GSK loses patent case on top asthma drug

Glaxosmithkline lost a patent case on its biggest-selling asthma drug in the High Court in London yesterday, paving the way for generic versions to take a bite out of its business in the UK.

Glaxosmithkline lost a patent case on its biggest-selling asthma drug in the High Court in London yesterday, paving the way for generic versions to take a bite out of its business in the UK.

India's Cipla and other generic firms had challenged a key patent on Seretide - also known as Advair - which expires in 2013 on the grounds of obviousness. Mr Justice Pumfrey said the claimants' case was overwhelmingly strong.

Given the relatively small size of the British market, the financial impact of a defeat will be limited but industry analysts believe it could damage sentiment and raise fears about patent threats in other markets.

The case rested on whether GSK scientists took a truly inventive step in combining two older drugs, Flovent and Serevent, to make Seretide/Advair. In the event, Justice Pumfrey ruled the combination was entirely obvious.

A spokesperson for Europe's biggest drugmaker said it was considering an appeal.

The victory for generic manufacturers means they could launch cheap generic versions of the inhaled asthma treatment as early as October 2005, although it may be later if other GSK defences hold.

GSK also has data exclusivity claims on the product which run through 2008 and patents covering the devices used to deliver it into the lungs that are valid until 2011 and 2012.

The chief executive of GSK, Jean-Pierre Garnier, acknowledged during a post-results analyst meeting last month that the patent protecting Seretide/Advair was not as strong in the UK as in the United States, but said winning or losing in the London court would make no difference in the all-important US market.

Analysts at JP Morgan calculate that loss of UK patent protection could slice some 1.2 per cent off the group's 2008 earnings per share.