Purepac Pharmaceutical Co. v. Thompson

• Decision Date: 20 January 2004
• Docket Number: No. 03-5121.,No. 02-5410.,02-5410.,03-5121.
• Citation: 354 F.3d 877
• Parties: PUREPAC PHARMACEUTICAL COMPANY, Appellee, v. Tommy G. THOMPSON, Secretary of Health and Human Services, and Lester M. Crawford Jr., Deputy Commissioner of Food and Drugs, Appellees. Torpharm, Inc. and Apotex, Inc., Appellants.
• Court: U.S. Court of Appeals — District of Columbia Circuit

354 F.3d 877

PUREPAC PHARMACEUTICAL COMPANY, Appellee, v. Tommy G. THOMPSON, Secretary of Health and Human Services, and Lester M. Crawford Jr., Deputy Commissioner of Food and Drugs, Appellees.

Torpharm, Inc. and Apotex, Inc., Appellants.

No. 02-5410.

No. 03-5121.

United States Court of Appeals, District of Columbia Circuit.

Argued November 25, 2003.

Decided January 20, 2004.

Appeals from the United States District Court for the District of Columbia (No. 02cv01657) (No. 03cv00254).

William A. Rakoczy argued the cause for appellants. With him on the briefs were Hugh S. Balsam and Arthur Y. Tsien. Hugh L. Moore, Jacqueline H. Eagle, and Matthew O. Brady entered appearances.

Andrew E. Clark, Attorney, U.S. Department of Justice, argued the cause for the federal appellees. With him on the brief were Peter D. Keisler, Assistant Attorney General; Eugene M. Thirolf, Director; Alex M. Azar II, General Counsel, U.S. Department of Health & Human Services; Daniel E. Troy, Chief Counsel; and Karen E. Schifter, Associate Chief Counsel. Christine N. Kohl, Attorney, U.S. Department of Justice; Douglas N. Letter, Litigation Counsel; and Howard S. Scher, Attorney, entered appearances.

Charles J. Raubicheck argued the cause for appellee Purepac Pharmaceutical Company. With him on the brief was Steven M. Amundson. James M. Webster, Mark C. Hansen, and Richard H. Stern entered appearances.

Before: GINSBURG, Chief Judge, and EDWARDS and TATEL, Circuit Judges.

Opinion for the Court filed by Circuit Judge TATEL.

TATEL, Circuit Judge:

To encourage the marketing of low-cost generic drugs, the 1984 Hatch-Waxman amendments to the Food, Drug, and Cosmetic Act grant companies that successfully challenge drug patents the right to sell their generic drugs without competition for 180 days. In this case, two companies, each seeking to market a generic drug, competed for the right to exclusivity. The Food and Drug Administration ruled that neither company could earn exclusivity by challenging the first of two patents, but it awarded exclusivity to one of the companies based on that company's challenge to the second patent. The district court rejected challenges to these two decisions, and the company denied exclusivity now appeals. Finding no error in the district court's two thorough and well-reasoned opinions, we affirm in all respects.

I.

The Food, Drug, and Cosmetic Act, 21 U.S.C. §§ 301-99 (FDCA), provides that a company wishing to market a new brandname drug must submit a New Drug Application, known as an NDA, to the Food and Drug Administration. See id. § 355(b)(1) (2000 & Supp. III 2003). Usually quite lengthy, NDAs must include, among other things, evidence of the drugs' safety and effectiveness, as well as information about patents that cover or might cover the drugs. Id.

In 1984, Congress passed the "Hatch-Waxman" amendments to the FDCA. See The Drug Price Competition and Patent Term Restoration Act of 1984, Pub.L. No. 98-417, 98 Stat. 1585 (1984) (codified in scattered sections of titles 21, 35, and 42 U.S.C.). Enacted to expedite the process by which companies gain approval to sell generic versions of already-approved brand-name drugs, the amendments allow companies seeking such approval to submit Abbreviated New Drug Applications, known as ANDAs, that "piggyback" on the safety-and-effectiveness information that the brand-name manufacturers submitted in their NDAs. See 21 U.S.C. § 355(j)(2)(A); 21 C.F.R. § 314.94(a)(3) (2003). "The result [is] to make practical the manufacture of generic copies which theretofore had been uneconomical." Mead Johnson Pharm. Group v. Bowen, 838 F.2d 1332, 1333 (D.C.Cir.1988).

Like NDAs, ANDAs must address patents that cover or might cover the relevant drugs. For each patent, companies can satisfy this requirement by including in their ANDAs one of several "certifications" that explain why the FDA should approve the application despite the patent's claim on the drug. 21 U.S.C. § 355(j)(2)(A)(vii). The certification at issue in this case — a "paragraph IV certification," named for the subsection of the law that describes it — states "that such patent is invalid or will not be infringed by the manufacture, use, or sale of the new drug." Id. § 355(j)(2)(A)(vii)(IV). In essence, applicants use paragraph IV certifications to challenge the validity of brandname manufacturers' patents.

An applicant that includes one or more paragraph IV certifications in its ANDA must inform both the patent holder and the company that submitted the NDA on which the ANDA "piggybacks." Id. § 355(j)(2)(B)(i). Once an applicant gives notice, the FDA must wait forty-five days before approving the ANDA, thereby giving the patent holder that much time to file a patent-infringement suit. Id. § 355(j)(5)(B)(iii); 21 C.F.R. § 314.107(f)(2). If the patent holder sues, the FDA must wait thirty months from the notice date before approving the ANDA unless the applicant wins the suit sooner or the court hearing the suit shortens the thirty-month period. 21 U.S.C. § 355(j)(5)(B)(iii).

In order to encourage paragraph IV challenges, thereby increasing the availability of low-cost generic drugs, the FDCA provides that the first company to win FDA approval of an ANDA containing a paragraph IV certification has the right to sell its drug without competition for 180 days. Id. § 355(j)(5)(B)(iv). The statute and the implementing regulation create this exclusivity period by prohibiting the FDA from approving any other ANDA that contains a paragraph IV challenge to the same patent until 180 days after the first company markets its drug or 180 days after the first company wins a patent-infringement suit involving that patent, whichever comes first. Id.; 21 C.F.R. § 314.107(c)(1).

Paragraph IV certifications are not the only way for ANDA applicants to satisfy their obligation to address all relevant patents. Applicants can instead submit one or more "section viii statements," named, again, after the relevant FDCA subsection — section 505(j)(2)(A)(viii). A section viii statement indicates that a patent poses no bar to approval of an ANDA because the applicant seeks to market the drug for a use other than the one encompassed by the patent. See 21 U.S.C. § 355(j)(2)(A)(viii). For example, if a brand-name manufacturer's patent covers a drug's use for treating depression, and the ANDA applicant seeks approval to use the drug to treat any other condition, then a section viii statement would be appropriate. Thus, whereas applicants use paragraph IV certifications to challenge the validity of admittedly applicable patents, they use section viii statements to assert that patents do not apply. The FDA has long required that for every patent ANDA applicants use either a paragraph IV certification or a section viii statement — they may not use both. As the FDA puts it, "either the applicant is seeking approval for the use claimed in the patent, or it is not." TorPharm, Inc. v. Thompson, 260 F.Supp.2d 69, 77 (D.D.C.2003) (quoting the record in that case) (internal quotation marks omitted).

Paragraph IV certifications and section viii statements have quite different consequences. Applicants submitting section viii statements have no obligation to provide notice, nor must they wait thirty months for FDA approval. As the district court explained, "the FDA may [thus] approve a section viii application immediately, making it an attractive route for generic manufacturers, even though a section viii statement does not entitle a successful applicant to the 180-day period of exclusivity bestowed on paragraph IV applicants." Purepac Pharm. Co. v. Thompson, 238 F.Supp.2d 191, 195 (D.D.C.2002).

In order to determine what patents cover existing brand-name drugs and hence whether any paragraph IV certifications or section viii statements are needed, applicants look in the "Orange Book," an FDA publication that includes all patent information that companies have submitted to the agency. "Method-of-use patents" — which cover specific uses for drugs — can be included in the Orange Book only if they cover drug uses that the FDA has approved. 21 C.F.R. § 314.53(b). In other words, companies cannot use the Orange Book to claim protection for uses that the FDA has not approved. The FDA, however, does not evaluate patent information that companies submit to it; it just passively publishes information it receives. This means that if one company submits patent information that a second company believes is false or violates the FDA's regulation prohibiting the listing of unapproved-use patents, the second company — after having the FDA verify the information's accuracy with the first company — must go to court to resolve the dispute. Meanwhile, the second company must, if it submits an ANDA, treat the disputed patent as valid. In other words, it must include in its ANDA either a paragraph IV certification or a section viii statement.

This case involves gabapentin, a drug sold by Pfizer, Inc. that the FDA has approved for treating epilepsy. In 1998, appellee Purepac Pharmaceutical Company submitted an ANDA seeking permission to sell a generic version of Pfizer's brand-name drug, Neurontin. Purepac's ANDA listed three patents that Warner-Lambert Company, which later assigned Pfizer the rights to the drug, had included in its gabapentin NDA. One of the three — the only one relevant to this case — was No. 5,084,479 (the '479 patent), a method-of-use patent. Seeking to sell its drug as a treatment for epilepsy, Purepac submitted a section viii statement about this patent because as it read the Orange Book, the patent covered gabapentin's unapproved use for treating neurodegenerative diseases. That is, Purepac asserted that the '479 patent posed no bar to FDA approval of its ANDA because the patent covered a use other than the one for which Purepac sought permission. Given that under FDA regulations, only approved-use method-of-use patents may be listed in the Orange...