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« 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


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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