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.
– 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?