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US court blow to Dr Reddy’s

Mumbai, Oct. 12: In a fresh setback to Dr Reddy’s Laboratories, a US court has ruled that three generic drug makers, including the Hyderabad-based drug major, have infringed certain patent claims of AstraZeneca over the blockbuster drug Prisolec. The ruling effectively prevents Dr Reddy’s and the other two from selling copycat forms of the drug.

In the highly-watched case, AstraZeneca had argued that its various patents over Prilosec entitled it to additional US marketing exclusivity over the drug, which generates sales of more than $ 6 billion per year.

When contacted, a DRL spokesperson did not comment and said the company would issue a detailed statement on the implications early next week.

Industry observers feel that the ruling will also affect Cipla Ltd as it had bagged rights to sell a key ingredient used in the drug to Andrx Corp, which too has been found by the US court of infringing AstraZeneca’s patent over the drug.

On Friday, Judge Barbara Jones of the US district court for the Southern District of New York ruled that three generic drug manufacturers infringed certain AstraZeneca Plc patent claims over Prilosec (omeprazole) even as she ruled that KUDCo, a unit of Germany’s Schwarz Pharma AG, did not infringe upon the two patents.

The two key patents that the three generic companies were found to have infringed pertained to a subcoating of the drug. The generic companies which were in the race to make copycat versions of the drug included Andrz Corp, Cheminor from the DRL stable, Genpharm, a unit of Merck KGaA of Germany and KUDCo.

AstraZeneca had maintained that its various patents over Prilosec entitled it to additional US marketing exclusivity over the drug. Its original US patent over omeprazole expired in early October.

Analysts note that the US court ruling could put further pressure on the DRL scrip when trading opens on Monday. The counter has recently witnessed a drastic fall in its values following a string of negative news that included Novo Nordisk of Denmark halting trials of Ragaglitazar, the anti-diabetes drug of DRL and a US court ruling against it and other generic drug manufacturers with regard to a patent infringement case over Bayer AG’s Cipro.

The Prilosec case had earlier witnessed numerous twists and turns with even allegations that AstraZeneca resorted to smokescreens to protect its monopoly.

It was in February 1999 that DRL filed an Abbreviated New Drug Application (ANDA) with a Paragraph IV certification with the US FDA for omeprazole capsules 40 mg, the generic version of Prilosec. Subsequently, AstraZeneca sued Dr Reddy’s and also other applicants for patent infringement.

On May 31 last year, the United States District Court for the Southern District of New York ruled that one of AstraZeneca’s seven patents that are a part of the litigation was not infringed upon by Dr Reddy’s. The trial with respect to the other patents continued.

Subsequently, on November 16 the US FDA denied Dr Reddy’s the grant of exclusivity on the ground that a patent for which Dr Reddy’s was the first to file, had expired during the pendency of the suit and that Andrx was the first to file with respect to the other patents.

Following this development, DRL had filed a complaint against the US FDA on January 30, 2002 in the United States District Court for the District of New Jersey where it sought the reinstatement of its 180-day marketing exclusivity for omeprazole capsules.

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