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
Accordingly, it is this 5th day of October, 1990, by the United States District Court for the District of Maryland,
(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.
Specifically, a manufacturer wishing to submit an ANDA for a non-identical copy of a listed drug must first submit a "suitability"
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:
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:
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).
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:
(Id., Exhibit 6). Because Pfizer has neither filed nor had approved an NDA for a tablet formulation of nifedipine, it could not provide the required certification as to the '986 patent.
In October 1987, Par Pharmaceutical, Inc. ("Par") filed a suitability petition with the FDA pursuant to 21 U.S.C. § 355(j)(2)(C) seeking permission to file an ANDA for a non-identical copy of Pfizer's approved nifedipine gel capsule. Par's proposed ANDA was for nifedipine in a tablet formulation. The "listed drug" Par referred to in its suitability petition was Pfizer's nifedipine capsule, Procardia. The FDA approved the petition on December 11, 1987. (Affidavit of Robert Bell, Exhibit 4).
On December 22, 1987, Pfizer filed a citizen petition under 21 C.F.R. § 10.25(a)(2) and § 10.30, requesting the FDA to declare "that patents claiming formulations of a drug which contain an active ingredient which is the subject of a pending or approved application may be filed" with the FDA under 21 U.S.C. § 355(b)(1) and (c)(2), and specifically asking the FDA to accept for filing information on the '986 patent and another patent number 4,562,069 (the "'069 patent"), both of which claim nifedipine in tablet formulation. (A.R. 2).
Par filed comments on Pfizer's citizen petition on February 24, 1988, supporting the FDA's position (A.R. 65), and Pfizer filed a reply on March 7, 1988 (A.R. 97).
In denying the petition, the FDA relied on its interpretation of the patent filing provisions in 21 U.S.C. § 355(b)(1) and (c)(2), which require information to be filed on "any patent which claims the drug for which the applicant submitted the application." The FDA interprets the term "drug" as used in § 355(b)(1) and (c)(2) to mean the "drug product" for which the NDA was filed, arguing that although an NDA must include information on the active ingredient or "drug substance" involved, an approved NDA covers only a specified drug product, which is then published in the list of "Approved Drug Products" issued by the FDA. (A.R. 109). The FDA further relied on the statutory language requiring an ANDA applicant to file
Finally, the FDA considered the purposes of the 1984 Amendments and concluded that "Congress intended to provide enhanced market protection only to those products for which an NDA applicant has submitted safety and effectiveness information, which can in turn be relied upon by a ANDA applicant." Pfizer submitted such data only for its capsule; it would receive all the patent protection on its gel capsule to which it is entitled under the Act. (A.R. 110). Accordingly, on March 30, 1988, the FDA denied Pfizer's petition and refused Pfizer's request for a stay of approval of the Par ANDA for nifedipine tablets.
On April 5, 1988, Pfizer filed the complaint in this case, seeking a declaratory judgment that patents claiming nifedipine in tablet formulations may be filed with the FDA under 21 U.S.C. §§ 355(b)(1) and (c)(2), and an injunction requiring the FDA to accept such patents. The action arises under 21 U.S.C. § 355 and the Administrative Procedure Act, 5 U.S.C. §§ 551-706. Pfizer claims that the FDA's decision, which constitutes final agency action under 21 C.F.R. § 10.45(d), was contrary to law. See 5 U.S.C. § 706(2)(A).
As stated by the D.C. Circuit in a case involving the FDA's interpretation of a different provision of the Amendments:
Mead Johnson Pharmaceutical Group v. Bowen, supra, 838 F.2d at 1335-1336. In a similar context, the Sixth Circuit stated:
Norwich Eaton Pharmaceuticals v. Bowen, supra, 808 F.2d at 491. See also Hillsborough County v. Automated Medical Laboratories, 471 U.S. 707, 714-715, 105 S.Ct. 2371, 2375-76, 85 L.Ed.2d 714 (1985); United States v. Rutherford, 442 U.S. 544, 551-54, 99 S.Ct. 2470, 2474-76, 61 L.Ed.2d 68 (1979) (upholding FDA interpretation of the term "new drug").
In this case, the agency's interpretation is not only reasonable but also consistent with the statutory language, the intent of Congress, prior judicial interpretations of § 355, and the agency's own regulations.
21 U.S.C. § 321(g)(1). This definition covers both a finished "drug product" and its active and inactive ingredient or ingredients. United States v. Generix Drug Corp., 460 U.S. 453, 459, 103 S.Ct. 1298, 1301, 75 L.Ed.2d 198 (1983).
The statutory provision at issue is 21 U.S.C. § 355, which relates to the approval of "new drugs."
Pfizer asserts that because the definition of a "drug" includes the components of a drug product, the word "drug" as used in 21 U.S.C. § 355(b)(1) and (c)(2) must mean active ingredients (in this case nifedipine) as well as drug products (Procardia); Pfizer further asserts that any patent claiming a drug product which contains the active ingredient nifedipine therefore must be filed pursuant to 21 U.S.C. § 355.
The meaning of the word "drug" in 21 U.S.C. § 355(b)(1) and (c)(2) cannot be determined apart from its context. Neither the FDA nor this court disputes that the definition of drug in § 321(g) covers both drug products and active ingredients. The relevant statutory section in this case, however, modifies the word "drug" by attaching the phrase "for which the applicant submitted the application." In that context the FDA's interpretation of drug as meaning drug product is consistent with and indeed required by the statute. Pfizer has submitted an NDA for Procardia (see FDA's Reply, Attachment A); not for nifedipine in isolation and not for the tablet formulations claimed by the '986 and '069 patents.
The other provisions of § 355(b) also are consistent with the interpretation of drug as drug product. For example, the statute requires that an NDA contain a "full list" of "components" of the drug, a "full statement" of the "composition" of the drug, and "samples" of the drug "and of the articles used as components thereof." 21 U.S.C. § 355(b)(1)(B), (C) and (E). Those requirements make sense in connection with a drug product, but not when applied
Further, the FDA's list of approved drugs, as required by statute, contains those for which an NDA was filed and approved. 21 U.S.C. § 355(j)(6)(A). That list includes Procardia, but not nifedipine in isolation or either of Pfizer's tablet formulations. (See FDA's Motion for Summary Judgment, Affidavit of Robert Bell, Exhibit 5). Accordingly, the "listed" drug to which Par refers in its ANDA properly can be only Procardia, and the certification required under 21 U.S.C. § 355(j)(2)(A)(vii) must relate only to patents which claim the drug product Procardia.
The FDA's interpretation of the term "drug" in § 355 as meaning a particular drug product is consistent with the intent of Congress in enacting both a streamlined approval process for generic drugs and additional marketing protection for pioneer drugs, under certain circumstances. The legislative history of the 1984 Amendments indicates that Congress was concerned about extending patent protection for pioneer drugs where the necessary regulatory delay to obtain FDA approval before marketing had effectively shortened the period of protection otherwise afforded by the patent. See H.R.Rep. No. 857 at 2648. Congress also wished to compensate pioneer manufacturers for the public benefit provided by allowing generic copiers to rely on the pioneer's safety and effectiveness data. Congress determined, however, that the appropriate cutoff date for certain protections was January 1, 1982; drugs approved before that date were not entitled to the additional non-patent "exclusivity" period created by the 1984 Amendments.
Procardia was approved in 1981. The only additional protection at issue in this case is the notice of ANDA filing and the automatic 30-month stay for patent infringement litigation Pfizer could obtain if the FDA accepted for filing its patents on the unapproved tablet formulations.
Pfizer has submitted in support of its position a letter from Senator Orrin G. Hatch to FDA Commissioner Frank E. Young, dated May 3, 1988, and a letter from Representative Edward R. Madigan to the Commissioner dated June 16, 1988. With all due respect to the authors of those letters, courts consistently have refused to determine legislative intent from later or even contemporaneously expressed opinions of individual legislators. While House and Senate reports may be consulted, reliance on the correspondence submitted by Pfizer would not be proper. See United
Prior to the enactment of the 1984 Amendments, the Supreme Court had recognized the FDA's interpretation of "drug" in the context of 21 U.S.C. § 355 as meaning the drug product for which approval was sought. In USV Pharmaceutical Corp. v. Weinberger, 412 U.S. 655, 664, 93 S.Ct. 2498, 2504-05, 37 L.Ed.2d 244 (1973), the Court stated:
Congress is assumed to know the judicial or administrative gloss given to particular statutory language, and therefore is assumed to have adopted the existing interpretation unless it affirmatively indicates otherwise. Cannon v. University of Chicago, 441 U.S. 677, 696-698, 99 S.Ct. 1946, 1957-58, 60 L.Ed.2d 560 (1979); Blitz v. Donovan, supra, 740 F.2d at 1245, quoting Florida Nat. Guard v. Federal Labor Relations Auth., 699 F.2d 1082, 1087 (11th Cir.), cert. denied, 464 U.S. 1007, 104 S.Ct. 524, 78 L.Ed.2d 708 (1983). This assumption may not be realistic unless the agency's construction has been brought to public attention. United States v. Rutherford, supra, 442 U.S. at 554 n. 10, 99 S.Ct. at 2476 n. 10. In this case, the agency's construction has been made wellknown through the regulations it adopted concerning new drug applications under 21 U.S.C. § 355. See generally 21 C.F.R. § 314.1 et seq. (1984). Congressional familiarity with the regulations is evidenced by the Committee's statement in its report that it intended to "clarify" the interpretation of 21 C.F.R. § 314.14(f)(5). H.R.Rep. No. 857 at 2668.
Pfizer claims that the FDA has been inconsistent regarding its interpretations of the 1984 Amendments. In support of this claim, Pfizer states that on November 16, 1984 (shortly after the 1984 Amendments became effective), the FDA issued a letter to "interested persons" stating that it intended to publish in the Approved Products List only patents on active ingredients and not on formulations. The tentative nature of this interpretation was evidenced by the FDA's further statement in the letter that it would be inviting comments from all interested persons on whether it had "excluded any patents that should have been included or included patents that should have been excluded." (Pfizer's Motion for Summary Judgment, Exhibit C at 4). Upon further consideration, the FDA adopted the position urged by the Pharmaceutical Manufacturers Association and on May 1, 1985, agreed that "the publication requirement includes formulation and composition patents that claim a listed drug product." (Id., Exhibit D). The FDA has not changed that position, which is more beneficial to Pfizer than its original intention of filing patents on active ingredients only. The FDA has never even tentatively endorsed an interpretation of the 1984 Amendments that would require manufacturers to file patent information on unapproved unlisted formulations. Nor has Pfizer shown any inconsistency in the FDA's interpretation of the word drug in § 355(b) to mean drug product.
Accordingly, for the reasons set forth above, it is hereby recommended that the defendant FDA's cross-motion for summary judgment be GRANTED; the plaintiff Pfizer's motion for summary judgment be DENIED; and judgment be entered in favor of the FDA.
21 U.S.C. § 321(p).