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Can Intellectual Property Rights Waiver resolve the COVID-19 Vaccine Shortage?


Intellectual property rights are the rights given to persons over the creations of their minds such as inventions, literary and artistic works, designs and symbols, names and images used in commerce. They usually give the creator an exclusive right over the use of his/her creations for a certain period of time. Intellectual property rights are protected by law, for example patents, copyright and trademark; which enable people to earn recognition or financial benefits from what they invent or create. By striking the right balance between the interests of innovations and the wider public interest, the IP system aims to foster an environment in which creativity and innovation can flourish.


Types of intellectual property


Copyright

Copyright is a legal term used to describe the rights that creators have over their literature and artistic works. Works covered by copyright range from books, music, paintings, sculpture and films to computer programs, database, advertisements, maps and technical drawings.


Patents

A patent is an exclusive right granted for an invention. Generally speaking, a patent provides the patent owner with the right to decide how -or- whether the invention can be used to others. In exchange for this right the patent owner makes technical information about the invention publicly available in the published patent document.


Trademark

A Trademark is a sign capable of distinguishing the goods or services of an enterprise from those of other enterprises. Trademarks date back to ancient times when artisans used to put their signature or “mark" on their products.


Industrial designs

An industrial design constitutes the ornamental or aesthetic aspect of an article. A design may consist of three-dimensional features such as the shape or surface of an article or of two-dimensional feature such as patterns, lines or color.


Geographical indication

Geographical indication and appellation of origin are signs used on goods that have a specific geographical origin and possess qualities, a reputation or characteristics that are essentially attributes to that place of origin. Most commonly a geographical indication includes the name of the place of origin of goods.


Trade secrets

Trade secrets are IP rights on confidential information which maybe sold or licensed. The unauthorized acquisition, use or disclose of such secret information in a manner contrary to honest commercial practices by others is regarded as an unfair practice and violation of the trade


Intellectual property rights – pros

There are few pros to protecting your rights in terms of intellectual property for instance patent, trademark and copyright all give your business important advantages and incentives. Trademark allows you to build your brand and create a strong company. That applies to every other company out there as well. Copyright ensures that a creator continues to own his or her artistic creation (books, artwork, graphic work) patents foster invention and innovation as well as encouraging inventors to fully explain what’s being invented and how it works.


Intellectual property rights - cons

While there are plenty of pros in favor of protecting your rights there are a few drawbacks here as well. For instance, copyright can be given to works that truly don’t deserve protection under the law and patents can be given to frivolous things ( Amazon’s patenting of pictures on a “white background” is a perfect example of patent frivolity) other cons involve costs- protecting your rights can very expensive. IPR lawyers, court costs, settlement fees, filing fees, and numerous other costs can mount very quickly, making protection of intellectual property rights expensive for even very large companies.


Advantages and disadvantages of intellectual property rights

There are many advantages and disadvantages of intellectual property (IP) that businesses should be mindful of. Intellectual property rights protects your companies inventions, processes and concepts which is crucial to maintaining your brand and competitive edge. While some IP rights are automatic others require a formal application before you have such protection. For example, copyright protection is usually automatic. However, patent and trademark protection involves a formal, and at times complex, application. Copyright generally includes protection over literary works, paintings, photographs, and other artistic works. Patents can protect a design, process or plant species. Trademark protects marks like a brand name or logo.


But defining what intellectual property is can be difficult. Unlike traditional property, such as a home, intellectual property can be a method that is used by more than one company. Therefore, a question becomes who is the actual owner or inventor of that method? If neither company has formal protection over the method, then several other factors are used to determine who is the owner is.


Advantages of intellectual property

There are many advantages to IP, including the following:

  1. There are no fees associated with IP

  2. Ability to have a competitive edge over other similar businesses.

  3. IP enhances your company’s value

  4. IP helps you market your company’s products and services

  5. You can more easily obtain financing for your business

  6. Greater export opportunities.

There is no fees if you want to enhance or change your invention, particularly if it isn’t formally protected. With that said, you should consider applying for formal patent protection once you’ve finished developing your product.


If you have patent protection over your intellectual property then you will inevitably have a competitive edge over the competition. This is because other businesses operating in same industry cannot copy, manufacture, use, or sell your product. Intellectual property can help generate even more income for your business through licensing agreements or sale of your invention. If you sell your business, it will be worth more if you have intellectual property protection. Such a sale can occur through a partial sale, full sale, merger, or acquisition.


You can easily market your business’s products and services if you have patent or trademark protection over your intellectual property. This can include the design of your product or logo. It can help you differentiate your business over others to draw in potential consumers.


If you have intellectual property protection, you can more easily obtain financing from lenders and other financial institutions since it enhances your credibility with such protection. Your business will get greater export opportunities since intellectual property can increase your competitive edge in the export markets. Therefore you can market goods internationally. To do this, you can enter into franchising agreements with international businesses that are located in countries where you want to do business or export your patented products . This can help increase profits drastically by reaching the international market across several countries.


Disadvantages of intellectual property

While there are several advantages, there are some disadvantages of intellectual property,too including the following:

  1. Additional costs

  2. Pirating

  3. Reduced quality

Protecting your intellectual property could cost a lot of money, particularly if you have a very complex product that involves designs, methods and processes. Therefore you could be filing several patent applications to protect one product. In addition if you hire a lawyer to assist the application process, you can expect to pay high level costs. You’ll also need to pay filing fees and other costs associated with the patent application process.

When it comes to highly sought- after intellectual property, it is hard to stop consumers from taking such intellectual property. Furthermore any attempt to enforce intellectual property rights could be reduce a company’s customer base.


As intellectual property rights become reduced, so too will the quality of the product being created. That is because there is much less of an incentive to do the work and put the time and resources in, especially if the company knows that its intellectual property rights aren’t absolute.


Trade related aspects of intellectual property rights (TRIPS)


The Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) is an international legal agreement between all the member nations of the World Trade Organization (WTO). It establishes minimum standards for the regulation by national governments of different forms of intellectual property (IP) as applied to national of the WTO member nations. TRIPS was negotiated at the end of the Uruguay Round of the General Agreement on Tariffs and Trade (GATT) between 1989 and 1990 and is administered by the WTO.

The TRIPS agreement introduced intellectual property law into the multilateral trading system for the first time and remains the most comprehensive multilateral agreement on intellectual property to date. In 2001, developing countries, concerned that developed countries were insisting on an overly narrow reading of TRIPS, initiated a round of talks that resulted in the Doha Deceleration. The Doha Declaration is a WTO statement that clarifies the scope of TRIPS, stating for example that TRIPS can and should be interpreted in light of the goal “to promote access to medicines for all".


Specifically, TRIPS requires WTO members to provide copyright rights, covering authors and other copyright holders, as well as holders of related rights, namely performers and sound recording producers and broadcasting organizations; geographical indications; industrial designs; integrated circuit layout-designs ; patents; new plant varieties; trademarks ; trade names and undisclosed or confidential information. TRIPS also specifies enforcement procedures, remedies and dispute resolution procedures. Protection and enforcement of all intellectual property rights shall meet the objectives to contribute to the promotion of technological innovation and to the transfer and dissemination of technology, to the mutual advantage of producers and users of technological knowledge and in a manner conducive to social and economic welfare, and to balance of rights and obligations.


Background and history of TRIPS

TRIPS was negotiated during the Uruguay Round of General Agreement on Tariff and Trade (GATT) in 1986-1994. Its inclusion was the culmination of a program of intense lobbying by the United states, supported by the European Union, Japan and other developed nations. Campaigns of unilateral economic encouragement under the Generalized System of Preference and coercion and Section 301 of the Trade Act played an important role in defeating competing policy positions that were favored by developing countries like Brazil, but also including Thailand, India and Caribbean Basin states. In turn, the US strategy of linking trade policy to intellectual property standards can be traced back to the entrepreneurship of senior management at Pfizer in early 1980s who mobilized corporations in the United States and made maximizing intellectual property privileges the number one priority of trade policy in the United states.


Unlike the other agreements on intellectual property, TRIPS has a powerful enforcement mechanism. States can be disciplined through the WTO’s dispute settlement mechanism.


Requirements

TRIPS require member states to provide strong protection for intellectual property rights. For example, under TRIPS:

  • Copyright terms must extend at least 50 years, unless based on the life of the author.(Art.12 and 14)

  • Copyright must be granted automatically and not based upon any “formality” such as registrations, as specified in the Berne Convention.

  • Computer programs must be regarded as “literary works" under copyright law and receive the same terms of protection.

  • National exceptions to copyright (such as “fair use" in the United States) are constrained by the Berne three-step test

  • Patents must be granted for “ inventions" in all “fields of technology” Provided they meet all other patentability requirements (although exceptions for certain public interests are allowed Art.27.2 and 27.3) and must be enforceable for at least 20 years (art.33)

  • Exceptions to exclusive rights must be limited, provided that a normal exploitation of the work ( Art.13) and normal exploitation of the patent (Art.30) is not in conflict

  • No unreasonable prejudice to the legitimate interests of the right holders of the computer programs and patents is allowed.

  • Legitimate interests of the third parties have to be taken into account by patents rights (Art.30)

  • In each state, intellectual property laws may not offer any benefits to local citizens which are not available to Citizens of other TRIPS signatories under the principle of national treatment (with certain limited exceptions, Art.3 and 5) TRIPS also has a most favored nation clause.

The TRIPS Agreement incorporates by reference the provisions on copyright from Berne Convention for the Protection of Literary and Artistic Works( Art.9), with the exception of moral rights. It also incorporated by reference the substantive provisions of the Paris Convention For the Protection of Industrial Property (Art.2.1) The TRIPS Agreement specifically mentions that software and databases are protected by copyright, subject to originally requirement (Art.10).


Article 10 of the Agreement stipulates: “ 1. Computer programs, whether in source or object code, shall be protected as literary works under the Berne Convention (1971). 2. Compilations of data or other material, whether in machine readable or other form, which by reason of the selection or arrangement of their contents constitute intellectual creations shall not extend to the data or material itself, shall be without prejudice to any copyright subsisting in the data or material itself”.


Post TRIPS Expansion

In addition to the baseline intellectual property standards created by the TRIPS agreement, many nations have engaged in bilateral agreements to adopt a higher standard of protection. These collection of standards, known as TRIPS+ or TRIPS-plus, can take many forms. General objectives of these agreements include:

  • The creation of anti-circumvention laws to protect Digital Rights Management systems. This was achieved through the 1996 World Intellectual Property Organization Copyright Treaty (WIPO Treaty) and the WIPO Performance and Phonograms Treaty.

  • More stringent restrictions on compulsory licenses for patents.

  • More aggressive patents enforcement. This effort has been observed more broadly in proposals for WIPO and European Union rules on intellectual property enforcement. The 2001 EU Copyright Directive was to implement the 1996 WIPO Copyright Treaty.

  • The campaign for the creation of a WIPO Broadcasting Treaty that would give broadcasters (and possibly webcasters) exclusive rights over the copies of works they have distributed.

Can IPR waiver resolve covid 19 vaccine shortage?

This is a complex question to which there is, so far, no clear answer. On the one hand, it is undeniable that intellectual property rights are a part of the problem of worldwide vaccine shortages- the logic of a wider production base globally leading to an exponential increase in vaccine production is undeniable. However, several caveats remain.


First, there may be serious issues associated with manufacturing vaccines, for example, with those based on messenger RNA(mRNA) technology, if there is just an easing of the associated intellectual property rights rules but no further support to generic pharmaceutical firms in countries such as India and South Africa. This is because a "tech transfer" is also needed for the latter to actually commence production, especially for mRNA vaccines, including the ones produced by Moderna and Pfizer along with BioNTech. To illustrate, Pfizer has pointed out that its vaccine requires the use of 280 components from 86 suppliers and highly specialized manufacturing equipment. Second there is a strong likelihood that it will take a considerable amount of time, even several years, for generic procedures plants to become operational at Optimal capacity. This raises the question of whether today’s vaccines would even be relevant at that point in time, especially if new variants prove resistant to vaccine formulations currently available.


Finally, there is the counter argument to calls for patent relaxation, that such policies could discourage pharmaceutical companies from investing in producing next- generation vaccines. Though many, including Mr.Biden, have argued that humanitarian need trumps the profit motive during a pandemic, the decision to waive all TRIPS rules should be preceded by rigorous analysis of the effects such a policy would have on the biotechnology sector and global supply chains for its products.


The story so far breaking with a long held position, the U.S Trade Representative, Katherine Tai, announced that the Biden administration would support waiving trade related aspects of intellectual property rights (TRIPS) for the production of COVID-19 vaccines. The news was welcomed by liberal activists and some global leaders, given that the United States was until now a major World Trade Organization (WTO) member blocking such a proposal, if passed by the WTO with the support of the European Union (EU) could dramatically alter how pharmaceutical companies worldwide access proprietary trade know how for the production of leading vaccines. However, question remain regarding whether the easing of TRIPS rules for COVID -19 vaccines will lead to a greater supply of efficacious vaccines in countries where they are the most needed, or if less circuitous options to boost supply are more relevant in the present scenario.


Arguments in favour of relaxing TRIPS rules

The broader context for emergency action aimed at rapidly increasing vaccine availability across the world is the sharp surge in COVID-19 cases in India and Brazil. Global concern also stems from the risk that the Indian variant, believed to be driving a second wave of devastating intensity in the country, could potentially fuel second or third waves across the world, causing a setback to the progress made in controlling transmission across the U.S and E.U. additionally, the Brazil and south African variants still pose a threat in some pockets. Across many affected nations, vaccines availability has emerged as a bottleneck impeding progress.


In this context, a fierce debate has been underway, pitting global vaccine access advocates against vaccine developers and pharmaceutical firms that rely on patented technology, usually of a highly specialized nature, to produce vaccines. The latest step by the U.S to declare its support for TRIPS waivers for such vaccines stems from the promise Joe Biden made during his election campaign, to “absolutely positively” commit to sharing vaccine technology if elected.


What actions are likely?

No significant steps forward will be possible until the major member nations of the WTO sign on, including the EU. The speed of potential action will also be dampened by the fact that in parallel to the waivers, a transfer of personnel, raw materials and equipment to developing nations will be necessary.


However, there is another possibility; Mr.Biden may either intend to release more of the existing U.S vaccine stockpile to other countries to meet emergency needs and seek cooperation of pharmaceutical companies in the mission, or he may be using the threat of the TRIPS waivers to nudge U.S vaccine producers to ramp up their production and donate more doses to countries like India and Brazil. Either way, it would be unwise for countries like India to rely on this initiative for an increase in vaccine supply.


REFERENCE

ACTS

1.Indian patents act, 1970


Websites

1.World Trade Organization,2021,TRIPS:What are IPRS, www.wto.org

2.Harrietpotter,2021,intellectual property, www.en.m.wikipedia.org

3.Narayan Lakshman,2021,IP rights and vaccines, www.thehindu.com

4.Backofficepro,2014,intellectual property rights pros and cons, www.backofficepro.com



Sujamol Jaimon

School of Indian legal thought, MG University











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