UCB, a global biopharma company, along with others has filed separate cases against as many as 15 drug makers, including India's Ranbaxy, Aurobindo, Zydus, Sun Pharma, Glenmark and Alembic Pharmaceuticals for allegedly infringing its patented drug Vimpat.
According to a petition filed by UCB Inc, UCB Pharma GMBH, Research Corporation Technologies, Inc and Harris FRC Corporation the patent of its drug Lacosamide Tablets, 50 mg, 100 mg, 150 mg and 200 mg would expire on March 17, 2022.
The patent infringement petition was filed in the U.S. district court for the district of Delaware.
For the 12 months ending March 31, 2013, Vimpat had U.S. sales of approximately $338 million, according to IMS Health.
The drug is approved as an adjunctive therapy to treat partial-onset seizures of people diagnosed with epilepsy aged 17 years and older.
According to petitioners, the patent which belonged to RCT, granted the licence to Harris. Harris in turn sub-licensed the patent to Schwarg which was acquired by UCB S.A. along with rights on Lacosamide.
The licence agreement between Harris and Schwarg was restated and amended for all countries of the world by and among Harris, UCB Pharma GMBH and UCB S.A.
"Aurobindo Ltd submitted its Abbreviated New Drug Application (ANDA) to the Food and Drug Administration (FDA) for the purpose of obtaining approval to engage in the commercial manufacture, use, offer to sale and or import of Aurobindo Ltd's ANDA products before expiration of the 551 patent.
"By filing it ANDA under... before the expiration of the 551 patent Aurobindo Ltd has committed an act of infringement," the petitioners alleged in case of Aurobindo.
Reacting to the petition, Mylan in a statement said 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.
Glenmark while confirming the petition against it, in a statement said: "If Glenmark is successful in its challenge of the patent, it will garner 180-day exclusivity for its products."
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.
The patent infringement petition was filed against Aurobindo Pharma Ltd, Accord Healthcare Inc, Alembic Pharmaceuticals Ltd, Amneal Pharmaceuticals, Apotex Corp, Breckenridge Pharmaceutical Inc, Glenmark Generics, Hetero USA Inc and Mylan Pharmaceuticals Inc. Petitions were also filed against Ranbaxy Laboratories Ltd, Sandoz Inc, ScieGen Pharmaceuticals Inc, Sun Pharma, Watson Laboratories Inc and Zydus Pharmaceuticals.