Opinion ID: 768768
Heading Depth: 2
Heading Rank: 1

Heading: The ANDA Process

Text: 2 As this court has described before, the Hatch-Waxman Act (the Act) amended the Federal Food, Drug, and Cosmetic Act, Pub. L. No. 52-675, 52 Stat. 1040 (1938) (codified as amended at 21 U.S.C. §§ 301 et. seq. (1994)) (the FDCA), as well as the patent laws. See Bristol-Myers Squibb Co. v. Royce Lab., Inc., 69 F.3d 1130, 1131-32, 36 USPQ2d 1641, 1642-43 (Fed. Cir. 1995); DuPont Merck Pharm. Co. v. Bristol-Myers Squibb Co., 62 F.3d 1397, 1399-1401, 35 USPQ2d 1718, 1720-21 (Fed. Cir. 1995). Under the FDCA, as amended by the Act, a pharmaceutical manufacturer submits an ANDA when seeking expedited FDA approval of a generic version of a drug previously approved by the FDA (a listed drug). See 21 U.S.C. § 355(j). An ANDA can be filed if the generic drug manufacturer's active ingredient is the bioequivalent 2 of the listed drug. See 21 U.S.C. § 355(j)(2)(A)(iv). When submitting an ANDA, a manufacturer must certify one of four statements concerning the applicable listed drug: (i) the listed drug is not patented (a Paragraph I certification); (ii) the listed drug's patent has expired (a Paragraph II certification); (iii) the expiration date of the listed drug's patent (a Paragraph III certification); or (iv) the listed drug's patent is invalid or . . . it will not be infringed by the manufacture, use, or sale of the new drug covered by the ANDA (a Paragraph IV certification). 21 U.S.C. § 355(j)(2)(A)(vii)(I)-(IV). If an ANDA is certified under Paragraph IV, the applicant must notify the patent's owner of the certification. See 21 U.S.C. § 355(j)(2)(B). 3 An ANDA certified under Paragraphs I or II is approved immediately after meeting all applicable scientific and regulatory requirements. See 21 U.S.C. §§ 355(j)(5)(A), (B)(i). An ANDA certified under Paragraph III must, even after meeting all applicable scientific and regulatory requirements, wait for approval until the listed drug's patent expires. See 21 U.S.C. §§ 355(j)(5)(A), (B)(ii). An ANDA certified under Paragraph IV is approved immediately after meeting all applicable scientific and regulatory requirements unless the listed drug's patent owner brings suit for infringement under 35 U.S.C. § 271(e)(2)(A) within forty-five days of receiving the notice required under 21 U.S.C. § 355(j)(2)(B). See 21 U.S.C. § 355(j)(5)(B)(iii). If suit is brought, the FDA is required to suspend approval of the ANDA, and the FDA cannot approve the ANDA until the earliest of three dates: (i) the date of the court's decision that the listed drug's patent is either invalid or not infringed; (ii) the date the listed drug's patent expires, see 35 U.S.C. § 271(e)(4)(A), if the court finds the listed drug's patent infringed; or (iii) subject to modification by the court, the date that is thirty months from the date the owner of the listed drug's patent received notice of the filing of a Paragraph IV certification. See 21 U.S.C. § 355(j)(5)(B)(iii)(I)-(III). 4 The Act modified the patent laws to provide that [i]t shall not be an act of infringement to make, use, or sell . . . a patented invention . . . solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs. 35 U.S.C. § 271(e)(1). A Paragraph IV certification, however, is deemed to be an act of infringement if the purpose of such a submission is to obtain approval under the [FDCA] to engage in the commercial manufacture, use, or sale of a drug . . . claimed in a patent or the use of which is claimed in a patent before the expiration of such a patent. 35 U.S.C. § 271(e)(2)(A); see also Glaxo, Inc. v. Novopharm, Ltd., 110 F.3d 1562, 1567, 42 USPQ2d 1257, 1261-62 (Fed. Cir. 1997). If the court determines that the patent is not invalid and that infringement would occur, and that therefore the ANDA applicant's [P]aragraph IV certification is incorrect, the patent owner is entitled to an order that FDA approval of the ANDA containing the [P]aragraph IV certification not be effective until the patent expires. Royce Lab., 69 F.3d at 1135, 36 USPQ2d at 1646 (emphasis omitted).