What is “Indemnity” and why vaccine manufacturers are demanding that?

Contents1 What is the News?2 What is Indemnity?3 Is Indemnity defined under the law on Drugs?4 Where is Indemnity defined then?5 Is the demand for indemnity a standard practice?6 What have the overseas vaccines companies got so far? What is the News? The Union government is in talks with foreign manufacturers of COVID-19 vaccines on… Continue reading What is “Indemnity” and why vaccine manufacturers are demanding that?

Voluntary Licensing Mechanism for Vaccines Will Ensure Social Justice

Synopsis: Other alternatives available to boost Vaccine supply are less effective. But Voluntary licensing Mechanism for Covid 19 vaccines will lead to affordable and accessible vaccines. Contents1  Background2 How voluntary licensing can make medical drugs affordable?3 What are the issues in other alternative mechanisms?4 Way forward  Background Affordable vaccination is the key to achieve global… Continue reading Voluntary Licensing Mechanism for Vaccines Will Ensure Social Justice

What is Compulsory Licensing?

What is the News?

Kerala High Court has asked the Centre to respond to a plea for invoking the compulsory licensing. Other capable vaccine manufacturers will also be able to produce Covid-19 vaccines by the use of the compulsory license.

About Compulsory Licensing:
  • Compulsory licensing(CL) is a process that allows governments to license third parties (that is, parties other than the patent holders) to produce, use and sell a patented product or process. By that, producers can manufacture patented drugs without the requirement of consent of patent owners.
  • The WTO’s agreement on intellectual property –TRIPS allows countries to issue compulsory licenses to domestic producers.
  • In India, Compulsory licensing is allowed and regulated under the Indian Patent Act, 1970.

Section 84 of the (Indian) Patent Act,1970: It provides that after three years from the date of the grant of a patent, any person can apply for the compulsory license, on certain grounds:

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

However, compulsory licenses can also be granted under exceptional circumstances.

Section 92 of the (Indian) Patent Act,1970: It authorizes the central government to issue a compulsory license at any time after the grant of the patent, in the case of:

  • National emergency; or
  • Extreme urgency; or
  • Case of public non-commercial use.

After the government issues a notification under Section 92 the companies can approach the government for a license. They can start manufacturing the patented drug by reverse-engineering the product.

Section 100 of the (Indian) Patent Act,1970:
  • It gives the central government the power to authorize anyone to use the invention for the purposes of the government.
  • Basically, this provision enables the government to license patents of the vaccine to specific companies. This is done to speed up manufacturing and ensure equitable pricing.

What is a Patent?

  • Firstly, a patent is an exclusive right granted for an invention. In other words, a patent is an exclusive right to a product or a process that generally provides a new way of doing something or offers a new technical solution to a problem.
  • Secondly, is a patent valid in every country? Patents are territorial rights. In general, the 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.
  • Thirdly, how long does a patent last? The protection is granted for a limited period, generally 20 years from the filing date of the application.

Source: Hindu Business line


US President to Remove the Ban on “H-1B Visa”

Issues Associated with IPR Waiver to Covid Vaccine

Synopsis: IPR waiver will not bring instant benefits. Thus, efforts must be made to share the excess stockpiles of vaccines lying with the developed countries. Introduction  The Biden administration announced that it would support a waiver on intellectual property rights (IPR) for the production of COVID-19 vaccines.  The original plan, for TRIPS waiver for Covid… Continue reading Issues Associated with IPR Waiver to Covid Vaccine

US Support to TRIPS Waiver – Challenges Ahead

Synopsis – US is supporting the TRIPS waiver on Covid-19 Vaccines. However, it may take much more time and effort to take benefits out of it. Contents1 Introduction2 Why developed countries were against the proposal to waive TRIPS?3 TRIPS Waiver Challenges- 4 Recommendations-  Introduction Firstly, the US is supporting a temporary waiver of the TRIPS agreement… Continue reading US Support to TRIPS Waiver – Challenges Ahead

Critical Analysis of U.S Support to temporary Patent Waiver for Covid Vaccines

Synopsis: Arguments, provided by MNC’s against Patent waiver on Covid technologies, are baseless. WTO should make efforts to bring consensus among nations for a temporary waiver. Contents1 Background2 Why the reasons, given for not accepting the Patent waiver proposal, are baseless?3 What are the other alternatives proposed for Patent waiver?4 What is the way forward?… Continue reading Critical Analysis of U.S Support to temporary Patent Waiver for Covid Vaccines

IPR Waiver For Covid 19 Vaccines

Synopsis: The US is now supporting the plea of developing countries for granting an IPR waiver to Covid-19 vaccines. The waiver would allow the countries to speed up the production process without the permission of manufacturing company. However, significant roadblocks exist that may prevent the grant of waiver. Contents1 Background:2 The October 2020 proposal:3 Need… Continue reading IPR Waiver For Covid 19 Vaccines

ICMR will get royalty from the sale of Bharat Biotech’s Covaxin

What is the News? Recently, the Indian Council of Medical Research(ICMR) has confirmed that it will receive royalty payments from the sale of Bharat Biotech’s Covaxin. Development of Covaxin: Firstly, Covaxin has been indigenously developed under the Public-Private Partnership by Hyderabad-based Bharat Biotech in collaboration with the ICMR.Edit Secondly, a Memorandum of Understanding (MoU) is… Continue reading ICMR will get royalty from the sale of Bharat Biotech’s Covaxin

How Government Regulate the Prices of Vaccines and drugs?

Synopsis: The Supreme Court recently reminded the government of its powers to regulate the pricing of vaccines and drugs. Contents1 Introduction:2 How does the government regulate the pricing of drugs?3 What prices the government cannot regulate?4 Various ways to regulate the pricing of vaccines:5 Way forward: Introduction: The Supreme Court has raised the issue of differential… Continue reading How Government Regulate the Prices of Vaccines and drugs?

Intellectual Property Rights(IPR) and Universal Vaccination – Explained, Pointwise

Contents1 Introduction2 Protection of Intellectual Property Rights under the TRIPS3 Intellectual Property Rights exemptions under WTO and TRIPS:4 Status of vaccine manufacturing5 About removing Intellectual Property Rights for Covid-19 vaccines6 Arguments for Intellectual Property Rights laws7 Arguments against Intellectual Property Rights laws8 Suggestions to improve vaccination Introduction The Covid-19 cases in India are increasing at… Continue reading Intellectual Property Rights(IPR) and Universal Vaccination – Explained, Pointwise

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