Mylan v FDA : Another Court Decision in Favour of ‘Authorised Generics’

See Teva Pharmaceuticals Industries Ltd. v Crawford, 410 F.3d 51 (D.C. Cir. 2005). See also Rein Frederick H. Kessel Amanda M. , US Case Reports: Teva v. Crawford, Authorizing ‘Authorized Generics?,’ 3 Journal of Generic Medicines 62–69 (2005) for a discussion of the D.C. Circuit's decision.

Teva Pharmaceuticals USA, Inc. v Crawford, 355 F. Supp. 2d 111, 112, n.1 (D.D.C. 2004).

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

Docket No. 2004P-0075/CP1, Citizen Petition of Mylan Pharmaceuticals, Inc., dated February 17, 2004 at 1.

Mylan also argued that prior FDA determinations treated generics and authorized generics as legally equivalent (Nifedipine Petition and Response). Petition at 3.

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

June 28, 2004 Letter from Mylan Pharmaceuticals Inc. to FDA, Docket Number 2004P-0075. Mylan's ANDA for nitrofurantoin was approved on March 22, 2004. Mylan began commercial marketing on March 23, 2004 and Watson launched an authorized generic on the same day. See Mylan v FDA, 454 F.3d at 273.

Mylan Pharms. Inc. v Food and Drug Administration et al., Civil Action No. 1:04cv242 (N.DW.Va.).

Mylan also alleged, inter alia, the following claims against P&G and Watson: ‘The P&G/Watson nitrofurantoin authorized generic scheme violates the federal and state antitrust and unfair competition laws … [and that b]y entering into and carrying out the P&G/Watson nitrofurantoin authorized generic scheme, P&G and Watson have tortiously interfered with Mylan's existing and/or prospective contractual and/or advantageous business relations.’ Mylan voluntarily dismissed these claims against P&G and Watson without prejudice.

The following language in the D.C. 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 D.C. Circuit precedent invalidating the 'successful defense’ requirement for 180-day exclusivity. See Mova Pharm., 140 F.3d at 1069; see also Granutec, Inc. v. Shalala, 46 U.S.P.Q.2d 1398, 1404 (4th Cir. 1998).

Quoting Federal Trade Commission, To Promote Innovation: The Proper Balance of Competition and Patent Law and Policy, Ch. 3, at 12 (Oct. 2003), available at http://wwwftc.gov/os/2003/10/innovationrpt.pdf.

Quoting Federal Trade Commission Information Collection Notice, 71 Fed. Reg. 16,779, 16,780 (Apr. 4, 2006).

See http://www.ftc.gov/os/2006/03/P062105AuthorizedGenericDrugStudyFRNotice.pdf.

PhRMA (Pharmaceutical Research and Manufacturers of America) has already commissioned a study of authorized generics from IMS Consulting. See Assessment of Authorized Generics in the US, Prepared for PhRMA, Spring 2006, IMS Consulting, http://www.phrma.org/files/IMS%20Authorized%20Generics%20Report_6–22–06.pdf(‘IMS Assessment’). The report, already criticised by GPha (Generic Pharmaceutical Association), concludes that ‘with an authorized generic in the market … the average generic price discount to the branded product is greater than comparable Paragraph IV examples in which there is no authorized generic’ IMS Assessment at 16.

See http://thomas.loc.gov/cgi-bin/Query/z?c109:S.3965:Mylan testified at a United States Senate Special Committee on Aging on July 20, 2006 in support of the same.