Tuesday, February 22, 2011

Vol. 1 No. 4: Should FDA Undertake More Than a "Ministerial" Role With Respect to Patent Information?

Should FDA Undertake More Than a "Ministerial" Role With Respect to Patent Information?
Brian J. Malkin, Partner, Frommer Lawrence & Haug LLP
Andrew S. Wasson, Associate, Frommer Lawrence & Haug LLP

Malkin and Wasson conclude that FDA needs to take a more active approach to patent regulation. “FDA’s hands-off policy with regard to patents,” they explain, “creates a vacuum often filled by parties with vested interests.” The authors recommend that FDA take the following steps in order to become more involved in reviewing patents: develop the internal competency to review patents; review and refuse to list patents that do not meet FDA criteria; ensure that the submitted method-of-use patent applications do not claim a use for which the application is submitted and hire patent attorneys to ease the implementation of these recommendations.

The authors specifically recommend that FDA:
  • Develop an internal competency to review patents beyond the "ministerial" requirements of its current regulations.
  • Review patents submitted for listing in the Orange Book for accuracy and proactively refuse to list patents that do not meet FDA’s listing criteria.
  • In the event that an applicant submits carved-out labeling, confirm that the listed method-of-use patent "does not claim a use for which the application is submitted." FDA should retain use code narratives for informational purposes only.
  • Hire patent attorneys, who are registered with the U.S. Patent and Trademark Office (the Patent Office), and preferably who have a pharmaceutical or medical background, to accomplish these recommendations.




This article is available for download at http://fdli.org/pubs/policyforum/ now. All issues of FDLI's Food and Drug Policy Forum are free to FDLI members and can be purchased by non-members.

If you have any difficulty posting your comment, please contact Sarah Sansolo at sks@fdli.org.


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