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COMPELLING REASON TO USE CL

Ramesh Shankar
Wednesday, August 11, 2021, 08:00 Hrs  [IST]

The Department related Parliamentary Standing Committee attached with the Union Commerce Ministry has recently recommended to the Indian government that it can consider invoking Compulsory Licensing (CL) option for production of medicines and vaccines for the treatment of Covid-19, since the pandemic has led to a national health emergency in the country. In its report on review of the Intellectual Property Rights Regime in India, which was presented to the Upper House of Parliament recently, the committee stated that generic production in large quantities without any obligation of patents would help in removal of supply constraints in availability of affordable drugs, medicines and vaccines at this time of high case load and death toll due to Covid-19 pandemic. The panel further recommended that the government should consider giving an expansive meaning to the Section 3(d) of the Patents Act, (which restricts grant of patent to incremental innovation) to avert any misinterpretation of the law. Section 3(d) in India's patent regime has acted as a protector against any attempt of repetitive patenting or extending terms of patents on spurious grounds. The committee in its report opined that Indian government must not compromise on the patentability criteria under Section 3(d) since India, as a sovereign nation, has the flexibility to stipulate limitations on grants of patents in consistence with its prevailing socio-economic conditions. Being a developing country, the provision has secured India’s interests especially in the pharmaceutical sector against rampant secondary patenting by foreign pharmaceutical companies for increasing their profitability. Thus, it ensures the growth of generic drug makers and the access of the public to affordable medicines.

The panel’s recommendation is not a bolt from the blue. In fact, there has been an outcry from different quarters urging the Indian government to use the options of compulsory licensing and government authorization by invoking powers under Sections 92 and 100 of the Indian Patents Act 2005 to shore up availability of Covid-19 drugs and vaccines in the country. Section 92 of the Patents Act is a special provision empowering the government to issue compulsory licenses for the manufacture of patented drugs in a public health emergency. And Section 100 of the Patents Act empowers the government to use patented inventions for government purposes. There can be no two opinions about the fact that the country is presently witnessing once-in-a-lifetime kind of healthcare emergency. So, the government can justifiably invoke these provisions which are WTO-compliant. It is not that the country so far did not invoke these provisions in the Patents Act. Earlier in the year 2012, the provision was used for allowing Indian drug maker Natco to locally manufacture Nexavar, a patented product of the German pharmaceutical firm Bayer, for treating kidney cancer patients. By any criterion, the situation now is more compelling as the humanity is facing the worst ever medical crisis triggered by the outbreak of Covid-19 pandemic. After the more dangerous second wave, the country is now staring at the possibility of third or fourth wave of Covid-19 pandemic. To deal with the situation, the country needs a sufficient supply of vaccines, medicines and different types of medical equipment. There are widespread complaints of shortage of vaccines, medicines and medical equipment across the country. And no doubt, patent protection is a major barrier to the generic production of these medicines. Covid-19 is a public health emergency, and the arising situation is apt for invoking the emergency powers under Sections 92 and 100 of the Indian Patents Act to increase the affordability and accessibility of the Covid-19 medicines and vaccines in the country.

 

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