A couple of days after The Medicines Company (NASDAQ:MDCO) received a breather in the form of a favorable court order in its lawsuit against the U.S. Patent and Trademark Office (PTO), the U.S. Food and Drug Administration (FDA) and the U.S. Department of Health and Human Services, the company suffered a setback when the PTO once again refused to extend The Medicines Company’s patent for key product, Angiomax.
The Medicines Company is seeking to extend the term of its principal US patent for Angiomax, which is scheduled to expire on March 23, 2010 (September 23, 2010 including six-month pediatric exclusivity).
The company had filed for Hatch-Watchman exclusivity way back in 2001. However, the patent extension request was filed a day late due to confusion related to the approval date for Angiomax. Since then, The Medicines Company has been petitioning the PTO to accept the late filing which was due to "unintentional circumstances." The PTO has already rejected the company’s petition a couple of times earlier.
On March 16, the court had ruled that the PTO should set aside its earlier denials and reconsider the company’s application. In response to the court’s order, the PTO once again denied the company’s application and granted an interim extension of the patent until May 23, 2010.
With Angiomax accounting for almost 95% of total sales in 2009, the entry of generic competition would be devastating for the company. Generic player Teva Pharmaceutical Laboratories Inc. (NYSE:TEVA) is looking to sell generic versions of Angiomax.
Investors were quick to the react to the latest response from the PTO, with the shares losing 15% on the news. We expect investor focus to remain on the resolution of the Angiomax patent issues. We currently have a Neutral recommendation on The Medicines Company.