This post is written from the perspective of a UK-based
European Patent Attorney.
‘A patent protects an invention’. This simple fact is used
as the basis of understanding what a patent is by many of those who use patents
as commercial instruments. That includes research companies, accountants and
investors. However the reality of what a
patent protects is much more complex and the purpose of this post is to
elucidate why patent protection is complicated.
1. Inadequate Protection of the Invention
The boundaries of
an ‘invention’ are not always clear, and if this is not thought about carefully
a patent may not adequately protect the invention. The claims of a patent need to cover all ways
of carrying out the invention. If they
are written too narrowly then some embodiments of the invention will not be
protected giving third parties the freedom to use them. That may lead to the patent being
commercially worthless.
2. The Extent to which Equivalents are Covered
There will often
be embodiments similar to the ‘core’ invention which are problematic to include
within the claims, and a strategy needs to exist to consider these. For example, if the core invention is use of substance
X to treat condition Y, then consideration will need to be given to the extent
the claims cover derivatives of X and treating conditions similar to Y.
3. Incremental Inventions
Small incremental
changes can be patentable and commercially valuable. That means that whilst a third party may have
filed a patent application for the main invention, it may be possible to obtain
patent protection for ‘sub-inventions’.
For example if the main invention concerns a new compound with useful
properties, then it may be possible to obtain patent protection for
compositions which include the new compound and other substances which might,
for example, enhance its properties.
That means in areas of commercial importance thought should be given to
whether patent applications should be filed to such sub-inventions.
4. A Combination of Features
An ‘invention’
can emerge from a combination of features.
This is important to bear in mind because usually scientists will think
in terms of broad scientific laws and concepts.
However a patent application can be based on a technical effect which
only occurs in very specific situations, such as use of a specific solvent, at
a particular concentration and temperature, in a particular vessel in a fluid
of particular viscosity. Such a specific
finding might not be worthy of publication in a scientific journal, but it may
be patentable, and the resulting patent protection may be commercially useful.
5. What is the Advantage?
An invention can
be seen as providing an ‘advantage’ of some sort. It must be remembered that there are many
types of advantages which are given by inventions and not all of these might be
apparent. Clearly certain advantages are
very apparent, such as the achieving of the scientific goal (e.g. successful
treatment of cancer). However,
consideration should be given to other types of advantages, such as reduction
in cost, simplification of the process, ease of manufacturing, etc. Patentability arguments based on such
advantages can be very influential in persuading an Examiner to allow a patent.
6. Validity is
Never Certain
One cannot be
100% certain of whether a patent is valid, though it is normally possible to have
some idea of how likely it is that a patent is valid. It is often difficult to predict whether a
patent will be revoked in proceedings which decide upon its validity. Points 7 to 10 below provide some reasons why
this is the case, but also at the end of the day judging patentability is
complex and not clear-cut. Experienced
judges will often disagree on the issue, and that must be borne in mind.
7. Unpredictability
of Amendments
Whilst a patent
as granted may not be valid, it can be amended to make it valid. Therefore possible amendments always need to
be considered when looking at validity of a patent. However, given that in theory the entire
description of a patent is available to be basis of making amendments it can be
hard to predict all possible amendments.
8. Will Post-filing Data be Accepted?
Whilst the data
in the specification is important in determining the scope of claims that will
be granted, data can also be filed during examination, and under certain
circumstances this will be accepted to support the teaching in the
specification and the scope of claims.
However this is not always the case. For example the European Patent
Office requires there to be some evidence of the function of a new gene in the
patent application itself.
9. Changing Prior Art Landscape
Whilst Patent
Office searches usually identify the most relevant documents third parties
attacking a patent will usually find further relevant documents. That means the prior art landscape can change
with time as more relevant documents are found.
In recent times crowdsourcing has been used as a very effective way of
locating relevant prior art documents.
10. The Limitations of Patent Office Examination
It must be
remembered that Patent Office Examiners have limited resources. They are not able to consult relevant
experts, for example. That means that in
practice many patents are granted that would not survive opposition or validity
proceedings in a Court. Further not all
Patent Offices have a high quality of examination which means some are more
lenient than others. In practice that
means that not all patents are enforceable.
In summary:
- it can be
difficult to determine what the invention is and how broadly to define it in
the claims,
- patents can be
granted to sub-inventions and these can be commercially useful,
- it can be
difficult to judge the validity of a granted patent, and in the case of an
invalid patent whether there are possible amendments that would make it valid.
All of this means
that assessment of a patent case and its commercial worth is complicated. A
patent perceived to be of high value can be rendered invalid overnight by the
finding of a new prior art document.
Business decisions and commercial strategies should therefore take such
factors into account as much as possible.
You may also wish to see related articles Biotech
Due Diligence Advice and What
Do You Need to Know About Commercial Biotech?