Drug Litigation Newsroom

FDA Proposed Rule Regarding The Application Of 30 Month Stays

The Washington Legal Foundation is filing these comments to offer its qualified support to the Food and Drug Administration's (FDA) proposed rule regarding the application of 30-month stays on approval of Abbreviated New Drug Applications (ANDA). WLF agrees with FDA (and conclusions reached by the Federal Trade Commission (FTC) in its July 2002 report entitled Generic Drug Entry Prior to Patent Expiration: An FTC Study) that pioneer drug companies have on occasion
improperly delayed entry of generic competition by invoking existing regulations to obtain multiple 30-month stays in the granting of ANDAs. WLF also agrees with FDA that it possesses statutory authority to adopt a rule stating that the 30-month stay may be invoked only once in connection with any ANDA. WLF nonetheless disagrees with portions of FDA's statutory analysis and believes that FDA lacks authority to adopt proposed 21 C.F.R. § 314.95(a)(3). In particular, FDA has misread Section 505(j)(2)(B)(iii) of the Federal Food, Drug, and Cosmetics Act ("FDCA"), 21 U.S.C. §
355(j)(2)(B)(iii); that section cannot not plausibly be read in the manner proposed by FDA. Moreover, it makes little sense as a policy matter to declare that only the first Paragraph IV certification filed by an ANDA applicant can give rise to a 30-month stay. Rather, because a principal purpose of the Hatch Waxman Act was to encourage the resolution of patent infringement disputes before a generic manufacturer begins marketing its product, the law ought to be interpreted as permitting a single 30-month stay, with that stay commencing on the date on which the generic manufacturer provides the
required notice with regard to the Paragraph IV certification that initially triggered the pioneer manufacturer's patent infringement action. If a pioneer manufacturer decides not to file an infringement action with respect to one patent for which a Paragraph IV certification has been filed, it should not thereby forfeit its right to seek a 30-month stay with respect to later patents that are issued before the ANDA is approved.