Patenting Medical Treatments in the US and Europe – A Guide for Practitioners

Maiwald and Sterne Kessler analyze how patents with claims directed to medical treatments are handled in the US and in Europe. Thank you to Associate Dr. Anja Fux and Partner Dr. Eva Ehlich for co-authoring.

The new EU clinical trial regulation (EU No. 535/2014) in force since January 31, 2022, and its revised transparency rules in force since June 18, 2024, can demand an early and far-reaching disclosure of clinical study information.

This disclosure may become prior art to later-filed patent applications claiming medical treatments such as specific dosing regimens, administration routes, patient populations, or combination therapies.

Because such disclosures may constitute prior art world-wide, patent practitioners globally must understand their implications for highly valuable medical treatment patents.

This article compares US and European patentability requirements for such inventions.

Medical Treatment Claims

In the US, medical treatments can be claimed in the form of method claims, the eligibility of which was reconfirmed by the Supreme Court in Mayo Collaborative Services v Prometheus Laboratories, 566 U.S. 66, 2012; 35 U.S.C. § 101.

In contrast, the European Patent Convention (EPC) excludes from patentability methods for treating humans by therapy (Art. 53(c) EPC) but does not prohibit patenting products for use in such methods (Art. 53(c), 54(4), 54(5) EPC).

Such purpose-limited product claims are construed to include the therapeutic effect as a functional technical feature and are therefore limited to achieving such an effect. G 6/88, Headnote and reason 9, G 2/88, Headnote III and reason 9, G 2/21, reason 74.

In contrast, method of treatment claims are not necessarily construed to require the claimed treatment to be effective, in which case the claims may encompass a method designed to treat, potentially impacting patentability criteria such as enablement, written description, and novelty. United Therapeutics v Liquidia Techs, 74 F.4th 1360, 1369 (Fed. Cir. 2023), Eli Lilly and Company v Teva Pharmaceuticals, 8 F.4th 1331, 1340-43 (Fed. Cir. 2021).

Read the article in its entirety at the link below.