Hope, IPR Laws, And A Covid-19 Vaccine

It had been the most promising vaccine so far, testing at over 95% effectiveness, and could be stored and transported in refrigerated trucks used for ordinary frozen food. That made it suited to most countries in the world. There was just one hitch. It was too expensive. At $100 a shot, two needed in quick succession, few governments could afford to procure it for their public health systems. In many such countries, private purchases would be too tiny to justify dispatching plane-loads. So even for those who could afford it, supply would be short and logistically difficult to come by.

Over 50% of the doses were going to be made in India – the country with the largest vaccine manufacturing capacity. Yet few Indians could avail its protection. The irony was not lost on Sangita, an office worker in one of India’s largest pharma companies, as she passed the vaccine facility every day. Last month, the vaccine company celebrated the dispatch of its first batch to a rich western nation. Sangita had watched them celebrate the shipment with banners covering their office glass and steel building in the ‘pharma park’.

The owner of the home where her mother worked had inoculated his family of five. They had to sign up with the vaccine company and wait a week, then visit its Indian partner clinic to take the shots. At Sangita’s home, nobody got the shot. After six months of no work and now a job at half her earlier salary of Rs 5,000 per month, Sangita couldn’t afford to vaccinate her aged parents, out-of-work husband, and two kids. If they could afford to inoculate just one or two, who would they pick? The parents, most susceptible on account of age but also at the end of their lives or the children whose natural immunity and good health may be protection enough. Or the two bread-winners. Now one.

The Indian government had been trying to buy large quantities of the vaccine, but the foreign inventor of the vaccine refused to sell at the price that the Indian government was willing to pay. Several foreign governments get involved since they had already placed orders and paid for the vaccines. Every day the newspapers and TV channels carried headlines that built hopes and then dashed them.

One reported that the vaccine inventor wanted to cut prices but couldn’t as it had incurred costs in developing patents, know how and trade secrets for the vaccine. Apparently, there are over 10,000 global patents that mentioned “vaccines”, of which 200 had been claimed to have used for this vaccine by the U.S. Food and Drug Administration at the time of approval. These 200 patents had all been registered in India as well, but the forms filed in the Indian patent office did not have details of which of them had been used in this vaccine. The Indian government was currently chasing down the vaccine company for further information on the patents but finding that it was against a brick wall, announced that it was overriding all patents during the pandemic. Many patent holders had obtained injunctions from Indian courts to block the government from overriding their patents. Any decision by the government to mitigate the immediate crisis could potentially hurt India’s other inoculation programs against tuberculosis, meningitis, etc which required patented drugs.

These technicalities didn’t deter Sangita from eagerly searching the news every morning in the office bus on her way to work. She’d look for signs that the patent impasse had been broken and that families like hers could get subsidized vaccinations. If she didn’t understand the jargon, she’d bookmark the story and during the lunch break, ask a colleague who worked in the R&D lab. The two would sneak into an unused prayer room and discuss “vaccine politics”. These were the strangest conversations she’d had but understanding the developments returned to her some semblance of control over her life. She felt better knowing where things were headed; a sense of preparation for all sorts of outcomes.

Today’s news had lifted her spirits. While the details were fuzzy, the headline suggested that the Indian government had threatened the vaccine inventor that if it didn’t cut prices to a reasonable amount and supply enough quantities immediately, the government would use the law to force the vaccine inventor’s hand. Sangita’s colleague explained that the government could use these three weapons:

• The same Indian Patent law that offered patent cover to medicines also allowed the government to compulsorily license all the patents required for the vaccine to another Indian company that is willing to manufacture and supply at an affordable price;
• Under the Essential Commodities Act it could direct the current Indian manufacturer to produce a sufficient quantity of the vaccines for the Indian government to distribute free and for the local retail market before being allowed to export-led production for the foreign inventor and its customers; and
• Under the Drugs and Cosmetics Act, the government could ensure it has sufficient vaccine quantities to inoculate on the basis of public interest needs – say frontline workers first, and then offer it on a subsidized basis to the old and infirm. After the government’s requirements are met – the manufacturer may be permitted to distribute and sell in the retail market. The government could limit the retail price to ensure against price gouging.

What if the government’s threats backfire and the foreign vaccine company just cancels manufacturing in India, wondered Sangita. Then the foreign vaccine company would struggle to supply to other countries that have paid already for supplies, said her colleague. What if other countries got angry that India was usurping their orders? Sangita asked. That could be tricky, her friend shrugged but if the law allows this, and all countries had similar laws, there was nothing they could do except vent their frustration.

Maybe just these threats will work and India will secure enough supplies to protect frontline workers. And soon enough the other vaccine makers will also be ready to manufacture and there will be adequate vaccines for the whole world just as it happened with Tamiflu, she said smiling.

That was the best news Sangita had heard all day. The vaccine had moved one step closer to her family. Sometimes hope is all it takes to brighten up the day. And IPR law.

Murali Neelakantan is an expert in healthcare laws. He was Global General Counsel at Cipla and Glenmark, and Senior Partner at Khaitan & Co.

The views expressed here are those of the author and do not necessarily represent the views of Bloomberg Quint or its editorial team.