US District Court upholds Horizon Pharma’s patent

The United States District Court for the District of New Jersey upheld the validity of Horizon Pharma’s patent covering Pennsaid (diclofenac sodium topical solution) 2% w/w, which Actavis Laboratories UT, Inc.(Actavis) has admitted that its proposed generic diclofenac sodium topical solution product would infringe.  

On July 6, 2015, Horizon filed a patent infringement lawsuit in District Court against Actavis related to Abbreviated New Drug Applications filed with the U.S. Food and Drug Administration to market a generic version of Pennsaid 2%.  The lawsuit claims infringement of Horizon’s U.S. Patent No. 9,066,913 (‘913 patent) titled “Diclofenac Topical Formulation,” which covers Pennsaid 2%.  The District Court’s decision was made based on the validity of Horizon Pharma’s ‘913 patent for Pennsaid 2% and the Court’s judgment will prevent Actavis from launching a generic version of Pennsaid 2% in the United States, the company said in its press release.

Pennsaid 2% has 18 Orange Book listed patents with terms that extend to 2030.