GlaxoSmithKline PLC
29 December 2002
Update On Paxil Patent Litigation
LONDON, 30th December, 2002 - GlaxoSmithKline (GSK) today 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, Paxil(R) (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(R) 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(R) product. Accordingly, GSK's published earnings guidance for
2002 and 2003 remains as previously stated.*
GSK's anti-depressent, Paxil(R) 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.
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
30 December 2002
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
Notes
Patent Ruling
5,900,423 Apotex motions denied
6,080,759 Split decision
6,113,944 Apotex motions upheld
6,172,233 Split decision
*Earnings Guidance
GSK expects business performance to deliver earnings per share growth of at
least 10% in 2002 and high single digits in 2003. This guidance assumes GSK
successfully defends its intellectual property surrounding Paxil(R) in the USA.
GSK is engaged in legal proceedings regarding validity and infringement of the
Group's patents relating to Paxil(R). Business performance growth is at
constant exchange rates and excludes merger items, integration and restructuring
costs and disposals of subsidiaries.
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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Does not distribute, republish or otherwise provide any information or derived works to any third party in any manner or use or process information or derived works for any commercial purposes.
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