Can AI draft the patent claims of my pharmaceutical patent application?

The other day I thought it would be a fun experiment to test out ChatGPT's capabilities for writing a patent claim for a new medical use of an existing pharmaceutical substance/compound. This type of patent pertains to the protection of the discovery that an existing medicine can be used for a new and specific medical purpose, e.g. you have found that your drug is effective in treating a different disease than what it was initially used to treat.

So I asked ChatGPT: "Let's imagine that I discovered that Ipilimumab can help alleviate migraines in humans. What would you propose as the first independent claim for my patent filing?", and this is what ChatGPT came up with:

"For a patent filing regarding the use of Ipilimumab for alleviating migraines, the first independent claim could be structured to focus on the novel therapeutic use of the compound."

This is logical, since the compound, Ipilimumab in this case, is already a well-known monoclonal antibody for the treatment of certain types of cancer. So yes, of course, the claims of our patent application should be focusing on this novel therapeutic use of Ipilimumab. Maybe AI is advanced enough to draft usable medical use claims?

Well, my fears of AI taking over the drafting work I do as a patent attorney were soon allayed when ChatGPT followed this first statement with the following independent claim:

"1. A method of treating migraines in a human patient, comprising administering an effective amount of Ipilimumab to the patient."

Where to start with this... At first glance I can already see three obvious flaws (in my opinion):

1. The so-called "method of treatment claim" that ChatGPT came up with is not a claim format that is allowed in every jurisdiction. Yes, in the USA such a method of treatment claim is possible, but in Europe... no Examiner will grant this claim. In Europe, this claim would have to be formulated as "Ipilimumab for use in the treatment of migraines...", whereas in some other jurisdictions they prefer the so-called Swiss-type claim: "Use of Ipilimumab for the treatment of migraines...". Thus, there is no one-size-fits-all claim format for the second medical use claim and more information is needed in order to draft the claim in the correct format. Before providing this claim, ChatGPT should actually first have asked what jurisdiction(s) I was planning to file my patent application in, which in turn should have changed the format of the claim it proposed.
2. The claim is already limited to only Ipilimumab. Why is ChatGPT proposing to use the name of the antibody instead of the sequence of the antibody? When drafting claims to protect a monoclonal antibody, it is pretty standard practice to claim it by (parts of) its sequence, while also adding in wording that allows for some sequence variation (e.g. sequence identity percentages). This creates a broader scope of protection. Sure, it's very possible that the Examiner will want to limit you to the actual sequence of the antibody during the prosecution of the application, but if you have already limited it to just that one antibody from the start, you can never expand your scope beyond that one antibody.
3. Related, to the second flaw: the use of the name also makes it immediately clear it is referring to one specific product. Personally, I would usually draft a claim for a monoclonal antibody by describing the binding target of the antibody instead of using its name. So, in this case I would change "Ipilimumab" into something along the lines of "an antibody or an antigen-binding fragment thereof capable of binding to human cytotoxic T-lymphocyte antigen 4 (CTLA-4)". With a little research it will become clear that the patent application concerns Ipilimumab, but at least it is not at first glance completely obvious to your competitors what you are working on. Additionally, using the wording "or an antigen-binding fragment thereof" again builds in a bit of a protective bubble around your one antibody that prevents competitors from immediately being able to evade your patent scope by only using part of your sequence.

More could be pointed out and improved about this independent claim, but I will spare you an even longer rant, since I think this suffices to get across my point. Instead, let's see what ChatGPT had to say about the dependent claims, because it provided some advice on those as well:

"Remember to elaborate on additional dependent claims detailing dosage forms, treatment regimens, or specific patient populations [...]", which is not very much to go on really. Dosage forms, sure those are important if you already know what dosage form you will definitely be using. Treatment regimens, yeah you guessed it also important, again if you already definitively know which treatment regimen you will be using. Specific patient populations? Now we are moving into a different type of medical use that can actually serve as the basis for an entirely separate application... None of these types of dependent claims listed really serve as a fall-back position for that first independent claim. You know, in case your first claim is rejected by an Examiner... which it most likely will be (and you should actually hope it will be, because if your initial first claim is not rejected, maybe you could have gotten a broader claim scope). In this case however, fall-back positions are possibly not provided because the first claim is already so limited.

If it were my claim, I would probably start with only the heavy chain and light chain CDR sequences of the antibody (not the full sequence), maybe even with some possible amino acid differences (depending on whether there is data for that or if it would be plausible that the CDRs would still bind). Based on that claim, I could have a fall-back on the CDR sequences without the amino acid differences. Then I could have a fall-back on the full sequence with some sequence variation. The next fall-back could be the full sequence without variation. This already creates two or three more layers of scope of protection compared to what ChatGPT is providing with its proposed claim. Naturally, your fall-back position options will change based on what kind of data you have generated and how extensive that data is, which is why I always tell my clients to generate as much data as they possibly (realistically) can.

Additionally, I would also add in claims in which the antibody is part of a composition, part of a pharmaceutical composition, a formulation of the antibody (if available), a process for making the antibody or composition, perhaps also a claim that specifies what types of migraines you're targeting, a claim for a kit, etc. There are plenty of options to create a robust claim set.

I also would like to note that because these medical use claims have so many different formats, I would add independent claims (or at least have them in the text of my application) covering the subject-matter of the first claim in every format that I know is accepted for different jurisdictions. This is to have direct basis for these claims should the client want to pursue the application in said jurisdiction.

Fortunately, ChatGPT did have a sensible final statement that I believe also proves my point once again: "Consulting with a patent attorney can also provide tailored guidance for your specific situation.". In other words, and to provide an answer to the question that was asked in the title: no, AI can not (yet) draft the claims for your pharmaceutical patent application and I would sincerely not recommend that you try (also taking into account most AI are web-based and may very well not be secure enough to keep your drafted claims confidential).

I think that one of the main issues with AI chatbots such as ChatGPT is that it doesn't ask questions about your input. In a conversation with a patent attorney, the patent attorney would be asking the client questions to get a better idea of what the invention is about and what would be a suitable first claim based on the client's wishes, whereas AI spits out an answer based on only the input that it receives without first questioning whether said input already provides the full picture. So unless you know exactly what to put into the AI, it's very unlikely that you will get the answer that you require. I could have given ChatGPT follow-up instructions on how to draft the claim more to my liking, but I already know patent law, so I know which questions to ask. At that point, I might as well just draft the claim myself...

So to conclude, if you have an invention that you want patented, please reach out to a patent attorney for help. Consider our services an investment into your company and your technology.

As a Dutch and European patent attorney specializing in the Life Sciences I am more than happy to help you with any questions or issues you may have. Feel free to send a message on LinkedIn or email me at [email protected] if you want to connect!