On January 29, 2003 the Commission filed an amicus brief in the U.S. District Court for the Eastern District of Pennsylvania regarding the pending patent litigation between SmithKline Beecham (now known as GlaxoSmithKline or GSK) and Apotex Corporation, Apotex, Inc. and Torpharm Inc. (Apotex) concerning GSK's antidepressant drug product, Paxil. The brief addresses Apotex's motion for an order requiring GSK to ask the U.S. Food and Drug Administration (FDA) to de-list two patents from the FDA's Orange Book. The district court previously held invalid the claims GSK relied on to list those patents in the Orange Book.
In the amicus brief, which can be found as an attachment to this press release on the FTC's Web site, the Commission asserts that a de-listing remedy is consistent with a judgment of invalidity. In addition, the brief discusses the potential anticompetitive effects that may result from improper patent listings in the Orange Book and describes the substantial benefits to consumers from eliminating artificial barriers to lower-cost generic products. The Commission vote to approve filing of the amicus brief was 5-0. (FTC File No. 001-0167; staff contact is Jeffrey W. Brennan, Bureau of Competition, 202-326-3688).
Copies of the documents mentioned in this release are available from the FTC's Web site at http://www.ftc.gov and also from the FTC's Consumer Response Center, Room 130, 600 Pennsylvania Avenue, N.W., Washington, D.C. 20580. Call toll-free: 1-877-FTC-HELP.