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COVID VACCINE AND PATENTS ACT



Introduction


COVID vaccine has become the lifeline and hope of all the people around the world . Without the vaccine we cannot win our fight against the mighty “corona virus". We must remember that “ No one is protected until everyone is.”

According to section 2(m) of the Patents Act, 1970 “patent" means a patent for any invention granted under the Act.

Patent is an intellectual property right and it is granted to the inventor a particular invention etc. by a sovereign authority. This patent results in the granting of certain exclusive privileges or rights to the inventor in respect of the invention or the design or even the patented process for a specified period of time . This privileges and rights are provided in exchange gor the disclosure of the invention. Patents are examples of incorporeal right.

Medicines , drugs and similar inventions are also covered by the Act. These inventions are patented to protect them from bring copied and vaccines are not an exception to this protection.


The Patents Act , 1970 , and the Patents Rules 1972, came into force on 20th April,1972, in place of the Indian Patents and Designs Act 1911. The Act was enacted on the basis of the suggestions of the Ayyangar Committee Report. One of the recommendations put forward by the Committee was to allow process patents only to inventions relating to medicines ,food and chemicals . Under Indian Patent law , a patent can be granted only for such an invention which is useful and it should be a fresh idea. For medicines or drugs and certain groups of chemicals for the grant of patent , the substance must be new , but it is also required that manufacturing process and the product must be patentable.


The vaccine

The countless efforts of the people around the globe has resulted in the production of a lot of vaccines to fight the corona virus –SARS Cov-2. The vaccines are developed using a lot of technologies, such as the Chinese companies Sinovac and Sinopharm developed inactivated virus vaccines , products of Pfizer or Biotech was mRNA vaccines ,vaccine developed by the University of Oxford /AstraZeneca , the Johnson & Johnson vaccine and the Sputnik V vaccine from the Gamalaya Research Institute was non-replicating viral vector vaccines and Novavax vaccine is a protein subunits vaccine.

There is a great interest shown by public about the efficiency and the effect of these vaccines.

Many research report analysis show that a very wide range of applicants are working on an effective solution against the corona virus . Data show that most of the applicants are organizations centred in China .

There are certain questions which needs to be answered :

What is going to be the internationalization strategy for the patent applications that have been submitted? This issue arises from the fact that after the date of the submission of the first application the applicant’s have up to 12 months to submit their application in another country.


An invention is patented only when it meets the requirements of patentability like industrial application , novelty etc. An interesting point is that , the patent system is disconnected from the health surveillance system so the granting of a patent does not mean that the product will be approved as a medicine.

Another interesting point to note is that although the protection of a technology by a patent gives its owners the right to prevent 3rd parties from exploiting it , in a pandemic context, the interest of the public becomes more important than the exclusivity of the exploitation .

If there is no agreement with government of a country and the patent owner , the patent laws of various countries allows for mandatory patent license and it means the patent holder is obligated to grant license for exploitation of the invention in the interest of the public.

There are opinions that the control that is given to patent holders currently during COVID-19 should be questioned. Patents have its own noteworthiness and implications in health-care because they function as private tools of governance over the patented inventions. Only by examining the role played by the patent holder in delivering access to diagnostics, vaccines ,medicines for COVID-19 we can say there can be equitable global access to the COVID vaccine.

On many occasions some of the patent rights holders voluntarily agrees to license their intellectual property rights, including their patents on COVID-19 vaccine techniques that too on a royalty free basis or at rational prices but other rights holders may not license their rights.


We know that patents are intellectual property rights and it allows the patent holders to restrict others from using their invention during the period of the patent which is generally 20 years . “Under the international trade law, all the 164 world trade organisation(WTO) contracting states , patents are made available for all fields of technology, such as medicines , vaccines and medical devices.”[1]

Patents support technological breakthroughs by furnishing an income stream for the holder of the patent and he can proffer licenses to third parties for fiscal return and who can choose to utilize or put to use the patented inventions as the sole , monopolistic supplier during the patent period and it may possibly increase the costs charged for acquiring or accessing the technology. This income stream can be utilized to retrieve development costs and generate profits and is often put forward as a key incentive for innovation.[2]

Patents also confer on patent holders a remarkable broader governance function which is often failed to be identified and which assures investigation in the COVID-19 view if global equitable access to treatments or vaccine can be attained.


All these issues are aggravated in the COVID-19 situation as it is our need to bring the COVID-19 pandemic under our control as soon as possible and the ideal way to do it is to maximize global access to COVID-19 diagnostics, treatments and vaccines for all . But the problem is that how these patents are used may result in snags to such access.

Let us take an example , if a patent holder take Gilead refuses licenses of other countries to produce a drug, take Remdesivir , this can limit who would lawfully provide the medicine. The manufacturing capacity of Gilead and to whom the licenses are granted to manufacture the medicine has a crashing impact on the amount of the drug manufactured. Considering the Remdesivir situation, at a time when the drug was considered a hopeful prospective treatment for the pandemic it was conceded that Gilead concurred to provide licenses voluntarily for Remdesivir with producers in Egypt, India and Pakistan to contribute to low and middle income countries .

As Remdesivir is proved as an efficacious treatment alternative for COVID-19 such voluntary licenses will reduce the issues for remdesivir in these countries. But this did not reduce the access problems elsewhere including higher income countries. It is also accepted that there are now important questions about the efficiency of Remdesivir in the COVID-19 situation .[3]

This example is applicable even now as it shows that even if treatment is at sometime found to be potentially effective for treating COVID-19 it does not guarantee that the treatment is accessible. Also the main key point is that the resolution to provide these licenses over the patented drugs or medicines to other producers completely at the option of the patent holder despite the continuance of the global pandemic .

“Furthermore , patents also affect the price of the patented technology as patent holders may decide to license or provide that technology for high prices which may far exceed production costs.”[4]“For example when it was still perceived as a potentially promising Covid-19 treatment option, the cost of Remdesivir is USA was initially reported to be approximately $3200 per six day treatment course , whereas the cost of its production was estimated at less than $6 for a six day treatment, representing a significant profit margin for the patent holder"[5]

Patent holders often argue that prices charged represent a way to recoup development costs and the costs of past failures, however it is difficult to assess this for several reasons . In particular such issues are exacerbated by the fact that the prices paid by States to access vaccine are often not disclosed.[6] Instead an opaque private governance networks works where stability of power deviates primarily in favour of the holders of the patents. This is troublesome for the pandemic situation where prompt and economical access to useful diagnostics, treatments and vaccines is indispensable to stem daily lives from being lost.


Indian scenario

On April 30,2021 the Supreme Court in its order has fought response from the Central government on various aspects related to the covid-19 management including its pricing policy. The Centre has filed an affidavit in response to the top court's order. The central government said it would be counter productive to invoke the Patents Act now , especially when it was engaged at the diplomatic circles to arrange more vaccines and medicines.

The court enquired as to why the government was not considering options under the Patents Act that authorized the government to enable production of generic drugs. Sections 92 and 100 of the Patents Act were stressed by the court in its order. Section 92 is a special provision enabling the central government to issue compulsory licenses for the manufacturer of the patented drugs in a public health emergency. Section100 allows to use patented inventions for government purposes. In US the Biden administration’s decision to lift patent protections on COVID-19 vaccines to help out the poor part of the globe receive more doses has been appreciated by the world countries and health advocates.


Conclusion

It us a public health emergency . In this unprecedented scenario the government can by mandatory licensing permit the pharma producers to produce the generic form of the patented medicines for the common good.


References

[1] Article 27, TRIPS agreement

[2] Mc Mahon A . Biotechnology, health and patents as private governance tools: the good, the bad and the potential for ugly? Intellectual Property Quarterly 2020; 18(3) : 161-79

[3] Pan H , Peto R, Karim QA, WHO Solidarity Trial Consortium . Repurposed antiviral drugs for Covid-19 interim WHO solidarity trial results medRxiv 2020 ; https://www.medrxiv.org

[4] Hill A, Wang J, Levi J, et al. Minimum costs to manufacture new treatments for Covid-19 .Virus Erad 2020; 6(2) : 61-9

[5] Davey M Gilead donates Covid-19 drug remdesivir to Australia’s medical stockpile after US buys up supply, 2020 . Available: https://www.theguardian.com

[6] Matthews D , Coronavirus: how countries aim to get the vaccine firstly by cutting opaque supply deals.


SUBMITTED BY:

NAVYA SURESH

3rd year

School of Indian Legal Thought

Mahatma Gandhi University , Kottayam ,Kerala


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