A British judge today upheld the exclusivity of the main European patent covering the active ingredient in Pfizer's cholesterol drug Lipitor but ruled that a second patent was invalid.
Judge Nicholas Pumfrey refused a declaration of non-infringement filed by generics manufacturer Ranbaxy Ltd regarding one patent, but found that the second patent was "invalid for anticipation and obviousness".
"The result, therefore, is that Ranbaxy had been part successful in these proceedings," he said while delivering his judgment. Ranbaxy said it would appeal against the decision. The verdict, if upheld on appeal, will mean Ranbaxy cannot launch a copycat version of the medicine until 2011.
"I'm happy with the patent we have won. We are going to appeal against the other (decision). Based on our data, we are sure we are going to win it. Irrespective of what today's verdict may have been, an appeal would have been filed by either party. We had already factored in this risk," said Malvinder Mohan Singh, president-pharmaceuticals, Ranbaxy.
This ruling followed a hearing in the UK High Court, which took place during July 18-25 this year. "In the US, a trial of issues similar to those heard in the UK took place in December 2004. A ruling is expected before the end of 2005," said a statement from Ranbaxy.
Ranbaxy can seek some comfort in that the court invalidated the related "species" patent on treatment, which Pfizer had argued was valid until 2010. "We are very happy with the judgment on the species patent. However, we are going in appeal on the first one. We never intended to launch the drug with only one patent," said a Ranbaxy spokesperson.
The UK court judgment comes as respite to Pfizer, which had lost a similar case to the Indian company in Austria. The Austrian court had ruled that Ranbaxy's generic drug was non-infringing on the patented Lipitor.
Ranbaxy will be represented on the appeal by Andrew Waugh, QC, as its former barrister David Kitchin, QC, has now been appointed a judge of the high court.
Pfizer said the decision upholding the exclusivity of the patent covering atorvastatin, the active ingredient in Lipitor, until November 2011, was an important victory for scientists.
"This court decision is consistent with the fundamental principle that patents laws exist to support and encourage medical innovators, not undermine them," Pfizer Chairman and CEO Hank Mckinnell said in a statement.
Pfizer said it would appeal against the decision on the second patent, which expires in July 2010 and covers the calcium salt of atorvastatin.
Bitter Pill
