no conflict in testimony, and no genuine issue of material fact.

The Court cannot grant Plaintiff's motion for summary judgment of no inequitable conduct as to the non-disclosure of the '985 Patent's adverse BPAI decision. The testimony of Dr. Goolkasian regarding the materiality of the BPAI decision creates a material issue of fact. See Nisus Corp. v. Perma-Chink Sys., 2005 U.S. Dist. LEXIS 41068, at *16 (E.D. Tenn. May 27, 2005) (noting that the "test for materiality involves whether a reasonable examiner would consider the withheld information material," and therefore, a former patent examiner may appropriately offer an opinion on the issue of materiality); Oasis Industries, Inc. v. G.K.L. Corp., 1996 U.S. Dist. LEXIS 1057, at *33 (N.D. Ill. Feb. 2, 1996) (finding three former PTO examiners with experience in examining design patents were qualified to testify regarding a reasonable examiner's opinion on materiality).*fn5

Dr. Goolkasian has extensive experience working at the PTO as an examiner, and in prosecuting pharmaceutical patents. Further, he has relevant academic training at the undergraduate and graduate levels. Dr. Goolkasian is sufficiently qualified to offer his opinion as to the materiality of the BPAI decision for the purposes of the Court's inequitable conduct analysis.*fn6

As there is conflicting expert testimony as to the materiality of the BPAI opinion, summary judgment is inappropriate. See Metro. Life Ins. Co. v. Bancorp Servs., L.L.C., 527 F.3d 1330, 1338-39 (Fed. Cir. 2008) (holding the "conflict in [expert] declarations created a genuine issue of material fact that made summary judgment inappropriate"); In re Gabapentin Patent Litig., 2005 U.S. Dist. LEXIS 37654, at *13 (D.N.J. Aug. 25, 2005).

Plaintiff's motion for summary judgment of no inequitable conduct is denied as to its non-disclosure of the BPAI opinion.

3. The Fuller and Wong Paper

Defendants assert that a paper titled Effects of Antidepressants on Uptake and Receptor Systems in the Brain by Fuller and Wong ("FULLER AND WONG") contradicts statements Plaintiff made to the examiner in obtaining the '590 Patent. Accordingly, Defendants argue that nondisclosure of the article constitutes inequitable conduct.

The FULLER AND WONG article contains a number of statements regarding the pharmacological effect of desipramine and other tricyclic antidepressants. Based on these statements, Defendants assert that the effects of desipramine are substantially similar to atomoxetine, and Plaintiff's attempt to distinguish the two compounds (to prevent the patent application from being denied as obvious) was disingenuous. Defendants, then, contend that the article was not disclosed in an effort to deceive the patent examiner. Defendants cite to two statements, in particular, that they believe contradict Plaintiff's arguments before the examiner. The statements are: "Compounds that inhibit norepinephrine reuptake but not dopamine or serotonin uptake include desipramine, protriptyline, maprotiline, nisoxetine and tomoxetine"; and, "There seems to remain a reasonable basis for expecting that monoamine uptake inhibition is a primary action of some antidepressant drugs that is relevant to their therapeutic use." Defendants assert that these statements evidence the similarities between desipramine and tomoxetine--similarities that Plaintiff tried to downplay in order to obtain its patent. Moreover, Defendants argue that even if teachings similar to those contained in FULLER AND WONG were disclosed in references before the examiner, they are presented in a more straightforward manner in this reference.

Plaintiff responds that the information contained in FULLER AND WONG is cumulative of material already before the examiner, and is thus not material. See Elk Corp. v. GAF Bldg. Materials Corp., 168 F.3d 28, 31 (Fed. Cir. 1999). Plaintiff argues that it provided statements to the examiner that were substantially similar to the statements Defendants cite, for instance: "Tomoxetine and the tricyclic antidepressants share the ability to inhibit the reuptake of the neurotransmitter norepinephrine"; "[T]omoxetine, imipramine, and desipramine selectively inhibited the depletion of norepinephrine"; "[Desipramine] has relatively high selectivity against neuronal uptake of norepinephrine"; and, "Duloxetine resembles . . . tomoxetine, desipramine . . . in antagonizing the depletion of cortical norepinephrine but not the depletion of striatal dopamine." Plaintiff argues that these teachings are akin to those of FULLER AND WONG, and therefore render the reference cumulative.

The Court agrees with Plaintiff. The above-excepted quotations illustrate that teachings substantially similar to those in FULLER AND WONG were before the examiner. Defendant Sun's expert, Dr. Sallee, confirms this conclusion. In his report, he opined that "[b]oth desipramine and tomoxetine are characterized in the literature as selective inhibitors of norepinephrine uptake." To support this opinion, Dr. Sallee cited BOLDEN WATSON 1993, WONG ET AL. 1982, and FULLER AND WONG 1985, among other sources. This indicates that he read the three cited references to stand for the same proposition. Defendants cannot now claim that the absence of one of these articles was a non-cumulative, material reference.

To the extent that Defendants suggest that the teachings were presented in a more straightforward way in FULLER AND WONG, that is inapposite. See Regents of the Univ. of Cal., 119 F.3d as 1575. To determine whether a reference is material to an examiner, "[w]hat is relevant is whether [a reference] discloses subject matter relevant to the examination of the . . . patent application that is not taught by the [references before the examiner]."*fn7 Here, the ...


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