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Dr Reddy's Laboratories has suffered a huge setback in its two-year legal battle with Pfizer with the US Court of Appeals of the Federal Circuit ruling that the patent extension covering Pfizer's Norvasc (amlodipine besylate) was applicable to Dr Reddy's AmVaz (amlodipine maleate), its first specialty drug offering.
Analysts point out that so confident was the company of crossing the legal hurdle that Dr Reddy's Laboratories had already set in motion the setting up of a marketing infrastructure in the United States for AmVaz. The decision represents close to a $200 million loss in market opportunity for Dr Reddy's.
With this decision, the US Court of Appeals has overturned a lower court's ruling that Pfizer's patent on Norvasc did not extend to cover AmVaz from Dr. Reddy's.
It has been a costly legal battle for Dr Reddy's and reports point out that the company could have spent upwards of $10 million in legal costs defending AmVaz.
Pfizer's Norvasc is the world's best-selling hypertension and angina drug with global sales of more than $2 billion in 2003.
The multinational holds patent rights for the drug right up to 2007.
In a faxed statement G V Prasad, CEO, Dr Reddy's said, "We are clearly disappointed by the court decision and had expected the views expressed by the chief judge in the dissent would have been the position of the majority.
"Despite the ruling, we remain committed to investing the resources to create a sustainable US-based business of specialty products and new chemical entities as well as generic medicines. We are making good progress in advancing our product pipeline, which now includes several projects under development targeting high-potential primary care and select specialty segments," the statement said.
To ensure that it minimises its risks, Dr Reddy's Laboratories had on February 24 announced that it had filed an abbreviated new drug application (ANDA) with the United States Food and Drug Administration (FDA) for AmVaz tablets of 2.5, 5 and 10 mg, with a paragraph IV certification on the two Orange Book patents listed for the drug.
The Orange Book is a listing of all the patents that have been granted by the Patent Office and is maintained by the US FDA.
Pfizer had reacted to the ANDA by filing a lawsuit against Dr Reddy's in the United States District Court for the District of New York alleging patent infringement on the two Orange Book patents.
The United States FDA (Food and Drug Administration) had initially approved AmVaz in October 2002, given its final approval in November 2003 and then in February this year had mentioned that it would be re-evaluating AmVaz.
Putting up a brave face, Prasad in the statement said, "The continuing growth in our core operations enables us to pursue opportunities in the higher-value segments of the pharmaceutical market. Based on our research strengths, commercialisation expertise, new product pipeline and world-wide presence, we remain committed to moving up the value-chain, migrating into a global specialty pharmaceutical company."