NEW YORK - Forest Laboratories Inc. and its wholly-owned subsidiary, Forest Laboratories Holdings Ltd., and H. Lundbeck A/S announced that they have entered into a settlement agreement with Sun Pharmaceutical Industries Ltd. and Caraco Pharmaceutical Laboratories Ltd. regarding pending patent infringement disputes.
According to Forest Laboratories, the disputes involve US Patent Re. No. 34,712, US Patent No. 6,916,941, and US Patent No. 7,420,069, which were licensed to Forest by H. Lundbeck A/S on an exclusive basis in the United States.
These patents are listed in the US Food and Drug Administration's Orange Book for Forest's LEXAPRO brand escitalopram oxalate tablet products.
Pursuant to the terms of the settlement agreement with Sun Pharma and Caraco, and subject to review of the settlement terms by the US Federal Trade Commission:
1. Forest and Lundbeck will provide licenses to Caraco for any patents related to LEXAPRO with respect to the marketing of Caraco's generic version of the product as of the date that any third party generic that has properly received final approval from the FDA enters the market, other than an authorized generic or the first filer with Hatch-Waxman related exclusivity.
2. Caraco will take over the commercialization and sale of several products from Forest's Inwood business.
3. In exchange for an upfront payment (and royalties but only if the technology is used), Sun Pharma will license to Lundbeck on a worldwide basis certain patent applications related to the synthesis of escitalopram and citalopram.
Forest and Lundbeck will reimburse certain of Caraco's legal costs in connection with these patent litigations.
Forest Laboratories is a US based pharmaceutical company with a long track record of building partnerships and developing and marketing products that make a positive difference in people's lives.
