Zocor ruling against FDA benefits generic-drug makers

By William Murphy

Published on May 02, 2006

Under rules for the U.S. registry of patents for branded drugs, Israel-based Teva Pharmaceutical Industries Ltd. and India-based Ranbaxy Laboratories Ltd. petitioned for the exclusive sales rights as the first generic-drug companies to challenge Merck's Zocor patents when they expire June 23.

Merck did not fight the two drug makers' petition, but pulled the patents from the registry without stating a reason. The U.S. Food and Drug Administration decided that because the patents no longer existed in the registry, Teva and Ranbaxy had no claim.

Teva and Ranbaxy sued the FDA on the grounds that Merck should have left the patents in the registry and that the two companies should be granted the six-month exclusive-sales period for their generic versions of Zocor.

Judge Roberts, of the District of Columbia, ruled that by denying Teva's and Ranbaxy's petition, the FDA unlawfully went against the intent of Congress to give generic drug makers incentive to challenge branded-drug patents. The FDA did not comment whether it would appeal the ruling, but a Ranbaxy official said he expects the FDA to decide before the end of June.

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