The Hindu Business Line : AstraZeneca Plc to sue Ranbaxy on ulcer drug

ASTRAZENECA Plc has decided to file a lawsuit in a New Jersey District Court against Ranbaxy Laboratories Ltd for `wilful infringement' of its patents protecting Nexium (esomeprazole magnesium) used in the treatment of heartburn and ulcers.

The drug, which is protected by six patents that expire between 2014 and 2019, generated revenue of $3.8 billion in 2004.

Ranbaxy had filed an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration (FDA) seeking permission to market a generic version of the patented drug in the US prior to the expiration of patents.

The Anglo-Swedish drug company had 45 days to file a lawsuit against Ranbaxy that would stop the US regulator from approving the request for 30 months or until an adverse court decision.

Besides this, AstraZeneca is already fighting a challenge to Nexium from Hyderabad-based Dr Reddy's Laboratories Ltd.

A statement on the company's Web site said, "AstraZeneca has full confidence in and will continue vigorously to defend and enforce its intellectual property rights protecting Nexium."

Meanwhile, when contacted, Ranbaxy officials maintained that as in other patent infringement litigations, here too the company would aggressively defend itself.

It had applied for approval to market generic versions of 20 mg and 40 mg Nexium capsules. In October this year, AstraZeneca had received a notice from Ranbaxy regarding its ANDA filings.

Analysts tracking the sector said that going forward multinational companies would aggressively protect their intellectual property rights making the entry of generics difficult.

"Ranbaxy is already fighting a slew of challenges for various blockbuster molecules including Pfizer's cholesterol lowering drug, Lipitor and GSK's Valtrex used for herpes medication. This is another addition to its list," they said.

Recently, the company won two out of the three patent claims for Clarithromycin 1,000 mg extended release (ER) drug used in the treatment a wide variety of bacterial respiratory tract infections including chronic bronchitis and acute maxillary sinusitis. Clarithromycin is the generic version of Biaxin, a drug manufactured by Abbott Laboratories.

While drugs worth $60 billion are expected to go off patent in the next few years, very few blockbuster new molecules are in the research and development (R&D) stage. Hence, generic companies are also likely to come up with non-infringing process patents so that they do not impact the innovator companies, said another analyst. "Innovators will strategise to protect their turfs and generic companies will do their best to dent it. Litigation costs are also expected to go up substantially," added the analyst.