Context

• In May 2016, the then Department of Industrial Policy and Promotion (now known as the Department for Promotion of Industry and Internal Trade) under the Ministry of Commerce released the 32-page National IPR Policy. The overall purpose of this document was to spell out the government’s comprehensive vision for the IPR ecosystem in the country towards shaping a more innovative and creative Bharat.

Crack Prelims 2023! Talk to our Rankers

What is a Patent?

• A patent is an exclusive set of rights granted for an invention, which may be a product or process that provides a new way of doing something or offers a new technical solution to a problem.

Know the basics: Intellectual Property rights (IPR)

• IPR refers to the legal rights that protect an individual’s or company’s creations and inventions (such as inventions, literature, music, and symbols) from being used or copied by others without permission.
• IP is protected in law by, for example, patents, copyright and trademarks, which enable people to earn recognition or financial benefit from what they invent or create.
• By striking the right balance between the interests of innovators and the wider public interest, the IP system aims to foster an environment in which creativity and innovation can flourish.

Three important objectives of National IPR policy document

• Strong and effective IPR laws: Under the head Legal and Legislative Framework, the goal was to have strong and effective IPR laws, which balance the interests of right owners with larger public interest.
• Modernise and strengthen IPR administration: Under Administration and Management, the objective was to modernise and strengthen service-oriented IPR administration; and
• Strengthening adjudicatory mechanism: Under Enforcement and Adjudication, the focus was to strengthen the enforcement and adjudicatory mechanisms for combating IPR infringements.

Changes in IPR ecosystem so far

• Structural and legislative changes: Over the last six years, the IPR ecosystem in this country has witnessed both structural and legislative changes.
• Intellectual Property Appellate Board (IPAB): IPAB was dissolved in April 2021 as part of tribunal reforms, and its jurisdiction was re-transferred to high courts.
• Dedicated IP Division: This was followed by the establishment of dedicated IP benches the IP Division by the Delhi High Court, arguably the country’s leading court on the IPR front, for speedier disposal of IPR disputes.
• IP friendly environment: Such measures, one presumes, are intended to convey to investors and innovators that Bharat is an IP-savvy and even IP-friendly jurisdiction without compromising on national interest and public health commitments.
• For instance: This is evident from the very same National IPR Policy which, among other things, expressly recognises the contribution of the Indian pharmaceutical sector in enabling access to affordable medicines globally and its transformation to being the pharmacy of the world.

What are the concerns?

• Patent-friendliness, rather patentee-friendliness: It appears that the patent establishment of the country has drawn a very different message it has gone on an overdrive to prove its patent-friendliness, rather patentee-friendliness, in the pharmaceutical sector at the expense of public health and national interest respectively.
• Evergreening of patents on critical drugs: Evergreening patents on drugs which relate to treatment of diabetes, cancers, cardiovascular diseases and other serious conditions continue to be granted to pharmaceutical innovator companies by the Indian Patent Office.
• Enforcements at the expense of statutory rights: Worse, they are regularly enforced through courts at the expense of the statutory rights of generic manufacturers and to the detriment of patients.
• Unavailability of affordable drugs: The delayed entry of generic versions of off-patent drugs affects adversely the availability of affordable medicines to patients in a lower middle-income country such as Bharat where most middle-class families and below are only a hospital-visit away from dipping into their hard-earned savings.

Way ahead

• It must be understood that IP legislations such as the Patents Act do not exist for the sole benefit of IP right owners.
• Patent bargain is in which the society is expected to benefit from dynamic innovation-based competition between market players.
• Clearly, there are four stakeholders under the Patents Act the society, government, patentees and their competitors.
• Each of these stakeholders has rights under the statute which makes all of them right owners.
• To interpret, apply and enforce the Act to the exclusive benefit of patentees, and that too evergreening patentees, is to abridge and reduce to a naught the legitimate rights of other stakeholders, leading to sub-optimal and worse, anti-competitive market outcomes.

Conclusion

• It is one thing to operate under the understandable belief that Bharat needs to add layers to its IPR ecosystem to attract investment. However, it is entirely another to equate IPR-sensitivity with a pro-patentee position at the expense of public health obligations and long-term national interest. Make in India must be reconciled with Atmanirbhar Bharat, and in the event of conflict between the two, the latter must prevail for Bharat to retain its position as the pharmacy of the world.

Mains question

Q. What is Intellectual property rights? Discuss the changes taken place in India’s IPR ecosystem so far and highlight the concerns.

(Click) FREE 1-to-1 on-call Mentorship by IAS-IPS officers | Discuss doubts, strategy, sources, and more

Get an IAS/IPS ranker as your 1: 1 personal mentor for UPSC 2024

Attend Now

The possibilities of new strain of Covid-19 emerging from any region of the world could derail the global recovery. To prevent that from happening vaccines need to be made available and affordable to all. This article discusses the ways to ensure that.

Ensuring affordability and availability of Covid vaccines

• To achieve global herd immunity and prevent new strains of COVID-19 from emerging, vaccines need to be affordable and available in massive quantities throughout the globe.
• Following three are the ways to ensure vaccine availability and affordability.
• 1) Voluntary linceses: This can happen through patent owners voluntarily licensing their products to other companies, especially Indian producers who are experienced at mass-producing low-cost medications.
• 2) Compulsory licenses: This can also be done by temporarily suspending patent rights for COVID vaccines.
• 3) COVAX option: Some favour ensuring access to COVID-19 vaccines through the COVAX programme.

Options to ensure vaccine availability and affordability

1) Voluntary licencing: Lessons from fight against AIDS

• Due to anti-TRIPS activism from low-income countries and low profits from low-income markets some manufacturers placed licensing agreements to produce AIDS drugs for which they owned patent rights in the UN-affiliated Medicines Patent Pool.
• Several India-based companies then used these voluntary licences to manufacture these drugs on a massive scale and sold them at prices they determined.
• This effort brought down the price of key AIDS medications in these countries.
• The United Nations’ Medicines Patent Pool and the World Health Organization’s COVID-19 Technology Access Pool are important tools in an effort to promote voluntary licensing for COVID products.
• Sharing patent rights through voluntary licensing would need to involve India’s large pharmaceutical sector.

Challenges in voluntary licensing

• So far, no patent holders have joined the WHO’s COVID-19 Technology Access Pool.
• This is why India and South Africa called on the WTO to temporarily waive patent protections for COVID-19.
•  Meanwhile, the UN Medicines Patent Pool stands ready to accept voluntary licences for COVID-19.

2) Compulsory licenses

• Compulsory licenses override patent rights to allow local production or import of drugs by generic manufacturers in the event of a public health crisis.
• Since 2003, this right has been enshrined in the Doha Declaration addendum to the WTO’s TRIPS agreement and this is what India and South Africa are lobbying for.
• The Doha addendum, Section 5c, offers AIDS, malaria and tuberculosis as examples of what qualifies as a health emergency.
• By this standard, COVID-19 should easily qualify.

Issues with compulsory licensing

• Good will: Manufacturers in India say they prefer to work with voluntary licences because there is more good will between companies while compulsory licences often come with a legal battle brought by the patent holder.
• Time factor: Voluntary licences also enable production to begin more expeditiously as they usually are accompanied by “technology transfer” meaning that the patent holder reveals to the licensee how to manufacture the medication.
• No need to reverse engineer: Volunatry licensing spares the licensee the lengthy and costly process of figuring out how to reverse engineer the product.

3) COVAX option and issues

• COVAX programme was established to purchase vaccine doses and donate them to low-income countries.
• It does not involve modifying patent rights.
• Underfunded: COVAX is also currently underfunded.
• Delay: The Director-General of WHO warned that people in the lowest-income countries might have to wait until 2022 to get vaccinated through this programme.

Government aid should entail an obligation

• The billions of dollars in government aid given to companies to help develop COVID-19 treatments should entail an obligation to enable the mass production of affordable vaccines.
• Patents are not ironclad ownership rights, they are a temporary contract that balances the public interest with the claims of the innovator. 

Consider the question “What is the importance of ensuring availability and affordability of Covid-19 vaccine throughout the world? What are the options available to ensure that?”

Conclusion

This is not just a question of social justice and ensuring life-saving therapies are available to the world’s poor. It is a necessary step to prevent deadlier, more contagious and possibly vaccine-resistant variants of COVID-19 from proliferating in an under-vaccinated world.

Get an IAS/IPS ranker as your 1: 1 personal mentor for UPSC 2024

Attend Now

The article highlights the challenges countries could face despite the patent waiver for Covid-19 vaccine.

TRIPS waiver for Covid-19 vaccine

• The United States has finally relented and declared its support for a temporary waiver of the Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement for COVID-19 vaccines at the World Trade Organisation (WTO).
• Hopefully, the U.S.’s decision would cause other holdouts like Canada and the European Union to give up their opposition.
• While the U.S.’s decision is to be welcomed, the devil would be in the details.

The challenges after waiver

1) Conditions of the waiver

•  If the experience of negotiating such waivers, especially on TRIPS, were anything to go by, it would be too early to celebrate.
• In the aftermath of the HIV/AIDS crisis the WTO adopted a decision in 2003 waiving certain TRIPS obligations to increase the accessibility of medicines.
• However, this waiver (later incorporated as Article 31 bis in the TRIPS agreement) was subject to several stringent requirements such as the drugs so manufactured are to be exported to that nation only; the medicines should be easily identifiable through different colour.
• Given these cumbersome requirements, hardly any country, in the last 17 years, made effective use of this waiver.

2) Countries will protect the interest of pharma companies

•  India and South Africa proposed a waiver not just on vaccines but also on medicines and other therapeutics and technologies related to the treatment of COVID-19.
• So, the U.S. has already narrowed down the scope of the waiver considerably by restricting it to vaccines.
• Medicines useful in treating COVID-19 and other therapeutics must be also included in the waiver.
• While the U.S. would not like to be seen as blocking the TRIPS waiver and attracting the ire of the global community, make no mistake that it would resolutely defend the interests of its pharmaceutical corporations.

3) Lack of access to technology

• The TRIPS waiver would lift the legal restrictions on manufacturing COVID-19 vaccines.
• But it would not solve the problem of the lack of access to technological ‘know-how’ related to manufacturing COVID-19 vaccines.
• Waiving IP protection does not impose a legal requirement on pharmaceutical companies to transfer or share technology.
• While individual countries may adopt coercive legal measures for a forced transfer of technology, it would be too draconian and counterproductive.
• Therefore, governments would have to be proactive in negotiating and cajoling pharmaceutical companies to transfer technology using various legal and policy tools including financial incentives.

4) Domestic IP regulation

• While a TRIPS waiver would enable countries to escape WTO obligations, it will not change the nature of domestic IP regulations.
• Therefore, countries should start working towards making suitable changes in their domestic legal framework to operationalise and enforce the TRIPS waiver.
• In this regard, the Indian government should immediately put in place a team of best IP lawyers who could study the various TRIPS waiver scenarios and accordingly recommend the changes to be made in the Indian legal framework.

Conclusion

Notwithstanding the usefulness of the TRIPS waiver, it is not a magic pill. It would work well only if countries simultaneously address the non-IP bottlenecks.

Get an IAS/IPS ranker as your 1: 1 personal mentor for UPSC 2024

Attend Now

Request for waiver

•  Last year, India and South Africa requested WTO for a temporary suspension of rules under the 1995 Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS).
• A waiver was sought to the extent that the protections offered by TRIPS impinged on the containment and treatment of COVID-19. 
• The request for a waiver has, since, found support from more than 100 nations.
• But a small group of states — the U.S., the European Union, the U.K. and Canada among them — continues to block the move.
• These countries have already secured the majority of available vaccines.
• But for the rest of the world mass immunisation is a distant dream.

Grounds on which patent laws are justified

• Patent laws are usually justified on three distinct grounds:
• On the idea that people have something of a natural and moral right to claim control over their inventions.
• On the utilitarian premise that exclusive licenses promote invention and therefore benefit society as a whole.
• On the belief that individuals must be allowed to benefit from the fruits of their labour and merit.
• These justifications have long been a matter of contest, especially in the application of claims of monopoly over pharmaceutical drugs and technologies.

Patent laws in India

• In 1959, a committee chaired by Justice N. Rajagopala Ayyangar objected to monopolies on pharmaceutical drugs through colonial-era patent law.
• The committee found that foreign corporations used patents to suppress competition from Indian entities, and thus, medicines were priced at exorbitant rates.
• The committee suggested, and Parliament put this into law through the Patents Act, 1970, that monopolies over pharmaceutical drugs be altogether removed, with protections offered only over claims to processes.
• This change in rule allowed generic manufacturers in India to grow. 

How TRIPS goes against the interest of developing countries

• WTO has into its constitution a binding set of rules governing intellectual property.
• Countries that fail to subscribe to the common laws prescribed by the WTO would be barred from entry into the global trading circuit.
• It was believed that a threat of sanctions, to be enforced through a dispute resolution mechanism, would dissuade states from reneging on their promises.
• With the advent in 1995 of the TRIPS agreement, this belief proved true.
• The faults in this new world order became apparent when drugs that reduced AIDS deaths in developed nations were placed out of reach for the rest of the world.
• It was only when Indian companies began to manufacture generic versions of these medicines as TRIPS hadn’t yet kicked in against India, that the prices came down.

 Argument in support of the patent regime

• Two common arguments are made in response to objections against the prevailing patent regime.
• One, that unless corporations are rewarded for their inventions, they would be unable to recoup amounts invested by them in research and development.
• Two, without the right to monopolise production there will be no incentive to innovate.

Issues with the argument in support of patent regime

• Big pharma has never been forthright about the quantum of monies funnelled by it into research and development.
• Moderna vaccine in the U.S. emanated out of basic research conducted by the National Institutes of Health, a federal government agency, and other publicly funded universities and organisations. 
• Similarly, public money accounted for more than 97% of the funding towards the development of the Oxford/AstraZeneca vaccine.
•  Therefore, the claim that the removal of patents would somehow invade on a company’s ability to recoup costs is simply untrue.
• The second objection — the idea that patents are the only means available to promote innovation — has become something of a dogma.
• The economist Joseph Stiglitz is one of many who has proposed a prize fund for medical research in place of patents.

Consider the question “What are the issues with the patent regime under the TRIPS in the field of medicine?”

Conclusion

We cannot continue to persist with rules granting monopolies which place the right to access basic healthcare in a position of constant peril. In its present form, the TRIPS regime represents nothing but a new form of “feudal calculus”.

Get an IAS/IPS ranker as your 1: 1 personal mentor for UPSC 2024

Attend Now