Pfizer, Inc. v. Food and Drug Admin., Civ. No. HM-88-1019.

• Decision Date: 05 October 1990
• Docket Number: Civ. No. HM-88-1019.
• Citation: 753 F. Supp. 171
• Parties: PFIZER, INC. v. FOOD AND DRUG ADMINISTRATION.
• Court: U.S. District Court — District of Maryland

753 F. Supp. 171

PFIZER, INC. v. FOOD AND DRUG ADMINISTRATION.

Civ. No. HM-88-1019.

United States District Court, D. Maryland.

October 5, 1990.

Richard M. Barnes and Charles P. Goodell, Jr., Baltimore, Md., Peter Barton Hutt, Herbert Dym, Bruce N. Kuhlik, Covington & Burling, Washington, D.C., George W. Evans, Marvin R. Frank and Peter C. Richardson, New York City, for plaintiff.

Glenda G. Gordon, Asst. U.S. Atty., John R. Bolton, Asst. Atty. Gen., Baltimore, Md., Kenneth L. Jost, Civ. Div., U.S. Dept. of Justice, Thomas Scarlett, Chief Counsel, and Mary K. Pendergast, Asso. Chief Counsel, Food and Drug Admin., Rockville, Md., for defendant.

ORDER

HERBERT F. MURRAY, Senior District Judge.

After the parties filed cross-motions for summary judgment, this case was referred to United States Magistrate Catherine C. Blake for rulings on those motions. Magistrate Blake issued a Report and Recommendation on October 2, 1989. Having conducted a de novo review of the file, the Magistrate's Report and Recommendation, and the plaintiff's objections thereto, this Court is prepared to rule and will adopt the Magistrate's Report in full.

In its Objection to the Magistrate's Report, plaintiff generally reiterates the arguments made in support of plaintiff's motion for summary judgment. Essentially, plaintiff challenges as erroneous the FDA's interpretation of the term "drug" in § 355(b)(1) and (c)(2) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 301, et seq. The FDA interprets the word "drug" as used in these sections to mean the "drug product" for which the new drug application ("NDA") was filed. Pfizer contends that the term "drug" in this context refers to both the drug substance (active ingredient) and the drug product. On this basis, Pfizer seeks declaratory and injunctive relief compelling FDA to accept and publish patent information on unapproved tablet formulations of nifedipine.

Plaintiff's argument is without merit. This Court agrees with the Magistrate that the FDA's interpretation is not only reasonable but also consistent with the language of the statute, Congressional intent, prior judicial interpretations of § 355, and the agency's own regulations.

Accordingly, it is this 5th day of October, 1990, by the United States District Court for the District of Maryland,

ORDERED:

(1) that the Magistrate's Report and Recommendation be, and the same hereby is, Affirmed and Adopted in full and incorporated herein;

(2) that defendant FDA's cross-motion for summary judgment be, and the same hereby is, Granted;

(3) that plaintiff Pfizer's motion for summary judgment be, and the same hereby is, Denied;

(4) that judgment be, and the same hereby is, Entered in favor of defendant FDA.

MAGISTRATE'S REPORT AND RECOMMENDATION

Oct. 2, 1989

CATHERINE C. BLAKE, United States Magistrate.

This case has been referred to me by Judge Herbert F. Murray pursuant to 28 U.S.C. § 636(b) and Local Rule 80 (now Local Rule 301) for a report and recommendation on pending summary judgment motions. Oral argument was heard on May 10, 1989. For the reasons set forth below, I will recommend that Pfizer's motion for summary judgment be denied and the FDA's cross motion for summary judgment be granted.

Under the Federal Food, Drug and Cosmetic Act ("the Act"), 21 U.S.C. § 301, et seq., a "new drug" is defined as "any drug ... the composition of which is such ..." that it is not generally recognized by qualified experts as safe and effective for use under the conditions recommended in its labeling. 21 U.S.C. § 321(p)(2). Before a new drug may be marketed in the United States, the Food and Drug Administration ("FDA" or "agency") must approve a new drug application ("NDA") submitted by the manufacturer. 21 U.S.C. § 355(a).

In addition to other information, the NDA must include a "full list" of "components" of the drug, a "full statement" of the "composition" of the drug, and extensive information on studies done to show that the drug is both safe and effective. 21 U.S.C. § 355(b). The agency is required to publish a list of "the official and proprietary name" of each drug approved for safety and effectiveness ("listed drug"), 21 U.S.C. § 355(j)(6), which it does in a publication entitled Approved Drug Products (the "Orange Book"). (See FDA's Motion for Summary Judgment, Affidavit of Robert A. Bell, Exhibit 5). Information concerning both the safety and the effectiveness of new drugs has been required under the Act since 1962. See Weinberger v. Hynson, Westcott & Dunning, Inc., 412 U.S. 609, 613-14, 93 S.Ct. 2469, 2475, 37 L.Ed.2d 207 (1973).

Once a drug has been approved and listed, another drug manufacturer may seek FDA marketing approval for an identical or closely similar product (a "generic" drug) by submitting and having approved an abbreviated new drug application ("ANDA"). 21 U.S.C. § 355(j). The Drug Price Competition and Patent Term Restoration Act, Pub.L. No. 98-417, generally known as the "Hatch-Waxman Amendments", enacted on September 24, 1984 (the "1984 Amendments"), significantly relaxed the ANDA procedures. The 1984 Amendments permitted a manufacturer of a generic drug to rely on the safety and effectiveness data submitted by the "pioneer" drug manufacturer with its NDA for the previously approved drug.¹

Specifically, a manufacturer wishing to submit an ANDA for a non-identical copy of a listed drug must first submit a "suitability" petition to the FDA, which shall be approved unless the FDA determines that new safety and effectiveness studies are necessary. 21 U.S.C. § 355(j)(2)(C).² If the petition is approved, the ANDA may be filed, and the manufacturer may rely on the safety and effectiveness data submitted with the pioneer drug's NDA. The manufacturer, however, must supply with the ANDA evidence showing the new generic drug is "bioequivalent" to and can be expected to have the same therapeutic effect on patients as the listed drug. 21 U.S.C. § 355(j)(2)(A)(iv).

The purpose of the 1984 Amendments was to facilitate the approval of generic drugs, thus making available more low-cost drugs to the public. As compensation to the pioneer drug manufacturer for sharing its safety and effectiveness data, and as an incentive for new drug research, the 1984 Amendments also provided varying periods of non-patent marketing exclusivity for drugs approved after December 31, 1981, and protections in the form of limited patent extensions under certain circumstances. Mead Johnson Pharmaceutical Group v. Bowen, 838 F.2d 1332, 1333 (D.C.Cir.1988), Norwich Eaton Pharmaceuticals v. Bowen, 808 F.2d 486, 488 (6th Cir.), cert. denied, 484 U.S. 816, 108 S.Ct. 68, 98 L.Ed.2d 32 (1987); Abbott Laboratories v. Young, 691 F.Supp. 462, 464 (D.D.C.1988); Glaxo, Inc. v. Heckler, 623 F.Supp. 69, 72 (E.D.N. C.1985).

In order to ensure that the holder of an NDA receives the patent protection it is entitled to, the 1984 Amendments also provide that an applicant for an NDA:

shall file with the application the patent number and the expiration date of any patent which claims the drug for which the applicant submitted the application or which claims a method of using such drug³ and with respect to which a claim of patent infringement could reasonably be asserted if a person not licensed by the owner engaged in the manufacture, use, or sale of the drug.... Upon approval of the application, the Secretary shall publish such information....

21 U.S.C. § 355(b)(1). An applicant for an ANDA seeking to rely on the safety and effectiveness data previously submitted in connection with a listed drug must file:

"a certification ... with respect to each patent which claims the listed drug ...

(I) that such patent information has not been filed,

(II) that such patent has expired,

(III) of the date on which such patent will expire, or

(IV) that such patent is invalid or will not be infringed by the manufacture, use, or sale of the new drug for which the application is submitted....

21 U.S.C. § 355(j)(2)(A)(vii). If the ANDA applicant files a certification under subclause (IV), it must also give notice to the patent owner and the holder of the NDA for the listed drug. 21 U.S.C. § 355(j)(2)(B)(i). If an action for patent infringement is filed within 45 days thereafter, the FDA must withhold approval of the ANDA for up to 30 months while the court action is pending. 21 U.S.C. § 355(j)(4)(B)(iii).

In 1981, the FDA approved Pfizer's NDA for nifedipine solution in a soft gelatin capsule, which Pfizer markets in the United States under the trade name Procardia. Nifedipine is recognized as a valuable therapeutic agent in the treatment of angina. After enactment of the 1984 Amendments, the FDA directed holders of previously approved NDA's to submit patent information as required under 21 U.S.C. § 355(c)(2).⁴ Pfizer submitted, and the FDA accepted for filing, information concerning patent number 3,644,627 (the "'627 patent"), which claims the drug substance nifedipine and its use in treating diseases of the circulation and angina pectoris, and patent number 3,784,684 (the "'684 patent"), which claims nifedipine solution in an oral release capsule. The '627 patent expires in 1989; the '684 patent expires in 1991. Both patents were published in the Orange Book with the listing for Procardia. (See Pfizer's Motion for Summary Judgment, Declaration of John E. Wolleben, and Exhibits 1-3 attached thereto).

Pfizer also submitted patent number 4,412,986 (the "'986 patent"), which claimed a tablet formulation of nifedipine. That patent does not expire until the year 2000. (Id., Exhibits 2, 4 and 6). The FDA, however, refused to publish that patent without a certification from Pfizer that the drug and the formulation or composition of the drug claimed by the patent was currently approved under 21 U.S.C. § 355. In a letter dated July 29, 1985, the FDA stated:

This policy was established to implement the statutory requirement that the formulation or product patent must apply

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