Mixed Paxil patent news for GSK
pharmafile | October 27, 2003 | News story | |
GlaxoSmithKline has received mixed news in the on-going patent battle with Canadian generics company Apotex over its biggest selling drug, antidepressant Paxil.
In a summary judgement a federal judge in Philadelphia ruled in favour of GSK in one of four challenges to Paxil core drug patents, in favour of Apotex in another and returned a split verdict on a further two.
Apotex has been trying to introduce its own version of Paxil (paroxetine), known as Seroxat in the UK, via its subsidiary company TorPharm Pharmaceuticals. Patents protecting Paxil aren due to expire until 2006-7, but Apotex is attempting to have them invalidated in this and other legal proceedings in Chicago.
Several other companies are also attempting to bring generic Paxil to the market and some analysts predict at least one version will be launched by next autumn.
Commenting on the ruling in favour of Apotex, the judge said that conflicting legal precedent meant "It is impossible to know which approach is best. We encourage counsel to seek clarification of the law on this issue."
GSK is to appeal against this ruling, while the remaining three will be given a full court hearing in the middle of the year.
Paxil is GSK's biggest source of revenue, and the 10th biggest drug of 2001, with sales of $2.7 billion. A successful patent challenge, coupled with GSK lacklustre pipeline and drooping share price, would seriously damage the company growth prospects.
In May last year, the company lost patent protection on the antibiotic Augmentin, its second biggest drug.
GSK remained upbeat, however, and reiterated its earnings per share growth guidance of at least 10% for 2002 and in the high single digits this year. "GSK continues to believe there are significant hurdles that prevent launch of a generic Paxil product," a company spokesman said.
