Even as Pune-based Gennova Biopharmaceuticals awaits a regulatory green light for the country’s first Covid mRNA vaccine, its parent company, Emcure Pharmaceuticals, is facing a trade secret lawsuit from US firm HDT Bio Corp.
In a lawsuit in strong terms in federal court in Washington, HDT alleged, “Emcure stole HDT’s technology, which HDT had licensed to its subsidiary Gennova for manufacture and distribution in India. The lawsuit demands that Emcure be permanently stopped from using HDT’s proprietary technology, in addition to seeking damages of $950 million (over ₹7,200 crore).
Responding to the question of whether the US lawsuit could derail Gennova’s mRNA vaccine regulatory process, a company insider said Activity area the approval process was underway in India and some aspects of the legal entanglement are heading towards arbitration.
“In response to Gennova’s termination of the license agreement, HDT invoked arbitration proceedings,” a Gennova spokesperson said. The agreement had been terminated at the end of last year.
Activity area has contacted HDT for comment on the issue and a response is awaited.
Meanwhile, Emcure said he had been “misnamed as a party” and was working to have the petition dismissed. “The license agreement, which is the subject of the lawsuit, is concluded between GBL and HDT. Emcure Pharma has no connection to the case,” he claimed. Emcure recorded total revenue of ₹6,091 crore for the financial year ending March 2021 and is in the process of going out with its initial public offering (IPO).
Its subsidiary, Gennova, further added that there was “no merit” in HDT Bio’s claims, and that there was “no breach of breach of contractual obligations or statutory provisions”.
Last April, the Indian Department of Biology announced that it had approved additional funding for clinical studies of this vaccine.
In its complaint, HDT said: “Emcure recently announced that it intends to make public the strength of its so-called ‘proprietary mRNA platform’, which includes a Covid vaccine. But this mRNA platform and this vaccine belong to the applicant 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 “substantially improves” existing vaccines with its self-amplified RNA, or “aRNA, which is effective at a much lower dose than regular mRNA,” the company said. Additionally, he added, the saRNA was delivered into human cells, using the company’s proprietary delivery platform called LION – a cationic nano-emulsion. This technology also made it possible to store the vaccine in standard refrigerators, a major obstacle to the distribution of other mRNA vaccines.
March 27, 2022