New Delhi: Covid-19 is a global pandemic and not merely restricted to India and, therefore, the central government is not in favour of exercising statutory powers under the Patents Act or the Drug Price Control Order to scale up production and regulate prices of drugs and vaccines required to treat those infected with the novel coronavirus, it has told the Supreme Court.
In an over 100-page affidavit filed Sunday night, the central government said it would be counter-productive to invoke the Patents Act now, especially when it was engaged at diplomatic levels to procure vaccines and medicines.
The affidavit was filed in response to the top court’s 30 April order in which it had sought response from the Centre on various aspects related to Covid-19 management, including its pricing policy.
One of the key questions related to the use of Patents Act. The court wanted to know why the government was not considering options under the law that allowed it to enable manufacturing of generic drugs.
Two sections — 92 and 100 of the Patents Act — were specifically pointed out in the court order. Section 92 is a special provision enabling the central government to issue compulsory licences for the manufacture of patented drugs in a public health emergency. Section 100 enables it to use patented inventions for government purposes.
Legal experts ThePrint spoke to said the government appears to be treading cautiously due to the ongoing negotiations at the World Trade Organization (WTO).
Advocate Ansh Luthra, who specialises in patents law, said: “It is a national public health emergency. In this scenario the government can, through compulsory licensing, allow pharma manufacturers to produce the generic versions of patented medicines for the larger public good.”
Another patent law expert, senior advocate Hemant Singh, feels the government should have engaged with the pharma industry and worked out feasible options with them on ramping up production of vaccines and drugs.
“The law gives the government the power to take over the patent temporarily. It is possible that some manufacturing units may not have the production capacity. But that is where the government should have stepped in to give them aid so that essentials required to combat Covid can be made easily available,” he said.
Govt engaging at ‘diplomatic levels’
Given the surge in Covid cases across the world, the government said there has been a demand for patented medicines, drugs and vaccines from all over the world. Therefore, the solution to such a problem needs to be found out essentially at an “executive level, engaging at diplomatic levels.”
Though the affidavit did not provide details about the government’s engagement at the global level, it did underline that the Centre was actively involved through diplomatic channels to find out a “solution in the best possible interest of India.”
“It is earnestly urged that any discussion or a mention of exercise of statutory powers either for essential drugs or vaccines having patent issues would have serious, severe and unintended adverse consequences in the country’s efforts being made on global platform using all its resources, good-will and good-offices though diplomatic and other channels,” the government stated in its affidavit.
However, it did not rule out the possibility of invoking the laws and rules at an opportune time in future.
On remdesivir production
In response to a pointed query by the top court as to why it did not invoke the Patent Act or Drug Price Control Order with respect to remdesivir — the anti-viral drug required to treat severe Covid-19 patients — the central government said it is because there is a shortage of raw material for its production.
Remdesivir is a patented drug for which the patent holder Gilead USA granted a voluntary licence to seven Indian manufacturers in 2020. No other company can produce the drug.
However, in an emergency situation, the government can opt for compulsory licensing under Section 92 of the Patent Act and allow other manufacturers to produce the drug.
According to the government, in view of the constraints in the availability of raw materials and essential inputs, any additional permissions and licences may not result in increased production immediately.
“The Government is also making all efforts to address the supplies of essential inputs, raw materials to ensure that the installed capacities are fully utilized,” the affidavit stated. It is also exploring options to procure the drug from Indian Missions abroad.
At the same time, it added, that in case the government receives an application under the law by any other manufacturer, asking the government to invoke the Patents Act then it can be considered to “effectively handle any future crisis.”
On its part, the affidavit added, the Centre took necessary steps to augment the production of remdesivir from 66,000 vials per day to 2 lakh per day. This was done after the Ministry of Health and Family Welfare said one crore vials of remdesivir would be needed every month to treat Covid patients.
So far as the drug tocilizumab is concerned, the Centre claimed it is processing applications from new manufacturers who have applied for manufacturing permission.