Barrier Therapeutics, Inc. (Nasdaq:BTRX), a pharmaceutical company developing and commercializing products in the field of dermatology, announced today that the U.S. Patent and Trademark Office (USPTO) has granted a second one-year interim patent term extension to United States Patent Number 4,911,932. This patent covers the Vusion(r) (0.25% miconazole nitrate, 15% zinc oxide, 81.35% white petrolatum) Ointment formulation and methods of treating diaper dermatitis. This action extends the term of this patent to March 27, 2009. The Company intends to list this extension in the Orange Book published by the U.S. Food and Drug Administration (FDA).
"Vusion is a key brand for Barrier Therapeutics, and we are pleased to receive this second one-year patent term extension from the USPTO as we continue our efforts to secure the full five-year patent term restoration under the Hatch-Waxman Act which, if granted, could protect Vusion to 2012," said Mr. Al Altomari, Chief Operating Officer.
This patent was originally scheduled to expire on March 27, 2007. Barrier Therapeutics has applied for up to five years of patent term extension under the United States Drug Price Competition and Patent Term Restoration Act of 1984, known as the Hatch-Waxman Act. This five year application is currently being reviewed by the USPTO, in consultation with the FDA. The interim extension was granted pursuant to a portion of the Hatch-Waxman Act that provides a process for applying for interim extensions of up to one-year at a time, if a patent is scheduled to expire during the review of the application. This second interim grant extends the patent term until March 27, 2009, or until a final determination on the five year application is made, if earlier. Based on the current stage of the review process, the Company does not anticipate a final determination on the five year application prior to March 2009. Accordingly, the Company anticipates that it will request a 3rd interim extension later this year. While the Company has submitted an application for patent term extension until March 2012, it is possible that the USPTO could reject that application or grant an extension for a shorter period of time.
No comments:
Post a Comment