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Patent Law

: Philip Brooks’ Patent Infringement Updates

Teva Intends to File Lawsuit Against Generic Filer for Patent Infringement

By Philip Brooks

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The following is excerpted from a July 11, 2008 Teva press release appearing at PharmaLive:

Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) 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.

Read the full press release here.

Full post as published by Philip Brooks’ Patent Infringement Updates on July 11, 2008 (boomark / email).