Teva Comments on Paragraph IV Filing for Copaxone; Intends to File Lawsuit Against Generic Filer for Patent Infringement

Jul 11, 2008 - Teva Pharmaceutical Industries Ltd. today commented on Momenta Pharmaceuticals, Inc./Sandoz Inc.'s announcement regarding the filing of a Abbreviated New Drug Application (ANDA) containing a Paragraph IV certification for COPAXONE(R) (glatiramer acetate), a leading multiple sclerosis therapy.
Teva expects to receive Momenta/Sandoz's Paragraph IV certification notice referring to Teva's U.S. Patent Nos. 5,981,589, 6,054,430, 6,342,476, 6,362,161, 6,620,847, 6,939,539, and 7,199,098 which cover the chemical composition of COPAXONE(R), pharmaceutical compositions containing it, and methods of using it. These patents are listed in the U.S. Food and Drug Administration's (FDA) Orange Book and expire on May 24, 2014.

Teva is committed to vigorously defending its intellectual property rights against infringement wherever they are challenged. Teva intends to file a lawsuit for patent infringement against Momenta/Sandoz within the 45 day period provided under the Hatch-Waxman legislation. The lawsuit will trigger a stay of the FDA approval of the Momenta/Sandoz ANDA until the earlier of the expiration of a period of 30 months or a district court decision in its favor.

Momenta/Sandoz cannot launch a generic version of COPAXONE(R) before it receives final approval of its ANDA from the FDA. COPAXONE(R) is a glatiramoid, a complex mixture of the acetate salts of synthetic polypeptides, non-uniform with respect to molecular weight and sequence. Due to the variability of the composition of the polymers, Teva believes replicating this formulation would be extremely difficult and presents a significant challenge. Moreover, once subcutaneously injected, it is rapidly hydrolyzed locally and no level of the intact drug can be measured in the blood, rendering a bioequivalence study comparing two formulations extremely difficult. Therefore, evidence supporting the effectiveness of a generic copy of glatiramer acetate cannot be derived from bioequivalence studies but from a full-fledged clinical study using clinical outcomes.