Dr. Reddy’s inks COVID-19 licensing deal amid furore over IP waiver

India-based generics drug maker Dr. Reddy's Laboratories has entered into a voluntary licensing agreement with Eli Lilly to expand access to COVID-19 treatment in India.

The royalty-free, non-exclusive licensing agreement, announced Tuesday, May 11, will see the two companies collaborating to manufacture and commercialise the drug, baricitinib, in India.

According to Dr. Reddy’s, the drug has received restricted emergency use approval from the Central Drugs Standard Control Organisation,Ministry of Health, India, for use in combination with remdesivir for the treatment of suspected or laboratory confirmed COVID-19.

It added that this partnership “comes at a critical juncture” in the country’s fight against the pandemic.

Deepak Sapra, chief executive officer at Dr. Reddy’s, said: “From the start, we have been determined to explore every possible avenue against COVID-19. Our collaboration with Lilly will help us make yet another treatment option available to patients in India.”

The development comes amid the controversy and debate stoked by the Biden administration’s decision to support a vaccine IP waiver put forward by India and South Africa.

The waiver seeks to temporarily cede certain provisions of the Trade-Related Aspects of Intellectual Property Rights Agreement to help bring an end to the global pandemic.

US trade representative Katherine Tai released a statement last week announcing the  Biden’s administration's support for the plan.

‘Drugmakers will have say’

In the wake of mounting concern from the pharmaceutical sector, US Health and Human Services Secretary Xavier Becerra has moved to reassure drugmakers that they will be allowed a say over the controversial waiver.

During a House Energy and Commerce Committee hearing held yesterday, May 12, Berrera said: “We are willing to sit down and negotiate to see if there’s a way to deal with this. Everything is still the same until we’ve negotiated.”

According to Becerra, President Biden has been having conversations with the pharmaceutical industry “from the very beginning” around vaccine IP, and that such communications are still ongoing.

“No action has been taken without consulting with all those who are stakeholders and certainly the industry that has helped create these vaccines,” he said.

A pending ‘catastrophe’

Roche chief executive Severin Schwan is one of the most trenchant critics of the proposal,  which he has denounced as a “catastrophe” comparable to the fallout from the nationalisation of drugmakers in East Germany.

He further argued that the proposal is “counterproductive” and will not solve supply shortages.

“We had enough experiments in the 20th Century nationalising the industry and we know what came out of that,” he told the Financial Times.

According to Schwan, the plan’s orchestrators are trying to “gain some brownie points with some institutions in the short term, even if it is very harmful for mankind in the long term”.

Biden’s proposal has also met with criticism from Italy and Germany. Italian Prime Minister Mario Draghi told a parliamentary hearing in Rome that ending the block on exports from countries like the US and the UK would be “easier” than waiving vaccine patents.

“Before getting to the liberalisation of vaccines, other simpler things should be done, such as removing the export block that today the US firstly and the UK continue to maintain,” he said.

“This, I would say, is the first thing to do. The fact of liberalising the patents, even temporarily, does not guarantee the production of the vaccine.”

Angela Merkel, the German chancellor, has also cast doubts over the proposal, claiming it could thwart entrepreneurial innovation.

Speaking at a press conference held after the US’ announcement, she said: “I do not think that a patent waiver is the solution to make more vaccines available to more people. Rather, I think that we need the creativity and the power of innovation of companies, and to me, that includes patent protection.”

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