Danish court overturns Lipitor patent challenge
pharmafile | September 5, 2008 | News story | Sales and Marketing | Denmark, Lipitor, Pfizer, generics
A court in Denmark has ruled in favour of Pfizer in challenges to patents on the active ingredient – atorvastatin – in its blockbuster Lipitor.
The Eastern Division of the High Court in Copenhagen has said that Pfizer's basic and enantiomer patents covering atorvastatin were valid. The former expires in November 2011 and the latter in July 2010 and both would be infringed by Indian generics manufacturer Ranbaxy's generic atorvastatin product, the ruling says.
The two companies have previous form in this area: last year Pfizer gained a court injunction ordering the withdrawal of Ranbaxy's generic version of Lipitor in Denmark after just 11 days on sale. Ranbaxy had gambled on the pre-emptive launch helping it to seize market share, but it may now have to pay damages to Pfizer.
For Pfizer it is particularly significant as the cholesterol-lowering Lipitor is the best-selling drug in the world. The decision, although subject to appeal, effectively means Ranbaxy cannot launch its generic product before November 2011.
"Today's decision is an important outcome for Pfizer and other medical innovators who invest in high-risk research to develop life-saving medicines for millions of patients," said Pfizer Denmark country manager Karin Verland.
The country is a relatively small market for Lipitor, with an estimated annual spend of $30 million, but Ranbaxy's manoeuvres raised the threat of the first generic versions of Lipitor to be approved in western markets.
Ranbaxy has already launched its atorvastatin product in India and some other emerging markets and seems in no mood to give up trying to tap into the lucrative global market for Lipitor.
But Pfizer has so far been successful in defending its Lipitor patents in the US, UK and other major markets, spurred on by worldwide sales of $12.7 billion in 2007.
Despite these moves Lipitor will be off-patent in a few years and the manufacturer's attempts to increase its indications have not met with great success.
Earlier this year the company announced that the statin had shown no impact on the treatment of Alzheimer's disease, scotching its hopes for a potentially lucrative licence extension.
Although the company carried out the largest ever study into the effects of a statin on the disease, Lipitor showed no significant differences in cognition or global function (key measures of Alzheimer's progression) and no statistically significant differences were seen on various cognitive, behavioral and functional secondary endpoints.
Related Content
EC approves Pfizer’s Emblaveo for multidrug-resistant infection treatment
Pfizer has announced that the European Commission (EC) has granted marketing authorisation for Emblaveo (aztreonam-avibactam) …
Pfizer’s Velsipity approved by EC for ulcerative colitis treatment
Pfizer has announced that the European Commission (EC) has granted marketing authorisation for Velsipity (etrasimod) …
EC approves Pfizer’s Elrexfio for relapsed and refractory multiple myeloma
Pfizer has announced that the European Commission (EC) has granted conditional marketing authorisation for Elrexfio …
