Repurposing and Enforcement during Patent Term Extensions for Pharma Products

Martin A. Voet and Louis C. Cullman

©2016. Published in Landslide, Vol. 8, No. 6, July/August 2016, by the American Bar Association. Reproduced with permission. All rights reserved. This information or any portion thereof may not be copied or disseminated in any form or by any means or stored in an electronic database or retrieval system without the express written consent of the American Bar Association or the copyright holder.

Imagine your client is developing a new use for the active ingredient in an existing pharmaceutical product. The active ingredient is a patented small molecule, formulated for oral delivery in treating gout. It has been approved by the FDA and on the market for years. Your client believes the same active ingredient, if formulated for topical ophthalmic use, would be useful in treating glaucoma. And because the active ingredient is already well characterized, she believes it would take her just a few years to develop the topical ophthalmic formulation and obtain approval for the new use. The patent for the active ingredient expires a few years from now, but it also received a patent term extension of five years.

Premium Content For:
  • Intellectual Property Law Section
Join - Now