IMPERIAL CHEMICAL IND. v. Danbury Pharmacal, Civ. A. 89-575-CMW.

Citation745 F. Supp. 998
Decision Date02 August 1990
Docket NumberCiv. A. 89-575-CMW.
PartiesIMPERIAL CHEMICAL INDUSTRIES, PLC, Plaintiff, v. DANBURY PHARMACAL, INC., Defendant.
CourtUnited States District Courts. 3th Circuit. United States District Court (Delaware)

Douglas E. Whitney, Donald F. Parsons, Jr., and Mary B. Graham of Morris, Nichols, Arsht & Tunnell, Wilmington, Del. (Paul N. Kokulis, Donald J. Bird, Stephen L. Sulzer, Alesia M. Woodworth, and Mark G. Paulson of Cushman, Darby & Cushman, Washington, D.C., of counsel), for plaintiff.

Jeffrey M. Weiner, Wilmington, Del. (Alfred B. Engelberg, Carmel, New York City, of counsel), for defendant.

OPINION

CALEB M. WRIGHT, Senior District Judge.

Plaintiff Imperial Chemical Industries, PLC ("ICI") brought this patent infringement action against Defendant Danbury Pharmacal, Inc. ("Danbury") on October 19, 1989.1 The subject patents are United States Patents 3,836,671 (the "'671 patent") issued to ICI on September 17, 1974 and 3,934,032 (the "'032 patent") issued to ICI on January 20, 1976.2 The '671 patent contains claims to a pharmaceutical composition useful for producing beta-adrenergic blockade (claims 1-4) in which the active ingredient is a certain alkanolamine derivative, and a method for the treatment or prophylaxis of angina pectoris and cardiac arrhythmias in warm-blooded animals by administering the composition (claim 5). The '032 patent has claims directed to a method for the treatment of hypertension in a warm-blooded animal by the administration of a particular alkanolamine derivative (claims 1-2). Danbury has admitted infringement and raised the affirmative defense of invalidity under 35 U.S.C. §§ 102 and 103 with respect to both patents.

Before ICI commenced this suit, Danbury had filed on June 30, 1989, two Abbreviated New Drug Applications ("ANDA's") with the United States Food and Drug Administration ("FDA") pursuant to 21 U.S.C. § 355(j). Danbury filed these ANDA's to obtain FDA approval to market a generic version of a drug encompassed by ICI's patents.3 Danbury amended these ANDA's on September 5, 1989, and simultaneously submitted a patent certification under 21 U.S.C. § 355(j)(2)(A)(vii) that the patents are invalid.4 Danbury's submission of the amended ANDA's and the patent certification constitutes infringement of the '671 and '032 patents under 35 U.S.C. § 271(e)(2)(A). The FDA's approval of Danbury's ANDA's would have been immediate unless ICI had brought suit within forty five days of ICI's notice of the patent certification. 21 U.S.C. § 355(j)(4)(B)(iii). Because ICI filed suit within the forty five day period, the FDA may not permit Danbury to market its generic drug for a period of 30 months from the date of the patent certification notice unless the patents are adjudicated to be invalid before the thirty month period expires. 21 U.S.C. § 355(j)(4)(B)(iii).

Danbury has not engaged and is not presently engaged in any commercial activity relating to the subject patents. Danbury filed a motion for summary judgment on February 9, 1990. Danbury seeks a declaration that the '671 and '032 patents are invalid for obviousness pursuant to 35 U.S.C. § 103.

The Court has jurisdiction over this controversy under 28 U.S.C. §§ 1331, 1338(a). Venue lies in this Court pursuant to 28 U.S.C. § 1400(b).

For the reasons which will be explained herein, the Court denies defendant's motion for summary judgment.

I. FACTS

The parties have deluged this Court with admissions, publications, affidavits, and numerous other documents in connection with this motion. The following discussion represents the Court's view of the salient facts of the present controversy.

A. Background and Development of Atenolol

The '671 and '032 patents contain claims directed to pharmaceutical compositions comprising an admittedly novel and unobvious compound — atenolol, and to methods of use of atenolol.5 Atenolol is a compound which is capable of producing beta-adrenergic receptor blockade ("b-blockade"), i.e. it is a beta-blocker.6 B-blockers function to inhibit stimulation caused by adrenaline and noradrenaline so as to reduce the work of the heart.7 In particular, b-blockers are synthetic compounds having the ability preferentially to occupy beta-adrenergic receptor sites ("b-receptors") located in various tissues throughout the body, and competitively interfere with the occupancy and stimulation of those sites by endogenous, naturally occurring cathecholamines (adrenaline and noradrenaline). This process diminishes or inhibits the body's response to the sympathetic amines adrenaline and noradrenaline, ultimately to reduce the work of the heart.8

The fundamental molecular structure of the compounds involved in this case can be represented by the following:

"R" represents one or more substituents which can be attached to the ring structure (aryl ring) of the molecule. Differences in the chemical structure of this molecule, particularly in the R group, can exert a significant influence on the resultant pharmacological properties.

Certain b-blockers demonstrate a preference or selectivity for the b-receptors predominantly located in the cardiac muscle, whereby the b-blocking effects on other muscles (such as muscles in the peripheral vascular or bronchial system) are significantly reduced. This result or effect is referred to as "cardioselectivity". There are various advantages to the use of a cardioselective b-blocker, mainly because they have reduced effects on the blood vessels and other organs.9 A cardioselective b-blocker is less likely than a non-cardioselective b-blocker, for example, to induce bronchospasm or asthma attacks, and exacerbate the rise in bloodpressure induced by cigarette smoking.10 Other b-blockers, when occupying a b-receptor, inhibit the effects of adrenaline and noradrenaline, but they also possess some stimulant activity of their own. B-blockers that act in this manner have intrinsic sympathomimetic activity (ISA).

One important prior art b-blocker, actually developed by ICI, was practolol:

Another important prior art b-blocker was propranolol:

It was known near the time of the invention of atenolol that propranolol was non-cardioselective and did not have ISA. Practolol was cardioselective but had ISA.11 At the time of the invention of atenolol, there was no compound known in the art which was cardioselective but without ISA.12

ICI had begun the development of atenolol by conducting research to develop a b-blocker with the following set of properties:

1. Potency equivalent to propranolol at the cardiac b-receptor sites;
2. Cardioselectivity; and
3. No ISA.

Dr. David James Le Count proceeded to direct complex and tedious research in 1967 at ICI. He ultimately synthesized atenolol in early 1968 and submitted it for biological evaluation. This testing indicated that atenolol was effective, cardioselective, and without ISA. The key distinction between atenolol and other known b-blockers was that atenolol had a carbamoylmethyl R group attached to the aryl ring structure:

B. Proceedings Leading to Issuance of ICI's Patents

ICI filed British Patent Application No. 9445 on February 21, 1969. This application disclosed the atenolol series and atenolol specifically. This British application was the original disclosure and basis for priority for each of the inventions claimed in ICI's Patent Nos. 3,663,607 (the "'607 patent"), the '671 patent, and the '032 patent. The PTO accorded each of these patents a priority date of February 21, 1969.

ICI's initial application in the United States Patent and Trademark Office ("PTO") was Serial No. 9451 filed February 6, 1970 (the "'451 application"). The '451 application disclosed and claimed, inter alia, compounds in the atenolol series, pharmaceutical compositions containing compounds in the atenolol series, and methods for the treatment or prophylaxis of heart disease and hypertension by the administration of an effective amount of compounds of the atenolol series. The PTO examiner reviewing the '451 application made a restriction requirement between the compound claims per se and the pharmaceutical composition and method of use claims.13 ICI decided to pursue the compound claims in the '451 application. The '451 application eventually issued as the '607 patent on May 16, 1972, and expired on May 16, 1989.14

Before the '607 patent issued, ICI filed divisional application Serial No. 233,781 on March 10, 1972 (the "'781 application") including claims directed to the pharmaceutical compositions and methods of use in the '451 application.15 The PTO examiner in charge of the '781 application issued another restriction requirement and allowed only a single method of use to be claimed together with the pharmaceutical compositions. The '781 application issued on September 17, 1974 as the '671 patent. ICI filed another divisional application directed to a method of treating hypertension, application serial no. 461,262 (the "'262 application"). The '262 application issued on January 20, 1976 as the '032 patent. A complete diagram of this network of applications and corresponding patents is shown in Appendix III.

During prosecution of the '781 application leading to issuance of the '671 patent, the PTO examiner initially rejected the claims under section 103 as being obvious over prior patents of Howe teaching practolol and other compounds which had the nitrogen of the group (-CO-NH-) bonded directly to the aryl ring.16 In its response, ICI contended that the insertion of the group RNHCO-CH2 in place of the group RCONH would not have been an obvious modification. ICI pointed to differences in the properties between the two compounds, and the PTO examiner later withdrew the rejection.17

ICI sought and eventually obtained FDA approval in 1981 to introduce atenolol into the market for use in the treatment of hypertension, and FDA approval in 1985 for atenolol's use in the treatment or prophylaxis of angina. ICI marketed its atenolol formulations under the brand name TENORMIN.18

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