Issue 39 October 2021 - Journal - Page 88
European Patent Office decisions and European case
law where it can.”
Lord Justice Birss proposed a three-stage test for
plausibility, or what he said may be more appropriately called “reasonable prediction”. This, he said,
should entail firstly identifying what it is which falls
within the scope of the claimed class; secondly, determining what it means to say that the invention works
– i.e. asking what is it for; and thirdly, asking whether
it is possible to make a reasonable prediction the invention will work with substantially everything falling
within the scope of the claim.
The Court of Appeal was considering the issues in the
context of a dispute over the validity of patents owned
by FibroGen for a product used to treat chronic kidney disease anaemia and related conditions, and
whether rival companies Akebia Therapeutics and Otsuka Pharmaceutical, who are both engaged in clinical trial testing for a rival product, infringed those
patents. The High Court previously ruled in favour
of Akebia and Otsuka.
Jadeja, said “In re-framing the critical question on
sufficiency as requiring only some, and not all, compounds falling within the claim to be found effective,
the Court of Appeal clarified that, for the purposes of
assessing if this could be done without undue burden,
it does not matter if any research project involves a lot
of work or is lengthy. It only matters that it can be
done with undue burden, for example, because the
necessary testing is routine and iterative.”
At the heart of the High Court’s decision was its view
that both families of patents in dispute in the case –
family A and family B – were lacking in sufficiency.
However, after hearing the arguments on appeal, the
Court of Appeal reversed the High Court’s findings
in relation to sufficiency. The court considered that
the ‘family A’ patents of FibroGen’s were valid after all
and that they had been infringed. It held, however,
that the ‘family B’ patents were still invalid on the basis
that the underlying invention was obvious.
“The question which will now be central to future
cases on this type of insufficiency is how many compounds or molecules need to be found effective. This
is necessarily a fact specific question which means we
will inevitably see more cases testing the boundaries
of the law of insufficiency,” she said.
First published by Pinsent Masons via Out-Law News.
Nicole Jadeja - Partner
+44 (0)20 7418 7340
The court also clarified the law in relation to
uncertainty insufficiency. It said that there is a distinction to be drawn between a claim that is difficult to
construe, or which has some room for doubt or fuzziness at the edge, and one that is conceptually uncertain. It said that where experts cannot agree on exactly
where the claim boundary lies, this would undermine
any claim for patent infringement but not render the
patent invalid on the basis of uncertainty.
Sarah Taylor - Senior Practice Development Lawyer
+44 207 054 2614
“The ruling will be welcomed by those in the
pharmaceutical industry,” Taylor said. “It offers important guidance to pharmaceutical manufacturers as
many pharma patent claims are framed with a structural feature and double functional features.”
Dr Yohan Samarasinghe
Consultant in Acute Medicine,
Diabetes and Clinical Pharmacology
“The ruling is positive from an innovator’s point of
view, as well as providing some clarity for those who
draft patents. It means that patents for broad chemical formulae when the therapeutic effect of the compounds covered by the formulae is included in the
claims may be less vulnerable to sufficiency attacks
than if the High Court’s original decision had stood,
and therefore may give pharmaceutical manufacturers increased confidence in the strength of such
patents. Arguments that such patents claim inventions
which are too broad, the limits of which cannot be ascertained even through an extensive research project,
will need to be far more nuanced and expert evidence
is vital in this regard,” she said.
Bsc(Hons), MBBS, MD, FRCP
I work in a busy, 720 bed, successful district general hospital in
Surrey. My principal role is that of an Acute Physician dealing with
all medical admissions either via the emergency department (ED) or
directly via general practitioners in the community.
Most of my work is on the Acute Medical Unit (AMU) and Ambulatory
Emergency Care Unit (AECU) of the hospital as well as the ED, but I also
do clinics, which primarily are in the field of diabetes, as well as general
medicine and hypertension.
In addition to the above fields I also trained in Clinical Pharmacology,
giving me an expertise in the management of patients with
hypertension and lipid disorders.
I also have a great interest in drug safety. I Chair the Frimley Health Area
Prescribing Committee and I am Clinical Governance Lead for the Medical
Directorate at Frimley Park Hospital.
Jadeja said: “Interestingly, the decision brings the law
in England and Wales in line with the German
Supreme Court decision in the case concerning
Dipeptidyl-Peptidase-Inhibitoren, which the Court of
Appeal found to be highly relevant. It noted that the
German ruling was not considered by the High Court
in this case. If this case is anything to go by, the UK
courts, as many predicted, still seem keen to algin with
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