The UK High Court recently
gave its judgment in the case of Merck, Sharp & Dohme Corp. and
Bristol-Myers Squibb Pharmaceuticals Ltd (collectively referred to in the
judgement as BMS) v Teva Pharma B.V. and Teva UK Ltd (Teva) (decision).  The judgement is interesting as it is one of
the few so called "quia timet" injunctions that has been issued by
the UK High Court on the basis of a contention by a patent proprietor that a
generic pharmaceutical company intends to launch its generic drug whilst the
patent and SPC under which the drug is protected are still in force.  A quia timet injunction is an injunction to
restrain harm which has not yet occurred but what is being threatened is
imminent.

The patent

Efavirenz is a drug used to
control HIV infections and is protected by the patent EP (UK) 0 582 455 (and
its associated SPC) which is owned by Merck.  The patent will expire on 3 August 2013 and the SPC on 20 November 2013.

Interim injunction

Teva obtained a marketing
authorisation for Europe for generic efavirenz in early 2012.  From its actions
in previous cases, such as the Warner Lambert case concerning generic
atorvastatin, Teva had a reputation to launch generic versions of a drug while
the patent and SPC protecting the drug were still in force.  BMS therefore asked Teva what its intentions
were regarding the launch of generic efavirenz.  Teva replied that its policy
was to not divulge commercial information to its competitors.  It also pointed
out that the grant of the marketing authorisation for generic efavirenz permits
but does not require Teva to market the generic product and that it was Teva's
policy to not infringe valid patents.

Dissatisfied with Teva's
reply, BMS applied to the UK court for injunctive relief alleging that Teva's
actions to obtain a marketing authorisation for Europe at an unusually early
time during the patent term and its reluctance to provide details of its
intentions concerning the launch of generic efavirenz in the UK indicated an
intention to infringe the patent and SPC.

Teva countered that the
claim should be struck out because it was not based on the validity of the
patent but instead on whether Teva's actions amounted to a threat to infringe.

The judge believed that BMS
had reasonable grounds for seeking injunctive relief.  In the judge's view, the
fact that Teva went to the trouble of obtaining a marketing authorisation for
efavirenz gave a concrete inference that Teva intended to sell efavirenz at
some time.  Furthermore, the judge found that the fact that Teva obtained the
marketing authorisation almost 22 months before patent expiry, which is
unusually early, supported an inference that generic efavirenz was intended to
be launched before patent expiry.

An interim injunction was
therefore granted on 15 March 2012 against Teva to prevent the launch of
generic efavirenz in the UK.

Final trial

At final trial (decision
issued on 9 July 2013) the only question that was considered was whether Teva,
by its actions, threatened to infringe EP (UK) 0 582 455 and its associated SPC
before their expiry and, thus, whether a final injunction for the remaining
term of the patent and SPC ought to be granted.

Teva argued that at the
time the action was brought (February 2012) it did not intend to launch generic
efavirenz before expiry of EP (UK) 0 582 455 and its associated SPC.  Teva
presented documentation from its in-house legal and commercial departments
which, Teva asserted, supported its position.

The judge summarised the
test under UK law for granting quia timet injunctions as whether, in all the
circumstances, there is a sufficiently strong probability that an injunction
will be required to prevent harm to the claimant occurring that the bringing of
proceedings by the claimant is justified.  The defendant's intentions before the action is brought are central to
the assessment.  Important considerations
are the defendant's subjective intentions and acts and what third parties would
perceive the defendant's intentions to be.

In the present case, in
considering the "third parties perceptions" arm of the test, the
judge held that when the action was brought, third parties would perceive that
there was a threat to infringe EP (UK) 0 582 455 and its associated SPC because
in the past Teva had launched products before expiry and without notice to the
patentee.  In considering the "subjective
intentions" arm of the test, during the case Teva had informed BMS that it
did not "have any plans to supply pharmaceutical products containing
efavirenz" in the UK before SPC expiry.  However, from internal documents disclosed by Teva during the trial, the
judge found that Teva was actively considering whether or not to launch its
generic drug in the UK before the expiry of the SPC.

The court therefore held
that it was appropriate to continue the preliminary injunction to restrain Teva
from infringing the patent and the SPC up to their expiry.

The judgement provides
useful guidance for pre-action correspondence which seeks to ascertain when a
company plans to launch its generic drug. 
If generics companies withhold such information from patent proprietors
they may face actions for quia timet injunctions.  Therefore, if a generics company is asked by
an originator company about its intentions concerning the launch of a generic
drug, the generic company should consider supplying assurances that generic
drugs will not be launched while patent rights remain in force.  Such assurance may be given under confidence
to prevent commercially sensitive information being divulged to competitor
generics companies.

This report comes
from European Patent Attorneys at WP
Thompson & Co., 55 Drury Lane, London UK.  Further details and
commentary can be obtained from Gill Smaggasgale,
a partner at the firm.