COVID-19, caused by the coronavirus SARS-CoV-2, has affected many people around the world and has been labelled a pandemic. This exceptional public health crisis has affected healthcare institutions significantly.
India is currently dealing with persistent issues in terms of avoiding the spread of COVID-19, as well as managing medicines, oxygen supplies, and vaccines. While the scenario appears to be normal given the current government-managed immunisation drives, there has been discussion about the possibility of patent rights impeding access to medicines and what can be done to improve the situation and minimise the damage caused by the pandemic. The COVID-19 pandemic has also tested India’s role in terms of medicine availability and global assistance.
Patent protection and access to life-saving drugs has been a hotly debated topic with opposing views. It is a minimum condition for a healthy existence to be able to explain a coherent need for access to medications. On the other hand, investors such as drug manufacturers and financial agencies who support research initiatives believe that patents provide a decent return on investment, even though these medicines have the potential to save many lives.
Patents promote innovation by safeguarding pharmaceutical companies’ monopolistic revenues and making it illegal for rivals to manufacture less expensive generic versions. The WTO creates an exception to its professed ethic of ‘free trade’ to limit free competition and penalise profits at monopolistic levels.
The moral justification has long been that patents protect pharmaceutical corporations’ economic interests, but that these economic interests are only a means to a larger goal of conducting more effective research on and management of these diseases. However, in the context of public health, the question of utilising innovation for the public during times of need is debatable.
Access to medicine is a fundamental tool for maintaining health and a fundamental human right. With the current pandemic, however, both the rights and the resources to support it are under threat.
Innovation in pharmaceuticals is essential for ensuring that people have access to new medicines for new challenges/diseases. It has been stated that a fully functional patent system would result in an inverse relationship between the cost of items obtained via the establishment of strict patentability criteria and the affordability of obtaining them. It appears sometimes that the IP system is suffering from a crisis of public legitimacy, as there have been views that those patents may hinder the mass population from receiving required pharmaceuticals at affordable prices and exercising their ‘right to health’.
In Mahendra Pratap Singh v State of Orissa and Ors (1996), the Supreme Court of India stated that “the government is required to assist people, and its endeavour should be to see that people get treatment and lead a healthy life”.
Furthermore, the court stated in the case of State of Punjab and Ors v Mohinder Singh Punjab Chawla (1996) that “it is now settled law that the right to health is an integral to right to life. The government has a constitutional obligation to provide health facilities” reaffirming the context of the right to life under Article 21 of the Indian Constitution and expanding on the concept of the right to health. Accordingly, any person suffering from COVID-19, or any other disease, has a right to health that requires access to treatment.
One of the most pressing issues is balancing the needs of patent-holding pharmaceutical businesses with the needs of public health, particularly during a public health crisis such as COVID-19.
The topic of public health was discussed during the fourth World Trade Organisation (WTO) ministerial session in Doha in 2001. The Doha Declaration established provisions for WTO members to issue compulsory licences to export generic versions of patented medicines to countries with insufficient or no pharmaceutical manufacturing capacity, as well as to allow parallel imports, reaffirming governments’ absolute right to protect public health.
The Doha Declaration declares that public health takes precedence over IP rights and that this applies not only to pharmaceuticals but also to vaccines, diagnostics, and other medical devices as needed.
The Indian Constitution also guarantees the right to life, which includes the right to good health. The right to life also encompasses the right to health and ‘access to medical treatment’, according to the courts. Residents must have access to life-saving medication, and the government must make every effort to guarantee that they do. The state is bound by the constitution to ensure that no one’s fundamental rights are infringed upon.
This issue was considered in the Ayyangar Committee Report as well, which was the foundation for the Indian Patents Act 1970 (Patents Act), which observed that, because India is a developing country, patents impose monopoly rights, preventing most of our population from receiving drugs. Hence, usually, the needs of the local population come first, followed by the needs of international businesses.
For decades, India has been a major supplier of low-cost pharmaceutical commodities in the form of generic pharmaceuticals, so it is also known as the “pharmacy of the developing world”. To preserve a delicate balance between a patentee’s monopoly rights and the government’s responsibility to provide accessible and affordable public healthcare in India, patent rights may be cancelled in exceptional circumstances.
As a result, the Patents Act has multiple provisions to deal with public health emergencies and to safeguard public health while respecting IP rights. The various provisions can be used in different circumstances, and it must be seen whether all these provisions can be utilised and under which circumstances. Section 47 defines the requirements for the awarding of patents, stating that any machine, equipment, other product, or process for which a patent has been granted may be imported or manufactured by or on behalf of the government for ‘merely its own use’.
Furthermore, in the case of patents on medicines or drugs, it authorises the government to import the applicable medicine or drug for its own use or for distribution. The phrase ‘merely for its ownuse’ is interpreted as ‘use in the public interest’ in this situation.
Another important provision is related to compulsory licenses. One of the significant principles of the working of patents in India is that patents do not in any way prohibit the central government from taking measures to protect the public’s health. While this appears to have far-reaching implications, any patent action involving compulsory licenses is difficult to pursue.
Under the compulsory license provisions, a third party can apply for a compulsory license, who needs to be an interested party. There are checks and balances before a compulsory license can be granted, such as that the party should have the capability and capacity to work on the patented invention and should first make efforts to obtain a voluntary license.
While this provision has been in place for several years, only one compulsory license for the drug Sorafenib has been granted. There were other cases as well, but they failed in the prima facie case of not fulfilling the basic criteria for making an application for a compulsory license.
Apart from the above provision, where any interested party can apply for a compulsory license, in cases of national emergency, like COVID-19, central government may notify that the patent is available for a compulsory license, and any person interested can make an application for a compulsory license.
There is a provision in the Patents Act, whereby an interested party can apply for a compulsory license for the export of patented pharmaceutical products, on the condition that the country of export has either granted a compulsory license or, by notification or otherwise, has allowed the importation of patented pharmaceutical products from India.
There is also a provision in the Patents Act whereby the central government, for a public purpose, can acquire an invention that is the subject of a patent or a patent application, by notifying it to that effect in the Official Gazette. In all such provisions, whereby a compulsory license or acquisition of the patent can be given, there is a provision for reasonable compensation to the patent’s right owner.
As a result of the World Health Organisation’s (WHO) request, research has taken place all over the world, yielding a variety of potential antivirals and vaccines. With multiple medications already in clinical trials, it is predicted that they will be released to the public sooner rather than later. There have been instances and apprehensions that patent rights over vaccines, drugs, diagnostic kits, etc. would hamper the accessibility of required products to the public in general.
While provisions have been made to balance patent rights and improve the availability and accessibility of necessary products in this pandemic, it is surprising that no action has been taken under the aforementioned provisions. While there has been discussion regarding the waiver of patent rights, so far, no significant development has taken place. While legal remedies are available, it is yet to be seen whether the necessary technology is available to work on the patented invention.
While in small molecules, reverse engineering is a promising method to develop working technology, there seem to be practical difficulties when it comes to working on patents related to biologics. As a result, if the necessary capacity to work on the patented invention is not available in the country, the legal remedies will be ineffective if the innovators refuse to transfer the technology. However, in this COVID-19 pandemic, a balance can be struck between innovators and the general public’s access to affordable healthcare. Interestingly, the COVID-19 pandemic started in 2019 and, within a short span of less than two years, multiple vaccines have been developed by multiple players.
Historically, innovators have argued about the enormous number of investments in developing a single promising molecule and more than a decade of research to keep drug costs high enough to recover the investment and fund future research. However, when the global need arose to address the COVID-19 pandemic, products could be brought to market in record time.
The regulatory authorities have also been quick in granting the necessary approvals. Given the short time frame for research and bringing the product to market, it is expected that the amount of investment should have been significantly lower than in the past. Another reason for innovators to keep the costs low could be the enormous volume of products required, since the pandemic is global. The share of the volume of infected people and the population of the world can bring reasonable returns for innovators.
Patents and public health are two sides of the same coin. The answer to promoting public health by making pharmaceutical items publicly accessible at affordable rates is to create a balance between the two.
It is worth noting that the Patents Act is adaptable enough to deal with a variety of prospective public-health-related concerns. It succeeds in finding a balance between the patentee’s rights and the rights of the public. However, there are various circumstances that would govern the applicability of these legal remedies.
While the Indian government can use any of the mechanisms described above under the Patents Act to satisfy its affirmative promises under Article 21 of the Indian Constitution and ensure that potential antivirals and vaccines for COVID-19 are available to the public, it appears that the Indian government has also recognised the practical difficulties in implementing the same.
Emergencies such as COVID-19 have an immediate influence on the availability and cost of drugs. Since the pandemic is not limited to a few countries, but is a global challenge, with a recurring surge in cases, handholding is to be done between patent owners and other players having the capacity to manufacture in volumes to address the needs of the global population.
Manisha Singh is a founder and the managing partner of LexOrbis. She oversees and supervises all practice groups at the firm.
Manisha is known and respected for her deep expertise on prosecution and enforcement of all forms of IP rights and for strategising and managing global patents, trademarks and designs portfolios of large global and domestic companies. Her keen interest in using and deploying latest technology tools and processes has immensely helped the firm to develop efficient IP service delivery models and to provide best-in-the-class services.
Manisha studied law at the Campus Law Centre of Delhi University of Delhi after completing her masters’ degree in economics from Patna.
Pankaj Musyuni is a managing associate at LexOrbis. He regularly advises clients on IP strategy and portfolio management.
Pankaj is an advocate registered with the Bar Council of India, as well as a patent agent. He has in-depth knowledge of patent law and regulatory framework and extensive experience in patent filing, drafting, prosecution and advisory matters, especially in the chemical, pharmaceutical and start-up fields.
Pankaj has a master’s degree in pharmaceutical science and management.