This article is written by Mahak Agarwal, from Institute of Law, Nirma University. This is an exhaustive article which deals with the barriers to access and reduces thereof to IPR during COVID 19.

Introduction

“The main challenge at the present time is not access to vaccines, treatments or cures for COVID-19, but the absence of any approved vaccines, treatments or cures to have access to.  The policy focus of governments at this stage should, therefore, be on supporting science and innovation that will produce a vaccine, treatments or cures.”

-WIPO

Currently, the whole world is going through a pandemic, and every nation, State, province, and individual is suffering from an emotional, economic, and social breakdown. This heartbreaking situation has arisen due to the outbreak of catastrophic and calamitous Coronavirus disease.

All the nations in the world are trying their best to control the spread of this disease. The most effective way to stop the spread of this disease is to practice social distancing. Therefore, many countries across the world have announced a nationwide lockdown. This lockdown has a very devastating effect on countries’ economies as well as on all sectors like agriculture, industry, stock markets, factories, refineries, power plants, the IT sector, and Intellectual Property.

The health department of every country is trying its best to develop a vaccine to combat the spread of coronavirus. It has made governments realize that IP might impede their access to medicines, vaccines, tech, or reagents since IP may affect a country’s ability to make drugs when it comes to healthcare, and make them available to its own people and others around the world.

In this article, I will discuss the various barriers to access and their impacts thereof, past experience with these barriers, and the measures taken by the governments to remove these barriers.  

Barriers to access to IPR and their impacts thereof during COVID-19

There can be a number of barriers to access, such as the lack of production capacity for essential medical supplies or equipment, barriers to cross-border transportation of these supplies and equipment, import taxes, lack of internal transport and distribution networks, and lack of sufficient health and infrastructure systems. Governments need to tackle those obstacles. Intellectual property (IP) can also be an obstacle to access if innovation yields successful results and countries are unable to pursue innovation on a suitable and affordable basis. 

Recently, in a communiqué released following the African Union (AU) conference on ‘Africa’s Leadership Role in COVID-19 Vaccine Production and Access,’ African Health Ministers took a critical move to express their concern that patents and other technical obstacles may have a negative effect on the ability to ensure that potential COVID-19 vaccines are available in developing countries. This understanding contrasts sharply with the belief widely held by pharmaceutical firms and certain stakeholders in the field of public health that intellectual property does not play a significant role in limiting access to vaccines. Not only did the AU make this crucial argument, but it also stressed that, in the interests of public safety, policymakers should make immediate use of legal and policy options to remove barriers to intellectual property as required. 

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Some of the barriers to access to IP are:

Patents

A patent is a title issued by the government that gives the title-holder the right to prohibit others from creating, using, and selling the “invention”. During the duration of the patent, the inventor may choose to make, use, and sell the patented invention or allow others to do so on an exclusive or non-exclusive basis.

Countries may follow strict patentability requirements when evaluating applications for pharmaceutical patents. Such a strategy pays off essential innovations. It does not allow claims which are not worthy of a patent grant, thereby discouraging patent applications for trivial inventions. It is of particular importance in the current crisis to implement policies that prohibit the granting of patents around the SARS-Cov2 virus itself, and in relation to the potential therapeutic application of existing medicines. In many countries, claims on the second medical use of medicines are permitted which expansively interpret patentability criteria. However, such claims shield treatment approaches and fail to meet innovation and industrial applicability criteria. The granting of such claims is not required under the TRIPS Agreement or other international treaties.

Trade secrets

Trade secrets, also known as “confidential information” or “proprietary information,” actually contain large quantities of knowledge required to identify, study, develop and produce diagnostics, medications, medicines, and vaccines. Potential trade secrets in Covid’s case include production methods, test results, medical formulas, cell lines, and other biological tools. Chemical formulae are also classic trade secrets. so are production processes. Cell lines, genomic information, and other biological material may also be considered trade secrets for vaccines and other biologic medicines.

Regulatory entities do not grant or confirm trade secrets, as opposed to patents; instead, one has a trade secret by keeping valuable information secret. Trade secrets are not intended to be shared unless authorized by the owner and then, usually, by the authorized party, under a requirement of secrecy. The main legal action in case of trade secret is therefore, for misappropriation by a former employee/competitor by commercial surveillance or incompetent trade secret management.

Techniques, procedures, compilations, processes, and applications used in medical equipment, such as ventilators and diagnostic tests or in the manufacture of vaccines or medicines, are protected by trade secrets. Hence, trade secrets may also become a barrier to access to these essential tools during the COVID-19 pandemic. Firms are gradually opting for protection of trade secrets for subject matter that they are able to keep confidential and for which patent rights might not be offered. 

Protection of test data

Protecting test data as required by the TRIPS Agreement does not pose an obstacle to the manufacture and delivery of the medicines needed, as it does not entail the granting of exclusive rights. Moreover, this protection extends only to new chemical entities and does not apply to vaccines or other biological medicinal items. Governments may also offer exceptions and exemptions where data exclusivity rules, such as those defined under free trade agreements, will prohibit generics and biosimilars from being accepted for marketing.

Eventually, the TRIPS Agreement enables countries to implement “health exceptions,” allowing a member of the WTO to take “any measure it considers necessary to protect its vital security interests.” This provision can be used to suspend enforcement of any Intellectual Property Rights (including patents and trade secrets) that may present an obstacle to the production or local manufacture of the goods and devices required to protect their populations.

Considerations on Intellectual Property barriers to treatment access

Past experience

The pneumococcal and human papillomavirus vaccines, patents, and know-how have shown that they can influence any stage of vaccine production and monopolies will impede the timely implementation of affordable vaccines in developing countries.

After Australia was the first nation to create an effective swine flu vaccine in 2009, worldwide demand for the vaccine exceeded Australia’s ability to manufacture it, and Australia’s government required Australian citizens to gain priority in receiving the vaccine before it could be distributed overseas. Given the pace at which COVID-19 is spreading globally, global demand for a vaccine is likely to surpass any availability, and political tensions between China and the United States could escalate the problem considerably.

Patents and scientific innovations are designed to function independently of policy. Political disputes need never to impede universal access to vital drugs and services in the face of a global pandemic. 

History 

First, in 1995, patents were part of the World Trade Organization ( WTO) framework – called the Trade-Related Elements of Intellectual Property Rights Framework (TRIPS). Developed countries have had one year to ensure that their patent laws complied with TRIPS. Developing countries needed to adopt TRIPS by the year 2000, but had patents in effect until 1 January 2005. More time was given to the less developed countries, initially, 11 years, extended to 2016, and now to 2021.

Doha Declaration 

In enforcing patents on pharmaceuticals there was concern about possible effects in developing countries on access to essential medicines. Thus, the TRIPS agreement included flexibilities that would allow developing countries to access these drugs, but these were not transparent and many governments were unsure how to use them. In November 2001, WTO ministers decided that TRIPS does not and should not prohibit members from taking measures to protect public health; they stressed the willingness of countries to use built-in flexibilities, and agreed to expand exemptions for the protection of pharmaceutical patents to least-developed countries by 2016 (now extended to 2021). Thus, The Doha Declaration came into existence.

Compulsory licensing (CL) is at the core of permitted TRIPS flexibilities. Compulsory licensing takes place when a government allows another to manufacture the patented product or method without the patent proprietor’s consent. This was originally only intended for domestic use but it allowed countries to issue CLs to import generics after 2003 when they had no supply themselves.

Indian Patent Law

India adopted, as needed, its patent law as of 1 January 2005 (Indian Patents Amendment act 2005). It does have very high patentability requirements. This is, because of strict definitions, it is harder to get a patent granted; for instance, on what is modern and creative and what is not. Tight patentability requirements combined with a large pharmaceutical industry, and Indian generic manufacturers’ willingness to engage (led by Yusuf Hamied of Cipla), India became the hub of production; providing the developing world with up to 90 percent of generic antiretrovirals (ARV). This created a massive price drop and helped us to get as many people on HIV care as we have.

Need to remove these barriers

Past experience has shown that patents can have a significant negative effect on the price and availability of new vaccines for resource-limited countries, by limiting vaccine manufacturers’ market entry in developing countries, and delaying access. We can not let history repeat itself and take the same course where we believe patents are not an issue and then overpay for costly vaccines to particular pharmaceutical companies. The world really can not tolerate any delays that might be caused by any potential COVID-19 vaccine having unjustified private influence.

The aim of establishing and honouring patent rights is for the general public good, i.e. invention in return for a restricted monopoly should be publicized. In order to facilitate further work, patents must be released to the public. 

Vaccines or drugs are the only viable remedies for human life to become normal again. Nonetheless, it would take at least 6-10 months for any vaccine/drug to be available, based on conservative estimates. And if permission is given for the distribution of a vaccine/drug, it would not be able to be made available immediately worldwide. This is because even after approval for commercial production is issued, say, in one country, approvals would be required in each and every country for the product to be available to the rest of the world. Countries will then prepare for the immediate manufacture and sale of the medication. Continuous dialogue among innovators, manufacturers and supply chains has to take place for this to happen. This needs a great deal of co-operation from private parties, governments, and international organizations.

Several innovations exist with COVID-19 outbreak. All of these inventions might be the subject of patent applications worldwide. It’ll be a couple of years before even patents are granted. There’s still tension among different stakeholders, though. For example, one country made attempts to gain exclusive rights to a developing vaccine. Conversely, partnerships are also taking place. The spirit of creative approaches is only on the anvil though. The problem that emerges is that the exclusivity that patent rights recognize would be harmful to society. Will patents create roadblocks, or does a solution exist?

Pandemics need solutions that disrupt them. Governments and international organizations, in order to ensure the framework is ready, must reach a consensus in advance. Procrastination can be catastrophic. In the aftermath of a pandemic, creating hindrances by means of exclusivity arguments can result in splitting countries, companies, and international organizations. That is not going to benefit patients and the whole world. When patent proprietors build impediments to the scope of patent rights, the world will continue to fear patents and this is not a situation in which IP owners should be. Under the TRIPS (Trade-Related Aspects of Intellectual Property Rights) law, there are many mechanisms available to guarantee access to drugs, such as mandatory licensing. All the same, society needs to value creativity outside the rules. In order to protect the sanctity and integrity of patent systems, and to ensure that an anti-IP sentiment is not generated globally, the existing regime needs to find answers. There is a likelihood in exceptional circumstances such as these that societies may resort to extreme steps to protect themselves. Solutions should be produced before any other proposals are proposed.

Steps taken by various companies to reduce these barriers 

Big corporations such as Intel, Medtronic as well as non-profit organizations such as the Mozilla Foundation and Creative Commons have promised to make their related Intellectual Property COVID-19 available, free of charge, so that it can be used to counter COVID-19. According to news, Medtronic, a medical device corporation known for manufacturing ventilators, has agreed to publicly share its Intellectual Property which is the concept of the Puritan Bennett 560 (PB 560) ventilator in the midst of the COVID-19 public health crisis caused worldwide. Ventilators are very important for the care of positive patients with coronavirus, and have recently been in short supply in many countries. This co-operative Medtronic gesture will also improve the supply of ventilators, as it will allow other businesses, academics, and individuals to manufacture ventilators using Medtronic’s designs.

If we want to mitigate the pandemic, such cooperation is crucial particularly in the field of bio pharmacy. With no available sight and death tolls constantly rising, free access to Intellectual Property — particularly among pharmaceutical companies, medical device manufacturers, and diagnostic kit manufacturers — will help to manufacture drugs and equipment needed to treat thousands of people with the deadly virus, regardless of where they live.

Creative Commons has joined forces with other legal experts and leading scientists to provide a simple way for universities, businesses, and other Intellectual Property Rights holders to support the development of COVID-19-related medicines, test kits, vaccines, and other scientific discoveries over the pandemic’s duration. The Open COVID Pledge provides the public with unrestricted, immediate access to IP rights to help address the COVID-19 crisis, eliminating unnecessary obstacles to the sharing of information and technologies that could save lives and reduce suffering.

The Pledge, formed by a coalition of scientists, lawyers, and entrepreneurs, grants anyone broad permission to use otherwise unavailable technology and content in the absence of it, in most cases removing the need for an expensive license or royalty arrangement.

So far, the Open COVID pledge has been taken publicly by Intel, Mozilla, and Creative Commons. Harvard, MIT, and Stanford committed to this plan, too. The University of Utah (Law and Biological Sciences Centre) and the Montreal Neurological Institute-Hospital are among the other institutions that have endorsed the undertaking. 

According to an article published in the Financial Times, a Swiss multinational healthcare company, Roche, which produces test kits and reagents used in them, has been vehemently criticized by Dutch lawmakers for ‘rationing supplies’ and for ‘significantly reducing national testing.’ Only after that criticism did Roche take the initiative to share the recipes of the research liquid demanded by the Government. The Guardian also observed in the United Kingdom that relying heavily on only a ‘handful’ of suppliers like Roche was the fundamental issue in that research.

Abbvie, a company based in Israel also announced that it will not impose its Intellectual Property Rights on trials concerning the use of Kaletra, a prescription drug that is approved for use in HIV care. This means that pharmaceutical and biotech companies around the world are free to make Kaletra and use it for Covid-19 in clinical trials without having to obtain a license and pay royalties. As the first corporation to obtain regulatory approval to manufacture a Kaletra generic, Mylan also surrendered its exclusive right to sell Kaletra in the US.

Steps taken by the authorities to reduce these barriers to access

At this period of suffering, world organizations and countries should not be afraid to use their powers under clauses written in their Intellectual Property Rights Acts to save their people’s lives. Several countries such as Chile, Israel, Germany, Canada, and France have worked proactively on it and relaxed their rules, even enacting new legislation to encourage mandatory licenses to be issued for the successful use, manufacture, and sale of any IPR-protected medication or vaccine in that country.

India, fortunately, has certain provisions in its Patent Acts that allow the Central Government to take over any patent which may be of use in a state of national emergency or in circumstances of extreme urgency under Sections 100 and 102 of the Patents Act, 1970. Compulsory licensing may also be used if a potential IP is used in a state of public health crisis or against any epidemic in accordance with Section 92 of the Patents Act, 1970.

Open-access letter from Chief Science Advisor or Equivalents representing Australia, Brazil, Canada, Germany, India, Italy, Japan, New Zealand, Republic of Korea, Singapore, United Kingdom and United States of America. To support the ongoing public health emergency response efforts, these countries urge publishers to voluntarily agree to make their COVID-19 and coronavirus related publications, and the available data supporting them, immediately accessible in PubMed Central and other appropriate public repositories, such as the WHO’s COVID-19 database, in both human and machine-readable formats to allow for full text and data mining using artificial intelligence with rights accorded for research re-use and secondary analysis

Also, The Director-General of the World Health Organization, inspired by the concern of Costa Rican officials that COVID-19 medicines will not be available to poor citizens, has approved the cooperative exchange of patent rights and the pooling of research data to assist in the creation of COVID-19 drugs, vaccines, and their expanded coverage. 

Measures taken by WIPO

World Intellectual Property Organisation has taken the following measure to contribute to the innovation challenge: 

• Established a clearing-house or policy-tracker offering information on steps taken by IP offices to contribute to progress by resolving distressed economic actors by extending deadlines and granting grace periods for charging fees. The policy tracker will also provide information on any regulatory interventions necessary or implemented in respect of conditions, restrictions or mandatory licenses.
• Provided a database, Patentscope, with more than 80 million technology disclosures, multilingual search facilities, an automatic translation program, and a specially built COVID-19 search and retrieval facility dedicated to improving access to technical knowledge revealed in published patents about innovations related to COVID-19 identification, prevention or treatment. Hundreds of thousands of scientific and technical organizations and commercial companies worldwide use this indispensable source of technological knowledge on a regular basis.
• Established a relationship with science, medical, and technological publishers, Access to Research and Innovation Creation (ARDI), which offers free online access to major scientific and technical journals to local non-profit institutions in the least developed countries, and access to institutions in middle-income developing countries at a modest cost.
• Established some 900 Technology and Innovation Support Centers worldwide to provide researchers in less developed, emerging and transition economies with access to patent and scientific data and publications and ancillary facilities.

Steps that need to be taken

To conquer these barriers, and to control patented health innovations and products, countries can make use of a range of public health safeguards for COVID- 19 treatment, diagnosis, and prevention. In particular, the Agreements on Trade-related Intellectual Property Rights (TRIPS) include flexibilities and the TRIPS and Public Health Declaration at Doha. As explained above, Some countries have already taken the lead in recognizing COVID-19 was an emergency for public health and took action to resolve any potential obstacles to IP.

Measures that can be adapted at the national, regional and international level include:

• Suspending the development and compliance of patents and other IPs relating to critical health inventions, materials, and COVID-19 products.
• Issue of compulsory licenses and government licenses to permit the manufacture, purchase, import, and export of proprietary goods, materials, and technologies, including the exploration of a regional approach and the adoption of expedited procedures to allow compulsory fast-track licenses for all relevant COVID-19 technologies. By incorporating legislation to allow for parallel imports, countries can procure lower-priced medical products. Countries can incorporate into their national laws the principle of international exhaustion of rights, allowing for parallel imports on an international scale. In this case, a patent holder does not have the right to prevent importation of a product covered by a patent that has been put on the market in any country by the patent holder, or by an authorized party. This can also include parallel importation of a patented product produced under compulsory license in a third country, up to certain quantities.
• Applying strict patentability requirements by excluding second medical uses from patentability as medical treatment methods and new types and derivatives of recognized medicinal products.
• Suspend the operation of data exclusivity, other market exclusivities, and patent linkages (or exemptions where appropriate under national or regional regulations) to allow for the accelerated regulatory approval of generic and bio-like items.
• Applying the ‘Bolar exemption’ which allows alternative manufacturers to undertake development and seek marketing and regulatory approval of generic and bio-like versions of patented medicinal products even during the patent term.
• Importantly, governments should implement and operationalize provisions in their laws and regulations to enable efficient use of compulsory licenses and non-commercial usage by governments to overcome barriers to access to patents. To promote their enforcement, the conditions for issuing these licenses under national laws and procedures should be streamlined as much as possible, in compliance with international legal obligations. Many countries have requirements for the compulsory licensing and non-commercial use by the government in their national patent laws. While there are several cases of instances where mandatory licensing and non-commercial use by the government have been used, it may be important to enforce protocols for the speedy issuance of these licenses. Such licenses do not prohibit the proprietor from further using the invention.

Government non-commercial usage (“government usage”) is a type of compulsory license that does not require a direct agreement with the holder of the patent, which is an exception often made in emergency public health situations. As in the case of a public health emergency, the reason is usually to encourage the public interest in obtaining the patented innovation. For example, compulsory licenses and government users may be used to import or produce a patent-protected diagnosis, vaccine, or medicine in the event that the right holder does not make them available in sufficient quantities or that they are overpriced.

• Negotiations on Free Trade Agreements must be stopped during the pandemic. If FTAs are signed, restrictive IP clauses that could impede timely and affordable access to medical technology must be omitted. Before entering into bilateral FTA negotiations, it is important to assess the effect on access to affordable medicines, including for COVID-19 care, of the restrictive IP provisions which are likely to be tabled.

Conclusion

A global framework is required to promote open and collaborative research and development and maintain the development and supply of critical diagnostics, vaccines, and therapies. To address the challenges of COVID-19, global cooperation is needed to assist developing and least-developed countries in expanding testing capability and allowing equal and affordable access to approved treatments and vaccinations.

The international health community should reassert the right of governments to use the flexibilities of TRIPS to protect public health, with WHO leading. Governments should move quickly to implement regulatory and legislative steps to ensure that no barriers to access to drugs, diagnostics, vaccines, and medical supplies and equipment are imposed by patents and other intellectual property rights.

Federal and regional regulations need to be checked to determine the degree to which they include the flexibilities mentioned above for the TRIPS. In particular, whether they require successful compulsory licensing or government use of patent-protected goods. If not, the required changes should be enforced immediately to streamline processes and promote the implementation of those steps.

References

1. https://newsroom.medtronic.com/news-releases/news-release-details/medtronic-shares-ventilation-design-specifications-accelerate
2. https://www.news18.com/news/tech/free-access-to-intellectual-property-is-crucial-in-mitigating-the-covid-19-pandemic-2570569.html
3. https://taxguru.in/corporate-law/intellectual-property-rights-vis-a-vis-covid-19.html
4. https://www.wipo.int/about-wipo/en/dg_gurry/news/2020/news_0025.html

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