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Pfizer pleased with court ruling on drug patent
New York, Feb 29: Pfizer Inc., the New York-based pharmaceutical giant, has said it is pleased with a US appeals court ruling which will prevent Dr Reddy`s Laboratories Ltd from releasing an alternative salt version to Pfizer`s blood-pressure treating drug Norvasc.
New York, Feb 29: Pfizer Inc., the New York-based pharmaceutical giant, has said it is pleased with a US appeals court ruling which will prevent Dr Reddy’s Laboratories Ltd from releasing an alternative salt version to Pfizer’s blood-pressure treating drug Norvasc.
The ruling given on Friday by the Washington-based court reversed the verdict of a lower district court, located at Newark in neighbouring New Jersey, and handed down a major victory for the drug giant. The New Jersey court earlier said Hyderabad-based Dr Reddy’s had not infringed on Pfizer’s patent for Amlodipine.
The appeals court ruling meant that Norvasc would continue to have marketing exclusivity till September 2007, Pfizer said. The company’s original patent on Norvasc expired last year, but was extended under a federal law.
Such extensions are given to drug firms to compensate them for lengthy reviews by the US Food and Drug Administration.
''This important decision by the expert appellate court responsible for patent matters confirms what we have maintained all along - that our patent for Norvasc covers Amlodipine and all its salt forms,'' said Jeff Kindler, Pfizer’s general counsel.
He added, ''Norvasc was introduced following a decade of scientific research and development. This innovative medicine provides significant benefits to millions of patients worldwide who suffer from high blood pressure and angina. We are gratified that the court recognised the importance of protecting the intellectual property created through our research efforts.''
Since its introduction in 1990, Norvasc is said to have become the world s most prescribed drug for hypertension. The drug had 4.3 billion dollars worth of global sales last year. Bureau Report
The ruling given on Friday by the Washington-based court reversed the verdict of a lower district court, located at Newark in neighbouring New Jersey, and handed down a major victory for the drug giant. The New Jersey court earlier said Hyderabad-based Dr Reddy’s had not infringed on Pfizer’s patent for Amlodipine.
The appeals court ruling meant that Norvasc would continue to have marketing exclusivity till September 2007, Pfizer said. The company’s original patent on Norvasc expired last year, but was extended under a federal law.
Such extensions are given to drug firms to compensate them for lengthy reviews by the US Food and Drug Administration.
''This important decision by the expert appellate court responsible for patent matters confirms what we have maintained all along - that our patent for Norvasc covers Amlodipine and all its salt forms,'' said Jeff Kindler, Pfizer’s general counsel.
He added, ''Norvasc was introduced following a decade of scientific research and development. This innovative medicine provides significant benefits to millions of patients worldwide who suffer from high blood pressure and angina. We are gratified that the court recognised the importance of protecting the intellectual property created through our research efforts.''
Since its introduction in 1990, Norvasc is said to have become the world s most prescribed drug for hypertension. The drug had 4.3 billion dollars worth of global sales last year. Bureau Report