Merck & Co. said Monday it developed the asthma treatment Singulair after two decades of research and urged a US federal judge to block Teva Pharmaceutical Industries Ltd. from selling a copy until a patent expires in 2012.
Teva Pharmaceutical Industries.
Photo: Ariel Jerozolimski
The research was "arduous and extensive" and involved more than 1,000 compounds, Merck lawyer Matthew Powers said in opening arguments in Federal Court in Trenton, New Jersey.
"Singulair was a revolutionary advance in the treatment of asthma," he said. "It should not be allowed to be copied."
Teva concedes that it infringes a basic patent on the drug. The issue before US District Judge Garrett E. Brown Jr. is whether the patent is valid and enforceable. The nonjury trial is expected to last this week, and the judge is unlikely to rule immediately.
Singulair generated $4.3 billion in global sales last year for Merck, the third-largest US drugmaker. Sales may reach $4.7b. this year, the Whitehouse Station, New Jersey-based company said February 3. Merck is eliminating 7,200 positions to save as much as $4.2b. before Singulair gets generic competition.
Singulair, approved by the FDA 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.
The discovery of the compound montelukast, the active ingredient in Singulair, resulted from almost two decades of research by Merck scientists for an asthma medicine that had fewer side effects than existing treatments, Powers said. The drug's development was marked by failures and setbacks amid competition from rival drugmakers, he said.
Ralph Gabric, an attorney for Teva, said Merck's patent wasn't new because it covers an obvious modification of earlier research on leukotriene blockers.
It was clear in 1991 that "far from a monumental step forward, the progress leading up to Singulair was a bunch of little steps," he said in his opening statement. Those steps would lead anyone knowledgeable in the field to Merck's invention, he said.
Gabric claimed that Merck misled the US Patent and Trademark Office so it could obtain the patent underlying Singulair. The once-a-day-pill has been approved for treatment of asthma, allergies and exercise-induced constriction of the bronchial tubes that carry air to and from the lungs.
