Intellectual Property Rights in India

Intellectual Property Rights in India

Digital Millennium Copyright Act

Note4Students

From UPSC perspective, the following things are important :

Prelims level : Digital Millennium Copyright Act

Mains level : GoI-Twitter row

Union Minister for Electronics and Information Technology was locked out of his Twitter account for an hour allegedly over a notice received for violation of the Digital Millennium Copyright Act (DMCA).

Why such a move by Twitter?

  • The DMCA oversees the implementation of two 1996 treaties signed by World Intellectual Property Organization (WIPO) member nations.

What is the DMCA?

  • The Digital Millennium Copyright Act, or DMCA, is a 1998 law passed in the US and is among the world’s first laws recognizing intellectual property on the internet.
  • The law oversees the implementation of the two treaties signed and agreed upon by member nations of the World Intellectual Property Organization (WIPO) in 1996.
  • WIPO members had then agreed upon two treaties, namely the WIPO Copyright Treaty and the WIPO Performances and Phonograms Treaty.
  • The said protection, accorded by each member state, must not be any less in any way than the one being given to a domestic copyright holder.
  • Further, it also obligates those signatories to the treaty to ensure ways to prevent circumvention of the technical measures used to protect copyrighted work.
  • It also provides the necessary international legal protection to digital content.

What is WIPO and how does it ensure the protection of content on the internet?

  • The rapid commercialization of the internet in the late 1990s started with static advertisement panels being displayed on the internet.
  • It became important for website owners to get the user to spend more time on their webpage.
  • For this, fresh content was generated by creators and shared over the Internet.
  • The problem started when the content would be copied by unscrupulous websites or users, who did not generate content on their own.
  • Further, as the Internet expanded worldwide, websites from countries other than the one where the content originated, also started to copy the unique content generated by the websites.
  • To avoid this and bring to task the unauthorized copiers, the members of WIPO, which was established in 1967, also agreed to extend the copyright and intellectual property protection to digital content.
  • As of date, 193 nations across the world, including India, are members of WIPO.

Who can generate a DMCA notice and how are they sent to companies or websites?

  • Any content creator of any form, who believes that their original content has been copied by the user or a website without authorization can file an application citing their intellectual property has been stolen or violated.
  • Users can either approach the website on which the content has been hosted, or third-party service providers like DMCA.com, which utilize a team of experts to help take down the stolen content for a small fee.
  • In the case of social media intermediaries like Facebook, Instagram or Twitter, content creators can directly approach the platform with proof of them being original creators.
  • Since these companies operate in nations that are signatories to the WIPO treaty, they are obligated to remove the said content if they receive a valid and legal DMCA takedown notice.
  • Platforms, however, also give the other users against whom allegations of content cheating have been made, a chance to reply to the DMCA notice by filing a counter-notice.
  • The platform shall then decide which party is telling the truth and shall accordingly, either restore the content or keep it hidden.

Intellectual Property Rights in India

How AIDS fight offers a COVID vaccine patent pathway

Note4Students

From UPSC perspective, the following things are important :

Prelims level : TRIPS

Mains level : Paper 3- Ensuring affordability and availability of Covid-19 vaccines

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.

Intellectual Property Rights in India

India should walk the talk on TRIPS waiver

Note4Students

From UPSC perspective, the following things are important :

Prelims level : TRIPS

Mains level : Paper 3- TRIPS waiver and India's stand

The article highlights the variance in India’s stand on intellectual property rights waiver for Covid related drugs on the international level and domestic level. 

Removing the IPR barrier

  • When the pandemic hit the globe, India and South Africa piloted the proposal to waive key provisions of the Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement on COVID-19 vaccines, drugs, therapeutics, and related technologies.
  • The core idea is that IPRs such as patents should not become barriers in scaling up production of medical products essential to combat COVID-19.
  • The TRIPS waiver proposal, now backed by the U.S. would give immunity to member countries from a legal challenge at the WTO if their domestic IPR laws suspend or do not enforce IP protection on COVID-19 medical products.
  • Member countries of the World Trade Organization (WTO) are under an obligation to ensure that their domestic intellectual property rights (IPR) laws conform to the requirements of the TRIPS agreement.

No use of compulsory licencing in India

  • The existing flexibilities under the Patents Act of 1970, such as compulsory licences, which are consistent with the TRIPS agreement, can be used to increase the supply of COVID-19 medical products.
  • However, despite the nudging by the judiciary and others, the government inexplicably hasn’t made use of compulsory licences in the pandemic.
  • While issuing compulsory licences for COVID-19 vaccines in the absence of technology transfer is easier said than done, they can be used to augment the supply of drugs and other therapeutics.
  • For instance, there are demands that compulsory licences be issued for drugs such as Remdesivir to augment supply.
  • Natco, an Indian pharmaceutical company, has requested a compulsory licence under Section 92 of the Patents Act for Baricitinib, a COVID-19 drug.
  • This is ironic because India has historically played a leading role in mainstreaming TRIPS flexibilities like the compulsory licence at the WTO.
  • The Central government, in an affidavit filed before the Supreme Court, states that the main constraint in boosting the production of drugs like Remdesivir is the unavailability of raw materials and essential inputs.
  • The affidavit further states, “it is presumptuous to assume that the patent holder will not agree to more voluntary licences”.

Issues with the government’s stand

  •  If that is the real bottleneck, and not IPR-related legal hurdles, why is India pushing for a TRIPS waiver at the WTO?
  • The first step in advocating for the removal of IPR-related impediments at the WTO is to make use of the existing lawful means.
  • Therefore, the government’s stand before the Supreme Court is not only contradictory with India’s position at the WTO but also severely undermines it.

Way forward

  • To make its TRIPS waiver stand convincing, the government needs to make aggressive use of Sections 92 and 100 of the Patents Act to license all patents necessary to make COVID-19 medical products.
  • The government should not only transfer Covaxin’s technology to domestic pharmaceutical companies, to boost national supplies, but also offer it to foreign corporations. 
  •  By unlocking its vaccine technical know-how to the world, India would demonstrate its resolve to walk the talk on the TRIPS waiver.

Conclusion

India must take a consistent stand on IPRs on COVID-19 medical products internationally and domestically.

Intellectual Property Rights in India

A TRIPS waiver is useful but not a magic pill

Note4Students

From UPSC perspective, the following things are important :

Prelims level : Not much

Mains level : Paper 3- Challenges after TRIPS waiver

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.

Intellectual Property Rights in India

How IPR served as barrier to the right to access healthcare

Note4Students

From UPSC perspective, the following things are important :

Prelims level : Patent Law, TRIPS

Mains level : Paper 3- Impact of IPR on right to access healthcare

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”.

Intellectual Property Rights in India

[pib] KAPILA for patent awareness

Note4Students

From UPSC perspective, the following things are important :

Prelims level : KAPILA program

Mains level : Patenting solutions in India

The Government has launched a campaign namely KAPILA for Intellectual Property Literacy and creating patent awareness, informed Union Ministry for Education to the Parliament.

Remember one thing, ‘KAPILA’ Program is related to IP awareness. It sounds much like an animal husbandry related initiative.

KAPILA Initiative

  • KAPILA is an acronym for Kalam Program for IP (Intellectual Property) Literacy and Awareness.
  • Under this campaign, students pursuing education in higher educational institutions will get information about the correct system of the application process for patenting their invention and they will be aware of their rights.
  • The program will facilitate the colleges and institutions to encourage more and more students to file patents.

Why in news?

  • As many as 46,556 users have registered for the Union Government’s Intellectual Property Literary project.
  • This marks the success of the campaign.

Intellectual Property Rights in India

PATENTS (AMENDMENT) RULES, 2020

Note4Students

From UPSC perspective, the following things are important :

Prelims level : Patent Act 1970

Mains level : Paper 3- Amendment to patent working disclosure rule and its implications

A recent amendment to a unique feature in patent law under which patentee/licensee has to disclose information regarding the extent to which they have worked patent in India, could have several implications.

Why the changes in rules matter

  • Indian patent law grants a 20-year patent monopoly to an inventor.
  • In exchange for such monopoly, India’s patent law imposes a duty on the patentee to commercially work the invention in India to ensure that its benefits reach the public.
  • Accordingly, section 146(2), a unique provision not found in patent laws of most other countries, requires every patentee and licensee to submit to the Patent Office an annual statement (Form 27 format) explaining the extent to which they have worked the invention in India.
  • This statement is meant to help the Patent Office, potential competitors, etc. to determine whether the patentee has worked the invention in India and made it sufficiently available to the public at reasonable prices.
  • A failure of this duty could trigger compulsory licensing or even subsequent revocation of the patent under the Patents Act, 1970. 
  • The central government recently amended the format of a statement that patentees and licensees are required to annually submit to the Patent Office.
  • The amendment has significantly watered down the disclosure format.
  • This could hamper the effectiveness of India’s compulsory licensing regime.
  • This in turn could hinder access to vital inventions including life-saving medicines, thereby impacting public health.
  • There has been significant pressure from multinational corporations and the United States government to do away with this requirement.

What changes were made through the amendment

  • The recent amendment to the form was made in response to a PIL filed by Shamnad Basheer before the Delhi High Court in 2015.
  • The PIL brought to the Court’s attention the rampant non-filing and defective filing of Form 27 and sought a direction to strictly enforce the patent working disclosure rules and take action against the violators.
  • The PIL also called for a reform of Form 27, arguing that the information it sought was grossly insufficient to ascertain the extent of the working of the patent.
  •  However, instead of strengthening the form, the amendment has significantly weakened it further, thereby defeating the entire purpose of the amendment exercise.
  • The amended form has removed the requirement of submitting a lot of important information.
  • It is no longer required to provide any information in respect of the quantum of the invention manufactured/imported into India, the licenses and sub-licenses granted during the year and the meeting of public requirement at a reasonable price.
  • It no longer requires quantum or the total units of the invention manufactured/imported in India.
  • The deletion of this requirement of its disclosure is shocking.
  • This is because,  it is the disclosure of this data by Bayer in Form 27 that played a crucial role in grant of India’s first compulsory license to Natco for the anti-cancer drug Sorafenib/Nexavar.
  • The removal of the requirement of submitting any licensing information, including the disclosure of even the existence of licenses means that the patentees/licensees can just self-certify that they’ve worked the patent.
  • The omission to mandate disclosure of details makes it extremely difficult to ascertain whether the invention has been made available to the public in sufficient quantity and at an affordable price.

Conclusion

The government has significantly weakened the critical duty imposed by the law on patentees/licensees to disclose patent working information. Therefore, the government must reconsider its amendments to the form taking into account the PIL recommendations and re-amend it to restore as well as strengthen its spirit.

Intellectual Property Rights in India

[pib] KAPILA Program

Note4Students

From UPSC perspective, the following things are important :

Prelims level : KAPILA program

Mains level : IPR protection measures

Union Education Ministry has launched ‘KAPILA’ Kalam Program for IP Literacy and Awareness Education campaign to bring awareness towards the patenting of inventions.

Remember one thing, ‘KAPILA’ Program is related to IP awareness. It sounds much like an animal husbandry related initiative.

‘KAPILA’ Program

  • KAPILA is an acronym for Kalam Program for IP (Intellectual Property) Literacy and Awareness.
  • Under this campaign, students pursuing education in higher educational institutions will get information about the correct system of the application process for patenting their invention and they will be aware of their rights.
  • The program will facilitate the colleges and institutions to encourage more and more students to file patents.

Intellectual Property Rights in India

Rethinking the role of Intellectual Property in Corona crisis

Note4Students

From UPSC perspective, the following things are important :

Prelims level : TRIPS.

Mains level : Paper 3- How Covid-19 could impact the intellectual property rights?

The article discusses the idea of creating a patent pool of the patents dealing with Covid-19. Such a patent pool will be effective in avoiding the possibility of the hostile response of societies towards patent rights. And also avoid the conflict between nations. corporations and international organisations.

Purpose of patent rights

  • 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.
  • Should pandemics such as COVID-19be an exception to this?
  • With the outbreak of COVID-19, there are several innovations.
  • All these innovations may be the subject matter of patent applications around the world.
  • It will be a few years before patents are even granted.
  • However, friction already exists among various stakeholders.
  • For instance, 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.
  • The question that arises is whether the exclusivity that is recognised by patent rights will be detrimental to society.
  • Will patents create roadblocks or is there a solution?

Possibility of conflicts over patent rights

  • Governments and international organisations need to arrive at a consensus in advance to ensure that the system is ready.
  • Procrastination would be disastrous.
  • Creating hindrances through exclusivity claims, in the wake of a pandemic, will result in dividing countries, corporations and international organisations.
  • 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 (Trade-Related Aspects of Intellectual Property Rights) regime, there are several tools such as compulsory licensing that are available to ensure access to medicines.
  • However, beyond the laws, society needs to respect innovation.
  • To protect the sanctity and integrity of patent systems, and in order to ensure that an 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.

The idea of creating a patent pool

  • One method by which aggregation and dissemination of innovative products can be ensured is by creating a patent pool.
  • Patent pools are usually effective in aggregating, administering and licensing patents related to specific areas of technology.
  • 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 wishes to obtain a licence will be able to approach the pool, agree to the terms, and begin to manufacture and sell the products.
  • Such pools are prevalent in, for instance, standard essential patents related to telecom and digital innovations.
  • At the moment, individual efforts are being made by research organisations to create their own pools.
  • A more fruitful endeavour 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.
  • This would not require countries 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 swathes of the population affected by the pandemic, who will need to be administered these products.

Way forward

  • 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.
  • Such a pool needs the cooperation of not just countries and international organisations but also the hundreds of researchers, innovators, companies and universities involved.
  • Doha Declaration: Pooling of patent resources is also in line with the Doha Declaration on Public Health which is a part of the TRIPS agreement.
  • This declaration recognises the need for taking measures to ‘protect public health’ and ‘promote access to medicines’.

A direct question on the issue can be asked by the UPSC, for ex-“Though IPRs have been provided to respect and protect the innovations and ideas, but in the wake of corona crisis, some strict provisions need to be changed. In light of the above statement, discuss the limitations of the exclusivity clause under the patents rights. And how can it be overcome in emergency situations?”

Conclusion

Public-private partnerships (PPP) need to be scaled up. Creation of the ‘PPP-pandemic patent pool’ at a global level, to pool all innovations, is the way forward. Let us not wait any longer.

Intellectual Property Rights in India

Global Intellectual Property Index 2020

Note4Students

From UPSC perspective, the following things are important :

Prelims level : Prospects of the Global IP Index

Mains level : Intellectual property rights and their protection in India

India has been ranked 40th out of 53 countries on a global intellectual property index, even as the country has shown improvement in terms of scores when it comes to the protection of IP and copyright issues.

GIP Index

  • The Global IP Index was released by Global Innovation Policy Center or GIPC of the US Chambers of Commerce.
  • The GIPC Index consists of five key sets of indicators to map the national intellectual property environment for the surveyed countries.
  • The major indicator categories are:
  1. patents, related rights, and limitations;
  2. copyrights, related rights, and limitations;
  3. trademarks, related rights, and limitations;
  4. enforcement;
  5. membership and ratification of international treaties.

India’s performance

  • India was placed at 36th position among 50 countries in 2019.
  • India’s score, however, increased from 36.04 per cent (16.22 out of 45) in 2019 to 38.46 per cent (19.23 out of 50) in 2020, a 2.42 per cent jump in absolute score.
  • However, India’s relative score increased by 6.71 per cent.
  • India also continues to score well in the Systemic Efficiency indicator, scoring ahead of 28 other economies in these indicators.

Challenges for India

  • GIPC has identified several challenges for India. Prominent among them are:

Patentability requirements, patent enforcement, compulsory licensing, patent opposition, regulatory data protection, transparency in reporting seizures by customs, and Singapore Treaty of Law of TMs and Patent Law Treaty

Measures to protect IPs in India

  • Since the release of the 2016 National IPR Policy, the government of India has made a focused effort to support investments in innovation and creativity through increasingly robust IP protection and enforcement.
  • Since 2016, India has improved the speed of processing for patent and trademark applications, increased awareness of IP rights among Indian innovators and creators, and facilitated the registration and enforcement of those rights.
  • To continue this upward trajectory, much work remains to be done to introduce transformative changes to India’s overall IP framework and take serious steps to consistently implement strong IP standards.

Intellectual Property Rights in India

Indian Performing Right Society (IPRS)

Note4Students

From UPSC perspective, the following things are important :

Prelims level : Indian Performing Right Society

Mains level : Civil socities and their functioning in India

  • The Economic Offences Wing (EOW) of the Mumbai Police has registered an FIR against a film producer others for alleged criminal breach of trust and failure of payment.
  • The FIR was registered on a complaint by the Indian Performing Right Society (IPRS). This is the first criminal case initiated by the IPRS after it was re-registered as a copyright society in 2017.

Indian Performing Right Society

  • The IPRS is a representative body of artists, including music owners, composers, lyricists, and publishers of music.
  • It collects royalties due to the artists if their work is used anywhere from a wedding to a New Year function or on radio or TV — in other words, wherever music is played.
  • The body was set up in 1969, and re-registered as a copyright society in 2017, following which it started functioning actively.
  • The IPRS has its offices in Mumbai, and lyricist Javed Akhtar is its chairman.

Functioning

  • A 2012 amendment in The Copyright Act, 1957 laid down that artists would get 50% of royalties every time their work was used, even if the copyright remained with the production house or the music brand.
  • It meant that every time a song was played in, say, a large party in a hotel or by a radio station, or streamed or even used as a mobile phone ringtone, 50% of the royalty would go to the production house or music company.
  • The other 50% would be split between the lyricist and composer of the song.
  • The IPRS is responsible for collecting the 50% royalty that is due to artists involved in “literary work accompanied to music” — meaning lyricists, music composers, and publishers of music.
  • While even individual artists can theoretically approach the users of their work directly, it is likely to be a difficult and long drawn-out process.
  • As members of IPRS, they have better infrastructure at their disposal to press their claim and collect the money due to them.

How does the process of licensing with the IPRS work?

  • The IPRS has a database of around 10 million songs, including Indian and international numbers, for which it collects royalty.
  • If cases of big events, the IPRS generally approach the organizers beforehand to inform them about the licensing required to play the songs of artists who are registered with them.
  • Most online streaming platforms are registered with IPRS, and licensed to use the artists’ songs.
  • After being re-registered as a copyright society in 2017 under the amended Copyright Act, the IPRS sent letters to all media platforms, asking them to ensure that artists are paid 50% of the royalty as per the Act.

Intellectual Property Rights in India

[pib] Patent Prosecution Highway (PPH) Programme

Note4Students

From UPSC perspective, the following things are important :

Prelims level : Patent Prosecution Highway (PPH) Programme

Mains level : IPR protection in India

The Union Cabinet has approved the proposal for adoption of Patent Prosecution Highway (PPH) programme.

About the PPH

  • The Patent Prosecution Highway (PPH) is a set of initiatives for providing accelerated patent prosecution procedures by sharing information between some patent offices.
  • The programme would be run by the Indian Patent Office (IPO) under the Controller General of Patents, Designs & Trade Marks India (CGPDTM) with patent offices of various other interest countries or regions.
  • It will initially commence between Japan Patent Office (JPO) and Indian Patent Office on pilot basis for a period of three years only.
  • Under this Pilot programme, Indian Patent Office may receive patent applications in certain specified technical fields only, namely, Electrical, Electronics, Computer Science, Information Technology, Physics, Civil, Mechanical, Textiles, Automobiles and Metallurgy etc.
  • The patent offices will frame their own guidelines for implementation of the programme.

Benefits of PPH

  • Reduction in time to dispose patent applications.
  • Reduction in pendency of patent applications.
  • Improvement in quality of search and examination of patent applications.
  • An opportunity for Indian inventors including MSMEs and Start ups of India to get accelerated examination of their patent applications in Japan.

Intellectual Property Rights in India

[op-ed snap] Lay off

Note4Students

From UPSC perspective, the following things are important :

Prelims level : FL 2027

Mains level : Pepsico suit against farmers will not benefit anyone.

CONTEXT

PepsiCo’s suing nine Gujarat farmers for alleged infringement of its intellectual property rights (IPR) over a proprietary potato variety makes for bad optics, bordering on a public relations disaster.

Background

  • The American food-and-beverage giant enjoys IPR protection in India for FL 2027, a potato variety with high dry matter and low sugar content that is better suited for making chips (normal table potatoes have more moisture, which adds to dehydration and energy costs during processing, and higher sugar that causes blackening on frying).
  • Such protection is, indeed, required for incentivising agricultural research and development of new plant varieties by breeders, both in the private and public sectors.

 Protection of Plant Varieties and Farmers’ Rights Act

  • Under the Protection of Plant Varieties and Farmers’ Rights Act, 2001(PPVFRA), over 3,500 varieties across a range of crops — including those bred or improved by individual farmers — have so far been granted registration certificates for up to 15 years.
  • These certificates confer on the breeders the exclusive rights over commercial production, sale, marketing, distribution, export and import of their protected varieties.

Exceptions Allowed

  • However, the PPVFRA simultaneously entitles farmers to “save, use, sow, re-sow, exchange, share or sell” the produce and seeds of any variety protected under the Act.
  • Such freedom is conditional only upon no sale of such seeds in branded form — in other words, being “put in a package or any other container and labeled”.

No violation of IPR

It is clear from this that the Gujarat farmers had not committed any IPR infringement by merely growing FL 2027 potato, even if without PepsiCo’s authorisation.

Mutual benefit agreement

  • PepsiCo may have developed this processing-grade variety solely for its Lay’s chips and for contract cultivation by farmers through a buy-back mechanism at pre-fixed rates.
  • The company claims to be working with some 24,000 farmers across nine states.
  • It’s fair to assume they benefit from the arrangement, both on account of being insulated from open market price fluctuations — huge in potatoes — and also receiving quality farm inputs and extension support.
  • PepsiCo may, in turn, have legitimate concerns over farmers independently cultivating its proprietary varieties and possibly even supplying their produce to rival chips/French fries makers.
  • But that still does not constitute an IPR infringement.

Way Forward

  • It would be in PepsiCo’s best interest to simply withdraw its suit against the Gujarat farmers, without attaching conditions.
  • A $65-billion multinational seeking Rs one crore each of damages from Average Joe farmers of Sabarkantha — that too, during election time — is going to only invite opprobrium and consumer backlash.
  • The losses from that will far outweigh any pyrrhic legal victory.

Intellectual Property Rights in India

[pib] Cabinet approves accession to three new agreements for IPR

Note4students

Mains Paper 2: Governance | Government policies & interventions for development in various sectors & issues arising out of their design & implementation

From the UPSC perspective, the following things are important:

Prelims level: All three agreements mentioned

Mains level: IPR protection in India


News

  • The Union Cabinet has approved the proposal for accession of India to:

The Nice Agreement concerned with the International classification of Goods and Services for the purposes of registration of marks

The Vienna Agreement establishing an International Classification of the figurative elements of marks

The Locarno Agreement establishing an International classification for industrial designs.

About these agreements

  1. These are open to States party to the Paris Convention for the Protection of Industrial Property (1883).
  2. Instruments of ratification or accession must be deposited with the Director General of WIPO.

Impact

  • Accession to these will help the Intellectual Property Office in India to harmonize the classification systems for examinational of trademark and design applications, in line with the classification systems followed globally.
  • It would give an opportunity to include Indian designs, figurative elements and goods in the international classification systems.
  • The accession is expected to instill confidence in foreign investors in relation to protection of IPs in India.
  • The accession would also facilitate in exercising rights in decision making processes regarding review and revision of the classifications under the agreement.

Intellectual Property Rights in India

Government introduces bill in Rajya Sabha to amend Cinematograph Act

Note4students

Mains Paper 2: Governance | Government policies & interventions for development in various sectors & issues arising out of their design & implementation

From the UPSC perspective, the following things are important:

Prelims level:  Cinematograph (Amendment) Bill, 2019

Mains level: Governance of broadcasts and creative industries in India


News

  • The union government has introduced a bill in the Rajya Sabha to amend the Cinematograph Act and impose strict penalty to combat the menace of film piracy.

Cinematograph (Amendment) Bill, 2019

  1. The Bill seeks to amend provisions of Cinematograph Act, 1952, in order to tackle film piracy by including penal provisions for unauthorized camcording and duplication of films
  2. It aims to check piracy, particularly the release of pirated versions of films on the internet that causes huge losses to the film industry and the exchequer.

Curbing Piracy

  1. The bill proposes to make film piracy offences punishable with imprisonment of up to three years and fines that may extend to ₹10 lakh or both.
  2. The proposed amendment states that any person, who without the written authorisation of the copyright owner, uses any recording device to make or transmit a copy of a film, or attempts to do so, or abet the making or transmission of such a copy, will be liable for such a punishment.

Expected Outcomes

  1. The film industry has been demanding for a long time that the government consider amendments to the law preventing camcording and piracy.
  2. The proposed amendments would increase industry revenues, boost job creation, fulfil important objectives of India’s National Intellectual Property policy.
  3. It will give relief against piracy and infringing content online.

What are IPRs?

Intellectual Property Rights (IPRs) are legal rights, which result from intellectual invention, innovation and discovery in the industrial, scientific, literary and artistic fields. These rights entitle an individual or group to the moral and economic rights of creators in their creation.


 

Types:

Patent- It is a set of exclusive rights granted by a sovereign state to an inventor for a limited period of time in exchange for detailed public disclosure of an invention.

Copyright- It is a legal right created by the law of a country that grants the creator of an original work exclusive rights for its use and distribution. It includes literary & artistic works such as novels, poems, plays, films, musical works, drawing, painting, photography, sculpture, architectural designs

Trademark- It is a recognizable sign, design, or expression which identifies products or services of a particular source from those of others. Trademarks used to identify services are usually called service marks.

Industrial design right- It is an intellectual property right that protects the visual design of objects that are not purely utilitarian. An industrial design consists of the creation of a shape, configuration or composition of pattern or color, or combination of pattern and color in three-dimensional form containing aesthetic value. An industrial design can be a two- or three-dimensional pattern used to produce a product, industrial commodity or handicraft.

Trade secret- It is a formula, practice, process, design, instrument, pattern, commercial method, or compilation of information which is not generally known or reasonably ascertainable by others, and by which a business can obtain an economic advantage over competitors or customers

Geographical Indication (GI)- It is a name or sign used on certain products which corresponds to a specific geographical location or origin (e.g. a town, region, or country). The use of a geographical indication may act as a certification that the product possesses certain qualities, is made according to traditional methods, or enjoys a certain reputation, due to its geographical origin. A recent example is of Indian variety of Basmati rice getting GI tag.

From above points, it is clear that IPR is a very sensitive issue in terms of businesses different kinds and international relations as well.

IPRs in pharmaceutical sector:

Some sectors are very sensitive in terms of IPRs like pharmaceuticals. Let’s explore briefly into IPR issues in pharmaceutical sector.

We hear of two kinds of drugs- generic and brand name drugs:

Generic drugs are those whose patent has expired or does not exist and which can be produced by any registered manufacturer without need of taking permission from any authority and also without any payment of royalty.

Brand name drugs are those which are patented and cannot be produced without the consent of the patent holder. A royalty is to be paid for production of these drugs.

But what happens if a company holds patent of an essential drug and there is an emergency in which the drug needs to be provided at low cost for vast populace? In this case, Compulsory Licensing comes to the rescue.

What is Compulsory Licensing?

  • A compulsory license provides that the owner of a patent or copyright licenses the use of their rights against a payment. This payment is either set by law or determined through some form of arbitration
  • In essence, under a compulsory license, an individual or company seeking to use another’s intellectual property can do so without seeking the rights holder’s consent, and pays the rights holder a set fee for the license
  • This is an exception to the general rule under intellectual property laws that the intellectual property owner enjoys exclusive rights that it may license – or decline to license – to others

Does there have to be an emergency?

Not necessarily. This is a common misunderstanding. The TRIPS Agreement does not specifically list the reasons that might be used to justify compulsory licensing. However, the Doha Declaration on TRIPS and Public Health confirms that countries are free to determine the grounds for granting compulsory licences.

In March 2012, India granted its first compulsory license ever. The license was granted to Indian generic drug manufacturer Natco Pharma Ltd for Sorafenib tosylate, a cancer drug patented by Bayer.

Here, first thing first, What is TRIPS?

  • TRIPS is an international agreement administered by the World Trade Organization (WTO), which sets down minimum standards for many forms of intellectual property (IP) regulations as applied to the nationals of other WTO Members
  • It was negotiated at the end of the Uruguay Round of the General Agreement on Tariffs and Trade (GATT) in 1994
  • TRIPS requires WTO members to provide copyright rights, covering content producers including performers, producers of sound recordings and broadcasting organizations, geographical indications, including appellations of origin, industrial designs, integrated circuit layout-designs, patents, new plant varieties, trademarks, trade dress, and undisclosed or confidential information
  • The agreement also specifies enforcement procedures, remedies, and dispute resolution procedures

Now, back to the topic…

India is a huge market for generic drugs and hence it is very obvious that there must emerge issues out of patents for pharmaceuticals.

One such case came up in 1998- Novartis v. Union of India & Others

It was a landmark decision by a two-judge bench of the Supreme Court, on the issue of whether Novartis could patent Glivec in India. It was the culmination of a seven-year-long litigation fought by Novartis. The Supreme Court upheld the Indian patent office’s rejection of the patent application.

Ground of rejection?

Novartis claimed patent for he changed form of Glivec on the basis of the increased bio-availability in the body of the patient by making changes in chemical composition of its original anti-cancer drug Imatinib Mesylate. This changed form of the drug could not withstand the ‘enhanced therapeutic efficacy’ test enshrined under Section 3(d) of Indian Patents Act and therefore it was rejected.

Recently, Gilead got patent for its Hepatitis C drug Solvadi. An application for the same patent was first rejected in January 2015 as lacking inventiveness and novelty. The decision, however, is seen as a major blow to the access to drug movement

Now let’s turn towards the latest developments in the IPRs in India.

New IPR Policy

Govt of India recently released a new National Intellectual Property Rights (IPR) Policy which is in compliance with WTO’s agreement on TRIPS

Why a new policy?

  • Global drug brands led by US companies have been pushing for changes to India’s intellectual property rules for quite some time now. They have often complained about India’s price controls and marketing restrictions
  • Also, an IPR policy is important for the government to formulate incentives in the form of tax concessions to encourage research and development (R&D)
  • It is also critical to strengthen the Make In India, Startup and Digital India schemes
  • The IPR policy comes at a time when India and other emerging countries faces fresh challenges from the developed world and mega regional trade agreements such as the Trans-Pacific Partnership (TPP)

Seven objectives:

  1. IPR Awareness: To create public awareness about the economic, social and cultural benefits of IPRs among all sections of society
  2. Generation of IPRs: To stimulate the generation of IPRs
  3. Legal and Legislative Framework: To have strong and effective IPR laws, which balance the interests of rights owners with larger public interest
  4. Administration and Management: To modernize and strengthen service-oriented IPR administration
  5. Commercialization of IPRs: Get value for IPRs through commercialization
  6. Enforcement and Adjudication: To strengthen the enforcement and adjudicatory mechanisms for combating IPR infringements
  7. Human Capital Development: To strengthen and expand human resources, institutions and capacities for teaching, training, research and skill building in IPRs

Highlights:

  • The new policy calls for providing financial support to the less empowered groups of IP owners or creators such as farmers, weavers and artisans through financial institutions like rural banks or co-operative banks offering IP-friendly loans
  • The work done by various ministries and departments will be monitored by the Department of Industrial Policy & Promotion (DIPP), which will be the nodal department to coordinate, guide and oversee implementation and future development of IPRs in India
  • The policy, with a tagline of Creative India: Innovative India, also calls for updating various intellectual property laws, including the Indian Cinematography Act, to remove anomalies and inconsistencies in consultation with stakeholders
  • For supporting financial aspects of IPR commercialisation, it asks for financial support to develop IP assets through links with financial institutions, including banks, VC funds, angel funds and crowd-funding mechanisms
  • To achieve the objective of strengthening enforcement and adjudicatory mechanisms to combat IPR infringements, it called for taking actions against attempts to treat generic drugs as spurious or counterfeit and undertake stringent measures to curb manufacture and sale of misbranded, adulterated and spurious drugs
  • The policy will be reviewed after every five years to keep pace with further developments in the sector

International angle:

Last month, the US Trade Representative kept India, China and Russia on its “Priority Watch List” for inadequate improvement in IPR protection. However, brushing aside concerns of the US on India’s IPR regime, the government said its intellectual property rights laws are legal-equitable and WTO-compliant. Thus, the government has not yielded to pressure from the United States to amend India’s patent laws.

Benefits:

  • The new policy will try to safeguard the interests of rights owners with the wider public interest, while combating infringements of intellectual property rights
  • By 2017, the window for trademark registration will be brought down to one month. This will help in clearing over 237,000 pending applications in India’s four patent offices
  • It also seeks to promote R&D through tax benefits available under various laws and simplification of procedures for availing of direct and indirect tax benefits
  • Unlike earlier where copyright was accorded to only books and publications, the recast regime will cover films, music and industrial drawings
  • A host of laws will also be streamlined — on semi-conductors, designs, geographical indications, trademarks and patents
  • The policy also puts a premium on enhancing access to healthcare, food security and environmental protection
  • Policy will provide both domestic and foreign investors a stable IPR framework in the country
  • This will promote a holistic and conducive ecosystem to catalyse the full potential of intellectual property for India’s growth and socio-cultural development while protecting public interest
  • It is expected to lay the future roadmap for intellectual property in India, besides putting in place an institutional mechanism for implementation, monitoring and review
  • The idea is to incorporate global best practices in the Indian context and adapt to the same

Challenges:

  • According to the policy, India will retain the right to issue so-called compulsory licenses to its drug firms, under “emergency” conditions
  • Also, the government has indicated that there is no urgent need to change patent laws that are already fully World Trade Organization-compliant. So India has resisted pressure from the US and other Western countries to amend its patent laws
  • The policy also specifically does not open up Section 3(d) of the Patents Act, which sets the standard for what is considered an invention in India, for reinterpretation

 

Published with inputs from Swapnil

 

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