Exceptions of TRIPS Agreement in Relation to Biotechnology

By Ayushi Budholia

Published on: 07 Aug 2022 at 23:00 IST

INTRODUCTION

With the advent of trade liberalization and globalization it has become easy for an owner of a product to trade its product across the borders. However, it comes with a threat on the right of the owner’s product and property. This threat can be prevented if the owner is available with the intellectual property rights. These property rights are essentially property rights and the Agreement on “Trade Related Aspects of Intellectual Property Rights” (hereinafter referred as TRIPS) was the result of intense negotiations between what was then known as the industrialized world and the non-industrialized world.^[1]

The World Intellectual Property Organization (WIPO) was signed in 1967 at Stockholm.^[2] It used to protect the intellectual property rights before the introduction of TRIPS. It was a result of two major treaties which are the Paris Convention for the Protection of Industrial Property^[3] signed in 1883 and the Berne Convention for the Protection of Literary and Artistic Works^[4] signed in 1886.

The negotiations on TRIPS Agreement began in Uruguay Round of General Agreement on Tariffs and Trade between 1986 and 1993. It is signed by all members of World Trade Organization (WTO) and is administered by it.^[5]

With the advent of inventions in biotechnology, the need of patents in them also originated. It is basically believed that patents in biotechnology gave life to the intellectual property rights.^[6] This Article give a brief analysis of the exceptions of Agreement on Trade Related Aspect of Intellectual Property Rights in relation to biotechnology.

WHAT ARE TRIPS?

The Uruguay round ends on 1^st January 1995 with the establishment of World Trade Organization (WTO). The Agreement on Trade Related Aspects on Intellectual Property (TRIPS) is one of the multilateral agreements which come under the WTO Convention. This means that all members of WTO are bound by the obligations under the TRIPS Agreement.^[7]

It was set up with an objective of strengthening and protecting the owner’s intellectual property rights on its product and property. The intellectual property rights are given to the person for its own unique invention. They are generally given for a certain period of time. There are broadly two main areas of the intellectual property rights, which are – copyrights and rights related to copyrights, and industrial property.

WHAT ARE THE EXCEPIONS OF TRIPS?

The Agreement on Trade Related Aspects of Intellectual Property consists of four types of exceptions-

• Compulsory licensing

It is a practice of the government to allow some third party to produce the patented product without the consent of the patent owner or plans to use the patent – protected invention itself.^[8]

The provision related to compulsory licensing is provided under Article 31 of Agreement on Trade Related Aspect of Intellectual Property. It talks about “Other use without Authorization of the Right Holder” and states that –

“Where the law of a Member allows for other use of the subject matter of a patent without the authorization of the right holder, including use by the government or third parties authorized by the government, the following provisions shall be respected:”
It further provides certain conditions related to compulsory licensing given under clause (a) to (l) of Article 31.

• Parallel Imports

Parallel imports refer to the importation of goods produced and circulated in one country by the owner of its intellectual property rights such as patents, and then imported into another country without the authorisation of the patent owner.^[9]

• Exclusion from patentability

The provisions related to exclusion from patentability are given under Article 27(2) and 27(3) of the Agreement on Trade Related Aspect of Intellectual Property.

They provide that the Governments can refuse to grant patents for three reasons that may relate to public health – inventions whose commercial exploitation needs to be prevented to protect human, animal or plant life or health, diagnostic, therapeutic and surgical methods for treating humans or animals, and certain plant and animal inventions.

• Exceptions to Exclusive Rights

The provision related to the exceptions to exclusive rights are given under Article 30 the Agreement on Trade Related Aspect of Intellectual Property. It provides that –

“Members may provide limited exceptions to the exclusive rights conferred by a patent, provided that such exceptions do not unreasonably conflict with a normal exploitation of the patent and do not unreasonably prejudice the legitimate interests of the patent owner, taking account of the legitimate interests of third parties.”

WHAT IS BIOTECHNOLOGY?

Biotechnology is the use of cellular and molecular biology to create or change items or processes. It encompasses scientific and industrial disciplines centred on understanding and manipulating living or biologically active material at the molecular level, frequently incorporating DNA methods and genetic information. Modern biotechnology is expected to lead to important breakthroughs in many fields, such as health, food, energy, and the environment.^[10] Biotechnology has great importance in the field of agriculture, medicines, protection of environment, fertilizers, etc.

PATENTING IN BIOTECHNOLOGY

The patents in biotechnology are given in the same manner as are given in the case of other technological inventions. However, they are followed by certain exceptions given under Article 27 of the Agreement on Trade Related Aspect of Intellectual Property.

• Clause 1 of Article 27

Clause 1 of Article 27 states that –

“Subject to the provisions of paragraphs 2 and 3, patents shall be available for any inventions, whether products or processes, in all fields of technology, provided that they are new, involve an inventive step and are capable of industrial application. Subject to paragraph 4 of Article 65, paragraph 8 of Article 70 and paragraph 3 of this Article, patents shall be available and patent rights enjoyable without discrimination as to the place of invention, the field of technology and whether products are imported or locally produced.”

This Article provides that patents must be granted to all those inventions which are new, involve an inventive step and are capable of industrial applications. It further prohibits any kind of discrimination on the basis of place of invention, the field of technology and whether the products are imported or locally produce.

• Clause 2 of Article 27

Clause 2 of Article 27 states that –

“Members may exclude from patentability inventions, the prevention within their territory of the commercial exploitation of which is necessary to protect ordre public or morality, including to protect human, animal or plant life or health or to avoid serious prejudice to the environment, provided that such exclusion is not made merely because the exploitation is prohibited by their law.”

This Article provides the exclusion of inventions from the patentability in the view of ordre public and morality. The patent can also be denied in order to protect human, animal or plant life or health or to avoid serious prejudice to the environment.

• Clause 3 of Article 27

Clause 3 of Article 27 states that –

“Members may also exclude from patentability:

(a) diagnostic, therapeutic and surgical methods for the treatment of humans or animals;

(b) plants and animals other than micro-organisms, and essentially biological processes for the production of plants or animals other than non-biological and microbiological processes. However, Members shall provide for the protection of plant varieties either by patents or by an effective sui generis system or by any combination thereof. The provisions of this subparagraph shall be reviewed four years after the date of entry into force of the WTO Agreement.”

This Article deals with the exclusion of patents in biotechnological areas. The sub-clause (a) allows the members to deny patents on diagnostic, therapeutic and surgical methods for the treatment of humans or animals.

The sub-clause (b) allows members to exclude plants and animals from patentability; but requires them to recognize patents over micro-organisms; patents for microbiological processes for the production of plants and animals; and either patent or sui generis protection for plant varieties. With regard to the protection for plants varieties, Members have the option provide sui generis protection for new plant varieties; or patent protection for new plant varieties; or both sui generis and patent protection for new plant varieties.^[11]

To give protection to intellectual property, the members are allowed to form their own domestic laws and rules related to the intellectual property rights following the minimum standards laid down in the TRIPS Agreement.

In India, the protection to intellectual property was first given under Patent Act of 1856. However, this Act was not in accordance with the international rules and norms. To remove this drawback, a major amendment was introduced in 1970. However, the provision related to biotechnological patents were introduced through the amendment of 2002.

CONCLUSION

The protection of Intellectual Property Rights is not a new concept. It exists from quite a long time and even before the exitance of TRIPS Agreement. Under the TRIPS Agreement, if the owner’s invention and product are new and unique, they are granted the intellectual property rights. However, there are certain exceptions given under the TRIPS Agreement. The Clause 2 and 3 of the Article 27 of the TRIPS Agreement deals with the exclusion of granting patent when it is necessary to protect ordre public or morality, and in case of biotechnological inventions respectively.

ABOUT THE AUTHOR

Ayushi Budholia is a third-year, B.A.LL.B Student of Lloyd Law College, Greater Noida.

REFERNCES

• https://deliverypdf.ssrn.com/delivery.php?ID=805083115115086067006090102124098124020009058049034037091095010006029076088000024124013048012118102116115019090111011005024079026033071081039091096026112126118105077003020092094079090068106095101011101113003004126066109092117103125126001027079090017&EXT=pdf&INDEX=TRUE
• https://www.wipo.int/treaties/en/convention/#:~:text=WIPO%2DAdministered%20Treaties-,Convention%20Establishing%20the%20World%20Intellectual%20Property%20Organization,and%20was%20amended%20in%201979
• https://www.wto.org/english/tratop_e/trips_e/public_health_faq_e.htm#:~:text=Compulsory%20licensing%20is%20when%20a,the%20patent%2Dprotected%20invention%20itself

1. Zain Jaffery, “The exceptions to patent rights under the WTO-TRIPs agreement: Is the right to health denied?”, available at: https://deliverypdf.ssrn.com/delivery.php?ID=805083115115086067006090102124098124020009058049034037091095010006029076088000024124013048012118102116115019090111011005024079026033071081039091096026112126118105077003020092094079090068106095101011101113003004126066109092117103125126001027079090017&EXT=pdf&INDEX=TRUE (last visited on April 18, 2022). ↑
2. World Intellectual Property Organization, “Convention Establishing the World Intellectual Property Organization”, available at: https://www.wipo.int/treaties/en/convention/#:~:text=WIPO%2DAdministered%20Treaties-,Convention%20Establishing%20the%20World%20Intellectual%20Property%20Organization,and%20was%20amended%20in%201979 (last visited on April 18, 2022). ↑
3. World Intellectual Property Organization, “Paris Convention for the Protection of Industrial Property”, available at: https://www.wipo.int/treaties/en/ip/paris/ (last visited on April 18, 2022). ↑
4. World Intellectual Property Organization, “Berne Convention for the Protection of Literary and Artistic Works”, available at: https://www.wipo.int/treaties/en/ip/berne/ (last visited on April 18, 2022). ↑
5. Wikipedia, the free encyclopedia, “TRIPS Agreement”, available at: https://en.wikipedia.org/wiki/TRIPS_Agreement (last visited on April 18, 2022). ↑
6. R.S. Crespi, “Patenting in Biotechnology: the Saga Continues”, available at: https://www.tandfonline.com/doi/pdf/10.1080/02648725.1998.10647957 (last visited on April 18, 2022). ↑
7. Zain Jaffery, “The exceptions to patent rights under the WTO-TRIPs agreement: Is the right to health denied?”, available at: https://deliverypdf.ssrn.com/delivery.php?ID=805083115115086067006090102124098124020009058049034037091095010006029076088000024124013048012118102116115019090111011005024079026033071081039091096026112126118105077003020092094079090068106095101011101113003004126066109092117103125126001027079090017&EXT=pdf&INDEX=TRUE (last visited on April 18, 2022). ↑
8. World Trade Organization, “Compulsory licensing of pharmaceuticals and TRIPS”, available at: https://www.wto.org/english/tratop_e/trips_e/public_health_faq_e.htm#:~:text=Compulsory%20licensing%20is%20when%20a,the%20patent%2Dprotected%20invention%20itself (last visited on April 18, 2022). ↑
9. Zain Jaffery, “The exceptions to patent rights under the WTO-TRIPs agreement: Is the right to health denied?”, available at: https://deliverypdf.ssrn.com/delivery.php?ID=805083115115086067006090102124098124020009058049034037091095010006029076088000024124013048012118102116115019090111011005024079026033071081039091096026112126118105077003020092094079090068106095101011101113003004126066109092117103125126001027079090017&EXT=pdf&INDEX=TRUE (last visited on April 18, 2022). ↑
10. World Intellectual Property Organization, “Patent Expert Issues: Biotechnology”, available at: https://www.wipo.int/patents/en/topics/biotechnology.html (last visited on April 18, 2022). ↑
11. Simon Walker, “The TRIPS Agreement, Sustainable Development and the Public Interest”, available at: https://portals.iucn.org/library/sites/library/files/documents/EPLP-041.pdf (last visited on April 18, 2022). ↑