Trips Waiver

Trips Waiver

Subject: Economy

Section: IPR

Context: India risks being left out of TRIPS waiver

New Draft TRIPS Waiver plan

• Draft waiver includes only COVID-19 vaccines and not other COVID-19 medical products
• Draft waiver proposes to waive only patents and not other IP rights.
• Draft waiver is not universal. Only those developing countries that exported less than 10% of world exports of COVID-19 vaccine doses in 2021 are covered for exportation and importation

What is Patenting all about?

• Patenting: WTO members have to provide patent protection for any invention, whether a product (such as a medicine) or a process (such as a method of producing the chemical ingredients for a medicine), while allowing certain exceptions. Patent protection has to last at least 20 years from the date the patent application was filed.
• Non-discrimination: Members cannot discriminate between different fields of technology in their patent regimes. Nor can they discriminate between the place of invention and whether products are imported or locally produced.
• Three criteria: To qualify for a patent, an invention has to be new (“novelty”), it must be an “inventive step” (i.e. it must not be obvious) and it must have “industrial applicability” (it must be useful).
• Disclosure: Details of the invention have to be described in the application and therefore have to be made public. Member governments have to require the patent applicant to disclose details of the invention and they may also require the applicant to reveal the best method for carrying it out.

Exceptions from Patenting

• Governments can refuse to grant patents for three reasons that may relate to public health:

1. 1. inventions whose commercial exploitation needs to be prevented to protect human, animal or plant life or health
   2. diagnostic, therapeutic and surgical methods for treating humans or animals
   3. certain plant and animal inventions

Under the TRIPS Agreement, governments can make limited exceptions to patent rights, provided certain conditions are met. For example, the exceptions must not “unreasonably” conflict with the “normal” exploitation of the patent.

Anti-competitive practice

• The TRIPS Agreement says governments can also act to prevent patent owners and other holders of intellectual property rights from abusing intellectual property rights, “unreasonably” restraining trade, or hampering the international transfer of technology.

Compulsory Licensing

• Compulsory licensing is when a government allows someone else to produce the patented product or process without the consent of the patent owner.
• The agreement allows compulsory licensing as part of the agreement’s overall attempt to strike a balance between promoting access to existing drugs and promoting research and development into new drugs. But the term “compulsory licensing” does not appear in the TRIPS Agreement. Instead, the phrase “other use without authorization of the right holder” appears in the title of Article 31. Compulsory licensing is only part of this since “other use” includes use by governments for their own purposes.

What are the grounds for using Compulsory Licensing?

1. The TRIPS Agreement does not specifically list the reasons that might be used to justify compulsory licensing.
2. In Article 31, it does mention national emergencies, other circumstances of extreme urgency and anti-competitive practices — but only as grounds when some of the normal requirements for compulsory licensing do not apply, such as the need to try for a voluntary licence first.

Parallel imports, Grey imports And ‘Exhaustion’ of Rights

• Parallel or grey-market imports are not imports of counterfeit products or illegal copies. These are products marketed by the patent owner (or trademark- or copyright-owner, etc) or with the patent owner’s permission in one country and imported into another country without the approval of the patent owner.
  • For example, suppose company A has a drug patented in the Republic of Belladonna and the Kingdom of Calamine, which it sells at a lower price in Calamine. If a second company buys the drug in Calamine and imports it into Belladonna at a price that is lower than company A’s price, that would be a parallel or grey import.
• The legal principle here is “exhaustion”, the idea that once company A has sold a batch of its product (in this case, in Calamine), its patent rights are exhausted on that batch and it no longer has any rights over what happens to that batch. The TRIPS Agreement simply says that none of its provisions, except those dealing with non-discrimination (“national treatment” and “most-favoured-nation treatment”), can be used to address the issue of exhaustion of intellectual property rights in a WTO dispute.

Doha Declaration on TRIPS And Public Health

• A large part of this was settled at the Doha Ministerial Conference in November 2001. In the main Doha Ministerial Declaration of 14 November 2001, WTO member governments stressed that it is important to implement and interpret the TRIPS Agreement in a way that supports public health — by promoting both access to existing medicines and the creation of new medicines.
• They therefore adopted a separate declaration on TRIPS and Public Health. They agreed that the TRIPS Agreement does not and should not prevent members from taking measures to protect public health. They underscored countries’ ability to use the flexibilities that are built into the TRIPS Agreement, including compulsory licensing and parallel importing. And they agreed to extend exemptions on pharmaceutical patent protection for least-developed countries until 2016.