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GlaxoSmithKline files suit against Dr Reddy's in US

BS Bureaux

GlaxoSmithKline Plc has filed a lawsuit in the US against Hyderabad-based Dr Reddy's Laboratories Ltd alleging infringement of three patents on Zofran, its anti-nausea medication.

In a faxed response to the queries made by Business Standard, Dr Reddy's said: "As is the normal procedure for all Para IV filings, GlaxoSmithKline Plc, the patent holder, for alleged infringement of its patents rights, challenged Dr Reddy's."

In June this year, Dr Reddy's had filed an abbreviated new drug application with the United States Food and Drug Administration for ondansetron, the generic version of Zofran. The application was meant for tablets of 4 mg, 8 mg and 24 mg with para IV certification on all Orange Book patents for the product.

The suit, filed in a federal court in Newark, New Jersey, USA, has been moved by two units of GlaxoSmithKline, the world's second largest drugmaker.

These are Glaxo Group Ltd and SmithKline Beecham Corp. The suit says that Dr Reddy's application has infringed three patents issued to it in 1987, 1988 and 1996. It has also asked the court to block the approval for Dr Reddy's before the patents expire.

Reacting to the lawsuit, Dr Reddy's said that it believed that it had the first-to-file status for all the three strengths of ondansteron and, if successful in the litigation, would enjoy a 180-day marketing exclusivity on the product.

"A para IV filing is made for a product which, we believe, does not infringe on the innovator's patent or when we believe the innovator's patents are not valid for various reasons," a Dr Reddy's spokesperson told Business Standard.

Zofran recorded worldwide sales of $228 million during first six months of this year, Bloomberg quoted GlaxoSmithKline spokeswoman Mary Ann Rhyne as saying. She said that the drug was used to treat post-operative nausea and vomiting, and for the management of chemotherapy and radiation therapy.

As per Dr Reddy's, the annualised sales of ondansetron hydrochloride, including oral solids and injectibles, were to the tune of $548 million during financial year 2000.

Recently, Dr Reddy's, as a result of its successful challenge to Eli Lilly's patents on Prozac, was able to launch fluoxetine 40 mg capsules and, in the process, became the first Indian company to get 180-day marketing exclusivity for a generic product in the US market.

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