What is “Indemnity” and why vaccine manufacturers are demanding that?
What is the News?
The Union government is in talks with foreign manufacturers of COVID-19 vaccines on their demand for Indemnity from liability as a condition for selling their vaccines to the country.
However, this has already given rise to a similar demand from domestic vaccine-maker Serum Institute of India(SII). As they believe, all players should be treated the same way.
Read Also :-The Johnson & Johnson ASR Implant Case
What is Indemnity?
- In simple terms, indemnity means security against a loss or other financial stress. This is commonly used in insurance contracts.
- In legal terms, It protects the manufacturers from any potential civil-legal liability or immunity from being sued by people for any unforeseen complications arising from their COVID-19 vaccine.
Is Indemnity defined under the law on Drugs?
- The law on drugs in India does not have a provision for indemnity related to the grant of approval for any new drug or vaccine in the country.
Where is Indemnity defined then?
- Section 124 of the Indian Contract Act, 1872 defines a contract of indemnity. It is defined as a contract by which one party promises to save the other from any loss caused to the latter.
- If the government gives an indemnity to vaccine manufacturers, then the government, and not the vaccine maker, would be liable to compensate any citizen who claims to have side effects/death due to taking the vaccine.
- In the event of a court ordering payment, the company will be in a position to recover the amount from the government.
Read Also :-The New Vaccine Strategy May Widen Inequality
Is the demand for indemnity a standard practice?
- Indemnity is essentially a contractual matter between the supplier and recipient.
- For example, Pfizer is believed to have obtained indemnity from several countries including the United Kingdom. However, it has declined to discuss the issue in public.
What have the overseas vaccines companies got so far?
- Firstly, the Drugs Controller-General of India has fast-tracked the import of vaccines by dispensing with the need for local trials.
- Secondly, foreign-produced vaccines that had been granted emergency approval for restricted use by certain regulators will also be granted Emergency Use Authorisation in India. These regulators include regulators in the US, UK, European Union and Japan or vaccines included in the WHO’s Emergency Use Listing.
- Thirdly, the New Drugs and Clinical Trial Rules, 2019 has set down stringent regulations for grant of approval as well as for trials.
- The Rules provide for payment of compensation by the sponsor of the trial or its representative to any participant who dies or suffers disability as a result of such trials.
- However, exemption from these trials has reduced the risk to overseas manufacturers.
Source: The Hindu
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.
- Affordable vaccination is the key to achieve global herd immunity and to prevent new strains of COVID-19.
- To make vaccines affordable there are multiple arrangements globally. Such as
- Voluntarily licensing: Manufacturers can place their licensing agreements for which they owned patent rights in the UN-affiliated Medicines Patent Pool.
- Compulsory licensing: Through TRIPS Waiver on Patent rights, for Covid-19 vaccines under WTO TRIPS agreement.
- COVAX Program: It was established to purchase vaccine doses and donate them to low-income countries but does not involve modifying patent rights
- WHO’s COVID-19 Technology Access Pool: a patent-sharing pool for Covid-19 products.
- However, a voluntary licensing mechanism will be more effective in achieving the target of affordable and universal vaccination. Further, it has been successfully demonstrated in making AIDS drugs more affordable.
How voluntary licensing can make medical drugs affordable?
- The case study of AIDS drugs can better explain how voluntary licensing can make medical drugs/ vaccines more affordable.
- During the 1990s, the WTO started implementing a global intellectual property regime known as the Trade-Related Aspects of Intellectual Property Rights agreement (TRIPS).
- After that, there was anti-TRIPS activism around the globe due to fear of price rise of essential medicines because of the TRIPS agreement.
- Responding to anti-TRIPS activism from low-income countries, some manufacturers who owned patent rights to produce AIDS drugs placed their licensing agreements in the UN-affiliated Medicines Patent Pool.
- This allowed Several India-based companies to use the voluntary licences to manufacture these drugs on a massive scale and sell them at prices they determine.
- This effort brought down the price of key AIDS medications in low-income countries. For instance, tenofovir, the first-line treatment for HIV/AIDS, has come down in price from $200-$500 per person per year to $39 per person per year in low-income countries.
What are the issues in other alternative mechanisms?
- First, the Voluntary licensing mechanism will reduce the cost and time taken to manufacture vaccines compared to producing vaccines through a ‘Compulsory licensing agreement’.
- Voluntary licensing enables goodwill among Patent right holding companies and general manufacturers.
- It will enable easy flow of “technology transfer” thereby reducing the cost and time taken to manufacture vaccines.
- About Compulsory licensing:
- Compulsory licenses is a mechanism to override patent rights. It allows local production or import of drugs by generic manufacturers in the event of a public health crisis.
- This right has been enshrined in the Doha Declaration addendum to the WTO’s TRIPS agreement.
- This is what India and South Africa are lobbying for in the WTO, having recently been joined by the United States.
- Second, COVAX Programme faces the issue of underfunding. Also, Similar attempts like COVAX Programme during the AIDS crisis were chronically underfunded and had only minor effects on that pandemic compared to the voluntary licensing.
- Third, the WHO’s COVID-19 Technology Access Pool too faces issues similar to COVAX Programme. For instance, no patent holders have joined this effort. This is the reason why India and South Africa called on the WTO to temporarily waive patent protections for COVID-19.
- Patents are not absolute ownership rights. They are a temporary contract that balances the public interest with the claims of the innovator.
- Further, billions of dollars are spent through public money to develop COVID-19 vaccines.
- Considering the above facts, patent owners should enable the mass production of affordable vaccines by granting voluntary licensing for Covid-19 vaccines.
Source: The Hindu
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
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.
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 vaccines, was drafted at the WTO by India and South Africa last year.
- During the 2020 U.S. presidential election, Joe Biden made a promise to share vaccine technology with countries that needed it if he won. He was expecting the deep gap of inequality in vaccine access.
How has the world reacted to this stance?
This policy stance of US has been rejected by major EU nations and met with counter-suggestion.
- The first refusal came from Germany. They said that it would create major complications for the production of vaccines, the major pharma corporations resonated with this view.
- French President Emmanuel Macron was relatively less antagonistic to considering the proposal. However, he lashed out at the Anglo-Saxons for hindering vaccine availability globally by blocking the export of ingredients.
- There is some substance to the argument that an IPR waiver may not fully resolve the vaccine shortage issue in countries suffering the worst of the pandemic now, even if it were to become a reality.
What to do?
- Firstly, the grant of a waiver would have to be supplemented by technology transfer. It will provide the pharmaceutical manufacturers with the required trained personnel, raw materials, and high-tech equipment and production know-how.
- Secondly, after tech transfer, there must be a scientific criterion to test the safety, immunogenicity, and protective efficacy of the vaccine developed by these generic manufacturers.
- Thirdly, the effect on global supply chains for vaccine production should be inspected so major troubles might be avoided.
- Lastly, other options to instantly address vaccine shortages should be considered. Developed nations should share a considerably greater part of their vaccine stockpiles, particularly in cases where the latter exceed projected domestic needs.
- There is a rumor that Mr. Biden’s waiver announcement might be a tactic to persuade pharmaceutical companies to accept less painful measures. This includes
- sharing some of their technology willingly,
- agreeing to joint ventures to increase global production expeditiously, and
- simply producing more doses at affordable prices to donate directly to where the need is most severe, especially in India.
Source: click here
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.
- Firstly, the US is supporting a temporary waiver of the TRIPS agreement [patent protection rules] on Covid-19 vaccines proposed by India and South Africa.
- Further, Article IX of the WTO Agreement allows for waiving obligations in exceptional circumstances.
However, developed nations [home to the big pharmaceutical companies] oppose the TRIPS waiver.
Why developed countries were against the proposal to waive TRIPS?
According to some developed countries-
- Firstly, if IP (intellectual property) not properly protected, investment in the medical field, especially in the area of infectious diseases, would be reduced.
- Secondly, it will also add a risk factor for the growth of medical technology which will be hindered, and essential products may not be developed in future crises.
Hopefully, just support for the waiver is not sufficient. There are many more challenges in achieving the final goal of mass production of vaccines in every country.
TRIPS Waiver Challenges-
- Firstly, Previous experience- TRIPS Agreement contains flexibilities. These include the freedom to use parallel imports and compulsory licenses that help countries get access to medicines. Yet such flexibilities are not always easy to use.
- For example- Following the HIV/AIDS crisis in Africa in the 1990s, the WTO adopted a decision in 2003 to waive certain TRIPS obligations.
- In 2003, a mechanism was developed that enables countries with no pharmaceutical manufacturing capability to use and benefit from compulsory licenses. However, it was subject to so many conditions that poor countries could not get the benefit of this waiver, such as
- The exporting country must ensure that the drugs so manufactured are exported to that nation only.
- The medicines should be readily identifiable through different colours, or shapes.
- Only the amount necessary to meet the requirements of the eligible importing country are manufactured
- The importing country has to notify the WTO’s TRIPS Council.
- Secondly, Time-taking process- Given the WTO’s consensus-based decision-making process and the complexities of the issues involved, negotiations on the text of the waiver will take time.
- Thirdly, the limited scope of the waiver- The US only supports waiving IP protection on Covid-19 vaccines. While medicines and other therapeutics and technologies related to the treatment of COVID-19 are being ignored.
- Forth, Non-IP challenges- The lack of access to technological know-how related to manufacturing COVID-19 vaccines will not be solved by TRIPS waiver.
- IP Waiver does not impose a legal requirement on pharmaceutical companies to transfer or share technology.
- Governments must negotiate with big-pharma firms for technology transfer by offering additional financial benefits and establishing a favorable policy environment.
- Countries should start working towards making suitable amendments to their domestic legal framework to operationalize and enforce the TRIPS waiver.
- Developed countries should consider waiving medicines and other therapeutics and technologies related to the treatment of COVID-19.
Source- The Hindu
Critical Analysis of U.S Support to temporary Patent Waiver for Covid Vaccines
- Last year, India and South Africa proposed in WTO for a waiver on patent protection. It was for technologies needed to combat COVID-19.
- While many low- and middle-income countries supported it, resistance came from the high-income countries (U.S., U.K, E U etc.,) and the Pharmaceuticals industry.
- Currently, the United States president, Joe Biden, has decided to support the India-South Africa proposal.
- However, the process may get delayed, despite the U.S. intervention. Because, the WTO works on a consensus-based approach. i.e., The World Trade Organization resolves debates by consensus and not by voting.
Why the reasons, given for not accepting the Patent waiver proposal, are baseless?
Many arguments against providing a Patent waiver were put forward. However, all such reasons are found to be baseless.
- First, critics argue that, the capacity for producing vaccines of assured quality and safety is limited to some laboratories. Further, it may be hazardous to permit manufacturers in low- and middle-income countries to work with technologies that they cannot handle.
- This argument is not valid, for many years multinational firms have subcontracted their patented pharmaceutical products to industries with low production costs in developing countries.
- Second, Critics argue that there is no evidence that extra capacity exists for producing vaccines outside of firms undertaking them now.
- But even this argument is not valid. For example, The World Health Organization’s mRNA vaccine technology transfer hub has already drawn interest from over 50 firms to produce the approved vaccines.
- Third, critics argue that the time taken for their utilization by new firms will be too long to help combat the present pandemic.
- Even this argument is baseless as nobody knows when the Pandemic will come to end. Further, combined with low vaccination rates and emerging Mutant variation in Covid virus makes it much more difficult to predict the end of the Pandemic.
- Fourth, multinational pharmaceutical firms argue that Patent waiver will allow China to steal their technologies, now and in the future.
- However, MNC’s forget to remember that the original genomic sequence openly shared by China, gave these firms a head starts in developing vaccines.
- Fifth, the most common argument by all MNC’s is that innovation and investment by industry will have to be financially rewarded to incentivise them to develop new products.
- But, even through compulsory licensing industry will be financially rewarded. Because royalties are paid to the original innovators and patent holders even if compulsory issues are issued bypassing patent restrictions.
- Further, much of the foundational science that built the path for vaccine production came from public-funded universities and research institutes.
What are the other alternatives proposed for Patent waiver?
- One, giving license to manufacturers in developing countries, while retaining patent rights. However, it will not guarantee equity in access to the products at affordable prices.
- Two, supplying vaccines to developing countries through the COVAX facility. However, this mechanism has failed to deliver on its promise. For example, U.S. States have received more vaccines than the entire Africa has from COVAX.
What is the way forward?
- First, considering the positive development from the U.S, developing countries must start issuing compulsory licences. Even, The Doha declaration on TRIPS permits their use in a public health emergency.
- Second, High-income countries and multilateral agencies should provide financial and technical support to enable expansion of global production capacity.
- Third, credible regulatory agencies and the World Health Organization can assess the efficacy and safety of their products.
Source: The Hindu
IPR Waiver For Covid 19 Vaccines
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.
- The US has shown its willingness to an IPR waiver for Covid-19 vaccines. It would be pursuing text-based negotiations on the waiver at the World Trade Organization (WTO).
- Under text-based negotiations, negotiators exchange their preferred texts and then try to develop a consensus over them.
- Experts believe that US support is based on an October 2020 proposal given by India and South Africa in the WTO.
- However, the October proposal called for a waiver on all Covid-19 interventions. This includes testing, diagnostics, and novel therapeutics.
|About Patents and Intellectual Property:|
The October 2020 proposal:
- India and South Africa had asked the WTO to waive certain conditions of the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement.
- The countries wanted a waiver over sections 1, 4, 5, and 7 that could impede timely access to affordable medical products to combat Covid-19.
- The sections relate to copyright and related rights, industrial designs, patents, and the protection of undisclosed information.
Need of IPR waiver:
- Boost Production: Currently, most production is concentrated in high-income countries. With a waiver, the middle-income countries would be able to manufacture covid vaccines with emergency use authorisations (EUA). This includes vaccines developed by Pfizer, Moderna, AstraZeneca, Novavax, Bharat Biotech, etc.
- Reducing Cost of Production: The manufacturing in middle-income companies is currently happening through licensing or technology transfer agreements. The companies which grant the license, charge a hefty price for it. The companies would not need a license after an IPR waiver.
- Avert legal Difficulties: The developing countries may face institutional and legal difficulties when using flexibilities available in the TRIPS Agreement. The waiver would help in averting this problem.
Roadblocks in granting IPR waiver:
- Procedure Complexities: The nature of text-based negotiations can delay the process. Further, even one country can veto the waiver as granting requires consensus among all 164 members of WTO.
- Disincentivization of Companies: Waiver may reduce the earning potential of companies. They may be disincentivized to do more research on tackling new variants. This may undermine the global response to the pandemic.
- Erosion of Public Trust: People may not trust the quality and efficacy of vaccines manufactured in a middle-income country.
- Production barriers: Ramping up production capacities will be a lengthy process. The developing countries that are currently producing Covid 19 vaccines are able to do so with the extensive support and grant of developed countries.
Other Challenges concerning the production and distribution of Covid vaccines in developing countries:
- Scarcity of Raw Material: It has been a growing issue for ramping up production. Several manufacturers have been relying on specific suppliers, and alternatives are limited.
- Trade Barriers: US has blocked exports of critical raw materials used in the Covid-19 vaccines using regulations like the American Defence Production Act. This led to a delay in the production of Covid vaccines by some companies in India.
- Acquisition Capability of Developed World: They have a higher propensity to purchase the vaccine. This has enabled them to acquire most of the supplies.
- Firstly, the developed countries should understand the plight of developing countries under the current extraordinary circumstances. The recent intention of the EU to support the U.S proposal should be materialised in reality.
- Secondly, other covid related interventions including testing, diagnostics, and novel therapeutics should be made part of IPR waiver proposal.
- Thirdly, the developing world should be given an opportunity to develop cheap and efficacious vaccines. They have already shown their manufacturing capabilities by developing good quality generic medicines in the past.
Source: Click Here
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 signed between the Bharat Biotech and ICMR. Under the MoU, Bharat Biotech will provide the following.
- Pay the royalty payments to the ICMR from the net sales on Covaxin.
- Prioritise in-country supplies.
- Intellectual property governing the use of Covaxin will be shared
- The name of the ICMR-National Institute of Virology(NIV) will be printed on the vaccine boxes.
- Covishield constitutes over 90% of the country’s vaccine supply so far. It has been developed from the partnership between Oxford University and AstraZeneca.
- On the other hand, Covaxin is almost entirely indigenous. Furthermore, it is yet to priced higher than Covishield.
Source: The Hindu
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.
The Supreme Court has raised the issue of differential pricing for Covid-19 vaccines for the center and states. It directed the central government to clarify in its affidavit the basis and rationale for pricing.
How does the government regulate the pricing of drugs?
- Firstly, the Government of India regulates the pricing of essential drugs through its Essential Commodities Act, 1955.
- Secondly, under Section 3 of the Act, the government has enacted the Drugs (Prices Control) Order. The DPCO lists over 800 drugs as “essential” in its schedule. Government caps the prices of medicines in this list.
- Thirdly, the capping of prices is done based on a formula. This formula is worked out in each case by the National Pharmaceutical Pricing Authority (NPPA). (The NPPA was set up in 1997).
What prices the government cannot regulate?
- Regulation through DPCO is not applicable for patented drugs or fixed-dose combination (FDC) drugs.
- For example, the price of the antiviral drug remdesivir. The government is not regulating the prices of this drug even though it is in great demand to treat serious cases of Covid-19.
Various ways to regulate the pricing of vaccines:
Experts suggest the government can use few methods to control the pricing of vaccines. These are,
- The Patents Act,1970: The act has two key specific provisions that could be potentially invoked to regulate the pricing of the vaccine. The two provisions are:
- Section 100: It gives the central government the power to authorise anyone (a pharma company) 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 ensuring equitable pricing.
- Section 92: It deals with compulsory licensing. It says that the government without the permission of the patent holder can provide license under the following situations:
- The circumstance of national emergency; or
- The circumstance of extreme urgency; or
- Case of public non-commercial use.
- After the government issues a notification under Section 92 the pharma companies can approach the government for a license. They can start manufacturing the patented drug by reverse-engineering the product.
- Epidemic Diseases Act,1897: It is another legal route suggested by experts to regulate the pricing of vaccines.
- Firstly, Section 2 of the Act: It empowers State Governments to take special measures and prescribe regulations during the outbreak of an epidemic disease.
- Secondly, if the State Government thinks that other Acts are insufficient, then the state may issue a public notice to prescribe temporary regulations for the public/class of persons to follow.
- Thirdly, the undefined powers under section 2 can be used to take measures to regulate pricing. However, the law is not sufficient for its implementation. Punishment for violation of orders under section 2 is nominal, which restricts its implementation.
- Fourthly, violation of the Act is penalised under Section 188 of the Indian Penal Code. It says that any person who disobeys an order given by a public servant will be punished with imprisonment up to 1 month. If such disobedience causes danger to human life, the term may extend to six months or a fine that could extend up to Rs 1,000.
The government has various ways to control the pricing of the vaccine. So the government has to resolve the challenges with the new vaccination policy. Further, to achieve universal vaccination for Covid-19 the government has to take these necessary steps.
Source: The Indian Express
Intellectual Property Rights(IPR) and Universal Vaccination – Explained, Pointwise
The Covid-19 cases in India are increasing at a very high rate in India. According to the government data, the number of positive cases is increasing at a rate of more than 3 lakh every day since April 21. Now, the only solution suggested by experts around the world is universal vaccination. The government with its new vaccination policy aims to vaccinate people above 18. However, vaccines are not available in sufficient quality to match demand.
One of the hindrances to the wide-scale production of vaccines is Intellectual property rights and the TRIPS (Trade-Related Aspects of Intellectual Property Rights) agreement.
Last October, India and South Africa also moved a motion at the WTO. In that motion, they asked the WTO Council on (TRIPS) to provide a waiver of Intellectual Property Rights for vaccine production. However, the proposal was opposed by the developed countries.
Protection of Intellectual Property Rights under the TRIPS
- TRIPS is a key legal instrument on intellectual Property Rights. The agreement imposes binding obligations on member countries to ensure a minimum level of protection and enforcement of IP rights in their territories.
- The developed countries especially the US aggressively pushed for the TRIPS agreement.
- Under the TRIPS agreement, the patent holders have the exclusive right to manufacture, sell, and use the vaccine or the drug for the entire term of patent protection. This entire term includes 20 years from the date of the filing of the patent.
- If a country violated the provisions of the agreement then the country has to face the WTO Dispute Settlement Body.
- A country can even file a complaint even when there is an allegation of the violation. This is called a non-violation complaint in WTO. However, the members of TRIPS agreed not to use them under the TRIPS Agreement.
Intellectual Property Rights exemptions under WTO and TRIPS:
Both the WTO and the TRIPS Agreement have certain exemptions. Such as,
- According to the Marrakesh Agreement or WTO agreement, any exceptional circumstances may waive off obligations imposed on a WTO member country. This waiver will include both the WTO Agreement and any other multilateral trade agreement. But to get such a waiver, the request has to receive three-quarters of the member’s support in the WTO Ministerial Conference.
- Furthermore, the Ministerial Conference can prescribe terms and conditions for such waiver.
- The Ministerial Conference can also review the waiver annually if the waiver is granted for more than a year.
- A waiver may be granted to an individual WTO member country or even collectively.
- If the waiver is requested from any multilateral trade agreements under TRIPS, then the country has to submit the request to the Council of TRIPS. So, the TRIPS Council has jurisdiction over it. The TRIPS council can provide waivers for the Covid-19 vaccine manufacturing, selling, and usage.
- Articles 31(f) of the TRIPS Agreement: This is one of the important provisions under the TRIPS Agreement. It provides for a compulsory license. Under this, the government can issue a license to make use of a patent without the patent holder’s consent. But, this drug can be used only for the supply of the domestic market. So the government cannot export the patented product.
- For example, In 2012, India permitted generic production of Bayer Corporation’s Nexavar. This drug was used for the treatment of Liver and Kidney cancer.
- Similarly, South Africa permitted the generic production of Anti-Retroviral Drugs used in HIV treatment.
- Apart from these three types, pharma companies also conclude voluntary licensing arrangements between pharmaceutical companies. For example, the licensing agreement between AstraZeneca and Serum Institute of India. Under this, the Serum Institute of India can produce vaccines for both domestic use and export.
Status of vaccine manufacturing
- The world’s largest vaccine maker, Serum Institute of Technology initially promised to supply 100 million doses of vaccines a month. But in reality, it only provided between 50 million to 60 million doses.
- On the other hand, Bharat Biotech has a planned production capacity of 12.5 million a month. Its current production is somewhere between 1-5 million.
- So, India’s monthly COVID vaccine manufacturing capacity is about 60-65 million doses only.
- The population of India is 1.3 billion. If the Covaxin and Covishield require two doses then India needs 2.6 billion doses. But the present production cannot meet that amount in a short time.
Situation in Europe:
- AstraZeneca’s entered into a contract with the European Union. It committed to supplying an initial 300 million doses of vaccine for distribution among the 27 member countries. Further, it provided an option to order another 100 million doses.
- But it delivered only 30 million doses in the first quarter of 2021. Further, the company also says it can only provide 70 million in the second quarter, rather than the 180 million it had promised.
So, the Covid-19 Vaccines are already in short supply. In this scenario, protecting the Intellectual Property is not only delay the universal vaccination but also extending the Covid-19 crisis itself.
About removing Intellectual Property Rights for Covid-19 vaccines
- As the Intellectual Property Rights hinder the supply of vaccines, both India and South Africa have proposed to waive off IP rights like patents, copyright, and trademarks for prevention, containment or treatment of Covid-19.
- Other developing countries started to co-sponsor the India and South Africa request. The TRIPS Council also discussed this issue both formally and informally.
- But many developed countries are opposing the move due to their arguments in favour of IP Protection.
Arguments for Intellectual Property Rights laws
The supporters of IP protection mention the below-mentioned points for strengthening IP policies through a network of national and international laws.
- Intellectual Property Rights incentivises innovation. It will provide income to the company invested in its research and capacity. So, the IPR policies will incentivise the companies to perform more research for their incentives.
- Higher cross-border IP protection would bring in greater dividends for their pharmaceutical corporations. The company can expand their operations in other countries and provide solutions to the domestic problem also in future.
- The Exemption clause to provide waiver: The country can get a waiver from the WTO if it wants a waiver for manufacture, sale, and usage. The WTO even provided collective waivers in two instances. Such as
- In 2003 waivers from certain GATT obligations were granted by the WTO to some countries. This is provided after they adopted certain necessary measures to prohibit the export and import of rough diamonds to non-participant countries in the Kimberley Process Certification Scheme
- In 2003, the General Council waved off export restriction under the compulsory licence. This is to provide more accessibility of medicines in LDCs and other developing countries that lacked manufacturing ability.
Arguments against Intellectual Property Rights laws
- Deny Right to health: Intellectual Property Rights especially patents, hinder the introduction of affordable vaccines and drugs in developing countries. Thereby, denying people their right to health.
- Patents can block the wider accessibility of vaccines and prolong the pandemic. For example, the entire vaccination exercise will end the pandemic not the invention of the vaccine and patenting it. So, the patents are reducing the accessibility of vaccines.
- Ambiguous definition: the term “exceptional circumstances” mentioned in the WTO Agreement is not mentioned anywhere in the Agreement.
- Preconditions to waiver: There are certain preconditions attached to the waiver. Such as, the pharmaceutical company must manufacture only the necessary amount to meet the needs of the eligible importing country
- Conditions in waivers: The waivers from the Intellectual Property Rights has so far come with stricter terms and conditions. For example, in waiving of export restriction on compulsory licence the conditions are,
- The LDC and other developing countries have to notify the TRIPS Council that they have insufficient or no manufacturing capability to manufacture the drug.
- They need to specify the required quantity
- Challenge with the compulsory license: The success of compulsory license depends on every country’s manufacturing capability(As other countries cannot export them). Further, the developed countries will exercise great pressure on countries issuing a compulsory license. For example, In 2012, the US government put great pressure on India for issuing a compulsory licence to the generic version of Bayer’s cancer drug.
Suggestions to improve vaccination
- WTO’s TRIPS Council has to recommend the General Council “a waiver”. This has to include a waiver from the implementation, application, and enforcement of certain provisions of the TRIPS Agreement. These related to waiving IP rights like patents, copyright, and trademarks for prevention, containment or treatment of Covid-19.
- As the Covid-19 pandemic is the worst global health crisis in the last 100 years. So, in this situation, protecting Intellectual Property Rights will aggravate the crisis. The WTO has to permit countries having manufacturing capabilities to manufacture the vaccine and export them globally.
- Many LDC and developing counties lack manufacturing capability in the pharmaceutical sector. But, they need Covid-19 vaccines for their population. So the WTO and developed countries have to look beyond IP Protection.
World Health Organization recently mentioned that “no one is safe unless everyone is safe”. So the vaccine manufacturers have to look beyond profit and try to serve Humanity. Further, the governments are ready to pay for vaccines, the only thing the global community expect from vaccine manufacturers is to set aside Intellectual property Rights during the Covid-19 pandemic alone.
Intellectual Property Rights vs Right to Access Basic Healthcare
Synopsis: Intellectual Property rules governed by TRIPS agreement are still hindering equal access to basic healthcare. Even a crisis like Covid-19 Pandemic could not bring any relief from this regime.
- Quick and efficient vaccination is the most appropriate way to achieve global herd immunity against the virus.
- However, compliance with TRIPS agreement deprives developing and least developed countries of their right to access affordable medical products.
- Hence, countries like India and South Africa requested a temporary suspension of rules under the 1995 TRIPS Agreement.
- But a group of states, the U.S., the European Union, the U.K., and Canada continues to block the waiver requested by India and South Africa in WTO.
- Compliance with the TRIPS agreement will hamper global efforts to eradicate Covid-19 at the earliest.
India and Patent laws
- India adopted the colonial-era laws that allowed for pharmaceutical patents.
- But in 1959, a committee chaired by Justice Rajagopala Ayyangar objected to this on ethical grounds.
- The committee stated that access to drugs at affordable prices is affected due to patent protection for pharmaceutical drugs.
- It also found that foreign corporations are misusing patent laws to avoid competition and to maintain monopolies. Further, lack of competition has given rise to exorbitant rates charged for essential medical drugs.
- With this backdrop, the Patents Act, 1970, was passed. It offered protection only over claims to process, and it helped to remove monopolies in pharmaceutical drugs.
- Further, it also allowed for the growth of generic manufacturers in India. As a result, life-saving drugs were made available to people at more affordable prices.
- For instance, drugs that reduce AIDS deaths in developed nations were made non-accessible for the rest of the world due to high costs.
- However, generic versions of these medicines manufactured in India helped to lower the price of AIDS drugs.
- But, with the advent of the TRIPS agreement in 1995, patent laws were again strengthened. Under WTO’s TRIPS agreement, countries violating patent laws are penalized by sanctions.
What are the arguments in support of protecting Patents?
- A patent is an exclusive right that a state gives to an innovator to make, use and sell an inventive product or process.
- Patent laws are usually justified on three distinct grounds:
- One, it is the natural and moral right of the people to claim control over their inventions.
- Two, exclusive licences promote invention and therefore benefit society as a whole (Utilitarianism)
- Three, individuals should be allowed to benefit from the fruits of their labor and merit
Why the above arguments are refuted?
- First, the claim that the removal of patent protection will incur a loss to the company involved in research and development is untrue.
- For instance, public money accounted for more than 97% of the funding towards the development of the Oxford/AstraZeneca vaccine.
- Second, the idea that patents are the only means available to promote innovation undermines other alternatives to promote innovation. For instance,
- According to famous economist Joseph Stiglitz, the prize funds for medical research can replace the patent system.
- It will be more efficient and more equitable as public funds will incentivize research while ensuring affordable medicines.
TRIPS regime is an example of inequitable existing world order. There is a need for a global collective action to replace the existing rules that place the right to access basic healthcare in danger.
Source: The Hindu
What led to the abolition of Intellectual Property Appellate Board?
Synopsis: A lack of effective government support provided to the Intellectual Property Appellate Board has led to its demise.
- The Intellectual Property Appellate Board (IPAB) established in 2003. It aimed to specifically deal with matters of intellectual property including copyright, trademarks, patents, and geographical indications.
- Further, since 2007 Novartis’ patent case, the IPAB has been authorized to hear and decide upon the appeals made by the Patent Controller under the Patents Act. Therefore, all pending appeals of Indian High Courts under the Patents Act transferred to IPAB.
- However, the IPAB stands abolished after the passage of Tribunal reforms (Rationalisation and condition service) ordinance 2021.
- India has been a good example for the world with regard to legislating TRIPS compliant Patent laws. For example, anti-evergreening provisions, compulsory licensing regime.
- However, by the abolition of IPAB, India has the missed opportunity to develop an effective indigenous appellate mechanism on patent law.
What are the reasons for the failure of IPAB?
- First, IPAB was not able to perform its adjudicatory functions due to administrative reasons. Many issues were pending in the court for resolution. For example,
- Petition on the constitutionality of the IPAB.
- Petitions to fill up the vacancies before the High Court in Delhi and Chennai.
- Also, Petitions in the Supreme Court for extension of the term of the chairperson.
- Second, the issue of understaffing. For example, it was functioning without a chairperson for almost two years. Also, there were subsequent delays in the appointment of the technical member for patents.
- Third, lack of judicial and institutional independence of the IPAB. Previous chairpersons raised this issue publicly.
- Fourth, lack of Power. For example, the highest authority on protecting technology and innovation working had to function during power cuts without any viable backup.
- Fifth, lack of efficiency. For example, the disposal rate was about 20 patent cases a year. Further, nearly 70% of the patent cases filed were either pending at some stage.
- Sixth, finally, the apathy of the government towards IPAB led to its demise. For example, most of the significant amendments to the Patents Act since 1970 came through, not by way of an Act passed by Parliament, but through an ordinance.
An appellate mechanism allows for the correction of unjustified patent grants at the Patent Office, by error or oversight. An effective appellate mechanism on patent law is critical for the innovation ecosystem.
Source: The Hindu
“ProrIISe Software” to automate legal process for Intellectual Property
What is the News?
Indian Institute of Science, Bengaluru, (IISc) and Prorigo Software Pvt. Ltd. jointly developed the ProrIISe Software.
About the ProrIISe Software:
- The ProrIISe Software aims to automate the legal and bureaucratic part of the patent process. It will be helpful for registering intellectual property developed by Indian academicians.
- Significance: This software is available at a lesser cost when compared to the software available outside India. Earlier the only choice available was outside software products.
- Version 2.0 of the software is aimed for release in 2021. This version will automate the financial part also.
- Similarly, Version 3.0 may release in 2022. It will bring out artificial intelligence approaches to processes required to evaluate a patent.
What are Intellectual Property Rights?
- Intellectual property rights (IPR) are the rights given to persons over the creations of their minds: inventions, literary and artistic works, and symbols, names, and images used in commerce.
- Conventions: The importance of intellectual property was first recognized in the Paris Convention for the Protection of Industrial Property(1883). Later it was also recognized in the Berne Convention for the Protection of Literary and Artistic Works(1886). The World Intellectual Property Organization (WIPO) administers both treaties.
What is a Patent?
- Patents are exclusive rights granted by the Government to a company /individual for an invention.
- Duration: Patents are time-bound. For example: In India patents are granted for a period of 20 years from the date of filing of the patent application.
Important Terms Related to India’s IPR:
- Evergreening of Patents: Evergreening to a variety of legal, business and technological strategies by which producers extend their patents over products that are about to expire, in order to retain royalties from them.
- Section 3(d) of the Indian Patent Act 1970 (as amended in 2005) does not allow patents to be granted to inventions involving new forms of a known substance unless it differs significantly in properties with regard to efficacy. This means that the Indian Patent Act does not allow the evergreening of patents.
- Compulsory licencing(CL): CL is the grant of permission by the government to entities to use, manufacture, import or sell a patented invention without the patent owner’s consent. The Patents Act in India deals with CL.
- Compulsory licensing is permitted under the WTO’s TRIPS (IPR) Agreement. The agreement provides conditions such as ‘national emergencies, other circumstances of extreme urgency and anti-competitive practices’ are fulfilled for CL.
Source: The Hindu
“International Intellectual Property Index” 2021 Released
What is the News?
The International Intellectual Property Index,2021 has been released.
About International Intellectual Property Index:
- It is an annual report that the US Chamber of Commerce Global Innovation Policy Centre(GIPC) releases.
- Aim: The aim of the index is to evaluate Intellectual Property rights in 53 global economies. These economies represent together over 90% of global GDP.
- Parameters: It ranks countries based on 50 unique indicators. These indicators are divided across nine categories of protection: 1) Patents 2) copyrights 3) trademarks 4) design rights 5) trade secrets 6) commercialization of IP assets 7) enforcement 8) systemic efficiency and 9) membership and ratification of international treaties.
Key Findings Related to India:
- India ranks 40 in the 2021 index among the 53 global economies. In 2020, India ranked 40 as well.
- Among BRICS nations, India registered the second-highest growth with an overall improvement of over 13%,
Other Key Findings Globally:
- Despite the challenges presented by COVID-19, the global IP environment continued to strengthen. In the 2021 report, 32 of the 53 economies had positive improvements in their scores.
- Further, the US, the UK, Germany, France, and Japan are the top five economies on the IP Index in 2021.
What is the News?
The Union Education Minister informed the Lok Sabha about the KAPILA campaign launched in October 2020. The campaign was launched on 89th birth anniversary of former President and Scientist Late Dr. APJ Abdul Kalam.
- KAPILA stands for Kalam Program for Intellectual Property Literacy and Awareness campaign.
- Nodal Ministry: Ministry of Education
- Objectives: The objectives of the campaign include
- To create awareness regarding Intellectual Property Rights(IPR) in Higher Education Institutions(HEIs),
- To develop training program on IPR for faculty and students of HEIs
- To sensitise and develop a vibrant Intellectual Property(IP) filing system.
- To enable IPR protection on the inventions originating from the faculty and students of HEIs
GI Geographical Indications tag for Basmati Rice to Pakistan : a cause of concern for India?
Synopsis: Pakistan secures the Geographical Indications (GI) tag for its Basmati rice. Experts say it would in no way affect India’s Basmati exports.
Before partition in 1947, both India and Pakistan shared the Basmati rice-growing zone. After partition, Basmati rice became a joint heritage of India and Pakistan.
What is the Geographical Indications (GI) tag?
A GI tag is a sign used on goods that have a specific Geographical Indications tag origin and possess qualities or a reputation that are specific to that origin.
- The tag can be awarded for agricultural products, foodstuffs, wine, handicrafts, and industrial products.
- A GI tag is a part of the intellectual property rights that comes under the Paris Convention for the Protection of Industrial Property.
- Once a product is accorded a GI tag, it is protected by various legislations, such as legislations by the World Intellectual Property Organization.
What are the regions comes under Basmati zone of both Nation?
India’s Basmati Zone includes- Jammu & Kashmir, Punjab, Haryana, Chandigarh, Delhi, Himachal Pradesh, Uttarakhand and Uttar Pradesh.
Pakistan’s Basmati belt was the Kalar bowl, a tract of land between Ravi and the Chenab rivers, covering the districts of Narowal, Sialkot, Gujranwala, Hafizabad, and Skeikhupura in Punjab province.
How did Pakistan get the GI tag?
Pakistan has been also exporting Basmati rice to European countries, along with India. It is only after enacting the act, that a country can claim for GI tag. Pakistan has just enacted the GI Act and is now following India’s path. Whereas, India enacted the GI Act in 2001.
India also applied for an exclusive GI tag to Indian-origin basmati rice. The application was published in the EU journal in 2020.
The geographical identity of Basmati is attached to the Indo-Gangetic Plains. Madhya Pradesh, which is outside this belt, also asked to be included in the GI tag for Basmati. It is only after the inclusion of MP that Pakistan pushed its case for Basmati and received it.
Is it a cause of concern for India?
It is not a cause of concern for India. India never contested Pakistan’s claim of GI tag for Basmati rice.
Initially, both countries were inclined to file for GI tag together, however, this move could not be successful, due to the following reasons;
- Firstly, Pakistan had no nodal authority with which the Agricultural and Processed Food Products Export Development Authority [APEDA] of India could have dealt.
- Secondly, the plan was interrupted by political issues also.
Pakistan produces Basmati only in its 14 districts in comparison to the 7 States of India. The output of India is very large in comparison to Pakistan, and it won’t be affected by the GI tag.
Impact of Diluting disclosure requirement in Patent Rules, 2003
Synopsis: The dilution of patent working disclosure rules obstructs the success of India’s compulsory licensing regime.
According to the new Patent Rules, 2020, licensees are no longer required to annually submit to the Patent Office disclosing the degree to which they have commercially worked or made the patented inventions available to the public in the country.
What were the requirement of disclosure in Patent Rules, 2003?
The purpose of granting patents itself is to ensure that the inventions are operated in India and are made available to the public in adequate amounts at rational prices.
- The information about the degree at which these patentees are operating in India is very important to check abuse of patent monopoly. For example, excessive pricing or scare supply of the invention
- Courts have refused a temporary ban in cases charging violation of a patent which has not been operated in India.
- Section 146 (2) asks every licensee to submit to the Patent Office an annual statement explaining the extent to which they have worked the invention in India was not found in patent laws.
- The disclosure is to be made in the Form 27 format as suggested under the Patent Rules, 2003.
Irregularities and PIL filed
- The amendment to the form was made after a PIL was filed by Shamnad Basheer before the Delhi High Court in 2015. The PIL was about the non-filing and defective filing of Form 27 by licensees and wanted an action against the violators.
- The PIL also called for a reform of Form 27 because the information it sought was totally insufficient to determine the level of the working of the patent.
- Court directed the government to bring an amendment to strengthened the patent working disclosure rules.
- However, after 2 years, instead of strengthening, government introduced an amendment that dilutes the disclosure requirements.
How government changed the disclosure requirement?
The amendment in patent laws has considerably weakened it and is defeating the whole purpose of the amendment exercise. The requirement of submitting a lot of important information was removed. The form now requires the patentees to provide only for the following information:
- Firstly, whether the invention has worked or not and the revenue generated from it (manufacturing and importing). Reasons for the invention not working and the steps being taken towards it to make it work.
- Secondly, they don’t have to provide data about the amount of the invention manufactured in India and imported which is vital for proper assessment.
- Licensees can just self-certify that they’ve worked the patent without having to prove the claim with the data on how they’ve done it, including through licensing/sub-licensing the patent.
- For instance, the disclosure of this data by Bayer in Form 27 played a crucial role in grant of India’s first compulsory license to Natco for the anti-cancer drug Sorafenib/Nexavar.
What are its impacts?
- Doing away with the condition of providing inventions for public requirement at a reasonable price, will have negative impacts on the affordability of new medicines in India.
- Doing away with the condition to disclose price and demand will make it difficult to assess the quantum of invention made available to the public in sufficient quantity and at an affordable price.
- The government must reconsider its amendments as it is going to impact public interest. Some inventions may remain inaccessible to public because of the lack of information. Such lack of accessibility in case of patented medicines could have adverse consequences for public health of the country.
Sci-Hub case: How scientific publishing works?
Synopsis: The recent case of Sci-hub filed by 3 scientific publishers in Delhi HC has highlighted the issues in scientific publishing. To under these issues, first we need to understand, how scientific publishing works.
What is the Sci-Hub case ?
- Recently, three scientific publishers’ companies such as Elsevier, Wiley, and the American Chemical Society (ACS) have filed a lawsuit against Sci-Hub owner Alexandra Elbakyan of Kazakhstan and others in the Delhi High Court.
- The publishers want Indians to be blocked from accessing the site called Sci-Hub, started by Ms. Elbakyan in 2011.
- To understand why the publishers wanted to block sci-Hub we need to understand the process of Scientific publishing in India and how Sci-hub changed this.
How scientific publishing works and how they are making profits?
- Scientists are usually paid by their institutions and their research grants come from various organizations. For example, in India Department of Biotechnology, the Council of Scientific and Industrial Research, and the Department of Atomic Energy are the major funding agencies.
- When Scientists complete their research paper, they tend to publish it in an academic journal run by publishers such as Elsevier, Wiley, and ACS.
- Before publishing, the journal seeks peer review of the paper but neither the authors nor the reviewer is paid, but they charge libraries and Indian Institutions a sky-high amount for their subscription.
- For example, it is estimated that about ₹1,500 crore is paid for India annually.
- Moreover, sometimes journals require authors to transfer copyright to them. This process has been generating huge profits to these academic publishers.
- Elsevier’s parent company RELX had profits of over 30% on revenue of nearly $10 billion in 2019.
- This has resulted in resentment against these companies and many alternatives have been explored such as open access model, author pays model etc.
How Sci- hub changed this publishing process
- First, Sci-hub operates based on open access and author pays model that enables scientists to search for academic papers from any publisher and freely download them.
- Second, Sci-Hub makes accessible to scientific literature without navigating institutional VPNs.
- Third, due to exorbitant amounts charged by other journals Sci-hub becomes easiest and sometimes only option though it has violated many copyrights owned by journals.
Is Sci-hub beneficial site for India?
- The content on Sci-Hub is beneficial to the scientific development of the country. For example, in 2020, when leading publishers made COVID-19-related articles free to read it resulted in a boom in research and development of dozens of vaccine candidates in a very short time period.
- Unlike, piracy in music and arts the Sci- hub piracy benefits the very people who create that content.
What is the way forward?
- Publishers should voluntarily reform their policies so that there will not be any need for platforms like Sci-Hub.
- Implementation of ‘one nation, one subscription’ system whereby, the entire content will be made available to all readers in India in exchange for a fixed and reasonable cost paid directly by the government.
Elsevier, Wiley, and ACS instead of escalating the Sci-hub issue, should work towards an equitable system of access to scientific literature that serves both their commercial interests and the Indian public.
Himachal Pradesh wants GI status for five products
Source: Click Here
News: Himachal Pradesh government is trying to obtain GIs (Geographical Indication) for five products from the state.
The Five Products are:
- Karsog Kulth: Kulthi or Kulth (horse gram) is a legume grown as a kharif crop in Himachal Pradesh. Kulth grown in the Karsog area of Mandi district is believed to be particularly rich in amino acids.
- Pangi ki Thangi: It is a type of hazelnut which grows in Pangi valley located in the north-western edge of Himachal. It is known for its unique flavour and sweetness.
- Chamba metal crafts: These include items such as metal idols and brass utensils which, historically, were made by skilled artisans in the courts of kings of Chamba. There are efforts to revive the trade, and a plate made from a brass-like alloy and having carvings of gods and goddesses is still popular.
- Chamba Chukh: It’s a chutney made from green and red chillies grown in Chamba and prepared in traditional and unique ways.The practice has largely declined in rural households of Chamba, but survives to some extent at the small-scale industrial level.
- Bharmouri Rajmah: It’s more specifically called the Kugtalu Rajmah, since it grows in the area around Kugti Pass in the Bharmour region of Chamba district. It is rich in proteins and has a unique flavour.
- What is a Geographical Indication? The World Intellectual Property Organisation defines a GI as a sign used on products that have a specific geographical origin and possess qualities or a reputation that are due to that origin.
- How many registered GIs does Himachal currently have? These include four handicrafts (Kullu Shawl, Chamba Rumal, Kinnauri Shawl and Kangra Paintings), three agricultural products (Kangra Tea, Basmati and Himachali Kala Zeera) and one manufactured product (Himachali Chuli Oil).