Will Patent Waiver for Covid-19 Vaccine be a Panacea?

Mathew Thomas, PhD

Introduction

What started as Corona virus infecting people in Wuhan, China, has now spread to almost all countries of the world. The virus is zoonotic and is transmitted between animals and humans; and belongs to the large family of viruses that cause illnesses ranging from common cold to severe respiratory diseases like MERS-CoV and SARS-CoV. The Spanish Flu in 1918 killed almost 20-30 million people worldwide, the Asian Flu of 1957-58, killed 1.1 million, and the Hong kong Flu in 1968, killed an estimated 1-4 million worldwide. The reported Covid deaths in India is around 2,48,016, whereas the estimated number of deaths is 7,36,811.To curb this death rate, the only solution is to achieve herd immunity. Herd immunity can be achieved if a percentage of the population is vaccinated.

To be vaccinated there must be a vaccine and vaccines are produced by pharmaceutical companies. To produce a vaccine pharmaceutical companies and research organizations spend both time and money. It was a global race to produce a vaccine. Since companies spend money on research for producing vaccines, the actual amount in producing a vaccine, drug or medicine is never revealed. When the vaccines are produced they will be protected under patent law, since they are intellectual property. Therefore the product and process is protected under law.Since it is a high end technology process and product, not very many companies or countries are capable of producing a vaccine.

The entire patenting system provides an incentive for innovation by offering a sort of limited monopoly to the inventor for a period of time which 20 years in most countries for disclosing the invention to the public.This means that during the entire period of protection, nobody can copy or produce the drug or medicine, in this case a vaccine. This means that for the entire period of 20 years the inventor reaps the benefit of his invention. This is a sort of quid pro quo for the inventor since he has disclosed the invention to the public.

What is a Virus?

Viruses are simple agents, which can be called as occurring in nature with many of them having 2-10 genes in them. To understand this, a human cell usually has about twenty thousand genes. To put it simply viruses are inactive unless they are inside a host cell. They exist in the form of independent particles and consist of genes, molecules of DNA(Deoxyribonucleic acid) or RNA(Ribonucleic acid), a protein coat called the capsid, and may contain an outside coat of lipids. Virus needs a living host for it to multiply. Bacteria are living organisms whereas viruses are just a piece of information, which when it infects a host cell,it asks the host cell to help it multiply. It replicates only in a living organisms, such as animals, plants, or bacteria, otherwise it does not replicate itself. They are capable of mutating into many strains.

Is Freeing Covid Vaccine an Answer?

The Patents Act, 1970, in India, provides for compulsory drug licensing in its ambit. In India, the first drug that was compulsorily licensed to Natco Pharma was Nexaver, a kidney cancer drug, whose patent was held by Bayer. When the Controller of Patents granted the license to Natco Pharma, the total sales worldwide of Nexaver was US $ 934 million and it was found that the drug clocked a sale of only ₹16 crore in 2009 in India and subsequently after compulsory licensing Natco Pharma, the drug was sold at ₹8,800. Compulsory licensing is permitted under TRIPS and most of the national laws provide for compulsory licensing in some form or the other. In the 60s and 70s the US government had made tetracycline and meprobamate for the military without permission from patent holders.It also leveraged the threat of compulsory licensing to bring down the price of patented drug Cipro by almost 50%.Cipro (ciproflaxin) is a brand name prescription for use as antibiotic to treat a variety of bacterial infections and was required during anthrax crisis. Some of the countries other than US, where compulsory license was issued was Korea, where the provisions of Article 107(1)(iii) of Korean Patent Law was invoked to issue compulsory license for non-commercial use of the drug Gleevec of Novartis. Indonesia too has issued compulsory licences for medicines to control HIV/AIDS, Cancer and Hepatitis B. The other countries that followed suit were Thailand, Malaysia, Zambia, Ecuador and Brazil and has a growing list of countries that have issued compulsory licenses. Most of the compulsory licenses issued were to reduce the prohibitive cost of anti-retroviral drugs used to combat AIDS/HIV medicines and make it more affordable to the public. Africa has the largest burden of diseases and poor drug manufacturing capabilities and pharmaceutical companies have resorted to differential pricing for Africa.

Even if developed, will the pharmaceutical company price it reasonably for the public, is question that needs to answered. The way out for India is to compulsorily license the vaccine for the sake of public health and public emergency, since the demand for the vaccine in the country of origin will be high, and it is unlikely that the company will be able to meet the demand worldwide. Thus, the only way is for the company is to license it for manufacture in other countries. But do those countries or companies, as mentioned above have the technical expertise to manufacture a vaccine is in doubt.

How are Vaccines made?

Vaccine manufacturing is a complex process. To state, some of the manufacturing process for vaccines requires about 280 different chemicals or ingredients to manufacture the vaccine. These chemicals or ingredients are to be processed at different time periods during the process of manufacture, making it difficult for countries with low scientific manpower pools. To develop a vaccine it takes about 10 years of research, from development to approval. But in the case of Covid-19 vaccine instead of sequentially following the steps for approval these were fast tracked to be in tandem or parallelly and that is how the vaccine was manufactured within eight months after the disease struck. There were 6,000 registered studies on Covid, 2,262 clinical trials of treatments, 42 candidates in clinical evaluation, and 162 candidates in preclinical evaluation( per WTO).

Vaccines are either protein based or virus based. Viruses reproduce a thousand fold in the human body to put it in simple terms and vaccines ensure that they reproduce very slowly, say maybe 20 times, thus enabling the body to fight it. Covid 19 vaccine is made up of messenger RNA(mRNA) for the spike protein of the virus. Once it is injected into the human body, the body responds to it by making the spike protein from the virus. The body realises that the protein is foreign and produces an immunological response to it(the other types of vaccines are not being discussed here). The vaccine production process is as follows; first is to generate the antigen which is done through growth of the pathogen for inactivation later, second to release the antigen from the cell and isolate the material used in the growth, third to purify the antigen(which may include ultra-filtration and chromatography), fourth to add an adjuvant which is to strengthen the vaccine for immune responses when administered and finally production, wherein all the components are added and mixed and the distribution of the vaccine is done. These are complex processes and needs high end technology.

IP Law

Do the provisions under the Patent law in India enable a compulsory license(after the mandatory period) for such a vaccine when it is a humungous public health issue? Can it do away with the period after which only, the compulsory licence can be issued ? While provisions exist to grant the license for manufacture in India due to public emergency, that the reasonable demand for the vaccine has not been met to an adequate extent, the government may issue a compulsory license, in addition to the grounds that the patented invention is not being worked in the territory to an adequate extent or if it is hindered by importation from abroad and or if it is not available at a reasonable price. Even if the vaccine is licensed to be produced by others domestically, it is unlikely that domestic manufacturers would be able to produce it in a reasonable time frame, considering the urgent and deadly situation now prevailing. The US, India and South Africa have already backed a proposal for patent waiver for Covid vaccine and gained some cohesion with over 100 countries backing it, while the rich countries like UK, Europe, Canada and Australia are blocking it. These are extraordinary times and requires extraordinary measures.India has the capability to produce vaccines. India does have a strong base for generic medicines and also research.India has exported vaccines to almost 84 countries, including to those countries which had poor or no manufacturing bases. TRIPS (Trade Related Aspects of Intellectual Property Rights) has adequate flexibilities for a patent waiver (Doha Declaration), but it seems to be best on paper.So we are in a Catch 22 situation.

Conclusion

However, the urgency with which the government has dealt with the infection, initially, is remarkable given the size of the population in India. However the response to the second wave leaves much to be desired. A patent waiver may not be the panacea for controlling Covid-19 infections. Even if the patent is licensed or the patent protections are waived it will be impossible for a country to start production in a reasonable time frame. The more virulent Covid strain is taking its toll. Those with co-morbidities must be extra careful. Initially when the government rolled out the vaccine there was much hesitancy and when the second wave struck, there was a mad rush to vaccinate. There weren’t enough vaccines when everyone rushed in for a shot. Simple preventive measures should stop the virus at bay, however there is a need for more public participation and education to combat the disease and simple precautions of social distancing, double masking and a self-imposed cautionary discipline, should see the rates of infection being brought down.

References

1.Michaela E. Nickol & Jason Kindrachuk, A year of terror and a century of reflection: perspectives on the great influenza pandemic of 1918–1919.

2.Institute for health metrics; healthdata.org.

3.WHO.int; Guidance document.

4.WTO.org;https://www.wto.org/english/tratop_e/covid19_e/faqcovid19_e.htm.

5.Derek Gatherer, The 2009 H1N1 influenza outbreak in its historical context; https://doi.org/10/1016/j.jcv.2009.06.004.

6.Colleen Chen Cheap Drugs at what price to innovation: Does the Compulsory Licensing of Pharmaceuticals Hurt Innovation, Berkley Technology Law Journal, Vol 18.1, p 16.