Bristol-Myers Squibb v. Andrx Pharmaceuticals

• Decision Date: 04 June 2004
• Docket Number: No. 03-60703-CIV.,03-60703-CIV.
• Citation: 343 F.Supp.2d 1124
• Parties: BRISTOL-MYERS SQUIBB COMPANY and E.R. Squibb & Sons, L.L.C., Plaintiffs, v. ANDRX PHARMACEUTICALS, INC. and Andrx Pharmaceuticals, L.L.C., Defendants.
• Court: U.S. District Court — Southern District of Florida

343 F.Supp.2d 1124

BRISTOL-MYERS SQUIBB COMPANY and E.R. Squibb & Sons, L.L.C., Plaintiffs, v. ANDRX PHARMACEUTICALS, INC. and Andrx Pharmaceuticals, L.L.C., Defendants.

No. 03-60703-CIV.

United States District Court, S.D. Florida.

June 4, 2004.

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Laura Besvinick, Luca Roberto Bronzi, Hogan & Hartson, Miami, FL, Pasquale A. Razzano, Henry Park, David F. Ryan, Fitzpatrick Cella Harper & Scinto, New York City, for Plaintiffs.

James Costigan, Alan B. Clement, Katharine G. Loving, Hedman & Costigan, New York City, Teresa Ragatz, Eric David Isicoff, Michael Darren Bon, Isicoff Ragatz & Koenigsberg, Miami, FL, for Defendants.

FINDINGS OF FACT AND CONCLUSIONS OF LAW

HUCK, District Judge.

THIS MATTER is before the Court for a ruling on the issues presented during a bench trial held from April 26 to 30, 2004. In this patent infringement action, the crux of the Plaintiffs' case relies on their suggestion that one of the ingredients, microcrystalline cellulose, in the Defendants' proposed medicinal tablet formulations can be divided into two portions, one portion of which functions actively as a binder and disintegrant and a second portion of which acts passively as a filler. The Court finds, largely on the ground that this is an artificial division of a single ingredient into two components that is neither based on scientifically sound principles nor satisfies the Court's construction of the patent claims, that the Defendants' products do not infringe Plaintiffs' patent.

Background and Procedural History

On April 10, 2003, Plaintiffs Bristol-Myers Squibb and its wholly owned subsidiary E.R. Squibb & Sons, L.L.C. (collectively referred to as "Bristol"), Delaware corporations located in New York, New York, filed this claim for infringement of one of its pharmaceutical patents against Andrx Pharmaceuticals, Inc., and its wholly owned subsidiary, Andrx Pharmaceuticals, L.L.C. (collectively referred to as "Andrx"), Florida corporations located in Davie, Florida, under the Hatch-Waxman Act, 35 U.S.C. § 271(e)(2).¹ The Hatch-Waxman Act establishes rules for patent infringement in pharmaceutical product cases which create a statutory act of infringement before a potentially infringing company actually brings its product to the market. See Glaxo Wellcome Inc. v. Andrx Pharm., Inc., 344 F.3d 1226, 1228 (Fed.Cir.2003); Yamanouchi Pharm. Co. v. Danbury Pharmacal, Inc., 231 F.3d 1339, 1347 (Fed.Cir.2000). Under the Hatch-Waxman Act, the producer of a generic pharmaceutical product does not have to provide the extensive safety and efficacy data required in a New Drug Application ("NDA") that must be submitted to the Food and Drug Administration ("FDA") before a new brand name drug can be put on the market. Rather, the generic company may submit an Abbreviated New Drug Application ("ANDA") which must merely provide sufficient technical data to demonstrate that the generic drug is bioequivalent to the brand name drug, meaning that it provides equivalent blood plasma levels of the active ingredient over time as the brand name product. The names of all new drugs for which patents have been issued are recorded in an FDA publication called "Approved Drug Products with Therapeutic Equivalence Evaluations," which is more commonly referred to as the "Orange Book."

The generic drug manufacturer must also explain to the FDA why its product does not infringe any patent listed in the Orange Book by certifying that (1) the brand name manufacturer has not filed a patent with the FDA, (2) the patent has expired (a "Paragraph II certification"), (3) the patent will expire before the generic product enters the market, or (4) the patent for the brand name drug is invalid or will not be infringed by production, use, or sale of the generic product (a "Paragraph IV certification"). 21 U.S.C. § 355(j)(2)(A)(viii). If an ANDA applicant completes a Paragraph IV certification, the applicant must also submit a detailed notice to the patent owner explaining the factual and legal basis for the opinion that the patent is invalid or that the generic product will not infringe the patent. Id. at § 355(j)(2)(B). Upon receipt of a Paragraph IV notification letter, the patent owner may file a suit for patent infringement within forty-five days of receipt of that letter, in which case the FDA may not approve the ANDA for thirty months or until a United States court finds for the defendant based on non-infringement, patent invalidity, or patent unenforceability. 21 U.S.C. § 355(j)(5)(B)(iii). The patent holder can thus establish infringement by showing that the generic company's certification "is in error as to whether commercial manufacture, use, or sale of the new drug (none of which, of course, has actually occurred) violates the relevant patent." Eli Lilly & Co. v. Medtronic, Inc., 496 U.S. 661, 678, 110 S.Ct. 2683, 110 L.Ed.2d 605 (1990).

On December 27 and 30, 2002, Andrx filed two ANDAs, Nos. 76-608 and 76-620, with the FDA seeking approval to sell different dosage levels of generic versions of Bristol's antihypertensive drug products containing fosinopril sodium which are sold under the brand name Monopril® and Monopril® HCT (a fosinopril product that also contains a second active ingredient, the diuretic hydrochlorothiazide ("HCT")). Although the Orange Book lists two patents for Monopril® and Monopril® HCT, the parties agree that the issues in this case all relate only to whether Andrx infringed United States Patent No. 5,006,344 (" the '344 patent"), issued April 9, 1991, and owned by Bristol's subsidiary, E.R. Squibb & Sons, Inc.² The '344 patent, which does not expire until July 10, 2009, describes a stable tablet containing fosinopril sodium or fosinopril sodium and HCT in combination with other inert pharmaceutical ingredients, known in the field as excipients. With respect to the '344 patent, on December 23, 2002, Andrx representative Ted Whitlock signed Paragraph IV certifications as to each fosinopril product Andrx intends to manufacture and sell, and, on February 21 and 24, 2003, signed two Notices of Certification of Invalidity or Noninfringement of a Patent, which were sent to Bristol Meyers Squibb Company.³ On April 10, 2003, within forty-five days of receipt of the Paragraph IV notice letters, Bristol timely filed identical complaints in both the United States District Court for the Southern District of Florida and the United States District Court for the Southern District of New York. Andrx filed an answer in this case on May 13, 2003. After some initial discovery and motions directed to determining the proper venue for this action, the New York case was transferred to the Southern District of Florida, and this case proceeded on the merits.⁴

On December 15, 2003, Andrx moved this Court to conduct a separate claim construction hearing under Markman v. Westview Instruments, Inc., 52 F.3d 967, 979 (Fed.Cir.1995), aff'd, 517 U.S. 370, 116 S.Ct. 1384, 134 L.Ed.2d 577 (1996). After full briefing and oral argument, the Court concluded that a separate Markman hearing was not necessary because the case was being tried only to the Court and because there was a significant overlap between the evidence of infringement and evidence that would be presented in a claim construction hearing. Therefore, the Court held that conducting two separate proceedings would be inefficient and more costly and, on January 15, 2004, denied Andrx's motion for a separate Markman hearing. On January 5, 2004, Bristol moved to amend its complaint to include a claim for willful infringement. The Court granted that motion on January 15, 2004. However, on February 6, 2004, the Court also granted Andrx's cross-motion to bifurcate the trial on willfulness, deciding that, if necessary, an additional trial on willfulness related primarily to Andrx's reliance on opinion of counsel, if Andrx chose to use such evidence, would be convened shortly after the first trial, allowing a brief period for additional discovery on that issue.

On February 6, 2004, the Court also denied as premature Andrx's motion in limine to exclude evidence regarding an experiment conducted by UPM Pharmaceuticals, a company utilized by Bristol. The Court noted that, because that motion relied heavily on concerns over the scientific validity and relevance of the experiment which would need to be resolved in a Daubert hearing, the Court would allow the parties, at trial, to present evidence and argument regarding that experiment and would decide at that time whether that evidence should be excluded. On March 9, 2004, with the consent of both parties, the Court specially set the trial on infringement for April 26, 2004. Prior to trial, Bristol filed a motion in limine to exclude evidence of patent invalidity on the ground that Andrx had not provided an expert opinion on invalidity due to indefiniteness, arguing that Andrx would not be able to prove indefiniteness due to double inclusion without expert testimony. The Court denied that motion on April 15, 2004.

The Court commenced a five day non-jury trial on April 26, 2004. Bristol presented evidence in the form of lay testimony from Dr. Nemichand Jain, one of the inventor's named in Bristol's '344 patent, from Stephen Davis, the patent lawyer who prepared the '344 patent application for Bristol, and from Ted Whitlock, Andrx's in-house legal counsel who prepared the Paragraph IV certifications and notice letters. Bristol also presented expert testimony, both in its case-in-chief and in its rebuttal case, from Dr. Alexander Klibanov, a Professor of Chemistry and Bioengineering at the Massachusetts Institute of Technology. Andrx presented lay testimony from Dr. Guohua Zhang, the Andrx formulator responsible for overseeing the development of Andrx's generic fosinopril products, and expert testimony from Dr. Reza Fassihi, a Professor of Biopharmaceutics and Industrial Pharmacy at the Temple University School...