Compulsory Licensing amid COVID19

 

 

The world moreover our nation is going through harsh times wherein in more than 3 lac cases (3,48,555 on 11th May) of COVID-19 are coming up every day, it is to be noted here that figure of active cases has reached 36,99,683 (as of 12th May). Many states have imposed lockdown to break the chain and curb the spread of COVID-19 apart from that vaccination drive is also going on though at a very lethargic pace, according to various government sources as of now around 17 Crore have been vaccinated. Basically in India, there are two vaccines which are manufactured i.e. Covishield by Serum Institute of India (sub-lease from AstraZeneca) and Covaxin by Bharat Biotech, apart from these two many countries are also sending their vaccine as Aid (Russia’s Sputnik). As mentioned before pacing of vaccination, drive is very slow going and unrushed, and after considering the article published in India Today it is apposite to say that considering the current pace of the vaccination drive it could take 3.5 years to vaccinate 75% of the population. Although Hon’ble Prime Minister initiated the phase III of vaccination policy from 1st May for 18-44 age group however many states were not prepared for phase III due to lack of vaccine as alleged by the respective states. Even now many states including Delhi, Rajasthan, Punjab, Odisha have raised the issue of shortage of vaccine in their respective states, in fact, the government of Odisha, have floated a global tender to procure vaccines from the global market.  Many people have suggested solutions so as to cope up with the shortage of vaccines and one of the suggestions among them is “compulsory licensing”. It is humbly submitted here that various courts have also mooted this issue from time to time and have inquired to the Central Government over usage of “Compulsory Licensing”.

According to World Intellectual Property Organization (hereinafter to be referred as WIPO) a patent is an exclusive right granted for an invention, which is a product or a process that provides, in general, a new way of doing something, or offers a new technical solution to a problem. It is submitted here that after considering the above definition it is apposite to say that patent grants an the exclusive right to the patentee for the patented product or process however in compulsory licensing is a license or authorization issued by the government to an applicant for making, using, and selling a patented product or employing a patented process without the consent of the patentee. The concept of compulsory licensing existed in the TRIPS agreement ever since it took effect in January 1995, in India, patents are governed by the Patent Act 1970 (hereinafter to be referred as the act of 1970), wherein chapter XVI deals with compulsory licensing.  Under  the Act of 1970 section 84 deals with compulsory licensing wherein it states that any person interested in a patented product/process can make an application to the Controller after 3 years from the date of  grant of patent for compulsory licensing. While considering an application for compulsory licensing controller will generally look into the three prerequisite requirements which are:-

  1. ·        Public Interest
  2. ·        Affordable Price
  3. ·        Invention not worked in India

 It is to be noted here that for compulsory licensing a person has to wait for 3 years from the date of the patent, however in today’s current harsh times section 92 is more relevant and applicable. It is to be submitted here that section 91 deals with special provision for compulsory licenses on notifications by Central Government, wherein according to Section 92 of the Act of 1970, compulsory licenses can also be issued suo motu by the Controller of Patents pursuant to a notification issued by the Central Government if there is either a “national emergency” or “extreme urgency” or in cases of “public non-commercial use”. 

It is apposite to say that compulsory license shall be used very judiciously as it slightly bends the basic structure of patent law.  India's first-ever compulsory license was granted by the Patent Office on March 9, 2012, to Natco Pharma for the generic production of Bayer Corporation's Nexavar, a life-saving medicine used for treating Liver and Kidney Cancer. Bayers sold this drug at exorbitant rates, with one month's worth of dosage costing around Rs 2.8 Lakh. Natco Pharma offered to sell it around for Rs 9000, making it affordable for people belonging to every stratum. All the 3 conditions of section 84 were fulfilled and the decision was taken for the benefit of the general public.

 

Compulsory licensing, simply means that the government can issue licenses to a patent without the approval of the patent holder due to some extraneous situation, like a pandemic. However even in these extraneous situation government cannot issue a license in favor of any interested person, government/controller have to look into capability and resource of the interested person. In the present case production of COVAXIN require a biosafety level 3 production facility. Thus it is appropriate to say that it is not just to say that compulsory license will resolve the issue of shortage of vaccine because the government has to look at all the requisite requirements such as section 84 as well as the required infrastructure required for the production of vaccines. Though the government is definitely positively looking into this issue and will take affirmative steps in the interest of the public.  

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