AI and machine learning have embedded themselves as crucial tools in all fields of technology and healthcare is no exception. In this article we shine the spotlight briefly on two important topics – AI in drug discovery (should you or should you not patent AI innovation in this field?) and the criteria for obtaining patent protection at the EPO for Healthcare AI innovation (can you get patents in this area?).
The answer to the first question is maybe, and the answer to the second question is a clear yes, if you can fit in with the EPO examination guidelines. Read more below but do not forget that while the EPO approach in this area is fairly settled, it is always possible to push the boundary, so if you are considering cases at the boundary of what you can or maybe even should patent, do get in touch with us to discuss.
AI and Drug Discovery
In the area of drug discovery, innovators have a strategic choice. Should you patent your AI based drug discovery method? Or should you patent the product that comes out of that method? Or both?
There are a number of strategic advantages to focussing your patenting activity on drug products, rather than on the tools you’re using to identify them.
Do you really want to disclose your AI method; maybe it’s better to protect it as a trade secret? In contrast, you’ll need to disclose your product eventually on the route to regulatory approval.
AI algorithms are often being developed so rapidly that the patent system isn’t ideal as a way to protect them; the patent application could too quickly become redundant. In contrast, your product isn’t as likely to change.
Even if you get a claim to your AI method granted, how will you know that someone is infringing your claim? It’s easier to detect infringement of a product claim than a method claim.
The EPO is developing a consistent and predictable approach to examining AI inventions. But EPO practice when it comes to pharmaceutical products is even more well established!
You can claim a product without having to disclose the AI/ML method used in its development.
A key question for innovators in this space is whether they will need any wet lab data to patent a pharmaceutical product in Europe. The requirement for sufficiency of claims to both pharmaceutical compositions and second medical use claims can be summarised as follows from T 1616/09:
For a pharmaceutical composition claim the application must:
Allow skilled person to produce the composition and
Leave no substantiated doubts that it could be used in therapy.
For a second medical use claim the application must:
Disclose composition in an enabling way and
Plausibly disclose the suitability of the composition for the claimed treatment.
An application with no wet lab data relying only on AI based predictions will have a challenging route to grant and may attract an opposition after grant. If possible, make your new chemical entity or get some clinical data to support your proposed repurposed drug. Then you can omit the AI/ML tool from your patent application.
The EPO’s approach to AI inventions: consistent and predictable
The EPO Guidelines make it clear that AI/ML is currently treated by the EPO as a mathematical method and that mathematical techniques such as AI/ML can contribute to technical character. There is a two hurdle approach, set out below, which gives applicants the tools they need to make a filing decision in Europe that they can have a reasonable amount of confidence in.
First: does the claimed subject matter have technical character as a whole? For this, you simply need ‘technical means’; in other words: a computer. Ensure your claim clears this hurdle by explicitly stating methods are ‘computer-implemented’ or by otherwise clearly defining a processor, server, device, network, etc.
Second: does the mathematical method itself contribute to the technical character? Two alternative lines of argument have been built up in EPO case law which applicants can rely on when ensuring a mathematical method, for example an AI method, contributes to the technical character of an invention. The most relevant line of argument for AI methods in the Healthcare sector relates to the technical application of the mathematical method. In summary, the EPO considers that an AI/ML or mathematical method may contribute to the technical character of an invention by virtue of its application to a specific field of technology. During prosecution you’ll need to be able to argue that the method, in the context of the invention, serves a technical purpose. This technical purpose needs to be sufficiently specific. Examples from the case law and examination guidelines include digital image enhancement or analysis (e.g. medical image segmentation); providing a medical diagnosis by an automated system processing physiological measurements; use of a neural network in a heart monitoring apparatus to identify irregular heartbeat; and providing a genotype estimate based on an analysis of DNA samples. Further, the claim needs to be ‘functionally limited’ to the technical purpose. In other words, it isn’t sufficient to simply define a technical purpose in the preamble of your claim. Instead, the mathematical method should be sufficiently linked to the technical purpose, for example by ensuring the claim defines the processing of data that is relevant to the technical purpose, and that the resulting output clearly contributes to the technical purpose.
Of course, while applications that can clear these hurdles shouldn’t expect eligibility issues at the EPO, that doesn’t necessarily mean that applications which can’t clear these hurdles have no chance at the EPO. Contact us and we’ll be able to give you a go / no-go assessment before filing in Europe. We love a challenge!
Stronger, faster and cheaper patents in Europe
What action can you take now? You could:
Review and update your guidance to US outside counsel regarding information to include in AI applications during drafting (e.g. technical application / purpose, claim types)
Review and update invention capture forms to capture information on technical effects and all possible technical purposes
Consider co-drafting with a European attorney to ensure appropriate language is included in the draft
Consider pre-filing reviews and amendments before filing in Europe
Consider a go/no-go assessment to allow you to concentrate your resources on those cases that are more likely to succeed in Europe.
If you have any questions, please contact a member of the team or your usual Kilburn & Strode advisor.