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  • Orange Book Blog is published for informational purposes only; it contains no legal advice whatsoever. Publication of Orange Book Blog does not create an attorney-client relationship. Orange Book Blog is Aaron Barkoff's personal website and it is intended for other attorneys. Orange Book Blog is not edited by McAndrews, Held & Malloy, Ltd. ("MHM") or its clients. No part of Orange Book Blog--whether information, commentary, or other--may be attributed to MHM or its clients. MHM represents many companies in the pharmaceutical and biotechnology industries, and therefore Orange Book Blog may occasionally report on news that relates to MHM clients. Orange Book Blog will always strive to be unbiased. All information on Orange Book Blog should be double-checked for its accuracy and current applicability. -- © Aaron F. Barkoff 2006-2017

« Merck Prevails in Patent Term Extension Case at Federal Circuit | Main | Pfizer and Mylan Fight to Defend Norvasc Exclusivity; Apotex, Teva and Others Battle for FDA Approval »

March 30, 2007

Comments

Robert Dailey

The case presents several interesting questions.

First, the holding is only directly binding on cases in which the NDA holder has sued the ANDA filer on at least one of its listed patents within the 45-day window and has refused to issue a covenant not to sue on the unasserted patents. The CAFC recognizes that this practice permits NDA holders to "game" the 30-month stay, i.e., they get the benefits of the 30-month stay while the ANDA filer remains on the hook for infringing the unasserted patents. Hence, the holding does appear to close an apparent loophole in how Hatch-Waxman handles the 30-month stay.

Second, Judge Friedman's concurrence addresses a much broader set of situations. This is perhaps a preview of the question that will be addressed by the pending DJ action filed by Apotex in the Eastern District of Virginia in Norfolk. In that case, gaming of the 30-month stay is not at issue: the NDA holder did not sue Apotex on any listed patent within the 45-day window (but had sued other ANDA filers on the listed patent). So, is Judge Friedman using his concurrence to give the Norfolk court a peek at the CAFC's hand? I guess we'll have to see.

Of course, other questions will remain. What if the NDA holder let the 45-day window pass and had never sued any ANDA filer on the patent? And how would the laches doctrine play out in all of this? Since Congress is in the process of considering legislation on reverse payments under Hatch-Waxman, maybe they should address these Hatch-Waxman issues as well.

Eric Messersmith

I thought that the 2003 Medicare Amendments went a long way in solving the bottleneck problem by providing that first to file paragraph IV certification ANDAs would be forfeited upon several critical dates (failure to market, etc.). Is this wrong?

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