Pharma Blog Watch

MedImmune, Sun in Dispute over Ethyol (Orange Book Blog)
In his blog, Aaron Barkoff outlines the ongoing patent litigation between MedImmune and Sun Pharmaceutical Industries over Ethyol.

"MedImmune earns about $100 million annually from sales of Ethyol (amifostine), an injectable drug approved for the relief of certain side effects of chemotherapy and radiation therapy. Sun Pharmaceutical Industries filed an [abbreviated new drug application] to market a generic version of Ethyol," he writes. "In what appears to have become the standard strategy to protect sales of a brand name drug against generic competition, MedImmune responded by filing both a patent infringement lawsuit in court and a citizen petition with the FDA."

"Last week in its patent infringement suit, MedImmune lost one battle and won another," he continues. The judge granted Sun's motion for summary judgment of noninfringement for one patent and denied Sun's motion for summary judgment of nonfringement for another patent. "MedImmune filed the patent infringement suit in August 2004, and therefore the 30-month stay on approval is set to expire next month. It will be interesting to see whether the FDA decides on MedImmune's citizen petition before then."