The State of Patentable Subject Matter Internationally

By: Adil Moghal (2018 Summer Associate) and Paul A. Calvo, Ph.D.

As evidenced recently in the United States, it may be difficult to tell what categories of inventions are eligible for patent protection in foreign jurisdictions. To further complicate issues, standards of eligible subject matter can differ from country to country. What follows is a survey of patent eligible subject matter in various jurisdictions.

A sampling of subject matter eligibility outside of the US is provided below. Certain categories of subject matter are excluded as patent ineligible in all countries discussed, such as scientific discoveries, purely intellectual activities, laws of nature, and mathematical equations; other categories are excluded as culture-specific, such as inventions “against public morality” or “against Sharia law”. Microorganisms can be claimed in all of the jurisdictions included here, and are therefore excluded, as are certain categories of subject matter mentioned in only one foreign jurisdiction, such as the explicit exclusion of methods of horticulture and agriculture in India and personal skills in Japan.

The features of subject matter eligibility discussed may be nuanced in certain jurisdictions because this is an evolving area of the law across the globe.

Methods of Treating Humans
Methods of treatment in humans varies widely by jurisdiction.

Methods of treatment are patent eligible in Australia and Russia.

Europe: Article 53(c) prohibits the patenting of methods for treatment of a human by surgery or therapy and diagnostic methods practiced on a human. However, it is permissible to patent products, such as substances or compositions, for use in any of these methods – for example, composition X for use in a method of therapy, diagnosis or surgery.

Canada: In contrast to claims for a method of medical treatment, a claim for a use of a compound or device to medically treat a disorder may be valid, so long as the claim does not limit the skill and judgment of a physician. For example, “1. The use of compound X to treat disorder Y” is considered to be patent-eligible subject matter in Canada. Addition of dosing regimen information may be deemed to limit the skill of a physician.

Mexico: Therapeutic method claims are accepted when drafted as second medical use formats: “Swiss-style type” or “EPC2000 type”.

Brazil: Therapeutic method claims are accepted in a Swiss-type format. Limitations may be placed in claimed subject matter regarding dosing regimens as they may be seen to cover therapeutic methods of treatment.

Japan: Therapeutic method claims are accepted when drafted in Swiss-type format or “composition for use” format.

Israel: Medical methods are not permitted in Israel. However, examples of acceptable formats include “Use of X in the preparation of a medicament for use in treating disease Y”. This is contrasted with the unacceptable format: “Use of X in the treatment of disease Y.”

South Korea: Methods of treatment are ineligible, but composition claims such as “a pharmaceutical composition comprising product X for the treatment of disease Y” are eligible.

Gulf Cooperation Council (GCC): As with methods of diagnosis, methods of treatment in the human body are patent ineligible subject matter, but products used as a part of treatment are eligible.

Diagnostic Methods
Diagnostic Methods are patent eligible subject matter in Australia and Russia.

Diagnostic methods are patent ineligible subject matter in India.

Europe: Diagnostic steps performed on the human body are ineligible, but diagnostic tests performed on samples obtained from a human body may be patented.

Canada: Methods of data acquisition are statutory subject matter, provided claims do not include ineligible subject matter, such as methods of treatment.

China: Methods for the diagnosis of diseases are not patentable. However, (i) the method of acquiring information from a living human or animal body as the intermediate result only; (ii) the method of acquiring information by processing or detecting the tissues, body fluid or waste isolated from the human or animal body as the intermediate result only; and (iii) the method of processing the acquired information, are not considered to be methods for the diagnosis of diseases if the immediate purpose is not to obtain the diagnostic result of a disease or health condition.[1]

Japan: Compositions, devices, systems or kits for use in diagnosis to be practiced on the human body are industrially applicable and patentable subject matter.

South Korea: Inventions that include the human body as an essential element are deemed patent ineligible subject matter.

GCC: Methods of diagnosis applied to the human body are ineligible, but products used as a part of diagnosis are eligible.

Plants and Animals
Plants and animals are patent ineligible subject matter in Europe, Canada, China, South Korea, India, Russia, and the GCC, but are eligible subject matter in Australia and Japan.

Software
Software is patent ineligible subject matter in Europe, Russia, Argentina, Brazil (copyrightable protection allowed) and the GCC, but is eligible subject matter in Canada, Australia and Japan.

China: Software patents are per se patent ineligible (though copyrightable). However, these are distinguished from computer-related inventions, which recite a computer program as part of an apparatus claim. Claims must recite technical solutions, because non-technical solutions are ineligible subject matter.

South Korea: Patents for software are only eligible if recorded on a storage medium, the combination of software and hardware represent an improvement over the prior art, the combination has a technical result, and the combination constitutes a complete technical solution.

India: Previously, software was per se unpatentable if not claimed in conjunction with novel hardware. Currently, the novel hardware requirement has been dispensed with, and examiners look to the underlying substance of claims as a whole. Computer programs are still per se unpatentable, but Indian examiners are allowing descriptions of technical solutions in the form of programs to be patented.

Business Methods
Business methods are patent ineligible subject matter in Europe, Japan, Russia, and the GCC, but are eligible subject matter in Canada, Australia, and South Korea (if presented as a specific technology in combination with computer technology).

China: Business methods are per se ineligible unless they recite technical features, especially those of a physical nature.

Brazil: Business methods are patent ineligible. However, technical processes that improve the implementation of a business method is patent eligible.

India: As with computer programs, examiners in India are encouraged to look at the underlying substance of claims as a whole. Business methods are unpatentable subject matter, but “the mere presence of words such as ‘enterprise’, ‘business’ [or] ‘business rules…’ should not imply the claims are automatically ineligible.

[1] https://www.lifesciencesipreview.com/article/china-v-us-what-can-be-patented-in-the-life-sciences-field

This article appeared in the October 2018 issue of Global Patent Prosecution Newsletter.