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Novartis Corp. v. Teva Pharmaceuticals USA

July 16, 2008

NOVARTIS CORPORATION; NOVARTIS PHARMACEUTICALS CORPORATION; AND NOVARTIS INTERNATIONAL AG, PLAINTIFFS,
v.
TEVA PHARMACEUTICALS USA, INC. DEFENDANT.
NOVARTIS CORPORATION; NOVARTIS PHARMACEUTICALS CORPORATION; AND NOVARTIS INTERNATIONAL AG, PLAINTIFFS,
v.
WATSON LABORATORIES, INC. AND WATSON PHARMACEUTICALS, INC., DEFENDANTS.



The opinion of the court was delivered by: Harold A. Ackerman, U.S.D.J.

FOR PUBLICATION

OPINION and ORDER

This suit relates to Teva's*fn1 marketing of generic versions of Novartis's*fn2 product Lotrel(r), a prescription drug medication for the treatment of hypertension*fn3 that is covered by Novartis's U.S. Patent No. 6,162,802 ("the '802 patent").*fn4 With discovery completed, the Court must now determine the meanings of various disputed claims contained in the contested patent in accordance with the instruction of Markman v. Westview Instruments, Inc., 52 F.3d 967, 976-79(Fed. Cir. 1995) (en banc), aff'd, 517 U.S. 370 (1996). The Court held a hearing for this purpose on June 26, 2008, and has carefully considered all of the parties' written and oral arguments. In the Opinion that follows, the Court sets forth its construction of the patent claims in dispute.

I. INTRODUCTION

A. Factual Background and Procedural History

The '802 patent, entitled "Synergistic Combination Therapy Using Benazepril and Amlodipine for the Treatment of Cardiovascular Disorders and Compositions Therefor," was filed on March 10, 1992. On December 19, 2000, after more than eight years of prosecution, the United States Patent and Trademark Office ("PTO") issued the '802 patent to Ciba-Geigy Corp., a predecessor of Novartis, as assignee of inventors Joseph Papa and Marc M.J. Henis. Generally, the '802 patent claims methods for the treatment of cardiovascular disorders, including hypertension, and pharmaceutical compositions combining two different anti-hypertensive agents, amlodipine and benazepril.

On March 3, 1995, Novartis received approval from the FDA to market Lotrel in six dosage strengths: 2.5/10 mg (amlodipine besylate/benazepril hydrochloride), 5/10 mg, 5/20 mg, 10/20 mg, 5/40 mg, and 10/40 mg. Lotrel is approved for the treatment of hypertension and has been marketed in the United States since its approval. In accordance with 21 U.S.C. § 355(b)(1), Novartis filed with the FDA the patent numbers and expiration dates for each patent covering Lotrel. The FDA publishes this information in a list of innovator drug products and their related patent information called Approved Drug Products with Therapeutic Equivalence Evaluations, commonly referred to as the "Orange Book."

21 U.S.C. § 355(j)(7)(A). The Orange Book listed four patents for Lotrel; however, the '802 patent represents the only remaining unexpired patent, and the only patent-at-issue in this matter.*fn5

On June 8, 2004, Teva filed an Abbreviated New Drug Application ("ANDA"), No. 77-179, pursuant to the Federal Food, Drug, and Cosmetic Act ("FFDCA"), 21 U.S.C. § 355(j), to market generic equivalents of four of Novartis's Lotrel drug products before the expiration of the '802 patent.*fn6

(Pl. Br. at 2.) Pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV), i.e., in a "Paragraph IV Certification," Teva certified in its ANDA that "to the best of its knowledge" its drug formulations would not infringe the '802 patent or that the '802 patent is invalid and unenforceable.*fn7 As required by statute, Teva served Novartis on or about August 6, 2004 with a notice of its position and intent to seek approval from the FDA. 35 U.S.C. § 355(j)(5)(B)(i); Mylan Pharms., Inc. v. Thompson, 268 F.3d 1323, 1327 (Fed. Cir. 2001). Novartis timely filed the instant lawsuit on September 16, 2004, pursuant to 35 U.S.C. § 217(e)(2), which gave rise to an automatic 30-month stay under the Hatch-Waxman Act,*fn8 during which time the FDA could not grant Teva final approval to market its proposed products. 21 U.S.C. § 355(j)(5)(B)(iii). The FDA granted tentative approval to Teva's ANDA on July 11, 2006. On or about February 6, 2007, the statutory 30-month stay expired. Id.

In May 2007, the FDA granted final approval to Teva's ANDA, and subsequently District Judge Dennis M. Cavanaugh granted Novartis's proposed TRO (Doc. No. 56), temporarily restraining Teva "from making, using, selling, or offering to sell products under its [ANDA No. 77-179]." (J. Cavanaugh's March 19, 2007 Order, at *2.) On June 11, 2007, this Court vacated the existing temporary restraining orders, and denied Novartis's motion for a preliminary injunction. The Court conducted a Markman hearing on June 26, 2008, during which each side was granted the opportunity to present testimony by one expert. Novartis's expert testified regarding the meaning of "physically separated." After cross-examining Novartis's expert, Teva declined to call its expert to the stand.

II. DISCUSSION

A. Claims of the '802 Patent

In this case, Novartis accuses Teva of infringing claims 1, 2 and 19 of the '802 patent under 35 U.S.C. § 271(a).*fn9 However, all claims of the '802 patent are implicated as they are all either directly or indirectly dependent on claims 1 and 19, the patent's only independent claims. Novartis asserts that Teva infringes the '802 patent directly and indirectly.

By way of background, claims 1-17 of the '802 patent are directed to a method of treatment of various conditions. This method of treatment utilizes the administration of a combination of benazepril, an angiotensin converting enzyme inhibitor ("ACEI" or "ACE inhibitor"), and amlodipine, a calcium channel blocker ("CCB"). Claims 2-16 are all dependent on claim 1, which reads as follows:

1. A method of treating a condition selected from the group consisting of hypertension, congestive heart failure, angina, myocardial infarction, artherosclerosis, diabetic nephropathy, diabetic cardiac myopathy, renal insufficiency, peripheral vascular disease, left ventricular hypertrophy, cognitive dysfunction, stroke, and headache, in a human in need thereof, consisting of administering a daily dose of

(a) benazepril, in free or pharmaceutically acceptable salt form, in an amount corresponding to from 2 mg to 80 mg of benazepril hydrochloride; and

(b) amlodipine, in free or pharmaceutically acceptable salt form, in an amount corresponding to from 1 mg to 20 mg of amlodipine free base, wherein the ratio of benazepril to amlodipine corresponds to a weight ratio of from 1:1 to 8:1 of benazepril hydrochloride to amlodipine free base.

('802 patent, col.5, ll. 6-21.) Dependent claims 2, 3, 17, and 18 are also of particular relevance to the instant dispute. See Pods, Inc. v. Porta Stor, Inc. et al., 484 F.3d 1359, 1366 (Fed. Cir. 2007) (noting that a court is "not limited to considering just the language of" a particular claim in dispute "because '[o]ther claims of the patent in question, both asserted and unasserted, [are] valuable sources of enlightenment as to the meaning of a claim term'") (citing Phillips v. AWH Corp., 415 F.3d 1303, 1314 (Fed. Cir. 2005)). These method claims provide:

2. The method of claim 1 wherein the benazepril and the amlodipine are administered in a single dosage form, such that the benazepril and amlodipine are physically separated from each other.

3. The method of claim 2 wherein the single dosage form comprises a capsule comprising within it (a) a coated compressed tablet of benazepril and (b) amlodipine powder.

17. The method of claim 1 wherein the benazepril is administered in a first formulation which is free of the amlodipine and the amlodipine is administered in a second formulation which is free of the benazepril.

18. The method of claim 17 wherein said first formulation and said second formulation are administered within about one hour of each other.

('802 patent, col. 5, ll. 22-28; col. 6, ll. 1-7 (emphasis added).)*fn10

Claims 19-33 of the '802 patent are directed to a pharmaceutical composition consisting essentially of a combination of benazepril and amlodipine. Claims 20-33 are all dependent on claim 19, which reads as follows:

19. A pharmaceutical composition consisting essentially of a daily dose of

(a) benazepril, in free or pharmaceutically acceptable salt form, in an amount corresponding to from 2 mg to 80 mg of benazepril hydrochloride; and

(b) amlodipine, in free or pharmaceutically acceptable salt form, in an amount corresponding to from 1 mg to 20 mg to amlodipine free base, wherein the ratio of benazepril to amlodipine corresponds to a weight ratio of from 1:1 to 8:1 of benazepril hydrochloride to amlodipine free base, such that the benazepril and the amlodipine are ...


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