ICMR to get royalty from sale of Bharat Biotech’s Covaxin
#GS3 #SCIENCE AND TECHNOLOGY # PATENT
● 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.
- 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.
- 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.
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
- 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
- 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
- Novelty: it should be new (not published earlier + no prior Public Knowledge/ Public Use in India)
- 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)
- 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