Indian maker of mRNA vaccine faces charges of trade secret theft, IP rights violations

Representative image.

A COVID-19 vaccine being made by Pune-based Gennova Biopharmaceuticals is in the eye of a storm after a US biopharma company filed a lawsuit against its parent company Emcure Pharmaceuticals, alleging trade secret theft and intellectual property right violations.

The lawsuit by HDT Bio Corp is over an exclusive agreement that gave Gennova a limited licence to use the US company’s technology to develop and sell a COVID-19 vaccine in India.

An Emcure spokesperson said the company had no connection with the matter and that the licence agreement, which is the subject of the suit, is between Gennova and HDT.

HDT Bio filed the lawsuit in a Seattle federal court earlier this week, accusing Emcure of planning to go public in India based on stolen technology and misappropriated trade secrets that the US company had licensed to Gennova.

The Seattle-based company claimed at least $950 million in damages and a court order permanently banning Emcure from using its secrets.

‘Indigenous vaccine’

Gennova recently submitted the vaccine’s phase 2 and 3 clinical trial data to India’s Central Drugs Standard Control Organisation for evaluation and regulatory approval. Its candidate has repeatedly been called India’s “indigenously developed mRNA vaccine.”

Various government authorities and agencies have been touting HGCO19, the mRNA vaccine by Gennova that first entered human trials in December 2020, as indigenous.

“India’s first indigenous mRNA vaccine candidate has received approval from Indian drug regulators to initiate phase I/II human clinical trials,” the department of biotechnology under the ministry of science and technology said in a statement on December 11, 2020.

HGCO19 was developed by Gennova and supported with seed grants under the Ind-CEPI mission, it added. The Coalition for Epidemic Preparedness Innovations (CEPI) is a global collaboration between public, private, philanthropic and civil society organisations founded in Davos by the governments of India and Norway, the Bill & Melinda Gates Foundation, the Wellcome Trust and the World Economic Forum.

VK Paul, member (health), Niti Aayog and chairman of the National Covid-19 taskforce and the National Expert Group on Vaccine Administration of COVID-19 has described Gennova’s mRNA vaccine candidate as a “homegrown vaccine” on several occasions.

Breach of contract

The 34-page lawsuit by HDT Bio, reviewed by Moneycontrol, says its COVID-19 vaccine (called “HDT-301”) is the “culmination of the life’s work of its scientists.”

Messenger RNA (mRNA) vaccines teach cells how to make a protein that will trigger an immune response inside the body to combat diseases like Covid-19. The Pfizer-BioNTech and Moderna Covid-19 vaccines are mRNA vaccines.

Apart from using mRNA to teach the immune system how to fight the virus, this vaccine also uses a special form of mRNA called “self-amplifying RNA” or “saRNA,” which is effective at a much smaller dose than regular mRNA.

Also, to deliver saRNA into human cells, HDT-301 uses a proprietary platform called LION, which gives the vaccine the advantage of being stored at standard refrigerator temperature. Other mRNA vaccines need to be stored at extremely low temperatures.

According to the lawsuit, HDT and Gennova entered into various contracts in 2020, culminating in the exclusive licence agreement giving the Pune-based company a limited licence to use HDT’s technology to develop and sell a Covid-19 vaccine in India. In exchange, HDT would receive payments and royalties, along with an unrestricted licence to use Gennova’s data to develop and sell the vaccine everywhere else.

It added that while Gennova had initially honoured the terms of the agreement, by late 2021, Emcure was proclaiming HDT-301 and the LION technology as its own.

Emcure, it said, sought two Indian patents on HDT’s technology and in August 2021 filed draft regulatory documents for a public stock offering in India, which described the COVID-19 vaccine as “indigenously developed,” touting Emcure’s “proprietary mRNA platform” and not mentioning HDT.

“By fall of 2021, Emcure and Gennova were refusing to share clinical data on the vaccine’s safety and efficacy with HDT,” it said and added that Gennova later insisted that it had independently developed the vaccine that was the same as HDT-301 except for the removal of one immunologically inactive component.

The lawsuit also alleged that Gennova refused to share royalties on the sale of the vaccine and terminated its contract with HDT.

Cinderella story

“Emcure claims that the vaccine and platform were developed by its minor subsidiary Gennova Biopharmaceuticals Ltd. Were that true, it would be stunning. Emcure and Gennova have no track record of developing original products,” HDT said in the lawsuit. “They also have no prior experience with RNA vaccines. Yet Emcure claims to have succeeded where many leading multinational developers have failed: in inventing a safe and effective mRNA vaccine against COVID-19.”

Emcure’s Cinderella story is a fairy tale spun to lure investors to a generics maker whose prior attempt to go public failed for lack of interest, it said.

No connection

A spokesperson with Emcure said the licence agreement, which is the subject matter of the suit, is between Gennova and HDT.

“Emcure Pharma has no connection whatsoever with the matter. Emcure has been legally advised that no suit lies against it; and it has been wrongly joined as a party. The company is initiating steps to have the claims dismissed,” the spokesperson added.

A query to Paul seeking his comments on the development remained unanswered.