Will The Medicines Company finally undo its patent-filing mishap? Apparently, a federal judge has taken pity on the company, which filed for its Hatch-Waxman patent extension on Angiomax one day too late. The judge has ordered the U.S. Patent and Trademark Office to reconsider its two rejections of the company's appeal--and to keep Medicines' patent in place while it's reconsidering.
The point of contention is quite narrow: After 5 p.m. on Friday, Dec. 15, 2001, FDA notified Medicines that its blood thinner Angiomax had won approval. Medicines had 60 days to apply for its patent extension; it filed that paperwork on Feb. 14, either 61 or 62 days later, depending on who's counting. However, if the notification came after close of business on Friday, should Medicines be allowed to count from the next business day, which would have been Monday, Dec. 18?
The U.S. Patent Office says Medicines filed too late. The letter of the law says so. But Judge Claude Hilton said that the PTO has been too inflexible. When FDA itself gets applications after COB, it dates them the next business day, the judge said. Why not the PTO?
Judge Hilton may just end up being the company's savior. Most of Medicines' revenue comes from Angiomax, and most of Angiomax's revenues come from the U.S. So losing out to generic competition in the U.S. could very well sink the entire company.
- read the New York Times story