Merck & Co. won a court ruling that prevents Teva Pharmaceutical Industries Ltd. from selling a copy of Merck’s best-selling drug, the asthma and allergy treatment Singulair, until August 2012.
U.S. District Judge Garrett E. Brown Jr. in Trenton, New Jersey, today rejected Teva’s arguments that the patent on the main ingredient of the medicine is invalid or unenforceable. The judge said Teva can’t sell a generic version of the drug until the patent expires. Teva, the world’s biggest generic-drug maker, said it is reviewing the decision.
The ruling involving a medicine that had 2008 sales of $4.3 billion gives Merck a needed victory as it faces the loss of patent protection in the next five years on drugs with more than $8 billion in annual sales. The Whitehouse Station, New Jersey- based company is buying rival Schering-Plough Corp. and cutting jobs to boost profits.
The patent covers montelukast, the active ingredient in Singulair. The medicine, approved by the U.S. Food and Drug Administration in 1998, is based on research that showed one way to treat the disease is to block leukotrienes, compounds that cause muscle contraction and increase secretions in the lungs.
Merck “put forth sufficient evidence of the failed attempts of others to develop a leukotriene antagonist,” Brown said in his opinion.
Patent Review
The U.S. Patent and Trademark Office is taking a second look at the patent to see if there’s prior know-how indicating it didn’t cover a new invention. Merck told the court the agency almost always grants requests to reconsider patents. The patent remains valid throughout that process.
“We invest heavily in the research and development that is needed to discover innovative medicines like Singulair, and we will vigorously defend our intellectual property rights,” Merck General Counsel Bruce Kuhlik said in a statement after the ruling.
Merck rose 77 cents, or 2.5 percent, to $31.48 in New York Stock Exchange composite trading. Teva’s American depositary receipts, each representing one ordinary share, rose 66 cents to $51.45.
More than 22 million people in the U.S. have asthma, a chronic disease caused by inflammation of the bronchial tubes, according to the American Lung Association. Narrowed airways can cause coughing and chest tightness and hamper breathing, and in extreme cases it may limit the flow of oxygen to vital organs and lead to death. There is no cure.
Merck Cuts
Teva, based in Petah Tikva, Israel, said in a statement that it’s “currently reviewing the court’s decision to determine its next course of action.”
Singulair accounted for about 18 percent of Merck’s $23.9 billion in 2008 revenue. Schering-Plough shareholders approved Merck’s $46.7 billion takeover offer this month.
Schering-Plough has said it plans to file for approval of seven drugs, which may each generate more than $1 billion in peak annual sales. Merck plans to eliminate 16,000 positions as part of the merger and to help stem the generic losses.
The case is Merck Sharp & Dohme Pharmaceuticals SRL v. Teva Pharmaceuticals USA, 07cv1596, U.S. District Court, District of New Jersey (Trenton).
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