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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

« Federal Circuit Invalidates Pfizer's Norvasc Patent; Mylan's Generic Expected to Launch Soon | Main | House Oversight Committee to Hold Hearing on Follow-on Biologics »

March 23, 2007



Thanks Aaron keeping us on beat.

This case really comes to prove how DUMB the Hatch-Waxman Act really is.

Apotex does the hard work...gets the case expiditiously to the Federal Circuit...argues well and has the patent invalidated...

But Mylan takes the cake...they have been dawdling for over five years at the District Court level... only to lose...now they get the 180-exclusivity...

Really DUMB...


But why didn't Apotex simply drop their appeal? They have nothing, or next to it, to gain by this decision...unless they happen to be in bed with Mylan somehow.

(For that matter, why didn't Pfizer drop its complaint against Apotex? After they had two D/Ct decisions of validity in hand, they could have let Apotex make a decision to enter at-risk, which they never would have done.)

It's not so much that H-W is dumb, but that Apotex either screwed up or didn't really appreciate the results of their gamesmanship.

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