TRENTON, N.J. (AP) – A federal court invalidated the patent for a blockbuster osteoporosis drug made by Merck & Co. on Friday, sending Merck shares plunging but offering patients with the brittle-bone disease the possibility of cheaper pills in a few years.
The U.S. Court of Appeals for the Federal Circuit in Washington, D.C., invalidated the patent for the once-a-week version of Merck’s Fosamax, which dominates the market for osteoporosis drugs. Under the ruling, generic competition could begin as soon as early 2008, instead of 2018.
Fosamax is the No. 2 drug for Whitehouse Station-based Merck. The company already is beleaguered by its voluntary withdrawal of arthritis blockbuster Vioxx, which is expected to cost the company billions of dollars to settle lawsuits by patients claiming it caused heart attacks, strokes and other serious medical problems.
Merck reported total sales of $3.16 billion for Fosamax last year, more than 90 percent of which were for the once-a-week version, according to company spokesman Tony Plohoros.
“Merck disagrees with the opinion of the court of appeals and is considering its options, including a request for reconsideration by the court of appeals,” he said.
Merck shares were down $3.34, or 10.7 percent, to $27.84 Friday afternoon in very heavy trading on the New York Stock Exchange.
“It’s a big deal,” said Barbara Ryan, a managing director at Deutsche Bank Securities Inc. “Merck obviously has a lot of issues facing it, including the withdrawal of Vioxx from the market and the loss of the Zocor patents in the middle of 2006.”
Zocor, for high cholesterol, is Merck’s biggest drug, with $5.2 billion in sales last year.
“The profit impact could be very severe,” Ryan said of the Fosamax patent loss.
Merck’s primary Fosamax patent, covering both the daily and weekly versions, is to expire in February 2018, according to Plohoros. Both versions cost about $80 for a month’s supply.
The once-a-week patent had been challenged by generic drug maker Teva Pharmaceuticals USA Inc.
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Associated Press Writer Krista Larson contributed to this story.
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On the Net: http://www.merck.com
AP-ES-01-28-05 1434EST
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