Medical Treatment, Protection of Environment and Patent Law

Knowledge Commune mobilized legislators to propose a patent law amendment to make clear that medical treatment is excluded from patentable subject matter. The amendment was introduced in the National Assembly of the Republic of Korea on 3 March 2021. The amendment also aims to ban technologies seriously harmful to the environment from patenting.

 

Medical treatment

 

So far, the medical treatment has not been patented in South Korea on the grounds that it lacks the industrial applicability. But this practice has been maintained by administrative regulations, not by legislations. This means that the administrative branch, the Korean Patent Office, [1] can change the practice and permit patenting of methods of treating human. Actually, in 2019, the Korean Patent Office  revised its Patent Examination Guidelines (January 2021 edition) to permit patenting “customized treatment and digital diagnostic technologies”. It also permitted patenting medical methods when the methods made use of bio big data or artificial intelligence. Its rationale is that such methods are software inventions, not medical method inventions.

In addition, from last year, the Korea Institute of Intellectual Property, which is a mouthpiece organization of KPO, began to speak out that diagnostic method should be put under the patent protection, and several practitioners and scholars have taken the same position. This movement is contrary to the international trend and more importantly to the information KPO provided to WIPO.

WIPO has conducted surveys on patent exclusion, limitation and exception. According to the WIPO’s surveys and experts’ reports, most of national laws exclude medical treatment such as a method of diagnosis, treatment, or surgery from patentable subject matters. Several international treaties also permit such an exclusion, e.g., Article 1709(3) of NAFTA, Article 27(3) of TRIPS; and Article 53(c) of EPC 2000.

WIPO’s survey of 2010 (SCP/15/3, Annex I and Annex IV) shows that  among 98 countries 79 countries exclude “therapeutic, surgical and diagnostic methods for treating human or animals” from the patentable subject matter. When comparing with the survey of 1987 (finding 44 countries’ exclusion among 106 countries), the exclusion of medical treatment was doubled in 2010 (from 41.5% to 80.6%). [2]

 

National laws excluding medical treatment from patentable subject matters

WIPO Survey in 1987 79 countries among 98 countries
WIPO Survey in 2010 44 countries among 106 countries

 

In 2020, WIPO updated exclusions of national patent laws, but the accuracy of the updated information is unreliable. The information for 2020 version is said to be “gathered from the primary legislation”, and WIPO did not consult the secondary legislation. However, the information on Japan and the Republic of Korea is wrong. Both the Japanese Patent Act and the Korean Patent Act do not have any provisions banning, explicitly or implicitly, medical methods from patenting. Both countries merely maintain administrative practices to oust the medical methods. Although the practices are supported by the courts in both countries, the administrative practices, i.e., the patent examination guidelines cannot be treated as the secondary legislation. In addition, exclusion lists of the Republic of Korea increased to eight in 2020 from two in 2010. [3]

However, there has been no legislative change in terms of the patentable subject matter. In other words, while the statutory provision on the medical treatment has been untouched, KPO provided for WIPO with conflicting, opposite answers. For the 2010 survey KPO replied to WIPO “[T]he Patents Act of South Korea does not expressly exclude methods of treatment from patentability.” (p. 37 of the Annex IV). But for the updated information in 2020, KPO replied WIPO’s questionnaire as if the Korean Patent Act bans the medical method. This reveals the double face of KPO. KPO has been fiercely resisted against any legislative attempts to revise the Patent Act to exclude the listed subject matter such as computer programs and medical methods from patenting.

 

Protection of Environment

 

The amendment also intends to make clear that any technologies causing serious prejudice to environment are excluded from the patentable subject matter. So far, the grounds under which environmentally harmful technologies are excluded are unclear. The KPO’s Examination Guidelines explains that where exploitation of an invention is liable to harm the environment, the invention falls under an invention liable to harm public health (p. 373). [4] For instance, where a certain material is listed as prohibited from using, producing, importing, selling, storing and distributing due to a likelihood of harm to human body or the environment by a governmental notice and the claimed invention inevitably uses such a material, the invention deems to harm the pubic health.

However, it is hard to say that such practices are established. So are the case laws because there have been few cases. Hence, legislative measures specifying a separate basis on which technologies detrimental to environment are excluded.

In many countries, environmentally harmful inventions are excluded from patentable subject matter on the morality or public policy grounds. This approach is reflected in TRIPS Article 27(2), which allows national laws exclude from granting patent “invention, the prevention … of the commercial exploitation of which is necessary … to avoid serious prejudice to the environment”. The European Patent Office takes the same position. [5]

According to the WIPO survey of 2010, technologies detrimental to the environment are excluded from patentable subject matter in 22 national laws. The updated information in 2020 indicates that 29 national laws provide separate basis on which technologies that are detrimental to environment or contrary to the protection of environment are excluded. [6]


 

  1. The Korean Patent Office misleadingly names itself the Korea Intellectual Property Office. This naming causes a confusion and misleads the international communities. Under the Korean laws, especially the Patent Act and the Government Organization Act, the KPO has no grounds under which it can be called KIPO.

  2. WIPO’s expert report does not provide an explanation on the reason of the increase.

  3. The updated information was kept the same as the revised lists for South Korea in 2012 (SCP/18/2 Annex [SCP/12/3 Rev.2 Annex II). For the reason of the sudden increase, KPO replied to Knowledge Commune that other countries such as Japan and Canada listed exclusions that are not explicitly mentioned in legislation and therefore KPO felt to apply the same standards.

  4. The Guideline uses the term “public hygiene” instead of “public health”.

  5. The EPO Boards of Appeal confirmed that, under EPC Article 53(a), inventions the exploitation of which is likely to seriously prejudice the environment are to be excluded from patentability as being contrary to ordre public. (Plant Genetic Systems N.V., et al. v. Greenpeace Ltd., T 0356/93 – 3.3.4, EPO Boards of Appeal (Feb. 21, 1995).) (Hee-Eun Kim, The role of the patent system in stimulating innovation and technology transfer for climate change, Nomos Verlagsgesellschaft mbH & Co. KG, 2011, p. 34)

  6. Algeria, Argentina, Bahrain, Barbados, Belize, Bolivia, Colombia, Costa Rica, Dominica, Dominican Republic, Ecuador, Egypt, Guatemala, India, Jordan, Kenya, Kyrgyz Republic, Republic of Moldova, Mongolia, Nicaragua, Pakistan, Panama, Papua New Guinea, Paraguay, Peru, Romania, Trinidad and Tobago, Tunisia, Uruguay.