The Supreme Court on Friday asked the central government why it is not considering the powers under the patent law for the compulsory licensing or government-approved use of drugs such as remdesivir, tocilizumab, favipiravar, which are used to treat COVID-19 patients , to claim something.
A bench made up of Judges DY Chandrachud, L. Nageswara Rao, and S. Ravindra Bhat raised the question while investigating the Suo-Moto COVID-19 case (In Re Distribution of Essential Supplies and Services during the Pandemic).
“Has the center considered using Section 92 of the Patents Act and issuing compulsory licenses so drugs can be manufactured while royalties are sorted?” The bank asked Attorney General Tushar Mehta.
The bank asked the center to explain why the Court should not issue an order to invoke Section 92 or Section 100 of the Patents Act to allow the manufacture of generic drugs related to remdesivir, tolicizumab, etc.
Section 92 of the Patents Act is a special provision that enables the central government to issue compulsory licenses for the manufacture of patented drugs in a public health emergency. Section 100 of the Patents Act allows the central government to use patented inventions for government purposes.
“This is exactly the case where we should apply for a compulsory license. This is a public health emergency situation,” Justice Ravindra Bhat noted during the hearing.
Justice Bhat also noted that India was at the forefront of the TRIPS negotiations on compulsory licensing provisions and the scenario at hand was possibly an appropriate case for their use. He also mentioned the NATCO case, in which the Indian government granted Hyderabad-based drug maker Natco a compulsory license to manufacture a life-saving kidney cancer drug patented by German Bayer.
“We were the first country to issue a compulsory license in the NATCO case, which concerned a life-saving drug. In view of the prevailing national emergency, a case is determined under Section 92 (3) of the Patent Act (for compulsory licensing)” said Justice Bhat.
Justice Bhat quickly added, “Of course we don’t mean it as a direction, just as an ongoing dialogue.”
“Countries like Germany, Canada and France have all issued compulsory licenses for essential medicines. The government can even take over (the invention) under Section 100 of the Patent Act or it can be licensed by the patent controller,” the judge continued.
The judge also mentioned that Bangladesh made a generic remdesivir that was exported to many countries. Jharkhand state recently asked for permission to import the cheaper generic remdesivir from Bangladesh, Justice Bhat said.
The bank also stressed that under the Drug Control Act, the central government has the power to regulate drug prices.
The bank aso asked serious questions Regarding the centre’s double pricing policy on COVID vaccines, which allows for different prices to be imposed on vaccines sold to the center, states, and private hospitals. The bank expressed concerns about the ability of private companies to secure shares between states.
“Don’t leave price fixing and sales to private manufacturers,” the bank noted.
“We cannot follow this private sector model in times of crisis. Yes, we have to create incentives, but we have to follow the National Vaccination Program. How will the private sector know how much to give to Maharashtra or Uttarakhand or Manipur or Gujarat? You can’t. You can’t.” Left to the manufacturers. This is justice to public goods. You have to take responsibility for it, “Judge Chandrachud told the attorney general.
The bank also pointed out that the drug AstraZeneca was being sold at much cheaper prices in the US and Europe than in India. It was asked why the vaccines are being offered at the current price when their manufacture was supported by government grants.
The matter will next be examined on May 10th. The center was asked to respond to the points raised by the bank.
Recently, the Delhi Supreme Court had also suggested that the center should consider mandatory approval of COVID-19 drugs.
Had a departmental bank consisting of Justice Vipin Sanghi and Rekha Palli observed in the order passed on April 20th as follows:
“Given the current situation, there can be no doubt that a case will be recognized for the exercise of its powers by the central government / controller in accordance with the above legal provisions. At the same time, the interests of the patent holder / license holder should be considered because of their Investment, inventions and hard work make such drugs available to the general public. The best way would be to encourage existing manufacturers to ram their production on a warfooting. They should also be encouraged to give other companies voluntary licenses to manufacture the However, if these efforts are not carried out early enough, the government / controller should not hesitate to invoke its jurisdiction and authority under the above provisions of the Patent Act as the lives of thousands of people come to an end COVI D lost in the country every day. People’s lives take precedence over everything else. Even if such forces are exercised, the patent owner / manufacturer can be adequately compensated by setting a fair license fee. The central government should take immediate action in this regard in relation to this order and report on progress at the next negotiating date. “
Also happened in the hearing: