AI-assisted drug discovery patents – current environment
What challenges are pharmaceutical companies facing when attempting to patent AI-assisted drugs?
Many countries provide opposition mechanisms in their patent systems. Opposition systems typically offer third parties an opportunity to oppose the grant of a patent within a certain period of time provided by the applicable law.
One of the main objectives of the opposition system is to provide a simple, quick and inexpensive mechanism that ensures the quality and validity of granted patents by allowing an early rectification of invalid patents.
Patent oppositions before the European Patent Office (EPO) are perfect examples of this, with the EPO issuing a notice in 2016 that it was adopting a workflow to aim to reduce total time needed for a decision in straightforward cases to 18 months, calculated as from expiry of the opposition period, and which has more recently been reduced to 15 months.
This aim was effective, although delays increased as a result of the outbreak of the pandemic in March 2020, the EPO aided by the introduction of oral proceedings via video conference from the start of 2021.
By 2021, the EPO reported that 44.6% of patent oppositions were decided within around 19 months (calculated as from expiry of the opposition period). Further improvements have been made since and the average time to a decision has decreased.
It is also of note in relation to patent oppositions before the EPO, although oppositions are relatively uncommon (it is rare that any more than approximately 5% of granted European patents face opposition in any calendar year), the opposition process is very effective for both opponents and for patent owners, depending upon how the results are viewed.
In 2023 (the latest statistics released), 38% of opposed patents were completely revoked by the EPO, about 32% of opposed patents were maintained in an amended form and only 30% of opposed patents were upheld without any changes.
Chemistry is relatively consistently the most opposed area, with food chemistry, pharmaceuticals and polymers being areas of particular activity.
According to these numbers, in around 70% of the cases opposed in 2023, the patent was either revoked entirely or if maintained, was maintained in an amended form. This figure illustrates that challenging a patent in an opposition before the EPO is effective at least 2/3 of the time in at least limiting the scope of the patent claims, and resulting in revocation of the patent about 1/3 of the time.
The numbers also show that patent owners are successful almost 2/3 of the time in having the patent maintained in at least a limited form.
Perhaps the most worrying aspect of the numbers in relation to patent opposition, is that almost 1/3 of patents, when challenged after grant, are revoked in their entirely, meaning that the patent was invalid when it was granted. So according to the EPO’s own statistics if the numbers hold up in extrapolation to all patents granted (and not just those which are opposed), 1/3 of the patents that the EPO grants, are invalid.
However, this statistic must be viewed with the understanding that the patent examination process is an inherently flawed process. Patent Examiners are often not persons skilled in the art of the invention, the searches that the examiners undertake are time limited by their very nature and often, the examiners do not have access to or do not search the common information pool that is available to those who actually work in the field of the invention, relying largely on patent databases and/or databases of articles.
So, what is the takeaway message in relation to patent oppositions before the EPO?
These numbers show that a balanced understanding of the validity of a patent that has been granted is important, and also, that the patent opposition process can be a useful one to both patent owners and third parties, in testing whether a granted patent is valid or not.
For more information regarding patent oppositions at the European Patent Office, or for any other IP query, please contact one of our attorneys.