Law360
August 15, 3012
Avanir Pharmaceuticals Inc. has settled a suit in Delaware federal court accusing Sandoz Inc.'s planned generic version of involuntary-emotion treatment Nuedexta of infringing three patents, the company announced Wednesday. Under the terms of the deal, Sandoz will be allowed to sell its generic version of Nuedexta on July 30, 2026, just before the Aug. 13, 2026 expiration of the last patent-in-suit — U.S. Patent Number 7,659,282 — or earlier under certain unspecified circumstances, according to Avanir. The remaining terms of the settlement were not publicly disclosed. “All claims, defenses and counterclaims are hereby dismissed without prejudice,” the parties said in a stipulation of dismissal filed with the court, requesting approval of the deal.
A representative for Sandoz did not immediately respond to a request for comment Wednesday.
Nuedexta, a combination of the drugs dextromethorphan and quinidine, is designed to treat pseudobulbar affect, a condition marked by sudden, involuntary outbursts of laughter or crying in patients with underlying neurological disorders such as multiple sclerosis, stroke or amyotrophic lateral sclerosis, commonly known as Lou Gehrig's disease. The drug, Avanir’s flagship product, produced about $57 million in sales in 2012, according to the biopharmaceutical company’s financial reports. Avanir sued Sandoz — the American arm of Swiss pharmaceutical giant Novartis International AG’s generic drug unit — in May, alleging its abbreviated new drug application to manufacture generic Nuedexta capsules, filed with the U.S. Food and Drug Administration, had infringed the ‘282 patent and U.S. Patent Numbers 8,227,484 and RE38,115, all of which cover the composition of the drug.
The ANDA originally had been filed with the FDA by Watson Pharmaceuticals Inc. — now known as Actavis Inc. after merging with Actavis Group — and was transferred to Sandoz in November as part of an an asset purchase agreement, according to the complaint.
Aliso Viejo, Calif.-based Avanir has vigorously defended its Nuedexta patents, launching numerous rounds of litigation against several drugmakers over their planned generic versions of the drug, targeting Par Pharmaceutical Cos. Inc., Wockhardt Ltd., Impax Laboratories Inc., Watson and other Actavis units.
Those suits are still pending, with Avanir explicitly stating in its settlement announcement that the deal “does not end Avanir's ongoing litigation against the other four ANDA filers.”
The patents-in-suit are U.S. Patent Numbers 7,659,282, 8,227,484 and RE38,115.
Avanir is represented by Jack B. Blumenfeld, Maryellen Noreika and Jeremy A. Tigan of Morris Nichols Arsht & Tunnell LLP.
Sandoz is represented by Richard L. Horwitz, David E. Moore and Bindu A. Palapura of Potter Anderson & Corroon LLP and Ralph J. Gabric, Laura A. Lydigsen, Yuezhong Feng and Danielle C. Cendrowski of Brinks Hofer Gilson & Lione.
The case is Avanir Pharmaceuticals Inc. et al. v. Sandoz Inc., case number 1:13-cv-00961, in the U.S. District Court for the District of Delaware.
