Dr. Reddy's Laboratories, Inc. v. Thompson

• Citation: 302 F.Supp.2d 340
• Decision Date: 15 September 2003
• Docket Number: Civil No. 02-452(WGB).
• Parties: DR. REDDY'S LABORATORIES, INC., and Dr. Reddy'S Laboratories Ltd., Plaintiffs, v. Tommy G. THOMPSON, as Secretary of United States Department of Health and Human Services; Lester Crawford, as Acting Principal Deputy Commissioner of Food and Drugs, United States Food and Drug Administration; United States Food and Drug Administration; and Andrx Pharmaceuticals, Inc., Defendants, v. Genpharm, Inc., Intervenor-Defendant.
• Court: U.S. District Court — District of New Jersey

Page 340

302 F.Supp.2d 340

DR. REDDY'S LABORATORIES, INC., and Dr. Reddy'S Laboratories Ltd., Plaintiffs, v. Tommy G. THOMPSON, as Secretary of United States Department of Health and Human Services; Lester Crawford, as Acting Principal Deputy Commissioner of Food and Drugs, United States Food and Drug Administration; United States Food and Drug Administration; and Andrx Pharmaceuticals, Inc., Defendants, v. Genpharm, Inc., Intervenor-Defendant.

Civil No. 02-452(WGB).

United States District Court, D. New Jersey.

September 15, 2003.

COPYRIGHT MATERIAL OMITTED

Budd, Larner, Rosenbaum, Greenberg & Sade, P.C., by Andrew J. Miller, Esq., Brian T. Moriarty, Esq., Vijayant Pawar, Esq., Short Hills, NJ, for Plaintiffs.

Robert D. McCallum, Jr., Assistant Attorney General, Christopher J. Christie, United States Attorney, by Susan Cassell, Asst. U.S. Attorney, United States Attorney's Office, Newark, NJ, Andrew E. Clark, Esq., Office of Consumer Litigation, U.S. Department of Justice, Washington, DC, Daniel E. Troy, Chief Counsel, Karen E. Schifter, Assoc. Chief Counsel, U.S. Food and Drug Administration, Rockville, MD, for the Government Defendants.

Proskauer Rose LLP, by Margaret A. Dale, Esq., Jennifer R. Scullion, Esq., Louis M. Solomon, Esq., Colin A. Underwood, Esq., New York, NY, Greenbaum, Rowe, Smith, Davis & Himmel LLP, by Richard L. Hertzberg, Esq., Woodbridge, NJ, for Defendant Andrx Pharmaceuticals, Inc.

Saiber, Schlesinger, Satz & Goldstein, LLC, by Arnold B. Calmann, Esq., Jeffrey Soos, Esq., Newark, NJ, Frommer, Lawrence & Haug LLP, by Edger H. Haug, Esq., Charles J. Raubicheck, Esq., Andrew M. Berdon, Esq., New York, NY, for Intervenor-Defendant Genpharm, Inc.

AMENDED OPINION

BASSLER, District Judge.

This is an action pursuant to the Administrative Procedure Act (APA), 5 U.S.C. § 701, et seq., challenging decisions made by the Food and Drug Administration (FDA) during the generic drug approval process for one of several generic versions of omeprazole, a drug consumers know by the brand name Prilosec®. Plaintiffs Dr. Reddy's Laboratories, Inc., and Dr. Reddy's Laboratories Ltd. ("Reddy") challenge the legality of certain aspects of the FDA's interpretation of the Drug Price Competition and Patent Term Restoration Act of 1994. Hatch-Waxman Act, Pub.L. No. 98-417, 98 Stat. 1585 (1984), codified at 21 U.S.C. §§ 355, 360, 35 U.S.C. §§ 156, 271, 282 ("Hatch-Waxman Amendments" or "the Amendments"). The FDA applied the allegedly erroneous interpretations of the Amendments in deciding that Reddy is not eligible to share a statutory exclusivity period for marketing its generic 40 mg omeprazole product with defendant Andrx Pharmaceuticals, Inc. ("Andrx").¹ Reddy now moves for summary judgment on its claims, challenging three FDA decisions, and asks the Court to vacate those decisions and remand this matter.

The generic omeprazole product at issue in this action is also the subject of a patent infringement action brought by AstraZeneca, L.P. ("Astra"), producer of Prilosec®, against Reddy, Andrx, Genpharm, and a fourth defendant. See In re Omeprazole Patent Litigation, 222 F.Supp.2d 423 (S.D.N.Y.2002).

The Court finds with respect to each of the FDA's decisions here at issue that the FDA interpreted the Hatch-Waxman Amendments in a permissible manner consistent with the statutory scheme therein devised to regulate the generic drug approval process. Therefore, Reddy's motion for summary judgment is denied, and summary judgment is granted instead in favor of the FDA on all claims. Furthermore, because Reddy seeks relief only against the FDA under the APA and seeks no relief against Andrx, all claims against Andrx are dismissed.²

I. Statutory & Regulatory Framework

It is by now well understood that the Hatch-Waxman Amendments accelerate the process by which the FDA approves generic drugs for manufacture and sale. Companies desiring to produce and sell new drugs in the first instance, so-called innovator companies, must file new drug applications (NDAs) with the FDA that include, inter alia, data on whether the new drug is safe and effective in use obtained through substantial testing. 21 U.S.C. § 355(a) & (b). Companies desiring to produce and sell generic versions of already-approved new drugs, however, need not submit the same testing data. Instead, generic drug makers file abbreviated new drug applications (ANDAs), the contents of which are set by the statute, that include data showing the generic drug to be the same as or the bioequivalent of an FDA-approved drug. See 21 U.S.C. § 355(j)(2)(A)(iv); Glaxo, Inc. v. Novopharm, Ltd., 110 F.3d 1562, 1568 (Fed.Cir.1997).

Because new drugs, and uses for those drugs, may be claimed by one or more patents, the Amendments insulate generic drug makers who want to submit ANDAs ("ANDA applicants") from patent infringement claims while they prepare their ANDAs for submission to the FDA. The statute designates as non-infringing activities those activities undertaken solely to develop and submit information to the FDA. See 35 U.S.C. § 271(e)(1); Eli Lilly & Co., 496 U.S. at 671, 110 S.Ct. 2683. Upon submission of an ANDA, however, the patent owner may sue the ANDA applicant for infringement of unexpired patents claiming the drug, or a use of the drug, "if the purpose of such submission is to obtain approval under [the FDCA] to engage in the commercial manufacture, use, or sale of ... [a drug product] claimed in a patent or the use of which is claimed in a patent before the expiration of such patent." 35 U.S.C. § 271(e)(2).

The statute requires NDA applicants to submit information on any patent that "claims such drug ... or a method of using such drug" and for which a claim of patent infringement could reasonably be asserted against an unauthorized party. 21 U.S.C. § 355(b)(1), (c)(2). The FDA publishes that patent information in a publication titled "Approved Drug Products With Therapeutic Equivalence Evaluations," commonly called the "Orange Book." See 21 U.S.C. § 355(c)(2); 21 C.F.R. § 314.53(a). Based upon the Orange Book listings, ANDA applicants, in turn, file with the ANDA one of four certifications, to be made "in the opinion of applicant and to the best of his knowledge," for each patent claiming the drug, or use of the drug, for which the applicant seeks approval: (I) that patent information has not been filed ("paragraph I" certification); (II) that the patent has expired ("paragraph II" certification); (III) that the patent will expire ("paragraph III" certification); (IV) or that a listed patent is invalid or will not be infringed by the manufacture, use, or sale of the new drug for which the ANDA is submitted ("paragraph IV certification"). 21 U.S.C. § 355(j)(2)(A)(vii); 21 C.F.R. § 314.94(a)(12).

Upon filing a paragraph IV certification, ANDA applicants must give notice to the patent owner and the holder of the approved NDA, the NDA holder being the innovator. 21 U.S.C. § 355(j)(2)(B); 21 C.F.R. § 314.95. The patent owner may then sue for patent infringement pursuant to § 271(e)(2), and, if the owner does so within 45 days of receiving the notice, approval of the ANDA is stayed at least thirty months from the date the owner receives notice of the certification. 21 U.S.C. § 355(5)(B)(iii). The purpose of the 30-month stay is to allow time for patent infringement litigation. See Ben Venue Labs., Inc. v. Novartis Pharm. Corp., 146 F.Supp.2d 572, 579 (D.N.J.2001). For while ANDA approval is stayed, "section 271(e)(2)(A) makes it possible for a patent owner to have the court determine whether, if a particular drug were put on the market, it would infringe the relevant patent." Bristol-Myers Squibb Co. v. Royce Labs., Inc., 69 F.3d 1130, 1135 (Fed.Cir.1995).

To encourage prospective ANDA applicants to risk the costly patent infringement suits triggered by their filing ANDAs, the statute also provides an incentive to ANDA applicants: an applicant who files an ANDA containing a paragraph IV certification on a patent is eligible for a 180-day marketing exclusivity period during which no other generic drug maker who subsequently files an ANDA containing a paragraph IV certification on that patent can be approved for marketing its version of the drug product. See Minnesota Mining and Mfg. Co. v. Barr Lab., Inc., 289 F.3d 775, 778 (Fed.Cir.2002); Mova Pharm. v. Shalala, 140 F.3d 1060, 1064 (D.C.Cir.1998). This marketing exclusivity period starts on the earlier of the date the first-to-file ANDA applicant begins commercially marketing its generic drug or the date of "a decision of a court" finding the patent invalid, unenforceable, or not infringed. 21 U.S.C. § 355(j)(5)(B)(iv); 21 C.F.R. 314.107(c)(1) & (2).

With respect to the omeprazole drug products, patent infringement issues have been adjudicated in the New York litigation and are now on appeal. This APA action is about whether the FDA properly determined that Reddy is not entitled to the 180-day marketing exclusivity period for its 40 mg generic omeprazole product based upon the paragraph IV certification it filed with its ANDA. More generally, this action is about the scope of the FDA's authority to review the contents of abbreviated new drug applications. Before analyzing the FDA's interpretation and application of the specific statutory provisions challenged in this action, the Court reviews the factual basis for Reddy's claims and the procedural posture of the case.

II. Factual & Procedural Background

A. The Omeprazole Delayed-release Capsule ANDAs

At the time the FDA rendered its decisions on the Reddy ANDA, Astra had listed eleven patents in the Orange Book.³ A review of the certifications filed for those patents is in order.

On March 17, 1998, Andrx submitted to the FDA an ANDA (ANDA No. 75-347) seeking approval to market 10 mg and 20 mg strengths of omeprazole. (Administrative Record (A.R.) 24.) Its application included one paragraph III certification ('431) and six paragraph IV...