Sunovion Pharmaceuticals and Bial Portela Files Patent Infringement Suit against A Host of Indian Drug Makers

Recently, The Bial – Portela & CA (“Bial”), a Portugal-based pharmaceutical company, and Sunovion Pharmaceuticals (“Sunvion”), a US-based pharmaceutical company have instituted suit of patent infringement against eight drug makers in the District Court of Delaware. The eight defendants are:

• Torrent Pharmaceuticals and Torrent Pharma Inc.,
• Alkem Laboratories and S&B Pharma, Inc.,
• Lupin Limited and Lupin Pharmaceuticals Inc.,
• Jubilant Life Sciences Ltd., Jubilant Pharma Ltd., Jubilant Generics Ltd. Jubilant Life Sciences (USA) Inc., and Jubilant Cadista Pharmaceuticals Inc.,
• Reddy’s Laboratories and Dr. Reddy’s Laboratories Inc.,
• Hetero Labs Ltd. Hetero Labs Limited Unit – V and Hetero USA Inc.,
• Apotex Inc., and Apotex Corp.,
• SPH Shanghai Zhongxi Pharmaceutical Co., Ltd.

The product in question is Aptiom®, an anti-epileptic drug with Active Pharmaceutical Ingredient (API) Eslicarbazepine Acetate. This drug is approved by the Food and Drug Administration (FDA) for the treatment of partial-onset seizures and is listed in the USFDA’s Orange Book under New Drug Application (NDA) No 022416. The Sunvion and The Bial

The asserted patents are:

• US Patent No 5753646 (Appl No 08/673,819), titled Substituted Dihydrodibenzo/B,F/Azepines, Method of their Preparation, Their Use in the Treatment of some Central Nervous System Disorders, and Pharmaceutical Compositions Containing them
• US Patent No 8372431 (Appl No 12/257,240), titled Pharmaceutical Composition Comprising Licarbazepine Acetate
• US Patent No 9206135 (Appl No 13/651,844), titled Asymmetric Catalytic Reduction of Oxcarbazepine
• US Patent No 9566244 (Appl No 14/108,615), titled Pharmaceutical Composition Comprising Licarbazepine Acetate
• US Patent No 9643929 (Appl No 14/944,546), titled Asymmetric Catalytic Reduction of Oxcarbazepine, and
• US Patent No 9750747 (Appl No 14/240,847), titled Treatments Involving Eslicarbazepine Acetate or Eslicarbazepine
• US Patent No. 10912781 (Appl No 15/397,945, titled Pharmaceutical Composition Comprising Licarbazepine Acetate

The Sunvion and Bial state the defendants submitted Abbreviated New Drug Application (ANDA) No. 211238 in order to manufacture, sell, and distribute tablets of eslicarbazepine acetate, the generic and pharmaceutically and therapeutically equivalent version of Aptiom®, allegedly before the expiration of the patent. Thus, the defendants have knowingly committed the act of infringing the plaintiff’s patent.

The matter essentially revolves around claim construction and interpretation of stereoisomer and composition of R- form and S- form including mixture (and racemic mixture) of the active ingredient licarbazepine acetate.

Author: Arindam Purkayastha – Patent Attorney at IIPRD. Email: [email protected]