Teva may take Dr Reddy's Laboratories to court for patent infringement

Global generic drug maker Teva Pharmaceutical Industries intends to file a law suit against Dr Reddy's Laboratories for allegedly infringing the patents of Copaxone (glatiramer acetate) injection 40mg/mL.

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. 

According to Teva, it has received a Para-IV notice from the Indian drug maker over the blockbuster drug, and the lawsuit may trigger a 30-month stay of 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.

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.

"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.

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.