Liveblog of 4/2 panel in European Bio-patent Law, Part III

By Nicholson Price

Third up is Dr. Maaike van der Kooij, discussing medical use claims at the EPO.

In general, methods of medical treatment aren’t patentable under Art. 53(c) of the EPC, but the way around is to claim a relevant product either for medical use (if the substance is known but not medically used (Art. 54(4)) or for a specific medical use (Art. 54(5)).  (From my point of view, this seems like another way that the EPO is trying to address its innovation mandate by working around what appears to be pretty clear language in the EPC, a pattern which we certainly see in the US in both PTO and Federal Circuit practice).

In medical use claims, the word “for” is a limiting feature – “for use” – and for the first medical use, compounds are claimed as “for use as a medicament/in therapy.”  For a second medical use, on the other hand, you claim a compound X “for use in a method for the treatment of disease Y.”  A few other formats are valid, but the EPO is pretty specific about the exact language they like to see.  (“Swiss type format” claims were briefly mentioned, but they’re a weird format and aren’t allowed any more as of 2008, so I’m skipping them here.)

Devices can’t be claimed like this (their effect is physical, not chemical).  And drugs have to be finished products, not intermediates.

She notes that such purpose-limited product claims are only available for methods which would otherwise be excluded by 53(c); something like “composition X for use as an antifungal” wouldn’t be allowed because it could be used on plants too, not just humans and animals.  (This seems like an attempt to limit the exception to an exception to avoid it swallowing the rule).

Finally, as with everything at the EPO, there need to be new technical features to allow patentability.

(There’s quite a lot going on with second medical uses, and it’s a rather complex doctrine.  There are also interesting features going on with the interaction between second medical uses and regulatory exclusivity for the innovator versus competitors–but that’s the subject for later thoughts.)

Read posts on the other presentations:

Part I: Dr. Aliki Nichogiannopoulou, EPO

Part II: Dr. Anja Schmitt, EPO

Part IV: Tom Kowalski, Vedder Price

W. Nicholson Price

W. Nicholson Price

Nicholson Price is an Assistant Professor of Law at the University of Michigan Law School. Previously, he taught law at the University of New Hampshire. He holds a PhD in Biological Sciences and a JD, both from Columbia, and an AB from Harvard. He clerked for Judge Carlos T. Bea on the Ninth Circuit, and was then appointed as an Academic Fellow at the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard. Nicholson teaches patents and health law and studies life science innovation, including big data and artificial intelligence in medicine. He recommends reading Bujold, Jemisin, and Older. His work has appeared in Nature, Science, Nature Biotechnology, the Michigan Law Review, and elsewhere. Nicholson is cofounder of Regulation and Innovation in the Biosciences, co-chair of the Junior IP Scholars Association, and a Core Partner at the University of Copenhagen’s Center for Advanced Studies in Biomedical Innovation Law.

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