Opinion ID: 178456
Heading Depth: 2
Heading Rank: 1

Heading: The Drug Approval Process

Text: In part, this appeal concerns the procedures for obtaining permission to sell either a new or generic drug under the Federal Food, Drug, and Cosmetic Act, ch. 675, 52 Stat. 1040 (1938) (codified as amended in scattered sections of 21 U.S.C.). Under the Act, the FDA must approve all new drugs before such drugs may be distributed in interstate commerce. 21 U.S.C. § 355(a). To obtain approval for a new drug, an applicant may file a New Drug Application (NDA) that includes examples of the proposed label for the drug and clinical data demonstrating that the drug is safe and effective for use. Id. § 355(b)(1)(A), (b)(1)(F). The NDA must contain the patent number and expiration date of any patent that claims either the drug or a method of using the drug if a claim of patent infringement could reasonably be asserted. Id. § 355(b)(1). The FDA publishes the names of approved drugs and their associated patent information in the Approved Drug Products with Therapeutic Equivalence Evaluations list, commonly referred to as the Orange Book. An applicant seeking approval to market a generic version of a drug may file either an Abbreviated New Drug Application (ANDA) or a 505(b)(2) application, which is also known as a paper NDA. Id. § 355(b)(2), (j). An ANDA allows an applicant to rely on the safety and efficacy information for the listed drug if the applicant can show that the generic drug is bioequivalent to the listed drug. An ANDA has three requirements that are particularly relevant here. First, the applicant must demonstrate that the route of administration, the dosage form, and the strength of the new drug are the same as those of the listed drug, unless the FDA has approved a suitability petition requesting permission to file an ANDA that differs from the listed drug in one or more of these respects. Id. § 355(j)(2)(A)(iii), (j)(2)(C). Second, subject to changes required by FDA regulations or a successful suitability petition, the applicant must also show that the labeling proposed for the new drug is the same as the labeling approved for the listed drug. Id. § 355(j)(2)(A)(v). Third, for each patent listed in the Orange Book that claims either the listed drug or a use of the listed drug for which the applicant is requesting approval, an ANDA must include either one of four certifications or a section viii statement. If an applicant chooses to submit a certification, the applicant must certify (I) that. . . patent information has not been filed, (II) that such patent has expired, (III) . . . 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. Id. § 355(j)(2)(A)(vii)(I)-(IV). These certifications are referred to as Paragraph I, II, III, and IV certifications, respectively. Assuming all regulatory requirements are satisfied, the FDA may immediately make effective the approval of an ANDA that includes either a Paragraph I or II certification. Id. § 355(j)(5)(B)(i). By contrast, the filing of a Paragraph III or IV certification may delay the effective date of an ANDA approval, and, in the case of a Paragraph IV certification, invite a patent infringement suit. See 35 U.S.C. § 271(e)(2), 21 U.S.C. § 355(j)(5)(B)(ii)-(iii). If, however, an applicant is seeking approval for a method of use not claimed in a method of use patent associated with the listed drug, the applicant must submit a section viii statement declaring that the patent does not claim such a use. 21 U.S.C. § 355(j)(2)(A)(viii). The applicant must also remove or carve out any mention of the patented method of use from the proposed label for the generic drug. See 21 C.F.R. § 314.92(a)(1); Novo Nordisk A/S v. Caraco Pharm. Labs., Ltd., 601 F.3d 1359, 1361 (Fed.Cir.2010) (Along with the section viii statement, the generic manufacturer must submit a proposed label to the FDA that does not contain the patented method of using the listed drug.). Unlike a Paragraph III or IV certification, the filing of a section viii statement will not by itself delay approval of an ANDA. Finally, in contrast to an ANDA, a paper NDA must include safety and effectiveness data. 21 U.S.C. § 355(b)(2). However, a paper NDA may rely on safety and effectiveness data not developed by the applicant. Id. As with an ANDA, a paper NDA requires the applicant to submit either a patent certification or a statement declaring that the patent does not claim the method of use for which the applicant is seeking approval. Id. § 355(b)(2)(A)-(B).