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Astellas Pharma, Inc. v. Ranbaxy Inc.

February 21, 2007

ASTELLAS PHARMA, INC., ET AL., PLAINTIFFS,
v.
RANBAXY INC., ET AL., DEFENDANTS.



The opinion of the court was delivered by: Cooper, District Judge

MEMORANDUM OPINION

Plaintiffs, Astellas Pharma, Inc. ("Astellas Pharma"), and Boehringer Ingelheim Pharmaceuticals, Inc. ("Boehringer") (collectively "Astellas") commenced this action against defendants Ranbaxy Inc., Ranbaxy Pharmaceuticals Inc., and Ranbaxy Laboratories Ltd. (collectively "Ranbaxy") alleging Ranbaxy infringed upon United States patent number 4,703,063 (the "'063 patent") held by Astellas. (Compl., at 4.) Ranbaxy asserted affirmative defenses and a counterclaim based on the alleged invalidity and unenforceability of the '063 patent. (Dkt. entry no. 4.)

Currently before the Court are a motion and a cross motion for summary judgment pursuant to Federal Rule ("Rule") of Civil Procedure 56. (Dkt. entry no. 17.)*fn1 Pursuant to a stipulation entered into between the parties and approved by the Court, Ranbaxy admits to infringing upon the '063 patent and agreed to the dismissal with prejudice of its affirmative defenses alleging invalidity or unenforceability under 35 U.S.C. §§ 101, 102, 103, and 112. (Dkt. entry no. 32, at 2.) The only affirmative defense and counterclaim not dismissed through the stipulation is the invalidity of '063 for obviousness-type double patenting, and thus the parties agree this is the only issue remaining before the Court. (Id.) For the reasons stated herein, the Court will grant Astellas's cross motion and deny Ranbaxy's motion.

BACKGROUND

Yamanouchi Pharmaceutical Co. ("Yamanouchi"), one of the companies that subsequently merged in 2005 to become Astellas Pharma, Inc., filed a patent application in 1981 for a class of sulfamoyl-substituted phenethylamines, believed to be useful for treating hypertension and related disorders. (Pls. Stmt. of Facts, at ¶¶ 2, 11; Defs. Stmt. of Facts, at ¶ 6.) The application contained claims to the class of new chemical compounds, which included tamsulosin, as well as the pharmaceutical compositions containing those chemical compounds and the processes for making the chemical compounds. (Pls. Stmt. of Facts, at ¶ 13; Defs. Stmt. of Facts, at ¶ 9.)

The patent examiner rejected the pharmaceutical composition and chemical compound claims, only allowing the claims for the processes to make the compounds. (Pls. Stmt. of Facts, at ¶ 16; Defs. Stmt. of Facts, at ¶ 8.) Patent number 4,373,106 (the "'106 patent") was issued to Yamanouchi in 1983 and it claimed the processes for making the new class of sulfamoyl-substituted phenethylamines. (Pls. Stmt. of Facts, at ¶ 19; Defs. Stmt. of Facts, at ¶ 9; see Decl. of Thomas R. Burns ("Burns Decl."), Ex. A.) The '106 patent expired on February 4, 2001. (Pls. Stmt. of Facts, at ¶ 20; Defs. Stmt. of Facts, at ¶ 12.)

Before the '106 patent was issued, Yamanouchi applied multiple times to the patent office to claim the pharmaceutical compositions and chemical compounds rejected by the examiner in the '106 application. (Pls. Stmt. of Facts, at ¶¶ 24-25; Defs. Stmt. of Facts, at ¶ 13.)*fn2 On October 27, 1987, the '063 patent claiming those pharmaceutical compositions and chemical compounds was issued to Yamanouchi. (See Burns Decl., Ex. B.) The eighteen claims in the '063 patent cover the chemical compounds (claims 1 & 3-18) and the pharmaceutical compositions (claim 2). (Id.) The '063 patent expires on October 27, 2009. (Pls. Stmt. of Facts, at ¶ 30; Defs. Stmt. of Facts, at ¶ 19.)

Boehringer, Astellas Pharma's marketing partner in the United States, filed a New Drug Application ("NDA") for tamsulosin with the Food and Drug Administration ("F.D.A.") on April 15, 1996. (Pls. Stmt. of Facts, at ¶ 39.) The NDA was approved exactly one year later and Boehringer began marketing tamsulosin in the United States under the trade name Flomax. (Id.) Flomax is used to treat benign prostatic hyperplasia. (Pls. Stmt. of Facts, at ¶¶ 4, 42.)

Ranbaxy filed an Abbreviated New Drug Application ("ANDA") on December 20, 2004, seeking approval to market generic tamsulosin hydrochloride capsules. (Dkt. entry no. 17, Decl. of Jay R. Deskmukh, at ¶ 4.) On April 6, 2005, Ranbaxy notified Astellas of the F.D.A.'s acceptance of Ranbaxy's ANDA. (Id. at ¶ 5.) Ranbaxy also provided Astellas with notice of its opinion that the '063 patent was invalid for, inter alia, double patenting over the claims of the '106 patent. Astellas subsequently filed the complaint for patent infringement against Ranbaxy in this Court. (Dkt. entry no. 1.)

DISCUSSION

Claim 3 of the earlier issued '106 patent states:

A process for producing sulfamoyl-substituted phenethylamine derivatives represented by the formula [DRAWING OF CHEMICAL FORMULA] wherein R1 represents an amino group or a mono- or di-lower alkylamino group; R2 represents a hydroxy group, a lower alkyl group or a lower alkoxy group; R3 represents a hydrogen atom or a lower alkoyl group, R4, R5, R6, R7, R8 and R9 each represent a hydrogen atom or a lower alkyl group; R10 represents a hydrogen atom, a lower alkyl group, or a lower alkoxy group; and Y represents an oxygen atom or a methylene group; said Y being an oxygen atom when R2 is a hydroxyl group, or the salts thereof which comprises reacting a compound represented by the formula [DRAWING OF CHEMICAL FORMULA] wherein R represents a hydrogen atom or a lower alkyl group and R1, R2, R4, R5, R6, R7, R8, R9, R10 and Y have the same significance as in the above formula with a halogenating agent and reducing the halogenated product.

(Burns Decl., Ex. A, at 28.) Claim 4 of the earlier issued '106 patent states: "The process as defined in claim 3 for the preparation of 5-[2-[2-(2-ethoxyphenoxy)ethylamino]-2-methylethyl]-2-methoxybenzensulfonamide." (Id.)

Claim 1 of the later issued '063 patent states:

Sulfamoyl-substituted phenethylamine derivatives represented by the general formula [DRAWING OF CHEMICAL FORMULA] wherein R1 represents an amino group or a mono- or di-lower alkylamino group; R2 represents a hydroxyl group, a lower alkyl group, or a lower alkoxy group; R3 represents a hydrogen atom, a lower alkoxy group or a lower alkyl group; R4, R5, R6, R7, R8, and R9 each represents a hydrogen atom or a lower alkyl group; R10 represents a hydrogen atom, a lower alkyl group, or a lower alkoxy group; and Y represents an oxygen atom, and the salts thereof.

(Id., Ex. B, at 26-27.) Claim 2 of the '063 patent states: "A pharmaceutical composition containing an effective []-adrenergic antagonistic amount of a compound of claim 1 and a pharmaceutically acceptable excipient." (Id. at 27.) Claim 14 of the '063 patent states: "The compound of claim 1 which is 5-{2-[2-(2-ethoxyphenoxy)ethylamino]-2-methylethyl} benzenesulfonamide." (Id. at 28.) Claims 4, 8, 10 & 14 of ...


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