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Articles

To Carve Out or Not to Carve Out – That is the Question

May 15, 2013

Articles

To Carve Out or Not to Carve Out – That is the Question

May 15, 2013

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To Carve Out or Not to Carve Out – That is the Question

This article appeared in Pharmaceutical Compliance Monitor, May 15, 2013, and is reproduced with permission.

In April, this column talked about Orange Book use codes in the wake of Caraco v. Novo Nordisk, 132 S.Ct. 1670 (2012) and how overbroad use codes may now be challenged by ANDA applicants as unlawful under the Hatch-Waxman Act. In particular, the article examined the use code drafter’s dilemma: too broad a use code and the brand could find itself the target of an antitrust suit; while too narrow a use code and the ANDA avoids the patent via the section viii “carve out” statute. It also offered advice on how to overlay patent claims on drug label language to ensure that the use code does not, in the words of the Supreme Court, “preclude generic marketing of non-infringing uses of the brand drug.”

This article looks at a slightly different use code issue, that being, when a use code cannot be carved out because it would leave the generic drug less safe or effective than the brand for the remaining non-protected conditions of use. 21 C.F.R. §314.127(a)(7). The FDA has been formally asked to address this issue more than a dozen times and only once has found for the brand. Although the “less safe or effective” standard is a demanding one it is not insurmountable. The way the FDA has implemented the use code carve out process is as follows: first, all of the use code language is scrubbed from the generic label to make sure there is no overlap between the two; second, the FDA analyzes whether the remaining “conditions of use” on the generic label are less safe or effective than those same conditions on the brand label, considering that brand still contains the use code language; and third, if the generic is found to be as safe and effective as the brand for the remaining (non-protected) conditions of use the section viii carve out will be allowed. Even if the carved out use is foreseeable and the generic is unsafely labeled for such use it will still be allowed. In this respect, the FDA has been steadfast in applying the “safe and effective” test only to the “on label” non-protected conditions of use.

Please read “To Carve Out or Not to Carve Out – That is the Question” for more information.

If you have any questions about this article or would like to discuss this topic further, please contact your Fish & Richardson attorney or the author:

BG_9585r57TerryMahn-144x200.jpg Terry G. Mahn
Principal
Washington, DC
202-626-6421
mahn@fr.com

 

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