Paxil Patent Ruling Issued
GlaxoSmithKline PLC
04 March 2003
Issued, London, March 4, 2003
Paxil Patent Ruling Issued
GSK Hemihydrate Patent Ruled Not Infringed in the U.S. - GSK to Appeal Ruling -
2003 Earnings Guidance Remains Unchanged
GlaxoSmithKline (GSK) today announced that a federal judge for the United States
District Court for the Northern District of Illinois (Chicago) has ruled in
GSK's litigation with TorPharm Pharmaceuticals (a wholly owned subsidiary of
Apotex) over GSK's anti-depressant drug, Paxil (paroxetine hydrochloride). The
judge ruled that GSK's patent in the United States covering the hemihydrate form
of Paxil is valid but not infringed by Apotex's product. The patent expires in
2006. GSK will appeal the ruling of non-infringement.
Although the judge did find it likely there would be some hemihydrate in Apotex'
product, he found that GSK did not show hemihydrate would be present in
sufficient amounts to infringe the patent under his claim interpretation. GSK
disagrees with that claim interpretation.
The ruling by Judge Richard Posner on the hemihydrate patent represents one
element of the current legal action between GSK and Apotex, which is seeking to
market an anhydrate form of paroxetine hydrochloride. GSK is continuing to
pursue litigation for infringement of other patents relating to Paxil against
Apotex and other generic companies in the United States District Court for the
Eastern District of Pennsylvania (Philadelphia). No trial date has been set. The
last-to-expire 30-month stay against FDA approval of Apotex's product under
Hatch Waxman law will expire on September 19, 2003.
Possible timing of a generic Paxil product remains unclear with the Philadelphia
trial still pending and the Chicago decision now moving towards appeal.
Consequently, GSK's published business performance earnings per share guidance
for 2003 remains as previously stated.* If a generic launch of paroxetine
hydrochloride became imminent, GSK would reassess this guidance.
Paxil was launched in the US in early 1993, and the first generic company,
Apotex, sought marketing approval in 1998 - only 5 years after first launch.
GlaxoSmithKline, one of the world's leading research-based pharmaceutical and
healthcare companies, is committed to improving the quality of human life by
enabling people to do more, feel better and live longer. For more information,
please visit the company's web site at www.gsk.com
SM Bicknell
Company Secretary
4 March 2003
Inquiries:
US Media inquiries GSK: Nancy Pekarek (215) 751 7709
Mary Anne Rhyne (919) 483 2839
(919) 412 9089
Patricia Seif (215) 751 7709
UK Media inquiries: Martin Sutton (020) 8047 5502
Siobhan Lavelle (020) 8047 5502
US Analyst/ Investor inquiries: Frank Murdolo (215) 751 7002
Tom Curry (215) 751 5419
European Analyst/Investor inquiries: Duncan Learmouth (020) 8047 5540
Anita Kidgell (020) 8047 5542
Philip Thomson (020) 8047 5543
*Earnings Guidance
The 2003 forecast is for high single digit percentage growth in business
performance earnings per share as long as there is no generic competition to
Paxil in the U.S. Business performance, which is the primary measure used by
management, is presented after excluding merger items, integration and
restructuring costs and disposals of subsidiaries. Growth is at constant
exchange rates (CER).
Cautionary statement regarding forward-looking statements
Forward-looking statements involve inherent risk factors and uncertainties. The
Group cautions investors that a number of important factors including those in
this document could cause actual results to differ materially from those
contained in any forward-looking statement. Such factors include, but are not
limited to, those discussed under 'Risk Factors' in the Operating and Financial
Review and Prospects in the Group's Annual Report on Form 20-F for 2001 filed
with the US Securities and Exchange Commission.
This information is provided by RNS
The company news service from the London Stock Exchange
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