ICMR to get royalty from sale of Bharat Biotech’s Covaxin

#GS3 #SCIENCE AND TECHNOLOGY # PATENT 

Context

● The intellectual property governing the use of Covaxin, jointly developed by Bharat Biotech and the Indian Council of Medical Research, was “shared” and the ICMR would receive royalty payments.

Public-Private Partnership

  •  The partnership between the two organisations involves 12 activities that include clinical and preclinical studies.
  • Five of these were funded entirely by Bharat Biotech:
  •  Candidate vaccine development, preclinical safety and toxicity studies in small animals (rats, mice and rabbits),
  •  Phase-1 clinical trials including funding of sites, hiring Clinical Research Organisation (CRO) for trial monitoring, insurance, laboratory testing;
  • Phase 2 clinical trials including funding of sites,
  • Hiring CRO for trial monitoring, insurance, laboratory testing and all other logistics and
  • Hiring a CRO for phase-3 trial monitoring, insurance and laboratory testing.

The activities funded by the ICMR were:

  •  Isolating the SARS-CoV-2 virus from a “huge number” of clinical samples, passage testing and confirmation;
  • BSL-3 facility validation of BBIL for Covaxin production;
  •  Vaccine strain characterisation by ELISA tests, electron microscopy, next generation sequencing;
  • Testing serum samples from preclinical studies in small animals;
  • Preclinical safety and efficacy in golden Syrian hamsters and preclinical safety and efficacy studies in rhesus macaques (monkeys);
  • Testing sera of Covaxin vaccinated individuals for U.K. strain, Brazil strain, South African strain and double mutant strain of SARS-CoV-2;
  • U.K. variant virus isolation and characterisation, titration, sequencing from clinical specimens and funding the site for the phase 3 clinical trial.

Vaccine pricing

  • Covishield constitutes over 90% of the country’s vaccine supply so far and has been developed as partnership between the Oxford University and AzstraZeneca.
  • Serum Institute of India is one among the many manufacturers in the world with a production licence and has to pay royalty to a foreign company.
  •  Covaxin on the other hand is almost entirely indigenous and yet is priced higher than Covishield.
  •  Both are so far being bought by the Central government for ₹150 a dose.
  •  However, Covishield was first offered to States at ₹400 a dose and ₹600 to private hospitals and Covaxin was offered at ₹600 for State governments and at ₹1,200 for private hospitals.
  •  Later Covishield’s price was reduced to ₹300 a dose for States and Covaxin reduced theirs to 400.

TRIPS Waiver to deal with CoVID-19

  •  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 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.

BIASA BASICS 

Intellectual Property Rights (IPR)

  • Intellectual Property Rights (IPR) are the rights acquired by an owner of an intellectual property.
  • Intellectual property is a category of property that includes intangible creations of the human intellect.
  • In simple terms, it refers to creations of the mind, such as
  • inventions
  • literary & artistic works
  • designs & symbols,
  • names & images used in commerce.
  • The main purpose of intellectual property law is to
  • encourage the creation of a wide variety of intellectual goods &
  • strike the right balance between the interests of innovators & wider public interest.

What is a PATENT ?

  • A patent is an exclusive right granted for an invention, which is a new product or process that meets conditions of
    • novelty,
    • non-obviousness, &
    • industrial use.
  • A patent provides the owner with the right to decide how – or whether – the invention can be used by others.

Criteria for issuing Patents in India

  1. Novelty: it should be new (not published earlier + no prior Public Knowledge/ Public Use in India)
  2. Non obviousness: It must involve an inventive step (technical advanced in comparison to existing knowledge + non‐obvious to a person skilled in the relevant field of technology)
  3. Industrial use: It should be capable of Industrial application
  • Patents in India are governed by “The patent Act 1970” which was amended in 2005 to make it compliant with TRIPS.

What cannot be patented?

  • Frivolous Invention: Invention that harms public order/Morality/ health of animals, plants & humans
  • Methods of agriculture or horticulture
  • Traditional Knowledge
  • Computer Program
  • Inventions related to Atomic Energy
  • Plants & Animals
  • Mere discovery of scientific principle

 

 

SOURCE: THE HINDU 

 

Print Friendly and PDF
blog comments powered by Disqus