Purdue Pharma, L.P. v. F.H. Faulding and Co., Civ.A. 96-427-JJF.

• Decision Date: 23 April 1999
• Docket Number: No. Civ.A. 96-427-JJF.,Civ.A. 96-427-JJF.
• Parties: PURDUE PHARMA, L.P., and The Purdue Frederick Company, Plaintiffs, v. F.H. FAULDING AND COMPANY, Faulding Inc., Purepac Pharmaceutical Co., and Zeneca Inc., Defendants.
• Court: U.S. District Court — District of Delaware

48 F.Supp.2d 420

PURDUE PHARMA, L.P., and The Purdue Frederick Company, Plaintiffs, v. F.H. FAULDING AND COMPANY, Faulding Inc., Purepac Pharmaceutical Co., and Zeneca Inc., Defendants.

No. Civ.A. 96-427-JJF.

United States District Court, D. Delaware.

April 23, 1999.

COPYRIGHT MATERIAL OMITTED

COPYRIGHT MATERIAL OMITTED

William J. Marsden, Jr., Joanne Ceballos, Potter Anderson & Corroon LLP, Wilmington, Delaware, S. Leslie Misrock, Stanton T. Lawrence, III, Victor N. Balancia, Todd A. Wagner, F. Dominic Cerrito, Pennie & Edmonds, New York City, for plaintiffs.

Jack B. Blumenfeld, Karen Jacobs Louden, Morris, Nichols, Arsht & Tunnell, Wilmington, Delaware, Edward J. Handler, III, Paul H. Heller, Steven J. Lee, Pamela G. Salkeld, William G. James, Kenyon & Kenyon, New York City, W. Charles Lucas, Laura Davies of Zeneca Inc., Wilmington, Delaware, for defendants.

MEMORANDUM OPINION

FARNAN, Chief Judge.

INTRODUCTION

This action was brought by Purdue Pharma L.P. and The Purdue Frederick Company (collectively, "Purdue") against Faulding Inc., Faulding Pharmaceutical Co., Faulding Services, Inc., Purepac Pharmaceutical Co. (collectively, "Faulding") and Zeneca, Inc. ("Zeneca") for infringement of U.S. Patent Number 5,672,360 (the "'360 Patent"). The '360 Patent issued to Purdue on September 30, 1997, and claims methods for-effectively treating pain by administering to an individual patient on a 24-hour basis an oral opioid formulation, in this case morphine, which achieves a certain pharmacokinetic profile, including a relatively large fluctuation in blood concentration levels of the drug. Purdue contends that Faulding's method of using Kadian, a sustained release oral morphine product, on a once-a-day basis literally infringes Claims 2, 4 and 11 of the '360 Patent.

In defense to this action, Faulding contends that Purdue has not established that Kadian infringes the '360 Patent. In addition, Faulding raises the affirmative defenses of invalidity and unenforceability of the '360 Patent. Specifically, Faulding contends that the '360 patent is invalid on the grounds of lack of written description, obviousness, anticipation and public use and unenforceable due to alleged inequitable conduct by Purdue before the United States Patent and Trademark Office ("PTO").

The Court has subject matter jurisdiction over this action pursuant to 28 U.S.C. § 1338(a), because this action arises under the patent laws of the United States, Title 35, United States Code. Additionally, the Court has personal jurisdiction over Faulding and Zeneca, because they are incorporated in the State of Delaware, and therefore reside in this District. Likewise, venue is appropriate in this District under 28 U.S.C. § 1391(b)-(c) and § 1400(b), because all Defendants are Delaware corporations which are subject to personal jurisdiction in this District. Neither jurisdiction nor venue is contested by the parties.

The Court bifurcated the liability and damages issues for purposes of trial and conducted a seven-day bench trial on the issues of infringement, validity and enforceability of the '360 Patent. On the fourth day of trial, the Court dismissed Purdue's claims against Zeneca, finding that Purdue provided insufficient evidence to support a finding of liability for infringement by Zeneca. This Memorandum Opinion constitutes the Court's Findings of Fact and Conclusions of law on the remaining claims and defenses presented by Purdue and Faulding.

BACKGROUND

I. The '360 Patent

Prior to the development of the '360 Patent, Purdue developed and marketed MS Contin, a sustained-release oral morphine formulation recommended for dosing on a twice-a-day basis, i.e. every 12 hours. MS Contin was launched in the United States in 1984. MS Contin and other twice-daily morphine products represented a significant advance over immediate release oral morphine formulations, because immediate release morphine formulations only provide about 4 hours of pain relief, have to be administered up to six times a day, and subject the patient to a continuing cycle of painful episodes that are difficult to bring under control. (Tr. 44; PTX 126, pp. 631-632; D.I. 199 at para 12).

Following its development of MS Contin, Purdue contends that, in the mid to late 1980s, it sought to develop an oral, sustained-release opioid formulation that would be suitable for once-a-day administration. (Tr. 54:25-55:-11; 457:6-14). The Purdue physicians and scientists directing this effort contend that they had in mind the unique goal of developing a once-a-day oral opioid formulation that would provide relatively large fluctuations, in excess of 100% fluctuations, in blood plasma concentrations of the opioid analgesic drug following administration. (Tr. 55:17-56:20). Particularly, the Purdue inventors contend that they sought to develop an analgesic treatment meeting three specific criteria or design goals: (1) a T_max (or time to maximum plasma concentration) relatively early in the 24-hour dosing interval, which was considered to be about the first third or so of the 24-hour dosing interval and which corresponds to about 2 to 8 or about 10 hours; (2) larger fluctuation in plasma opioid concentrations than a 100% fluctuation; and (3) effective treatment of pain for about 24 hours. (Tr. 55-75; 459:2-10). According to Purdue, this proposed treatment method was contrary to the accepted clinical view that sustained-release formulations in general should provide minimal fluctuations during the dosage interval. (Tr. 50:10-52:18; Tr. 249-250; PTX 162, p. 188; PTX 164, p. 744). As described by Purdue, these minimal fluctuations were plasma concentration levels of the active drug where the variation between the maximum and minimum concentrations did not exceed 100%, which corresponds to a peak or maximum plasma concentration that is twice or less the minimum concentration.

Purdue contends that by mid-1988, Dr. Goldenheim and Dr. Kaiko, two of the Purdue inventors, conveyed the design goals for their method to Mr. Oshlack, Purdue's senior scientist responsible for developing new dosage forms. (Tr. 63, 84:6-9, 42:17-21; 462:11-463:9; 561:20-562:9; 564:20-565:3). By July 1988, Mr. Oshlack developed two experimental morphine formulations for clinical testing to see if the results would meet the design goals. The results of the clinical study on the two experimental formulations ("Clinical Study MC88-0504") showed that the formulations met the first two design goals, achieving a T_max within the first third of the dosing interval and a plasma opioid fluctuation greater than 100%. (Tr. 59-63; 464:12-465:6, 465:25-467:1, 566:9-567:2, PTX 117). However, Clinical Study MC88-0504 failed to meet the third design goal of providing effective treatment of pain for 24 hours, because the results failed to achieve sufficiently high plasma opioid levels for the entire intended 24-hour dosing interval. (Id.) Despite its initial failure, Purdue contends that it continued pursuing the development of a once-a-day formulation meeting its design criteria.

By 1993, Purdue contends that clinical work established that Purdue had developed a formulation that satisfied all of its design goals. Thereafter, Purdue worked with its outside patent counsel, Mr. Davidson to prepare a series of patent applications on the once-a-day oral opioid inventions, including U.S. Patent Application Serial No. 08/578,688 (the "'688 Application") that became the '360 Patent.

Despite the issuance of the '360 Patent, Purdue does not currently sell any once-a-day opioid analgesic products in the United States, nor does it have a New Drug Application ("NDA") pending for a once-a-day morphine product. (Tr. 113-114). In addition, Purdue has not conducted any clinical trials in the United States wherein a morphine formulation within the scope of the claims of the '360 Patent was administered on a once-a-day basis to a patient in pain. (Tr.480). At trial, Purdue announced its plan to seek an NDA for a drug that uses the '360 invention in the first quarter of 1999.

II. Faulding's Accused Product — Kadian

According to Faulding, its sustained-release morphine project began in 1987 under the internal project designation "Molly," and rapidly became Faulding's "number one priority." (Tr. 1036, 1040, 747, 806, 876). According to Faulding, the goal of the Molly project was to develop a formulation that would provide pain relief for a minimum of 12 hours. To this end, Faulding sought to develop a formulation that could be administered every 12 or 24 hours. (Tr. 749). In addition, Faulding contends that it specified ten desired characteristics for the formulation: (1) minimal peak-to-trough variation in blood morphine concentrations when administered twice daily; (2) minimal diurnal variation; (3) the co-administration of food should not alter the absorption rate when compared with administration in the fasted state; (4) minimal variation between inter- and intra-subject blood morphine pharmacokinetics; (5) with respect to items 1 to 4, significant advancement when compared to MST (Purdue's MST Continus, the overseas counterpart of MS Contin); (6) stability with respect to drug content and drug release rate; (7) polymer coats applied in aqueous or ethanol solutions for manufacturing rather than polymer coats applied in organic solvents such as methanol and methylene chloride; (8) raw materials used in production must be supported by Certificates of Analysis meeting the appropriate pharmacopeial standards; (9) morphine raw material sourced from Australian production; and (10) patent protection. (Tr. 879-883; DTX 650 at FA 112342).

Under the direction of Dr. Angelo Morella, Faulding initially developed two formulations, designated Molly 1 and Molly 2, which were tested in human subjects in clinical trial MOB-2/88. Although Molly 1 and Molly 2 met many of Faulding's objectives, including an extended T_max, Faulding sought to create a formula with an even...