The UK Supreme Court’s
decision in the Warner-Lambert pregabalin matter could have
onerous consequences for innovator pharmaceutical firms and
biotech companies, according to in-house counsel.
Sources say the decision is bad for rights holders because
they will need to provide a broader range of evidence
– which will take more time to gather – to
justify the scope of their patent protection for second medical
"As with many Supreme Court decisions, we will have to wait
and see how the lower courts apply it," says the patent
attorney at a UK pharmaceutical firm. "But my concern is that
the higher hurdle for plausibility will be applied more widely,
and that would increase the burden on patent applicants."
The vice-president of IP at a UK biotech company adds that
the decision does not reflect the scientific reality of drug
development because of the complexities associated with animal
Last month, the Supreme Court
rejected Warner-Lambert’s appeal that its
patent for medication used to treat anxiety, epilepsy and
neuropathic pain was sufficiently disclosed, and upheld Mylan
and Actavis’s appeal that the disputed claims were
not even partially sufficient.
"My concern is that the higher hurdle for plausibility
will be applied more widely, and that would increase
the burden on patent applicants"
The question surrounding the case was how the concepts of
sufficiency and infringement were to be applied to a patent
relating to a specified medical use of a known pharmaceutical
The reportedly raises the bar for Swiss form claims, and
some of its reasoning could also apply to the medical use
claims in the Article 54(5) EPC2000 format.
"My first thoughts were that it was interesting that the
opinion on 'plausibility’ was not unanimous, and
the majority verdict was for a 'higher’ bar," the
head of IP at the commercial arm of a UK university tells
The decision was welcomed by generics drug companies, who
say it will benefit them.
"This is an important decision and a good one for us," says
the IP head at a Spanish drug company. "It will have an impact
on our future decisions, but it obviously depends on the cases
and the kind of projects we are working on, and whether there
are patents on second medical use indications."
The vice-president of IP at an Indian pharmaceutical firms
adds that the generics companies should now ask Pfizer, which
owns Warner-Lambert, for damages because of the
company’s mistaken interpretation and the fact
that it deprived generics companies of revenue and patients
with access to a cheaper version of the drug.
The innovator impact
Sources say the decision could have a particularly severe
impact on SME innovators.
The vice-president of IP at a UK biotech company points out
that small companies and research institutions are often under
pressure to file patent applications earlier than large
"There is a drive to publicly disclose the invention earlier
at a conference, for example, or when seeking funding," she
says "This decision puts us at a clear disadvantage as it seems
the evidentiary bar has been set much higher, requiring much
more data to be available at the filing date and we will not be
able to rely on supplementary data to support our case as we
Furthermore, she adds, the decision does not reflect the
scientific reality of drug development.
"My concern is that this decision will lead to us
needing human clinical data in the application in order
to obtain second medical use claims"
Many animal models and particularly mouse models, she
explains, may be representative of a type of disease such as a
number of types of pain, but not necessarily all subtypes such
as neuropathic versus other pain.
But because the test models are in non-human animals, there
will always be differences in the varying systems, including
the precise effect of a therapy and how this is measured
compared with the equivalent outcome in humans.
"There are some diseases for which there are no animal
models that are a complete and true representation of what
happens in the human system but the results obtained from the
models available give confidence of what might be expected when
the drug is used for treatment of a disease in humans," she
She adds this true for a number of therapeutic areas, and
the scientific community and regulatory authorities accept that
fact and still allow drugs to enter the clinic to be tested on
"They clearly think it plausible that it is possible on the
basis of this data that the drug will have an effect on the
diseases the applicant seeks to test."
Yet, she adds, the Supreme Court is alluding in this
decision that such claims are only obtainable once a company
has an animal model that is specific for that disease or
clinical data to show it works in that disease.
"We can’t be expected to test every single
model in a disease area – these models are expensive
and there are a great deal of ethical considerations that go
with performing in vivo studies.
"Furthermore, there may be some diseases for which a mouse
model just isn’t available. My concern is that
this decision will lead to us needing human clinical data in
the application in order to obtain second medical use
She adds that for small companies, it is likely that second
medical use claims will not be available because there will be
a disclosure of the diseases being tested at some point before
the data is available.