Wyeth, Teva patent settlement over Effexor XR now in effect

By E. Janene Geiss

Philadelphia, Jan. 13 - Wyeth said that its patent litigation settlement with Teva over a generic version of Wyeth's Effexor XR extended-release venlafaxine capsules became effective Friday upon the entry of certain orders by the U. S. District Court for the District of New Jersey and the execution of certain settlement documents.

According to an 8-K filing with the Securities and Exchange Commission, under terms of the definitive agreements governing the settlement and orders of the court, the litigation has been dismissed and Teva will be permitted to launch generic versions of Effexor XR extended-release capsules and Effexor immediate-release tablets in the United States pursuant to the following licenses granted by Wyeth as part of the settlement:

• A license, exclusive for a specified period and then non-exclusive, under Wyeth's U.S. patent rights permitting Teva to launch an AB rated, generic version of Effexor XR in the United States beginning July 1, 2010, subject to earlier launch based on specified market conditions or developments regarding the applicable patent rights, including the outcome of any future generic challenges to such patent rights; and

• An exclusive license under Wyeth's U.S. patent rights permitting Teva to launch an AB rated, generic version of Effexor in the United States beginning June 15, 2006 subject to earlier launch based on specified market conditions.

In connection with each of these licenses, Teva will pay Wyeth specified percentages of gross profit from sales of each of the Teva generic versions, the filing said.

These sharing percentages are subject to adjustment or suspension based on market conditions and developments regarding the applicable patent rights, the filing said.

The companies also have executed definitive agreements with respect to generic versions of Effexor XR in Canada, according to the filing.

Wyeth is a Madison, N.J., research-driven pharmaceutical and health care products company that develops, manufactures and markets pharmaceuticals, vaccines, biotechnology products and nonprescription medicines. The company's major divisions include Wyeth Pharmaceuticals, Wyeth Consumer Healthcare and Fort Dodge Animal Health.

Teva is a Petach Tikva, Israel-based drug development company.

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