In a continued attempt to get its Angiomax patent extended, The Medicines Co. (MDCO) recently filed yet another 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. This time, the company has applied to the court to set aside the PTO’s recent denial of the company’s patent extension application.
Last week, the PTO rejected The Medicines Co.’s application and granted an interim extension of the patent until May 23, 2010 (November including 6-months pediatric exclusivity). The Medicines Co. is asking the court to ignore this denial and direct the PTO to accept its patent term extension application as having been filed on a timely basis. Moreover, the company wants the court to order the PTO to extend the term of the patent under the Hatch-Waxman Act.
Angiomax (bivalirudin), The Medicines Co.’s lead product, is a specific and reversible direct thrombin inhibitor that was launched in early 2001.
The Medicines Co. 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 company has been petitioning the PTO to accept the late filing which was due to “unintentional circumstances.” The PTO has already rejected The Medicines Co.’s petition a couple of times earlier.
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. (TEVA) is looking to sell generic versions of Angiomax.
As such, the company is vigorously working on getting its patent extended. We expect investor focus to remain on the resolution of the Angiomax patent issues. We currently have a Neutral recommendation on The Medicines Co.
Read the full analyst report on “MDCO”
Read the full analyst report on “TEVA”
Zacks Investment Research
