GSK Annual Report 2002

Operating resources
Intellectual property
GlaxoSmithKline regards its intellectual property as a key business
asset. The effective legal protection of intellectual property is
critical in ensuring an effective return on investment in R&D.
Intellectual property can be protected by patents, trade marks,
registered designs, copyrights and domain name registrations.
Patent and trade mark rights are regarded as particularly valuable.
Patents
GlaxoSmithKline’s policy is to obtain patent protection on all
significant products discovered or developed through its R&D
activities. Patent protection for new active ingredients is available in
all significant markets. Protection can also be obtained for new
pharmaceutical formulations and manufacturing processes and for
new medical uses and special devices for administering products.
The patent position with respect to significant products is as
follows:
Augmentin. In the USA patents on the key active ingredient,
potassium clavulanate, extending to 2018, were held invalid by
decisions of a federal court in 2001 and 2002. These decisions are
under appeal. In other markets, the patents on potassium
clavulanate have expired, except in Italy (2006 c ).
Avandia and Avandamet. The basic patent on the active ingredient
rosiglitazone in these products is not due to expire until 2011 a in
the USA and 2013 in Europe. Patents on the commercial form of
the active ingredient rosiglitazone maleate are not due to expire
until 2015 in the USA and 2014 b in Europe.
Avodart. Patents on the active ingredient dutasteride have a
normal expiry of 2013 (USA) and 2014 (Europe). Requests for
extension of term of these patents are pending and are expected
to extend the terms of these patents to 2015 a in the USA and
2017 b in Europe.
Combivir. The patents on the specific combination of lamivudine
and zidovudine are not due to expire until 2012 in the USA and
2013 b in Europe.
Coreg. GlaxoSmithKline is exclusive licensee under the US patent
on the active ingredient carvedilol, which is not due to expire until
2007 a .
Epivir. The patents on the active ingredient lamivudine are not due
to expire until 2009 a in the USA and 2011 b in Europe.
Flixotide/Flovent and Flixonase/Flonase. In the USA, the patent on
the active ingredient fluticasone propionate expires in 2003, but
protection is expected to be extended by virtue of paediatric
exclusivity until May 2004. In most European countries protection
is not due to expire until 2005.
Imigran/Imitrex. The patents on the active ingredient sumatriptan
are not due to expire until 2008 in the USA and 2006 b in Europe,
(2010 c Italy).
Lamictal. The patents on the active ingredient lamotrigine are not
due to expire until 2008 a in the USA (2009 by virtue of paediatric
exclusivity) and 2005 b in Europe. GlaxoSmithKline has initiated
legal action in the USA against a generic manufacturer that is
attempting to launch its own version of the product prior to this
patent expiry.
Levitra d . GlaxoSmithKline has co-promotion rights under the US
patent on the active ingredient vardenafil which is not due to
expire until 2018 in the USA.
Description of business GlaxoSmithKline 23
Paxil/Seroxat. The patent protecting the commercial form of
Paxil/Seroxat is not due to expire, in most major markets, until
2006. GlaxoSmithKline has initiated patent infringement litigation
in the USA, Europe and several other markets against a number of
generic manufacturers who are attempting to launch their own
versions of the product prior to this patent expiry.
Retrovir. There are no patents on the active ingredient zidovudine.
Patents covering pharmaceutical formulations containing
zidovudine and their medical use are not due to expire until 2005
in the USA and 2006 in Europe.
Seretide/Advair. The patents on the specific combination of active
ingredients salmeterol and fluticasone propionate are not due to
expire until 2010 in the USA and 2013 b in Europe. A patent
challenge has been made to the combination patent in the UK.
Serevent. Patents on the active ingredient salmeterol xinafoate are
not due to expire until 2005 b in most of Europe (2008 b in France
and 2009 c in Italy) and until 2008 in the USA.
Valtrex. The patents on the active ingredient valaciclovir are not
due to expire until 2009 a in the USA and 2009 b in Europe.
Wellbutrin SR and Zyban. Patents on the basic active ingredient
have expired. Various formulation patents protect the currently
marketed SR (sustained release) formulations, the latest of which
is not due to expire in the USA until 2013. These patents are under
legal challenge in the US courts. In Europe, regulatory data
exclusivity provides protection until at least 2005, and until 2009
in some countries.
Ziagen. The patents on the active ingredient abacavir are not due
to expire until 2011 a in the USA and 2014 b in Europe.
Zofran. The patents on the active ingredient ondansetron are
not due to expire until 2005 in the USA and 2005 b in Europe,
(2010 c Italy). Patents on use in treating emesis expire in 2006.
GlaxoSmithKline has initiated legal action under these patents
against generic manufacturers in the USA.
Trade marks
All of GlaxoSmithKline’s pharmaceutical products are protected by
registered trade marks in major markets. In general, the same mark
is used for a product in each market around the world, but there
may be local variations. For example in the USA the trade mark
Paxil is used instead of Seroxat and Advair is used instead of
Seretide.
Trade mark protection may generally be extended for as a long as
the trade mark is used by renewing it when necessary.
GlaxoSmithKline’s trade marks on pharmaceutical products
generally assume an increasing importance when the patent for
that product has expired in a particular country and generic
versions of the product become available.
In the Consumer Healthcare business trade marks are particularly
important, as the business is very brand orientated and many
products do not have patent protection.
GlaxoSmithKline is routinely engaged in legal disputes in defence
of intellectual property rights on many of its products (see Note 30
to the Financial statements, ‘Legal Proceedings’).
a Including extension of term
b Including extension of term by supplementary protection certificates
c Including extension of term by national supplementary protection certificate, as
notified following a recent change in Italian law but subject to legal challenges
d a Registered Trademark of Bayer AG.