Wolf Greenfield wins three more years of patent protection for Shire Pharmaceuticals' ELAPRASE treatment
August 2008By: Michael T. Siekman
On behalf of our client, Shire Pharmaceuticals, Wolf Greenfield recently obtained an additional 1,126 days of patent term for ELAPRASE (idursulfase), a treatment for patients with Hunter Syndrome (Mucopolysaccharidosis II, MPS II). Hunter syndrome is a rare, life-threatening genetic condition that results from the absence or insufficient levels of the lysosomal enzyme iduronate-2-sulfatase. Without this enzyme, cellular waste products accumulate in tissues and organs, which then begin to malfunction.
Shire's ELAPRASE product is the first and only treatment approved for people suffering from Hunter syndrome. The product, which is given as weekly infusions, replaces the missing enzyme that Hunter syndrome patients fail to produce in sufficient quantities.
Shire is the exclusive licensee of 5,932,211 ('211 patent), which covers ELAPRASE. The '211 patent had an original expiration date of August 3, 2016. The Certificate Extending Patent Term extends the expiration of the '211 patent up to September 3, 2019--more than an additional 3 years. The market for ELAPRASE is estimated to exceed $300 million/year.
The Drug Price Competition and Patent Term Restoration Act of 1984 (known as the "Hatch-Waxman Act") established the ability for companies to recoup some of the patent term lost during the lengthy FDA approval process required to market a drug, biologic, or medical device in the US. Wolf Greenfield attorneys have assisted clients with Patent Term Extension issues for drugs, biologics, and medical devices. If you have any questions regarding these issues, please contact your Wolf Greenfield attorney or Michael Siekman.
