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Barr challenges Sensipar patents in US

This article was originally published in Scrip

Executive Summary

Barr Laboratorieshas initiated a challenge to the patents listed by Amgenin connection with its hyperparathyroidism drug Sensipar (cincalcet HCl). The ANDA containing a paragraph IV certification to several Orange Book-listed patents has been accepted for filing by the FDA, and the certification states that the patents, Nos 6,211,244, 6,313,146, 6,031,003 and 6,011,068, are invalid or will not be infringed; Amgen is the exclusive licensee of the patents. On July 25th, Amgen, Brigham and Women's Hospital and NPS Pharmaceuticals filed suit in a district court in Delaware, alleging infringement of the patents and triggering the 30-month stay of approval. Amgen said in the complaint that it wants a court order ensuring that FDA approval will not come before the expiration of the patents, or any later date of exclusivity to which plaintiffs become entitled.

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