Establishing inventive step in Swiss-type use claims – A case study on disease subtypes and known APIs.

As pharmaceutical innovation increasingly targets specific disease subtypes and personalised therapies, patent protection strategies must evolve accordingly—especially in jurisdictions like China, where method of treatment claims are not patentable.

This article explores a successful approach to secure protection for a known active pharmaceutical ingredient (API) used to treat a disease subtype under China's Swiss-type use claim framework. It highlights how inventive step can be established through clinical distinction and strategic claim drafting, offering valuable insights for patent professionals and innovators worldwide.

Understanding Swiss-type use claims in China

In China, direct claims to methods of medical treatment are excluded from patentability. Instead, applicants must rely on Swiss-type use claims, typically structured as: