Context: This year the World Intellectual Property Day, celebrated on April 26, holds special importance in the times of COVID-19 pandemic. It provides an opportunity to reflect upon the role of IP and also deploy IP to find a solution in order to save humanity.
The purpose of creating and recognising patent rights is for the common public good, i.e., innovation should be made public in exchange for a limited monopoly.
Thus, patents need to be disclosed to the public in order to enable further research.
A patent is essentially a limited monopoly whereby the patent holder is granted the exclusive right to make, use, and sell the patented innovation for a limited period of time.
Vaccine development: A long haul
- Vaccines or medicines are the only permanent solutions for human life to become normal again.
- However,as per estimates, it will take at least 6-10 months for any vaccine/drug to be available.
- Even when approval for marketing of a vaccine/drug is granted, it will be impossible for it to be made instantly available across the world.
- This is because even after approval for commercial production is granted, in order for the product to be available to the rest of the world, each country needs to approve it.
- Then countries will have to gear up for instant manufacturing and marketing of the drug.
- For this to happen, continuous dialogue has to take place among innovators, manufacturers and supply chains.
- This requires tremendous efforts by private players, governments and international organisations.
Patents : Roadblock to Solution
- Patent exclusivity
- With the outbreak of COVID-19, there are several innovations.
- All these innovations may be the subject matter of patent applications around the world.
- However, friction already exists among various stakeholders.
- For example, one country made attempts to obtain exclusive rights to a vaccine being developed, on the other hand, there are also collaborations taking place.
- However, the spirit of collaborative solutions is only on the anvil.
- Road Ahead for Stakeholders - At institutional level
- Pandemics need disruptive solutions.
- Governments and international organisations need to arrive at a consensus in advance to ensure that the system is ready.
- Creating hindrances through exclusivity claims, in the wake of a pandemic, will result in dividing countries, corporations and international organisations.
- In turn, this will not benefit patients and the world as a whole.
- If patent owners create impediments on the strength of patent rights, the world will start despising patents and that is not a situation IP owners ought to be in.
- Under the TRIPS regime, there are several tools such as compulsory licensing that are available to ensure access to medicines.
- At societal level
- However, beyond the laws, society needs to respect innovation.
- To protect the sanctity and integrity of patent systems, and in order to ensure that anti-IP sentiment is not generated globally, answers need to be found within the existing regime.
- In exceptional circumstances such as these, there is a likelihood that societies may resort to extreme steps to protect themselves.
- Before such ideas are floated, solutions should be created.
Creation of a patent pool - A panacea ?
- It is a method by which aggregation and dissemination of innovative products can be ensured.
- Patent pools are usually effective in aggregating, administering and licensing patents related to specific areas of technology.
- Such pools are prevalent in, for instance, standard essential patents related to telecom and digital innovations.
- Creation of a pool and immediate licensing will ensure that there are hundreds of manufacturers across the world.
- As a result, vaccines and medicines will be quickly available.
- Some part of the royalties could then be disbursed to patent owners on a periodic basis and some part could be retained to fund further research to deal with such pandemics in future.
- Such pools are usually managed by a central agency and the patents which become part of the pool are readily made available for licensing.
- Some pools even publish the royalty rates payable for such licences.
- Anyone who seeks a licence will be able to approach the pool, agree to the terms, and begin to manufacture and sell the products.
Need for a Global pool of COVID-19 related innovations
- At the moment, individual efforts are being made by research organisations to create their own pools.
- A more fruitful effort would be to create a global pool of COVID-19-related innovations, or innovations related to rare pandemics, in respect of vaccines and medicines.
- This could be managed by a trustworthy international organisation.
- All countries ought to have the right to implement these innovations without further permission from the patent-holders and without resorting to provisions such as compulsory licensing, state acquisition, etc.
- Even if royalties are at a minimal level, the revenues would still be in billions of dollars owing to the large coverage of the population affected by the pandemic, who will need to be administered these products.
- Such a pool needs the cooperation of not just countries and international organisations but also the hundreds of researchers, innovators, companies and universities as the stakeholders.
- Further, the concerns pertaining to patents and profits to be earned therefrom should be put aside
- The world needs to come out of this crisis quickly and patents ought to accelerate rather than impede the path.
- Combating the crisis and earning collectively is the need of the hour.
- It is also in line with the Doha Declaration on Public Health which is a part of the TRIPS agreement.
- The Doha Declaration recognises the need for taking measures to protect public health and promote access to medicines.
- Lastly, Public-private partnerships (PPP) need to be scaled up.
- Creation of the PPP-pandemic patent pool at a global level, to pool all innovations, should be taken up the priority.
IPR Policies in India
- As a member of the WTO, it is committed to the Agreement on TRIPS.
- India is also a member of World Intellectual Property Organization, which is a body responsible for the promotion of the protection of IPRs throughout the world.
National IPR Policy
- The National Intellectual Property Rights (IPR) Policy 2016 was adopted in 2016.
- It can be seen as a vision document to guide future development of IPRs in the country.
- It seeks to achieve Creative India; Innovative India.
- Nodal Authority
- Department of Industrial Policy & Promotion (DIPP), which falls under the Ministry of Commerce, is appointed as the nodal department to coordinate, guide and oversee the implementation and future development of IPRs in India.
- It seeks to create a single platform for all IPRs, by accounting for all inter-linkages and to create and exploit synergies between all forms of intellectual property (IP), concerned statutes and agencies.
- It brings in place an institutional mechanism for implementation, monitoring and review.
- It also aims to incorporate and adopt global best practices.
Some Notable Issues and Provisions related to IPR in India
Section 3(d) of the Indian Patent Act 1970
- It does not allow patents to be granted to inventions which
- Does not result in the enhancement of the known efficacy of that substance or
- The mere discovery of any new property or new use for a known substance or
- Of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant.
- This means that the Indian Patent Act does not allow evergreening of patents.
- It has been a cause of concern for the pharma companies.
- Section 3(d) was invoked by the Indian Patent Office (IPO) for rejecting the patent for Novartis drug Glivec.
Evergreening of Patent
- In India patents are granted for a maximum term of 20 years.
- After the expiry of the patent, the invention is free for use, manufacture, sale or import.
- However, most of the pharmaceutical companies seek to extend this exclusivity beyond the period of 20 years.
- When the term of patent is nearing its end, these companies make trivial /insignificant variations to the existing patented invention and apply for a new patent.
- In this manner, they extend their monopoly.
Section 84 of the Patents Act, 1970
- Compulsory licencing has come as a problem for foreign investors who bring technology to India’s realm as CL allows license to Indian manufacturers to produce a patented product.
- CL allows use, manufacture, import or sell a patented invention without the patent-owner’s consent.
- CL is allowed under the WTO’s TRIPS Agreement provided with exemptions such as national emergencies, other circumstances of extreme urgency, etc.
TRIPS (Trade Related Intellectual Property Rights)
- The TRIPS Agreement plays a critical role in facilitating trade in knowledge and creativity.
- It also plays an important role in resolving trade disputes over intellectual property, and in assuring WTO members the latitude to achieve their domestic objectives.
- The Agreement is legal recognition of the significance of links between intellectual property and trade.
- The WTO’s TRIPS Agreement is an attempt to narrow the gaps in the way these IP rights are protected and enforced around the world, and to bring them under common international rules.
- It establishes minimum standards of protection and enforcement that each government has to give to the intellectual property held by nationals of fellow WTO members.
Five broad areas of coverage
- The manner in which general provisions and basic principles of the multilateral trading system apply to international intellectual property.
- Minimum standards of protection for intellectual property rights that members should provide.
- The procedures for members to provide for the enforcement of those rights in their own territories.
- Settling of disputes on IP between members of the WTO
- Special transitional arrangements for the implementation of TRIPS provisions.
Doha Declaration on Public Health
- In 2001, at the annual ministerial meeting of the WTO in Doha, Qatar, countries agreed to redress that imbalance, and firmly restated the primacy of health over commercial interests.
- The Doha Declaration reaffirmed countries' right to use TRIPS safeguards such as compulsory licences or parallel importation to overcome patent barriers to promote access to medicines, and guided countries in their use.
- One final significant achievement of Doha was to extend the deadline by which the least developed countries had to grant and enforce pharmaceutical patents, from 2006 to 2016.
Image Source: The Hindu