24 Jul 2013, BioSpectrum Bureau , BioSpectrum
Singapore: In a move that is threatening to become a high profile patent infringement suit, global biopharma company UCB has filed cases against 15 major pharmaceutical companies. Even big Indian pharma giants like Ranbaxy, Aurobindo, Zydus, Sun Pharma, Glenmark and Alembic Pharmaceuticals have been sued for allegedly infringing UCB's patented drug Vimpat.
According to a petition filed by UCB in the US District Court for the district of Delaware, UCB Pharma GMBH, Research Corporation Technologies Inc and Harris FRC Corporation the patent on its drug Lacosamide Tablets would expire on March 17, 2022. The drug is approved as an adjunctive therapy to treat partial-onset seizures of people diagnosed with epilepsy aged 17 years and older. For the 12 months ending March 31, 2013, Vimpat had US sales of approximately USD 338 million, according to IMS Health.
The patent infringement petition has been filed against Aurobindo Pharma, Accord Healthcare, Alembic Pharmaceuticals, Amneal Pharmaceuticals, Apotex Corp, Breckenridge Pharmaceutical, Glenmark Generics, Hetero USA, Mylan Pharmaceuticals, Sandoz, ScieGen Pharmaceuticals, Sun Pharma, Watson Laboratories and Zydus Pharmaceuticals.
Many companies have come forward and made a statement in the matter. Glenmark confirmed the petition against it and said in a statement, "If Glenmark is successful in its challenge of the patent, it will garner 180 day exclusivity for its products."
Meanwhile in the case of Aurobindo, the petitioners have mentioned, "Aurobindo submitted its ANDA to the FDA for the purpose of obtaining approval to engage in the commercial manufacture, use, offer to sale sale and or import of Aurobindo's AMNDA products before expiration of the 551 patent. By filing it ANDA before the expiration of the 551 patent Aurobindo has committed an act of infringement."
Mylan on the other hand has reacted to the petition in a statement claiming that it believes it is one of the first companies to have filed a substantially complete ANDA containing a Paragraph IV certification for this product and expects to be eligible for 180 days of marketing exclusivity upon final FDA approval.
The petitioners requested the court to issue a permanent injunction and enjoining the respondents from engaging in the commercial manufacture, use offer to sell or import until the expiration of the patent or any later date of exclusivity to which the petitioners are entitled.