Pfizer Inc. v. Ranbaxy Laboratories Ltd.
| Decision Date | 16 December 2005 |
| Docket Number | No. CIV.A. 03-209-JJF.,CIV.A. 03-209-JJF. |
| Citation | 405 F.Supp.2d 495 |
| Parties | PFIZER INC., Pfizer Ireland Pharmaceuticals, Warner-Lambert Company, Warner-Lambert Company, LLC, and Warner-Lambert Export, Ltd., Plaintiffs, v. RANBAXY LABORATORIES LIMITED and RANBAXY PHARMACEUTICALS, INC., Defendants. |
| Court | U.S. District Court — District of Delaware |
Rudolf E. Hutz, Esquire, Jeffrey B. Bove, Esquire, Collins J. Seitz, Jr., Esquire and Mary W. Bourke, Esquire of Connoly Bove Lodge & Hutz LLP, Wilmington, DE, for Plaintiffs.
Steven J. Balick, Esquire and John G. Day, Esquire of Ashby & Geddes, Wilmington, DE, of Counsel: Darrell L. Olson, Esquire, John P. Giezentanner, Esquire, Douglas G. Muehlhauser, Esquire, William R. Zimmerman, Esquire, Payson LeMeilleur, Esquire, Sheila N. Swaroop, Esquire, Darryl H. Steensma, Esquire and Walter S. Wu, Esquire of Knobbe, Martens, Olson & Bear, LLP, Irvine, CA. Jay R. Deshmukh, Esquire and George E. Heibel
Esquire of Ranbaxy, Inc., Princeton, NJ, for Defendants.
This action was brought by Plaintiffs, Pfizer Inc., Pfizer Ireland Pharmaceuticals, Warner-Lambert Company, Warner-Lambert Company, LLC and Warner-Lambert Export, Ltd. (collectively, "Pfizer") against Defendants, Ranbaxy Laboratories Limited and Ranbaxy Pharmaceuticals Incorporated (collectively, "Ranbaxy") for infringement of U.S. Patent No. 4,681,893 (the "'893 patent") and U.S. Patent No. 5,273,995 (the "'995 patent"). The '893 and '995 patents pertain to an atorvastatin calcium pharmaceutical composition sold by Pfizer under the registered name Lipitor ®. Lipitor ® is prescribed by doctors for the treatment of elevated cholesterol and is the largest selling pharmaceutical in history. This lawsuit arises in connection with Abbreviated New Drug Application ("ANDA") No. 76-477 filed by Ranbaxy seeking to commercially manufacture, use and sell a drug product containing atorvastatin calcium as its active agent. Pfizer filed four Complaints against Ranbaxy alleging that Ranbaxy's proposed ANDA product infringes the '893 and '995 patents under 35 U.S.C. § 271(e)(2). These Complaints have been consolidated into this action. By its Complaints, Pfizer has asserted two patents against Ranbaxy, the '893 patent and the '995 patent. Specifically, Pfizer alleges infringement of claims 1-4, 8 and 9 of the '893 patent and claim 6 of the '995 patent.
In response to Pfizer's Complaints, Ranbaxy filed an Answer and several Counterclaims. Ranbaxy alleges that it does not infringe either the '893 or '995 patents. Ranbaxy also challenges the validity of the patent term extension granted by the PTO for the '893 patent. With regard to the '995 patent, Ranbaxy contends that the asserted claim of the '995 patent, claim 6, is invalid for double patenting, obviousness and anticipation. Ranbaxy also contends that the '995 patent is unenforceable as a result of inequitable conduct by Warner-Lambert Company before the PTO.
The Court has subject matter jurisdiction over this action pursuant to 28 U.S.C. §§ 1331 and 1338, because this action arises under the patent laws of the United States. The Court also has subject matter jurisdiction over Ranbaxy's counterclaims pursuant to 28 U.S.C. §§ 1338, 2201 and 2202. The parties have submitted to the personal jurisdiction of the Court, and venue in this District is appropriate pursuant to 28 U.S.C. §§ 1391 and 1400.
The Court conducted a bench trial on the issues presented by the parties.1 This Memorandum Opinion constitutes the Court's findings of fact and conclusions of law on the issues raised during trial.
Pfizer Inc. is a Delaware corporation having a place of business in Morris Plains, New Jersey and corporate offices in New York City. Warner-Lambert Company was a Delaware corporation that became a wholly-owned subsidiary of Pfizer Inc. on June 19, 2000. Warner-Lambert Company was then converted into Warner-Lambert Company, LLC, a Delaware limited liability company. Warner-Lambert Export, Ltd., is a corporation formerly organized under the laws of Ireland with a registered office located in Dublin, Ireland, Pfizer Ireland Pharmaceuticals is a partnership between C.P. Pharmaceuticals International, C.V., a limited partnership under the laws of the Netherlands, and Pfizer Overseas Pharmaceuticals, a private limited company incorporated in Ireland. Pfizer Ireland Pharmaceuticals is a wholly-owned subsidiary of Pfizer Inc. with registered offices in Dublin, Ireland. Through Parke-Davis Pharmaceuticals Research, a division of Warner-Lambert Company, Pfizer holds an approved New Drug Application for the atorvastatin calcium pharmaceutical composition sold under the name Lipitor®.
Ranbaxy Pharmaceuticals Incorporated is a Delaware corporation with a place of business located in Princeton, New Jersey. Ranbaxy Laboratories Limited is a corporation of India with corporate offices located in New Delhi, India. Ranbaxy Pharmaceuticals Incorporated is a wholly-owned subsidiary of Ranbaxy Laboratories Limited.
The '893 patent is entitled "Trans-6-[2-(3- OR 4-carboxamido-substituted pyrrol-1-yl)alkyl]-4-hydroxypyran-2-one inhibitors of cholesterol synthesis." The inventor of the '893 patent is Dr. Bruce D. Roth. Pfizer has identified to the Food and Drug Administration that the '893 patent covers the atorvastatin calcium composition sold by Pfizer since 1997 under the name Lipitor®. The '893 patent was to expire on May 30, 2006; however, the PTO granted an extension pursuant to 35 U.S.C. § 156, extending the expiration date of the '893 patent to September 24, 2009, excluding a six month pediatric extension.
The '995 patent is entitled "[R-(R*,R*) ]-2-(4-fluorophenyl)-β, δ -dihydroxy-5-(1-methylethyl-3-phenyl-4-[(phenylamino)) carbonyl]-1H-pyrrole-1-heptanoic acid, its lactone form and salts thereof." Dr. Bruce D. Roth is also the inventor of the '995 patent. The compound covered by the '995 patent is commonly referred to as atorvastatin calcium. The '995 patent expires on December 28, 2010.
Claim construction is a question of law. Markman v. Westview Instruments, Inc., 52 F.3d 967, 977-78 (Fed.Cir. 1995), aff'd, 517 U.S. 370, 388-90, 116 S.Ct. 1384, 134 L.Ed.2d 577 (1996). When construing the claims of a patent, a court considers the literal language of the claim, the patent specification and the prosecution history. Markman, 52 F.3d at 979. In Phillips v. AWH Corp., 415 F.3d 1303, 1312-1317 (Fed.Cir.2005), the Federal Circuit reaffirmed the claim construction principles set forth in Markman and reemphasized that the specification is the single best source for discerning the meaning of a claim.
A court may consider extrinsic evidence, including expert and inventor testimony, dictionaries, and learned treatises, in order to assist it in understanding the underlying technology, the meaning of terms to one skilled in the art and how the invention works. Phillips, 415 F.3d at 1318-319; Markman, 52 F.3d at 979-80 (citations omitted). However, extrinsic evidence is considered less reliable and less useful in claim construction than the patent and its prosecution history. Phillips, 415 F.3d at 1318-319 ().
In addition to these fundamental claim construction principles, a court should also interpret the language in a claim by applying the ordinary and accustomed meaning of the words in the claim. Envirotech Corp. v. Al George, Inc., 730 F.2d 753, 759 (Fed.Cir.1984). If the patent inventor clearly supplies a different meaning; however, then the claim should be interpreted according to the meaning supplied by the inventor. Markman, 52 F.3d at 980 (). If possible, claims should be construed to uphold validity. In re Yamamoto, 740 F.2d 1569, 1571 n. * (Fed.Cir.1984) (citations omitted).
The parties' claim construction disputes impact the field of stereochemistry, a subfield of chemistry. Stereochemistry is concerned with the three-dimensional structure of organic molecules in space. An isomer is one of several molecular entities that have the same atomic composition or molecular formula, but a different stereochemical formula, meaning the atoms are the same in number and type but different in their spatial arrangement. Stereoisomers are compounds that have the same atoms and the same connection pattern of atoms or groups of atoms, but are different in the way that those atoms or groups of atoms are arranged in space. Enantiomers are stereoisomers that are non-superimposable mirror images of each other. Enantiomers have identical physical properties, including solubilities and melting points, with the exception of their interactions with chiral matter and planepolarized light. A racemate, or racemic mixture, is an equal mixture of two enantiomers, such that it contains 50% of one enantiomer and 50% of its opposite enantiomer. Racemates and enantiomers are distinct compounds, and in general, have different physical properties such as solubility and melting points.
Optical activity is a compound's ability to rotate plane-polarized light. A pure enantiomer rotates plane-polarized light in only one direction to the maximal amount permitted by that molecule. An unequal mixture of two opposite enantiomers is optically active and the degree of optical rotation reflects the...
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