Open Access Open Access  Restricted Access Subscription or Fee Access

Patenting Therapeutic Methods: Statutes and Strategies

Seema Soni, Pratap Devarapalli


Patenting medical therapeutic methods has become one of the toughest tasks for inventors and scientists in some jurisdictions where these methods are excluded from patentable subject matter. There are recent amendments by different countries in relation to patentability aspects of Therapeutic methods. In this scenario, analysis of these recent amendments would provide a path for researchers in the field to identify whether their inventions are considered as patentable subject matter. Our analysis sheds some light on different statutes and regulations of major jurisdictions on the patentable subject matter and patentability aspects of therapeutic methods. Furthermore, we have identified that most of the jurisdictions restrict inventors in patenting therapeutic methods. However, some countries such as United States and Australia allow patents related to therapeutic methods. We think adapting different strategies that are provided in this article would help researchers, inventors and patent attorneys in patenting the inventions related to therapeutic methods. Moreover, while applying the provided strategies, it is suggested that inventors should draft the patent claims by keeping a note of different statutes and regulations of countries in which they are interested to file the patent applications.


Patents; Medicine; Therapeutic Methods; Medical treatment methods;

Full Text:



Miller-Keane, Encyclopedia and Dictionary of Medicine, Nursing, and Allied Health (7th ed, 2003). Retrieved March 30 2017 .

Edwin Smith papyrus, Egyptian medical book. (Encyclopedia Britannica, 1998).

WIPO, ‘World Intellectual Property Indicators’ (2016) World Intellectual Property Organization.

United States Code Patents Act 1952, §35 USC 287(c) (2012).

*The European Patent Convention 1973, Article 53(c) (2000).

Joos v Commissioner of Patents (1972) HCA 38.

Anaesthetic Supplies Pty Ltd v Rescare Ltd (1994) 50 FCR 1.

Bristol-Myers Squibb Company v FH Faulding & Co. Ltd (2000) FCA 316.

**Apotex Pty Ltd v Sanofi-Aventis Australia Pty Ltd (2013) HCA 50.

*Indian Patent Act 1970 (Cth) s 3(i).

Chinese Patent Law 1984, Article 25(3) (2008).

Examination Guidelines for Patent and Utility Model in Japan 2015 Part III, Chapter 1 (§3.1).

Janssen Inc v. Mylan Pharmaceuticals ULC, 2010 FC 1123.

From Canadian Intellectual Property Office Guidance Document “Examples of purposive construction analysis of medical use claims for statutory subject-matter evaluation” .

Otsuka Pharmaceutical Co., Ltd., "Substituted Carbostyril Derivatives as 5-HT1A Receptor Subtype Agonists".

**Otsuka Pharmaceutical Co., Ltd v Generic Health Pty Ltd (No 4) (2015) FCA 634.


  • There are currently no refbacks.