Trade Related Intellectual Property Rights (TRIPS)

Subject – Economy

Context – At WTO meet, India to push for TRIPS waiver of Covid-19 health products

Concept –

India will continue to push for inclusion of temporary waiver of Trade Related Intellectual Property Rights (TRIPS) provisions for Covid-related medical products in the WTO response package being worked out, as its domestic vaccine and pharmaceutical industry is on board.
India is insisting that the WTO response package that is being worked out to meet Covid challenges must necessarily include provisionson temporary waiver of TRIPS obligations for Covid health products, including vaccines, as mentioned in the proposal by India and South Africa that has been co-sponsored by 64 WTO members.

About TRIPS

The WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) is the most comprehensive multilateral agreement on intellectual property (IP).
It plays a central role in facilitating trade in knowledge and creativity, in resolving trade disputes over IP, and in assuring WTO members the latitude to achieve their domestic policy objectives.
It frames the IP system in terms of innovation, technology transfer and public welfare.
The Agreement is a legal recognition of the significance of links between IP and trade and the need for a balanced IP system.

TRIPS Agreement & Indian Law

The TRIPS agreement was negotiated in 1995 at the WTO, it requires all its signatory countries to enact domestic law.
It guarantees minimum standards of IP protection.
Such legal consistency enables innovators to monetise their intellectual property in multiple countries.
The TRIPS Agreement is also described as a “Berne and Paris-plus” Agreement.
It is applicable to all WTO members.
In 2001, the WTO signed the Doha Declaration, which clarified that in a public health emergency, governments could compel companies to license their patents to manufacturers, even if they did not think the offered price was acceptable.
This provision, commonly referred to as “compulsory licensing”, was already built into the TRIPS Agreement and the Doha declaration only clarified its usage.
Under Section 92 of the 1970 Indian Patents Act, the central government has the power to allow compulsory licenses to be issued at any time in case of a national emergency or circumstances of extreme urgency.

To know about IPRs in India, please refer July 2021 DPN.

Amendment to the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS)

An amendment to the WTO’s intellectual property (TRIPS) agreement entered into force on 23 January 2017.
Aimed at improving poor countries’ access to affordable medicines, the amendment makes permanent a decision on patents and public health originally adopted in 2003.
- The amendment was formally built into the TRIPS Agreement after two-thirds of the WTO’s members accepted it.

2003 decision

In August 2003, WTO members agreed to remove an important obstacle to affordable drug imports: they waived the limitation in the TRIPS Agreement to predominantly supply the local market when generic medicines are produced under compulsory licence.
The system established by the decision empowers importing developing and least-developed countries facing public health problems and lacking the capacity to produce generic drugs to seek such medicines from third country producers under “compulsory licensing” arrangements.
This amendment allows exporting countries to grant compulsory licences to generic suppliers exclusively for the purpose of manufacturing and exporting needed medicines to countries lacking production capacity.

2005 decision

WTO members agreed on 6 December 2005 to permanently incorporate the 2003 waiver decision into the TRIPS Agreement.
Following a recent rapid increase in the pace of acceptances, the amendment entered into force on 23 January 2017.
This additional flexibility to protect public health is therefore an integral part of the TRIPS Agreement.

Compulsory licensing

Compulsory licensing is a government’s authorization to someone else to produce the patented product or process without the consent of the patent owner.
The TRIPS Agreement allows compulsory licensing as part of the Agreement’s overall balance between promoting access to existing drugs and promoting research and development into new drugs.
Article 31 of the Agreement allows compulsory licensing and government use of a patent without the authorization of its owner, under a number of conditions aimed at protecting the legitimate interests of the patent holder.
The option to grant a compulsory licence under Article 31 for the purpose of manufacturing or import is available to all members.
It can cover all products or technologies needed to treat a disease or to fight a pandemic.
Under the conditions in Article 31, normally, the person or company applying for a licence must have first attempted, unsuccessfully, to obtain a voluntary licence from the right holder on reasonable commercial terms.
If a compulsory licence is issued, adequate remuneration must still be paid to the patent holder.
However, for “national emergencies”, “other circumstances of extreme urgency” or “public non-commercial use” (or “government use”) or anti-competitive practices, there is no need to try for a voluntary licence.

The Doha Declaration on the TRIPS Agreement and public health

WTO members adopted a separate Declaration on TRIPS and Public Health in 2001. It states that the TRIPS Agreement does not and should not prevent members from taking measures to protect public health.
It clarified TRIPS flexibilities regarding compulsory licensing and exhaustion, and also created the basis for extending the transition period for least developed countries in the pharmaceutical sector.
In particular, it dispelled the myth that compulsory licences should be limited to emergency situations by confirming that WTO members were free to determine the grounds under which compulsory licences could be issued.