Even as Pune-based Gennova Biopharmaceuticals awaits a regulatory go-ahead on the country’s first mRNA Covid vaccine, its parent company, Emcure Pharmaceuticals, faces a trade-secret-linked law-suit from US-based firm HDT Bio Corp.

HDT allegation

In a strongly-worded lawsuit in a Washington federal court, HDT alleged: “Emcure stole HDT’s technology, which HDT had licensed to its subsidiary Gennova for the manufacture and distribution in India.” The suit calls for Emcure to be permanently stopped from using HDT’s proprietary technology, besides seeking damages of $950 million (over ₹7,200 crore).

Responding to whether the US suit could derail the regulatory process for Gennova’s mRNA vaccine, a company insider told BusinessLine the approval process was on course in India, and aspects of the legal tangle are being headed for arbitration.

“In response to Gennova’s termination of the licence agreement, HDT has invoked arbitration proceedings,” said a Gennova spokesperson. The agreement had been terminated late last year.

BusinessLine has reached out to HDT for comment on the issue and a response is awaited.

Meanwhile, Emcure said it had been “wrongly named as a party”, and was working to have the petition dismissed. “The Licence Agreement, which is the subject matter of the suit, is between GBL and HDT. Emcure Pharma has no connection whatsoever with the matter,” it maintained. Emcure clocked a total revenue of ₹6,091 crore for the year ended March 2021, and is in the process of coming out with its Initial Public Offering (IPO).

Its subsidiary, Gennova, further added there was “no merit” in HDT Bio’s claims, and that there was “no contravention of breach on any contractual obligations or provisions of law”.

Last April, India’s Department of Biology had said it had approved additional funding towards the clinical studies of this vaccine.

In its suit, HDT said: “Emcure recently announced that it intends to go public on the strength of its so-called “proprietary mRNA platform”, which includes a Covid vaccine. But that mRNA platform and vaccine belong to Plaintiff HDT Bio Corp.”

HDT’s Covid vaccine (HDT-301) uses mRNA to teach the immune system how to fight the virus. But the HDT candidate “dramatically improves” upon existing vaccines through its self-amplifying RNA, or “saRNA, which is effective at a much smaller dose than regular mRNA,” said the company. Further, it added, saRNA was delivered into human cells, using the company’s a proprietary delivery platform called LION — a cationic nano-emulsion. This technology also allowed the vaccine to be stored in standard refrigerators, a key barrier in the distribution of other mRNA vaccines.

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