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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 2006-2013

« Patent Litigation Under a Future Biosimilars Act | Main | C5 "Pharma Patent Lifecycles" Conference, London, June 26-27 »

May 26, 2008

Comments

Sean

It would seem that any applicant could simply do a section viii "carve-out."

The drug was approved in 1991 and the patent has priority only to 1999, so either the patent is claiming a method that can (in theory) be carved out, or it is invalid (e.g, on an inherency argument). Giving the benefit of the doubt to King on validity, a carve-out would seem appropriate.

According to the OB, there are multiple exclusivities for different uses, so it would seem that a section viii carve-out would be the simple solution to the problem for a generic applicant.

However, that might lead to a delay in approval, for labeling review, so King (& Cobalt) might benefit from this maneuver anyway.

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