This was one of a number of issues in
a dispute between Warner-Lambert
(a member of the Pfizer group) and
Actavis.
Warner-Lambert markets Lyrica
®
(pregabalin) for epilepsy, generalised
anxiety disorder (GAD) and
neuropathic pain. Warner-Lambert’s
patent for the compound per se
expired in 2013, but it still holds a
European patent directed to the use
of Lyrica for the treatment of pain,
and in particular neuropathic pain.
Actavis applied for marketing
authorisation to sell generic
pregabalin (under the trade name
Lecaent) for the treatment of epilepsy
and GAD. These indications are
not covered by Warner-Lambert’s
remaining patent, and so sale of
Lecaent for these indications would
not infringe the patent.
Warner-Lambert was concerned
that the active ingredient pregabalin
would be prescribed for the
treatment of pain, rather than
Lyrica
®
. If this occurred, pharmacists
might dispense Actavis’ Lecaent,
without realising that the use of
pregabalin to treat pain was the
subject of a patent held by Warner-
Lambert.
In an interesting development in the
dispute, the High Court granted an
order which forced NHS England
to issue guidance to doctors and
pharmacists detailing when Lyrica
®
must be prescribed. In particular, the
guidance indicated that “pregabalin
should only be prescribed for the
treatment of neuropathic pain under
the brand name Lyrica
®
...”.
This decision is the first time that
a UK court has granted an order
that directly affects the prescribing
practice of doctors. This order
should reduce the likelihood of a
generic drug being prescribed in
place of Lyrica
®
for the treatment of
neuropathic pain, thereby helping to
maintain Warner-Lambert’s market
position. If this approach is followed
in other cases, it could provide
a useful tool for the holders of
patents covering the use of drugs or
compounds for particular conditions
to prevent generic competitors from
affecting sales of their patented
branded drugs.
As it happens, the UK High Court has
recently ruled that Warner-Lambert’s
patent is invalid (although it is likely
that this decision will be appealed).
Accordingly, doctors can continue
to prescribe pregabalin generically
and pharmacists can dispense
generic pregabalin for any indication.
Nevertheless, this decision on validity
does not change the fact that the
High Court can issue orders which
modify NHS prescribing practices and
as a result, help to enforce patents.
To find out more
contact Becky Davidson
Patent medicines?
Are doctors’ prescribing
practices influenced by patents?
When prescribing medicines, doctors in the UK
typically refer to the active ingredient of the medicine,
rather than the trade name or brand name used by
the manufacturer. However, if a prescription refers
to a brand name, the pharmacist is legally obliged to
dispense that particular brand, whereas if a drug has
been prescribed with reference to its active ingredient,
the pharmacist can dispense a generic version of the
drug. Uncertainty can arise because prescriptions
typically refer to the active ingredient only, and not to
the symptom (the “indication”) for which the medicine
is being prescribed.
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