Patents for the Pharmaceutical drugs | TRIPS Agreement

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UPSC Syllabus: Mains – GS Paper III – Economy

Sub Theme: TRIPS Waiver to deal with CoVID-19 | UPSC

Context: Intellectual property regime has acted as a lethal barrier to the right to access health. Even request for a temporary waiver is not getting accepted.

Waivers are already in place under the World Trade Organisation’s Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). Developed nations including USA and European Nations, have blocked such waivers. This blockage has restricted essential drugs and vaccines to developing nations.

What is a patent?

A patent is an exclusive right granted for an invention, which is a product or a process that provides, in general, a new way of doing something, or offers a new technical solution to a problem. To get a patent, technical information about the invention must be disclosed to the public in a patent application.

Patent is provided for the period of 20 years. Exclusive rights are only applicable in the country or region in which a patent has been filed and granted, in accordance with the law of that country or region. Patent rights are usually enforced in a court on the initiative of the right owner.

In India, Patents are provided by Indian Patent Office. Any appeal against the order or violation goes to Intellectual Property Appellate Board.

Patents are justified:

  1. People have something of a natural and moral right to claim control over their inventions.
  2. Exclusive rights promote invention.
  3. Individuals should be allowed to benefit from their labour and merit.
  4. Innovation is an expensive activity to undertake.

However, these patents have been taken as a medium to own monopoly.

Background in India: India adopted the colonial patent protection regime (Indian Patents and Design Act, 1911). However, in 1959, a committee chaired under the N. Rajagopala Ayyangar objected this regime on ethical grounds. India adopted a new Patents Act in 1970 and this led to the rise in generic medicines production in India. India is now the largest generic medicine producer in the world. India’s efforts on HIV and Cancer drugs are well appreciated.

A generic drug is a medication created to be the same as an already marketed brand-name drug in dosage form, safety, strength, route of administration, quality, performance characteristics, and intended use. These similarities help to demonstrate bioequivalence, which means that a generic medicine works in the same way and provides the same clinical benefit as the brand-name medicine. In other words, you can take a generic medicine as an equal substitute for its brand-name counterpart.

One important waiver: Compulsory licensing

For patents: when the authorities license companies or individuals other than the patent owner to use the rights of the patent — to make, use, sell or import a product under patent (i.e. a patented product or a product made by a patented process) — without the permission of the patent owner. Allowed under the WTO’s TRIPS (intellectual property) Agreement provided certain procedures and conditions are fulfilled (Chapter 16).

The following conditions should be fulfilled by the applicant:

  • Reasonable requirements of the public with respect to the patented invention have not been satisfied.
  • Patented invention is not available to the public at a reasonably affordable price.
  • Patented invention is not used in India.

Benefits of such waiver:

Countries would be able to facilitate a free exchange of know-how and technology surrounding the production of vaccines.

Why should waiver be provided?

Most of the general medicines are produced under the research of Government funding mechanism or donations. For example: 97% of the funding towards the development of the Oxford/AstraZeneca vaccine recently was public money. Then how can they create monopoly on this.

The cost of innovation or R&D could be easily provided through a one-time payment or prize money rather a long-term patent.


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