According to Teva, it has received a Para-IV notice from the Indian drug maker over the blockbuster drug, and the law suit may trigger a “30-month stay" of Food and Drug Administration (FDA) approval of Dr Reddy’s Abbreviated New Drug Application (ANDA). Under Para IV notice, the generic drug maker has to notify the patent holder within 20 days of ANDA application.
If patent holder files infringement suit against ANDA applicant within 45 days from receiving notification in the court, then the litigation starts. Copaxone (glatiramer acetate injection) is for treatment of patients with relapsing forms of multiple sclerosis, an inflammatory disease in which the insulating covers of nerve cells in the brain and spinal cord are damaged.
“Teva Pharmaceutical Industries confirms that it has received the first paragraph IV notice for its three-times-a-week Copaxone (R) 40 mg/mL product from Dr Reddy’s Laboratories. Inc Teva will continue to vigorously defend its Copaxone intellectual property rights against infringement wherever they are challenged. Teva intends to file a lawsuit for patent infringement against Dr Reddy’s within the 45-day period provided under the Hatch-Waxman Act.
“The filing of the lawsuit will trigger a 30-month stay of FDA approval of Dr Reddy’s ANDA," Teva said in a statement here. The Israeli drug maker already is involved in various legal battles with other drug firms over the patent litigations of Copaxone.
Recently, United States Supreme Court denied Teva’s application for an injunction seeking to prevent launch of a generic version of Copaxone involving Natco Pharma. Other drug makers involved in generic forms of Copaxone are: Novartis AG’s Sandoz Inc-Momenta Pharmaceuticals Inc and Mylan Inc-Natco Pharma Ltd.