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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 2006-2014

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July 03, 2008

Comments

anon

I don't think your analysis of the failure to market provisions is correct. "a final decision from which no appeal (other than a petition to the Supreme Court for a writ of certiorari) has been or can be taken that the patent is invalid or not infringed" means a decision from the Fed. Cir.

Aaron Barkoff

Thanks for your comment. I don't read the forfeiture provision that way. I'm not aware of any court or FDA interpretation of this specific clause, but it seems to make sense that if a patentee hasn't appealed a district court judgment of invalidity, then the first applicant should have to market its drug product. If you're aware of any authority for your reading of the provision, please pass it along.

jane

the second, i.e., the '812 patent, was approved just five and a half months after the '086 patent. the '812 patent *references* the '086 patent.

clearly, boehringer was not trying to hide anything. is it not possible that they really thought there were two patentable items? and doesn't the fact that both patents were approved do anything to protect them? obviously they were not the only ones who thought they were both valid.

moreover, the '812 was further validated in 1999, when it received the 4+ year extension you mentioned.

what sort of chance do you think a class action suit characterizing this situation as anti competitive practices and alleging intent on boehringer's part would have?

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