Teva v Crawford : Authorising ‘Authorised Generics’?

Allergan, Inc v. Alcon Labs, 324 F.3d 1322, 1325 (Fed. Cir. 2003).

Drug Price Competition and Patent Restoration Act (1984) Pub. L. No. 98–417, 98 Stat. 1585.

Mova Pharm Corp v Shalala, 140 F.3d 1060, 1064 (DC Cir. 1998).

Docket No. 2004P-0261/CP1. Teva's petition was also submitted as a comment in support of Mylan's Citizen Petition, Docket No. 2004P-0075/CPI. Mylan's petition also asked the FDA to prohibit the marketing and distribution of authorised generics during the 180-day exclusivity period.

Teva also argued that prior FDA determinations treated generics and authorised generics as legally equivalent (nifedipine petition and response).

sNDAs are typically required if any manufacturing, labelling, packaging or product code changes are made to a brand drug product in order to ensure their safety and efficacy. See Petition at pages 14–15.

Comment of the Generic Pharmaceutical Association in Support of Citizen Petition Docket No. 2004P-0075/CP1 at pages 2–3.

http://www.fda.gov/ohrms/dockets/dailys/04/july04/070704/04p-0261-pdn0001.pdf.

Teva filed this action in connection with the drug gabapentin.

The following language in the DC Circuit's decision (‘The statute rewards the first generic applicant successfully to challenge the patent on an approved drug with a 180-day exclusivity period …’) is contrary to earlier DC Circuit precedent invalidating the ‘successful defence’ requirement for 180-day exclusivity. See Mova Pharm, 140 F.3d at 1069; Granutec, Inc v Shalala, 46 USPQ2d 1398, 1404 (4th Cir. 1998).

Mylan Pharmaceuticals Inc v Food and Drug Administration et al. Civil Action No. 1:04cv242 (N.D. W. Va.).

See Andrx's Citizen Petition, Docket No. 2004P-0563/CP1 at page 3.

See Letter from Jane A. Axelrad to David L. Rosen re: Docket No. 2004P-0563/CP1, 24th June, 2005.

A copy of the letter can be found at http://leahy.senate.gov/press/200505/051205b.html.

See Mylan's 2005 annual report at page 3.