Introduction
This circular relates to biotech patent practice in Europe. It is based on our experience of drafting and
prosecuting biotech applications. The
circular is written from the viewpoint of practice at the European Patent
Office (EPO), though many of the issues that are discussed are also applicable
to other territories.
The Patentability of a
Biotech Invention
Assessing the patentability of a biotech invention is often
more difficult than for other technology areas.
As well as the usual analysis of the contribution over the prior art, it
is more likely that there will be a need to consider whether European practice
allows patent protection in that area and for that type of invention. In addition, it is not always straightforward
to determine whether the available data is enough to comply with the disclosure
requirements for an application.
The European Patent Convention (EPC)
excludes certain subject matter from patentability, for example for moral
reasons. For other subject matter it is not
possible to obtain patent protection due to the way that EPO practice and case
law have developed, such as for a new medical use of a known device or for discovering
the mechanism of action of a known drug.
Is there enough data
to file?
Inadequate disclosure in an application can lead to objections
of lack of support, lack of sufficiency, lack of industrial applicability or that
the application does not show that the problem has been solved (which is an
objection of lack of inventive step) . Such
objections are more likely if the claims are broad, and for biotech cases they
often are. Therefore it is important to
ensure that the application contains appropriate disclosure and data to support
the claims. For inventions concerning
therapy it can take many years for clinical trial data to be produced. However EPO Examiners will normally accept in vitro data that demonstrates the
technical effect. Post-filing data can
be filed during examination and that is often helpful.
In general the more data there is the more convincing the
application will appear to be and more likely to support broader claims. In
addition, there is often more flexibility to change the problem being solved during
examination. It is preferable for there
to be exemplified embodiments across the breadth of the claims, particularly if
the claims cover use of a broad range of compounds. In the case of gene sequences, the industrial
applicability of the gene needs to be mentioned in the application.
Drafting Biotechnology
Cases
When drafting a biotech case it is important to think
carefully about the claim scope. Whilst
broad claims are often appropriate, claims which are too broad can be
detrimental to a case. Sometimes it is a
case of striking the correct balance between inventive step and sufficiency to
arrive at a scope which is credible from the available data. Essentially the claims as initially drafted
should come across as a reasonable extrapolation from the Examples and with a
clear distinction over the prior art.
Whilst amendments are of course possible later, it is advantageous to
have an initial position which is credible and potentially defensible.
EPO Examiners often focus on the technical effect(s)
achieved by the invention. When drafting
one should identify all of the technical effects to make sure they are reflected
in the specification. For example a new
product may have improved activity, but it might also be more stable, easier to
make or have fewer side effects. Synergistic
effects should in particular be identified and highlighted.
When assessing the contribution the invention makes the EPO
will normally look at the problem being solved.
However the problem being solved will depend on the prior art and if new
prior art is discovered the problem may change.
For biotech cases the problem can change substantially, and the application
will need to be drafted in a way which bears this in mind. Essentially this means looking at inventions as
something quite fluid which are only really defined during examination. It is therefore important, for example, to
consider giving appropriate ranges for parameters which are used to define the
invention.
The Claims
For biotech inventions the inventive concept often leads to
many different independent claims, and so it is important to ensure that all
possible independent claims are considered when drafting. An invention based on the finding of a gene
polymorphism that causes a disease condition can lead to the claims to the
following subject matter: a diagnostic test, a polynucleotide comprising the
polymorphism, a protein comprising the resultant mutation, probes capable of
detecting the polymorphism, an antibody capable of detecting the mutation, vectors,
transgenic animals with the polymorphism, kits containing the probes or
antibody, and possibly screening claims, such as use of the transgenic animals
to identify substances able to reverse the effect of the polymorphism.
It is also important to identify all the different ways of
putting the invention into practice.
Given the complexity of biological systems this is not always
straightforward. For example if the
invention concerns a diagnostic test in which the presence of a specific
polymorphism is detected, then one should consider whether there are other
polymorphisms linked to the specific polymorphism that could also form the
basis of the diagnostic test.
Lack of Unity
The EPO is strict on lack of unity, and lack of unity is
often found on biotech cases. This is
now more problematic given that the EPO has imposed stricter deadlines for
filing divisional applications. When lack of unity is found Examiners will tend
to split the claimed subject matter into different inventions along the lines
of the sequences that can be used in the invention. Sometimes each sequence is deemed a separate
invention, leading to a large number of inventions being identified. This is unfortunate as there are often other
ways to define the inventions that lead to a lower number of total inventions. However given the present practice of the EPO,
if the invention relates to multiple sequences then the most important sequence
should be listed first (either in the claims or in the description).
It is important to think about unity when drafting. If possible, one should seek to highlight why
the claims relate to a single invention and aim to draft the claims in a manner
where the contribution of the non-sequence aspects is emphasised.
Problematic Subject Matter
As mentioned above certain subject matter cannot be patented
in Europe due to exclusions from patentability or because of the way that EPO case
law has developed. If this is relevant
to the invention then European Patent Attorneys can advise on whether
appropriate drafting of the claims will allow some protection to be obtained
for the invention.
The Biotech Directive
defines subject matter that is excluded for moral or other reasons, such as
parts of the human body, human embryos, methods of cloning humans, certain
methods of changing genetic identity and certain transgenic plants.
Methods of in vivo diagnosis
and therapy and methods of surgery are also excluded from patentability in
Europe. For diagnostic and therapeutic
inventions it is normally possible to obtain patent protection using other
claim types, such as diagnostic or medical use claims. Medical use claims are directed to use of a therapeutic
substance in therapy. European practice
allows such claims to be additionally limited in many different ways, for
example by patient group, dosages, administration schedules or methods of
administration, and so a wide range of inventions can be protected. However there are still problematic areas,
such as new medical uses of known devices, particularly where an electrical
impulse or electromagnetic radiation is delivered (instead of a substance). Other problematic areas are those where the
invention is not restricted to use of a specific therapeutic substance or treatment
of a specific condition, such as a new delivery system for example. This is because Examiners are reluctant to allow
medical use claims which define substances functionally and which are not
limited to treatment of a defined specific disease condition.
In cases where the invention has both in vivo and in vitro
steps it can be unclear as to whether it can be worded as an allowable medical use
claim. For example it is presently
unclear to what extent medical use claims can encompass a diagnostic or screening
step. For in vivo diagnosis the case law is complicated and continues to evolve.
EPO Examiners usually apply the exclusion of surgical
methods from patentability broadly, so that taking a sample from a body, or
administering via injection, or even by particles, can lead to objections. In many case the objection can be overcome by
excluding the relevant step from the claims, but clearly for certain inventions
this might not be possible.
In general, defining substances in the claims in a
functional way is problematic. If this
needs to be done then fall-back positions relating to specific defined substances
should be present in the application. Reach
through claims are not allowable (which define substances on the basis of them being
identifiable using a specified screening method). In addition Examiners are increasingly strict
on defining disease conditions in a mechanistic or functional way (such as ‘a
condition in which TNF-α levels are elevated’).
If such a definition is used in the claims, then the application needs
to contain details of how the skilled person can determine whether or not a
given condition falls within the definition which is used.
Inventions relating to the elucidation of the mechanism of
action of a known therapy are problematic since it can be difficult to draft a
claim that will be considered novel over the known therapy. Essentially such cases are only allowable if
knowledge of the mechanism will be reflected in the therapy being performed in
a different way.
At present the position of the EPO is unclear on the novelty
of medical uses claims where the patient group that is treated overlaps with
that treated by a known therapy. For
example if it is found that patients with certain biomarkers are particularly
receptive to treatment with a known cancer drug, it is unclear whether a
medical use referring to the treatment of patients with the biomarker will be
deemed to be novel. This does of course
have tremendous implications for the rapidly developing field of personalised
medicines.
Polynucleotide and Polypeptide
Sequences
Where an invention concerns a specific polynucleotide or
polypeptide sequence then it is normally desirable to also cover variants. This is usually done by drafting claims that
cover homologues of the sequences defined using percentage identity or
homology. In such cases the description of
the application should refer to an algorithm that can be used to calculate the identity/homology.
EPO Examiners are increasingly taking a strict view of
variant sequences, and may want further limitations in the claims so that only useful
variants are covered. Normally the
variants are required to have a particular activity. However if possible the application should
identify preferred variants defined by specific sequences and the application
should include data for variants.
Antibodies
It is normally acceptable to define antibodies with
reference to the epitope that is bound, and one finds that in general EPO Examiners
will accept the term ‘specifically binding’ to distinguish over prior art
antibodies. However if the prior art is
very close, an Examiner may take a stricter view. In the case where an antibody is an important
part of the invention one should consider providing further preferred features of
the binding properties. In particular it
is useful to define polypeptides which the antibody fails to bind. This can be done, for example, by referring
to polypeptides having less than a defined percentage identity to the natural
epitope sequence.
The European Patent
Office (EPO)
The EPO has a highly developed practice and case law in
biotech. It is a sophisticated patent
office that is capable of properly assessing the patentability of biotech
inventions, having Examiners who can understand complex biotech inventions and
who take a consistent approach to patentability. Whilst
there have been suggestions that the EPO grants too many biotech patents with broad
claims, in our experience we find that EPO Examiners normally do find a fair
balance between the rights of the applicant and the rights of third parties.
Dialogue with the
Examiner on Difficult Biotech Cases
In our experience biotech cases can be the most challenging
during examination. However it is
important to realise that at the EPO a real dialogue is possible with the
Examiner. Whilst the EPO does have an established
practice and case law which seems quite strict, Examiners are open to the
arguments made by applicants. They will
change their initial view of a case and are flexible enough to adopt a case by
case analysis when it is appropriate.
Perhaps one mistake that applicants make is to pursue claims
which are too broad for too long in examination. It can be more effective to appreciate the
Examiner’s position and make limiting amendments earlier when these will be inevitable
for a case to be allowed. Amendments can
be powerful way of changing the perspective of the Examiner on a case and are a
sign that the applicant is cooperating.
Inventive Step
Inventive step on biotech cases is often complicated, and
might involve many documents. Due to the
nature of biotech research it is often possible to find a prior art document
that has some suggestion of the invention.
However the EPO will accept inventive step arguments based on an analysis
of the likelihood of the invention working.
Thus the test of ‘reasonable expectation of success’ is often used. This means that whilst an invention can seem obvious
from one document, it is possible to show inventive step based on other
documents which, for example, give reasons as to why the skilled person would
not have expected the invention to work.
EPO Examiners are also receptive to arguments based on
surprising advantageous properties, and the more surprising and advantageous
the invention is, the more likely the case is to be allowed, though it might
seem obvious from the prior art. Essentially
the surprising advantageous property becomes part of the problem being
solved. Thus the problem is not simply finding
a compound with the required activity, but is to find a compound with high
activity, for example. The skilled
person would have less expectation of this second problem being successfully
solved.
Sometimes it can be helpful to file evidence or an expert declaration
during examination. These can be persuasive
in showing Examiners the expectations of the skilled person at the priority
date. Given that negative results rarely
get published, it can be difficult to show through published documents that in
a particular field there would have been no expectation of a certain approach succeeding.
Appeal from
Examination
Whilst appeal should not be viewed as an opportunity for the
entire case to be looked at again, in practice it is very helpful. Appeal Boards are open to the arguments presented
to them and are prepared to take a different view from Examining Divisions.
