Warner-Lambert Co. v. Teva Pharmaceuticals Usa

• Decision Date: 02 October 2003
• Docket Number: No. 99-CV-922.,99-CV-922.
• Citation: 289 F.Supp.2d 515
• Parties: WARNER-LAMBERT COMPANY, Plaintiff, v. TEVA PHARMACEUTICALS USA, Defendant.
• Court: U.S. District Court — District of New Jersey

289 F.Supp.2d 515

WARNER-LAMBERT COMPANY, Plaintiff, v. TEVA PHARMACEUTICALS USA, Defendant.

No. 99-CV-922.

United States District Court, D. New Jersey.

October 2, 2003.

COPYRIGHT MATERIAL OMITTED

Michael R. Clarke, Esq., Drinker, Biddle & Shanley, Florham Park, Robert L. Baechtold, Esq., Nicholas M. Cannella, Esq., Joseph M. O'Malley, Jr., Esq. (Argued), F. Christopher Mizzo, Esq (Argued)., Fitzpatrick, Cella, Harper & Scinto, New York City, for Plaintiff, Warner-Lambert Company.

Arnold B. Calmann, Esq., Robert B. Nussbaum, Esq., Saiber, Schlesinger, Satz & Goldstein, Newark, Albert E. Fey, Esq., W. Edward Bailey, Esq. (Argued), A. Joy Arnold, Esq. (Argued), Sasha G. Rao, Esq., John P. Hanish, Esq., Staci Levin Julie, Esq. (Argued), Fish & Neave, New York City, for Defendant Teva Pharmaceutical USA.

OPINION

DEBEVOISE, Senior District Judge.

On January 15, 1999, defendant Teva USA ("Teva"), using a Federal Drug Administration ("FDA") procedure known as an Abbreviated New Drug Application ("ANDA") sought approval from the FDA to engage in the commercial manufacture, use and sale of a generic drug formulation containing the active ingredient quinapril hydrochloride. By filing its ANDA Teva was able to rely on portions of an FDA submission already on file for a corresponding branded formulation sold by plaintiff, Warner-Lambert Company ("Warner Lambert"). The FDA had approved Warner-Lambert's drug which is sold in the United States under the name Accupril and which is the subject of Warner-Lambert's U.S. Patent No. 4,743,450 ("the '450 patent").

In connection with its ANDA submission Teva filed a so-called "Paragraph IV Certification" with respect to the '450 patent, asserting that the '450 patent is invalid under 35 U.S.C. § 102 and 103. In response to notice of Teva's Paragraph IV Certification and acting pursuant to statutorily prescribed procedures Warner-Lambert commenced this patent infringement action.

I. Background

The '450 patent, which is entitled "Stabilized Compositions", issued on May 10, 1988 from patent application number 17,962 ("the '962 application"), filed February 24, 1987. The '450 patent is directed to stabilized compositions of certain Angiotension Converting Enzyme ("ACE") inhibitors. The ACE inhibitors of the '450 patent are prescribed for the treatment of hypertension. The problem that the '450 patent addresses is summarized in the section entitled "BACKGROUND":

Certain ACE (Angiotension Converting Enzyme) inhibitors, which are useful as antihypertensives, are susceptible to certain types of degradation. Specifically quinapril and structurally-related drugs can degrade via (1) cyclization via internal nucleophilic attack to form substituted diketopiperazines, (2) hydrolysis of the sidechain ester group, and (3) oxidation to form products having often unwanted coloration.

Cyclization takes place when one part of the ACE inhibitor compound reacts with a different part of the same compound to form an altered, inactive "cyclized" compound. Hydrolysis is the reaction with water to form a hydrolysis degradation product. Oxidation forms products having unwanted coloration. The invention of the '450 patent resulted from Warner-Lambert's efforts to develop a stable dosage of its ACE inhibitor, quinapril hydrochloride ("quinapril") which was subject to degradation due to cyclization, hydrolysis and oxidation.

The invention as described in the '450 patent is: "It has been discovered that stable compositions containing ACE inhibitors of the type discussed above can be produced by using certain additives as stabilizers ..." For example: "The invention deals with: ... III. A method of making a pharmaceutical dosage form which comprises the step of including in the formulation suitable amounts of: (a) on ACE inhibitor, and (b) stabilizers which contain alkaline agents alone or alkaline agents in combination with saccharides (i.e., sugars) as one or more cyclization, hydrolysis, and discoloration inhibitor(s)."

The '450 patent sets forth seventeen claims, two of which are independent claims. The independent claims read:

Claim 1

1. A pharmaceutical composition which contains:

(a) a drug component which comprises a suitable amount of an ACE inhibitor which is susceptible to cyclization, hydrolysis, and discoloration;

(b) a suitable amount of an alkali or alkaline earth metal carbonate to inhibit cyclization and discoloration, and

(c) a suitable amount of a saccharide to inhibit hydrolysis.

Claim 16

16. A process for stabilizing an ACE inhibitor drug against cyclization which comprises the step of contacting the drug with:

(a) a suitable amount of alkali or alkaline earth-metal carbonate and,

(b) one or more saccharides.

On June 3 and 4, 2002 the court held a hearing in accordance with Markman v. Westview Instruments, Inc., 517 U.S. 370, 116 S.Ct. 1384, 134 L.Ed.2d 577 (1996), aff'g 52 F.3d 967 (Fed. Cir.1995)(en banc). The most serious dispute concerned the construction of the phrase "an alkali or alkaline earth metal carbonate" as used in Claims 1 and 16 of the '450 patent. Teva contended that "carbonate" encompasses "carbonate or bicarbonate." Warner-Lambert contended that the word means only a "carbonate" and does not include a bicarbonate. Ruling on these contentions the court held in its June 13, 2002 opinion that "`an alkali or alkaline earth metal carbonate' as used in Claims 1 and 16 of the '450 Patent means the salt of an alkali metal or alkaline earth metal cation, and a carbonate (CO₃^-2) anion; it does not include a bicarbonate (HCO₃^-1) anion." (Slip Opinion at pp. 17, 18).

Of relevance to the motions now pending in the instant case is the disposition of a related action, Schwarz Pharma, Inc., Schwarz Pharma AG and Warner-Lambert Company v. Teva Pharmaceuticals USA, Civil No. 01-4995 (the "Schwarz Pharma Action"). On October 26, 2001 Schwarz Pharma, Inc. and Schwarz Pharma AG ("Schwarz Pharma"), as licensees of the '450 patent, filed a complaint alleging that Teva's moexipril product infringed the '450 patent.¹ Teva's accused moexipril hydrochloride formulation used sodium bicarbonate as an alkaline stabilizer. Teva contended that, applying the court's Markman ruling in the instant case, its formulation cannot literally infringe the claims of the '450 patent nor can its formulation infringe the claims of the '450 patent under the doctrine of equivalents. It moved for summary judgment on the ground of noninfringement.

Holding that Schwarz Pharma was not bound by the Markman ruling in the instant action to which it is not a party, the court considered Schwarz Pharma's contention that the phrase "an alkali or alkaline earth metal carbonate" as used in Claims 1 and 16 of the '450 patent encompasses a bicarbonate. The court held once again that "carbonate" does not include bicarbonates and, therefore, Teva's accused product that contained a bicarbonate and not a carbonate did not literally infringe the '450 patent. The court also held that the accused product did not infringe the '450 patent under the doctrine of equivalents. These rulings resulted in an order granting Teva's motion for summary judgment in its favor on the ground of non-infringement.

Discovery proceeded in the instant case, and now Warner-Lambert and Teva have filed a number of interrelated motions for summary judgment and for other rulings.

II. The Motions

Teva moves for a summary judgment that its accused quinapril hydrochloride formulation does not infringe claims 1, 4-10 or 12 of the '450 patent. It is Teva's contention that Warner-Lambert cannot establish that lactose in Teva's accused quinapril hydrochloride formulation inhibits hydroysis or that magnesium carbonate in its formulation inhibits cyclization and discoloration. Warner-Lambert counters with a motion for summary judgment of infringement of claims 1, 4-10, 12, 16 and 17 of the '450 patent. It further moves for summary judgment of validity.

Teva moves for summary judgment that the '450 patent is unenforceable due to Warner-Lambert's inequitable conduct. The alleged inequitable conduct is Warner-Lambert's intentional failure to disclose to the United States Patent and Trademark Office ("PTO") the existence of a preexisting drug that was directly material to the patentability of its claims, namely, Vasotec, an ACE inhibitor sold by Merck & Co. Warner-Lambert counters with a motion for summary judgment of "no inequitable conduct."

Further, Teva moves for an order granting it leave to amend its answer to add an additional unenforceability defense, namely, that during the prosecution of the '450 patent the patentees and the prosecuting attorney made material and intentional misrepresentations to the PTO concerning the inventorship of the '450 patented work. Finally, Teva moved for an order striking Warner-Lambert's defenses relating to Teva's allegations of inequitable conduct or, alternatively, for an order that Warner-Lambert has waived the attorney-client privilege by asserting these defenses.

Because there is no genuine issue of material fact with respect to infringement, Teva's motion for a summary judgment of non-infringement of claims 1,4-10 and 12 of the '450 patent will be denied. Warner-Lambert's motion for summary judgment of infringement of claims 1,4-10, 12, 16 and 17 of the '450 patent will be granted.

Because there are no genuine issues of fact with respect to the validity of claims 1,4-10 and 12 of the '450 patent, Warner-Lambert's motion for a summary judgment of validity as to those claims will be granted. The doctrine of judicial estoppel does not preclude Teva from contending that carbonates are interchangeable with bicarbonates despite the position Teva took in the Schwartz Pharma action. Because there are genuine issues of fact concerning the question whether a person of skill in the art would have found it obvious to substitute "an alkali or alkaline earth metal carbonate" for sodium bicarbonate, Warner-Lambert's ...