Elan Corp., Plc v. Andrx Pharmaceuticals, Inc.

• Decision Date: 14 March 2002
• Docket Number: No. 98-7057-CIV.,No. 98-7164-CIV.,98-7164-CIV.,98-7057-CIV.
• Citation: 272 F.Supp.2d 1325
• Parties: ELAN CORPORATION, PLC, Plaintiff and Counter-Defendant, v. ANDRX PHARMACEUTICALS, INC, Defendant and Counter-Plaintiff. Elan Corporation, PLC, Plaintiff and Counter-Defendant, v. Andrx Pharmaceuticals, Inc, Defendant and Counter-Plaintiff.
• Court: U.S. District Court — Southern District of Florida

272 F.Supp.2d 1325

ELAN CORPORATION, PLC, Plaintiff and Counter-Defendant, v. ANDRX PHARMACEUTICALS, INC, Defendant and Counter-Plaintiff.

Elan Corporation, PLC, Plaintiff and Counter-Defendant, v. Andrx Pharmaceuticals, Inc, Defendant and Counter-Plaintiff.

No. 98-7164-CIV.

No. 98-7057-CIV.

United States District Court, S.D. Florida, Miami Division.

March 14, 2002.

Order on Post Trial Motions March 24, 2003.

COPYRIGHT MATERIAL OMITTED

Steven Ira Peretz, Kluger Peretz Kaplan & Berlin Miami Center, Miami, FL, James B. Monroe, Liam O'Grady, James R. Barney, Finnegan Henderson Farabow Garrett & Dunner, Washington, DC, Terri Ellen Tuchman Meyers, Kluger Peretz Kaplan & Berlin, Fort Lauderdale, FL, for Elan Corp., PLC.

Gerald J. Houlihan, Houlihan & Partners, Miami, FL, for Andrx Pharmaceuticals, Inc.

FINDINGS OF FACT AND CONCLUSIONS OF LAW

JORDAN, District Judge.

Elan Corporation filed suit against Andrx Pharmaceuticals for patent infringement under 35 U.S.C. §§ 271(e) and 281-283. Andrx answered and interposed counterclaims, including a claim that Elan's patent was invalid. Subject matter jurisdiction exists pursuant to 28 U.S.C. §§ 1331, 1338, 2201 and 2202, and venue is proper in this district pursuant to 28 U.S.C. §§ 1391(c) and 1400(b).

After considering the evidence and arguments presented at a bench trial, I conclude that Elan's patent is invalid by virtue of the on-sale bar. See 35 U.S.C. § 102(b). As explained below, Elan commercially offered to sell an embodiment of its patent — a once-daily tablet with controlled release of naproxen — to Lederle Laboratories in 1987, several years prior to the critical date under § 102(b).

I. BACKGROUND AND PROCEDURAL POSTURE

Elan is an Irish corporation having its corporate offices and principal place of business in Dublin, Ireland. See Pretrial Stipulation at Exh. 3 ¶ 1 [D.E. 79] (April 14, 2000).¹ Elan is engaged in the business of researching and developing new pharmaceutical products, and sells these new products throughout the world. See id. ¶ 2.

Andrx is a Florida corporation with its corporate offices and principal place of business in Fort Lauderdale, Florida. See id. ¶ 13. Since the filing of the original statement of undisputed facts, Andrx has moved its corporate offices to Davie, Florida, but continues to maintain manufacturing facilities at its Fort Lauderdale address. See Andrx's Post Trial Findings of Fact and Conclusions of Law at 2 n. 3 [D.E. 212] (March 12, 2001). Andrx is engaged in the business of developing generic equivalents to brand-name pharmaceutical products. See Pretrial Stipulation at Exh. 3 ¶ 4.

A. NAPROXEN SODIUM

Naproxen sodium is a non-steroidal, anti-inflammatory drug (NSAID) exhibiting analgesic and antipyretic properties. See id. ¶ 5; Plaintiff's Exh. 302 at 6. Naproxen sodium is commonly used to relieve mild to moderately severe pain caused by rheumatoid arthritis, osteoarthritis, and other inflammatory conditions. Chronic complaints make it desirable to maintain a constant level of medication in the patient's blood stream over a period of time. See Pretrial Stipulation at Exh. 3 ¶ 6; Plaintiff's Exh. 302 at 6.

B. ELAN'S COMMERCIAL NAPROXEN SODIUM PRODUCT

On March 29, 1994, Elan filed, with the Food and Drug Administration (FDA), New Drug Application (NDA) No. 20-353 directed to Naprelan®. See Pretrial Stipulation at Exh. 3 ¶ 10. This filing consisted of 305 volumes and over 40,000 pages of information, including clinical data demonstrating the safety and effectiveness of Naprelan®. See id. The FDA approved Elan's Naprelan® NDA on January 5, 1996. See id. ¶ 11. Naprelan® was launched commercially in April of 1996. See id. ¶ 12. In 1997, during the first full year of production, Naprelan® sales in the United States exceeded $100 million. See id. ¶ 13.

C. ELAN'S '320 PATENT

Elan is the assignee of U.S.Patent No. 5,637,320 (the '320 patent) and presently retains all rights to the '320 patent. See id. ¶¶ 16, 23. The '320 patent — which remains in force until June 10, 2014 — lists two inventors: Edward A. Bourke and Seamus Mulligan. See id. ¶¶ 21-22. Elan manufactures and sells a controlled-release form of naproxen sodium under the brand name Naprelan®. See id. ¶ 8. Naprelan® provides naproxen sodium in a tablet form which may be administered once a day, for 24-hour relief. See id. ¶ 9. The parties agree that the formulation of Naprelan® "falls within the scope of the claims" of the '320 patent. Id. ¶ 16.²

The claims of the '320 patent are directed to naproxen formulations for once-daily oral administration, comprising naproxen in a multi-particulate pellet form, to allow a controlled release of the naproxen. See Plaintiff's Exh. 302 at 6. Each of the controlled-release pellets of the formulation has a core of naproxen, or a pharmaceutically acceptable salt of naproxen, in association with an organic acid. See id. A multi-layer membrane surrounds each core. See id. The drug-acid core of the pellet works in conjunction with the multi-layer membrane to provide a controlled release of naproxen over an extended time period. See Testimony of Christopher Rhodes, Trial Transcript at 538, 540 (Feb. 4, 2001); Plaintiff's Exh. 302 at 6. In one claimed embodiment of the invention, a second portion of naproxen also may be added, designed to promptly release the drug after oral administration. See Plaintiff's Exh. 302 at 6-7. The second portion of naproxen provides an immediate analgesic effect to accompany the sustained delivery of the medication. See id.

By providing naproxen in a controlled-release form that may be administered once a day, Elan's patented technology eliminated the need for patients suffering from chronic pain and discomfort to take repeated doses of prior medications, which were administered two to four times per day to provide continuous relief. See Rhodes Testimony, Trial Transcript at 542; Plaintiff's Exh. 302 at 7. Elan's patented technology also reduced the level of gastrointestinal irritation associated with prior medications, which can lead to great discomfort and can even lead to serious medical problems such as ulcers. See Plaintiff's Exh. 302 at 7.

The membrane in the patented formulation delays and controls the dissolution and release of the naproxen, allowing sustained delivery for 24-hour relief. See id. The membrane additionally eliminates "dose dumping" and reduces the amount of direct contact of the drug with the gastrointestinal tract, thus reducing irritation. See Rhodes Testimony, Trial Transcript at 542; Plaintiff's Exh. 302 at 7-8. The organic acid in the pellet core adjusts the micro-environment pH in the core and thereby assists in delaying dissolution and release of the naproxen. See Plaintiff's Exh. 302 at 7.

1. PROSECUTION OF THE '320 PATENT

On January 15, 1990, Elan filed in the Republic of Ireland a provisional patent application entitled "Controlled Absorption Naproxen Formulation for Once-Daily Administration" (the Irish priority application). See Pretrial Stipulation at Exh. 3 ¶ 17. On January 14, 1991, Elan filed U.S.Patent Application Serial No. 07/641,441, claiming a priority date of January 15, 1990, under 35 U.S.C. § 119, based on the earlier-filed Irish priority application. See id. ¶ 18.

On June 1, 1993, Elan filed a continuing patent application under 37 C.F.R. § 1.62 of prior application Serial No. 07/641,441, which the PTO assigned U.S. Serial No. 08/070,659. See id. ¶ 19. That application included a claim to priority of the earlier-filed Irish priority application. See id. On April 14, 1994, Elan filed a continuing patent application under 37 C.F.R. § 1.62 of prior application Serial No. 08/070,659, which the PTO assigned U.S. Serial No. 08/227,566. That application also included a claim to priority of the earlier-filed Irish priority application. Continuing patent application Serial No. 08/227,566 matured into the '320 patent, which issued on June 10, 1997. See id. ¶ 20.

Marla Church was a registered U.S. patent agent during the prosecution of the applications leading to the '320 patent and participated in the prosecution of the '320 patent. See id. ¶ 24. On May 21, 1991, Ms. Church submitted an Information Disclosure Statement (IDS) to the PTO, listing 11 separate references. See id. ¶ 25. Ms. Church does not know who informed her of the identity of the 11 separate references. See id. An article — Kelly et al., "Pharmacokinetic Properties and Clinical Efficacy of Once-Daily Sustained Release Naproxen," 36 Eur.J.Clin.Pharmacol. 383 (1989) (hereinafter "Kelly") — was included in the Elan IDS submitted to the PTO during the prosecution of the '320 patent. See id. ¶ 28; Defendant's Exh. 10. European Patent Application No. 0255002/A1 (Rotini et al.) was also included in Elan's IDS submitted to the PTO during the prosecution of the '320 patent, as was European Patent Application No. 0313328/A1 (Barry et al.). See id. ¶¶ 30-31.

Examiner Raj Bawa, Ph.D., the examiner at the PTO who reviewed the applications that led to the '320 patent, considered all of the references listed in the IDS submitted by Ms. Church during the prosecution of the '320 patent. See id. ¶ 26. Examiner Bawa found the claims that issued in the '320 patent to be patentable over all references listed in the IDS submitted by Ms. Church during the prosecution of the '320 patent. See id. ¶ 27.

2. CLAIMS OF THE '320 PATENT

The '320 patent contains one independent claim, Claim 1. See id. ¶ 32. Claims 3, 5, 11, 12 and 16 are dependent on Claim 1. Claims 6 and 8 are dependent on Claim 5. Claims 13, 14, 15, and 17 are dependent on Claim 12. See id. ¶ 34.

Patents are directed to those skilled in the art to which they pertain, and patent claims are interpreted as they would be understood by those skilled in the art. See generally Markman v. Westview Instruments, Inc., 52 F.3d 967, 979 (Fed.Cir.1995) (en banc), aff'd, 517 U.S. 370, 116 S.Ct. 1384, 134 L.Ed.2d 577 (1996). The '320 patent is directed to those...