AstraZeneca sues Glenmark over patent violation

Written by Soma Das | New Delhi | Updated: Jun 30 2010, 07:09am hrs
Swiss drug firm AstraZeneca has sued Mumbai-based drug maker Glenmark Pharmaceuticals in the US last week, alleging the latter is infringing its patent on the blockbuster cholestrol-lowering drug Crestor (rosuvastatin calcium) by attempting to manufacture and market its generic version. Global annual sales of Crestor are projected to touch $6.5 billion in 2013, from $4.5 billion in 2009. The US market contributed around $2.1 billion to sales in 2009, grwoing 25%.

Crestor is being chased by eight other companies of which at least two- Sun Pharma and Aurobindo Pharma are Indian. Sources told FE that Glenmark has re-oriented its strategy on Crestor reading signals from the ongoing patent litigation related to Crestor, (now in advanced stages), which appear at this point to be heading in favour of generic companies.

Glenmark had earlier applied for a Para III filing on the concerned patent (314), but has now opted for a Para IV filing making it inevitable for Astra Zeneca to challenge the claim.

In a Para III filing, the applicant acknowledges the patent of the approved drug and intends to enter the market after the patent for the approved product expires. In Para IV filing the company claims that its generic product does not infringe upon the existing patent or the patent of the branded product is invalid.

The patent under current litigation is scheduled to expire in 2016. Other companies battling it out in US to grab the generic opportunity include Cobalt

Pharmaceuticals, Teva Pharma, Apotex, Par Pharma, Sandoz, Mylan.

A Glenmark spokesperson said: As a policy, we do not comment on sub-judice issues.