GlaxoSmithKline (GSK) announced that a federal judge for the United States District Court for the Eastern District of Pennsylvania (Philadelphia) has ruled on summary judgement motions filed by TorPharm Pharmaceuticals (a wholly owned subsidiary of Apotex) in litigation over GSK's anti-depressant drug, PaxilÒ (paroxetine hydrochloride).
The judge ruled in GSK's favour on one patent, denying the motions for invalidity and non-infringement; in Apotex's favour on a second patent, holding the patent invalid; and split the decision on the remaining two patents, holding some claims in the patents invalid but denying Apotex's motions on other claims. Claims in three of the patents will proceed towards trial in the normal course of the litigation. A trial date for the case has not yet been set.
With respect to the claims held invalid, the judge noted that there was conflicting legal precedent and he commented that "it is impossible to know which approach is correct…. We encourage counsel to seek clarification of the law on this issue." GSK will seek an immediate appeal of the rulings with respect to the claims held invalid.
The summary judgement rulings represent one element of the current legal action between GSK and Apotex. GSK is continuing to pursue litigation against Apotex in the United States District Court for the Northern District of Illinois (Chicago) on its patent covering the hemihydrate form of Paxil expiring in 2006. Summary judgement motions seeking to invalidate this patent have already been dismissed and the time for filing of further summary judgement motions in this case has now expired. A trial date for this case has not yet been set.
GSK continues to believe there are significant hurdles that prevent launch of a generic Paxil product. Accordingly, GSK's published earnings guidance for 2002 and 2003 remains as previously stated.
GSK's anti-depressent, Paxil was launched in the US in early 1993, with patent expiry in 2006. The first generic company, Apotex, sought marketing approval in 1998 - only 5 years after first launch.