When the Generic has No Remedy: FDA,Use Codes and the Case of Novo Nordisk v. Caraco

Novo Nordisk A/S v. Caraco Pharmaceutical Laboratories, Ltd., 601 F.3d 1359 (Fed. Cir. 2010).

F.D.C.A. § 505 (b)(1).

F.D.C.A. § 505 (c) (2).

The Orange Book is available online at http://www.fda.gov/Drugs/InformationOnDrugs/ucm129662.htm.

The other certifications are Paragraph I (certifying that there are no patents listed), Paragraph II (stating that a listed patent has expired) and Paragraph III (requesting FDA approval after patent expiration). When more than one patent is listed, an ANDA can have any combination of Paragraphs II, III and IV certifications.

Such patents should not be listed in the Orange Book, but commonly are.

A section viii does not actively disqualify an ANDA from the 180-day exclusivity. For example, a first-to-file ANDA with both a Paragraph IV certification and a section viii statement would be eligible for the 180-day exclusivity by virtue of the Paragraph IV.

See, for example, 54 Fed. Reg. 28872, Section Q.3; See also, Purepac Pharmaceutical Co. v. Thompson, 238 F.Supp.2d 191, 204–05 (D.DC 2002); Watson Pharm., Inc. v. Henney, 194 F.Supp.2d 442, 445 (D. Md. 2001).

68 Fed. Reg. 36,682 (18 June 2003).

Id. See also, Purepac v. Thompson, 354 F.3d 877, 881 (DC Cir. 2004).

Purepac at 881.

Prandin® product labeling, ‘Indications and Usage,’ 14 May 2010.

Novo Nordisk v. Caraco, 656 F.Supp.2d 729 (E.D. Mich. 2009).

This section of the FDA law permits an ANDA applicant to file a counterclaim against an NDA holder seeking correction or deletion of patent information in the Orange Book on the grounds that the patent either does not claim the approved drug, or an approved method of using the drug.

Novo Nordisk v. Caraco, 656 F.Supp.2d at 731–732.

Novo Nordisk v. Caraco, 601 F.3d at 1364.

Id. at 1365.

Id. at 1366.

Id. at 1367–1368.

Id. at 1368.

Id. at 1368–1369.

Id. at 1371.

Id. at 1371–1372.

Id. at 1380.

Id. at 1381.

Id. at 1382.

Id. at 1382.

Every three-judge panel is supposed to be bound by previous decisions, unless overturned by an en banc (full nine-judge panel) decision. In practice, however, when one panel wants to rule differently on an issue than a previous panel, the later panel generally has little difficulty in distinguishing the previous case on its facts.

Novo Nordisk v. Caraco, Case No. 2010–1001 (Fed. Cir. 29 July 2010).

Hatch-Waxman Counterclaims Not Available for Overbroad Use Codes in Orange Book, Pharmaceutical Law & Industry Report, Vol. 8, p. 512 (23 April 2010).

Jarvis L.M. (2010) Pharmaceuticals: Big firms will fight the patent cliff. Chemical & Engineering News 88(2): 17(11 January).

After listing the information required in an ANDA, the statute expressly prohibits FDA from requiring any additional information in an ANDA than that listed in the statute. See F.D.C.A. § 505(j)(2)(A), final sentence. There is no such prohibition relating to ‘patent information’. It does not appear from the Novo decision that Caraco's counsel argued this point.