The company expects that the patent will be officially issued later in 2009, and if issued, the patent’s initial 20-year term would expire in 2024. The company said that it has a number of other pending patent applications covering various aspects of Kuvan compositions and dosing.
Jean-Jacques Bienaime, CEO of BioMarin, said: “We believe the issuance of this patent will be significant in strengthening our proprietary position on Kuvan. This patent would prevent potential competitors from using or copying Kuvan’s approved dosing regimen.
“Based on the claims allowed by the US Patent and Trademark Office, we believe that the once daily dosing regimen will prevent therapeutically equivalent generic competition to Kuvan while the patent is in force.”