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Patents: Key to the Development and Manufacturing of COVID-19 Treatments and Vaccines

Patent Law In India:

In India, the patent law is highly drafted unambiguously to accredit a new invention in the pharmaceutical products or vaccines and to address public health problems provided that a compulsory license to the product patentee shall be granted in such exceptional circumstances. And the provisions for Compulsory Licensing of a patent product are provided under Chapter XVI of Section 84 and 92 of the Indian Patent Act, 1970. Foremost, the Provisions pertaining to compulsory licensing are internationally governed by the International legal agreement called Trade-Related Aspects of Intellectual Property Rights (TRIPS) between all the member nations of the World Trade Organization (WTO).

Section 84 states that "Compulsory license provides national governments to allow manufacturers/companies to replicate products and processes under patent. The license can be given, three years after the issuance of a patent if the reasonable requirements of the public with respect to the patented invention have not been satisfied or the patented invention is not available to the public at a reasonable price or the patented invention is not worked in India". On the other hand, Clause 3(d) states that the discovery of a variant of an existing substance or process that does not enhance efficacy significantly is not patentable. The clause attempts to discourage frivolous inventions. These provisions attempt to balance the two ideals of ensuring "access to medicines" and fostering innovation.

Under Section 92 of the Act, the Central Government in National Emergency or in circumstances of Extreme Urgency or in case of public non-commercial use (in large), if satisfied and is necessary in respect of any patent in force, shall grant the compulsory licenses to the companies at any time after the sealing thereof to work the invention. Upon such declaration, the Controller in settling the terms and conditions of a licence granted without any prolonged process, shall endeavour to ensure that the articles manufactured under the patent shall be available to the public at the lowest prices consistent with the patentees deriving a reasonable advantage from their patent rights.

In addition, India supplies affordable and low-cost generic drugs to millions of people around the globe. The Indian pharmaceutical industry is the world's third largest drug producer by volume and the country's market manufactures 60% of vaccines globally. This constitutes 40 to 70% of supply to satisfy the World Health Organization's (WHO) demand for Diphtheria, Tetanus and Pertussis (DPT) and Bacillus Calmette Guerin (BCG) vaccines and 90% of the global demand for the measles vaccine. Subsequently, in this Covid-19 pandemic, the Government of India is more concerned in acquiring the license to such product manufacturers to cater the effective and essential needs of the citizens of India.

Indian Case-Laws:
India's First ever case of Compulsory License: In 2012, Natco Pharma was granted a compulsory license to manufacture a generic variant of the drug Nexavar. Nexavar is the original formulation of Bayer and is used in treating kidney and liver cancer. The drug costs US$5,500 per month with regard to the generic variant that costs US$141. Therefore, Bayer contested the license in the Indian court and lost. The arguments used were that the drug availability did not meet the reasonable requirements of the public, that it was not reasonably affordable, and was not sufficiently worked in India, not being locally manufactured.

In the case of granting compulsory license in pharmaceutical industry, the controller rejected the grant on various grounds like failing to prove prima facie case, not applying for a license of patent prior to applying for compulsory license and failure to prove public use of the product sought to be use by the compulsory license. It is said that in the law of patents, it is not sufficient merely to have registration of a patent. The Court must look at the whole case, the strength of the case of the patentee and the strength of the defence.

Recently, the Indian courts have ruled that the provision against anti-competitive practices in the competition act and the provision of compulsory licensing in the patent act are not in exclusion of each other; in fact they have to be read conjunctively. The question whether a patentee had adopted anti-competitive practices could also be considered by the Controller. However, if CCI has finally found a patentee's conduct to be anti-competitive and its finding has attained finality, the Controller would also proceed on the said basis and-on the principle akin to issue estoppel, the patentee would be estopped from contending to the contrary.

Provision Of Compulsory Licenses In Other Countries:

The measures adopted by individual countries against the monopoly of the Covid-19 vaccine. In the pandemic's current context, the compulsory license instrument, however, has not attracted only developing countries. States like Germany, Israel, Ecuador, Brazil and Chile are moving towards compulsory licenses for patents related to the handling of unexpected pandemic.

Israel issued a compulsory patent license related to Lopinavir/Ritonavir (brand name Kaletra), a medicine used to treat HIV, which as mentioned above, is currently being tested for effectiveness in the treatment of COVID-19 in combination with other drugs. The licence allows the importation of lopinavir/ritonavir from a pharmaceutical company. It was later reported that AbbVie has since announced that it will not enforce its patent rights throughout the world over the Kaletra drug. AbbVie has become the first big drug maker to waive its rights to profit from a drug that might be used to treat the Coronavirus.

On March 25, 2020, the COVID-19 Emergency Response Act received royal assent in Canada. The Patent Act amendments add to the section on the use of patents by government, providing a new compulsory licensing regime.

The United Kingdom and Canada have both stipulated the decriminalization of the exploitation of patents related to COVID-19. The decriminalization would entail the exclusion of counterfeiting crimes regarding COVID-19 patents. The compulsory license, instead, would have the goal of ensuring equal access to drugs relating to the cure of the pandemic.

Concluding Facts:
For Invention of Vaccines, the bonds of Innovative finance mechanisms have been successful in raising funds for vaccines in the past and should be used to fund the development of Covid-19 vaccines. The International Finance Facility for Immunisation (IFFIm) raises funds with vaccine bonds. Such bonds are launched with advanced market commitments, where donors make funding commitments to vaccine manufacturers. So, in return to this, the companies can sign a legally binding commitment to provide the vaccines at a price affordable to low-income and middle-income countries.

Award Winning Article Is Written By: Ms.Ayesha Khan
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Authentication No: MY451730718237-30-0524

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