J&J lost patent for drug galanthamine

Johnson & Johnson, the world's largest maker of health care products, lost a patent decision over its Alzheimer's treatment Razadyne, paving the way for sales of low-cost generic versions of the medicine by seven rivals.

In a ruling made public yesterday in federal court in Delaware, U.S. District Judge Sue Robinson said the patent is invalid because it doesn't adequately define how to use the drug, which has the chemical name galanthamine hydrobromide.

 

The decision will allow generic versions of Razadyne approved by the U.S. Food & Drug Administration to be sold in the United States, pending the appeal, the patent holders said in the statement. The patent, issued in 1987, expires in December 2008.

In 2005, the Johnson & Johnson subsidiaries sued units of Israel's Teva Pharmaceutical Industries, the world's biggest maker of generic drugs; Barr Pharmaceuticals, which Teva is buying; Mylan, the largest U.S. generic drugmaker; and Dr. Reddy's Laboratories, India's No. 2 drugmaker.

Also sued were the Purepac unit of Icelandic generic drugmaker Actavis Group HF; Alphapharm, part of Germany's Merck KGaA; and Par Pharmaceutical, according to Robinson's decision. She said the defendants admitted infringement and she held a 2007 non-jury trial on validity.

Following the ruling, Barr said it received final FDA approval to sell the generic version in 4-, 8- and 12-milligram tablets and plans to begin sales "immediately."