Gennova’s mRNA vax in legal storm after HDT Bio Corp sues Emcure

Pune-based Gennova Biopharmaceuticals’ mRNA Covid-19 vaccine is in the eye of the storm after US based start-up HDT Bio Corp filed a lawsuit in a Seattle federal court against Gennova’s parent company Emcure Pharmaceuticals. HDT has accused Emcure of ‘stealing’ and misappropriation of HDT’s billion dollar trade secrets and sought $950 million in damages.

The US firm has alleged that Emcure ‘willfully and maliciously’ violated the Defend Trade Secrets Act and Washington’s laws against trade secret theft. Emcure Pharma did not immediately respond to the queries.

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.

The lawsuit filed in a Seattle federal court is over an exclusive agreement between Gennova and HDT, which gave the former a limited license to use the US firm’s proprietary technology to develop and sell an mRNA based Covid-19 vaccine in India.

HDT has sought $950 mn in damages and a court order permanently banning Emcure from using its trade secrets.

HGCO19, the mRNA vaccine candidate from Gennova, which is now in clinical trials in India, has received grants from the Ind-CEPI mission.

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.

What is the lawsuit about?
The 34-page lawsuit by HDT Bio, reviewed by Business Standard, says that HDT and Gennova entered into various contracts in 2020, which led to an exclusive license agreement giving the Pune based company a limited license to use HDT’s technology to develop and sell a Covid19 vaccine in India. HDT, in return, would receive royalties and payments. It would also have an unrestricted license to use Gennova’s data to develop and sell the vaccine elsewhere.

In the lawsuit, HDT has claimed that by late 2021 Emcure, the parent company of Gennova, which is also going for an initial public offering (IPO) in the Indian bourses, started proclaiming the HDT-301 and LION technology as its own. HDT-301 is the Covid19 vaccine the ‘culmination of the life’s work of its scientists, the US firm has claimed.

mRNA vaccines require sub-zero temperatures to remain stable. However, thanks to the proprietary LION platform, the Gennova-HDT vaccine cand be stored in 2-8 degree Celsius temperature. This makes it a much more lucrative option compared to the currently available mRNA vaccines from Pfizer-BioNTech and Moderna which have very stringent temperature requirements in logistics.

HDT says that its vaccine candidate ‘dramatically’ improves upon the existing mRNA vaccines in two ways – first it uses a special form of mRNA called “self-amplifying RNA” or “saRNA,” which is effective at a much smaller dose than regular mRNA. Lower dosages mean fewer adverse reactions and lower costs. And, secondly, to deliver saRNA into human cells, HDT-301 uses a proprietary delivery platform called LION™. LION™ is a cationic nano-emulsion—i.e., a positively charged (cationic) mixture (emulsion) of very small (nano) particles. “Unlike some other vaccines, which must be stored and transported at extremely cold temperatures with LION™ can be stored in standard refrigerators or even freeze-dried and stored at temperatures exceeding 100 degrees Fahrenheit. LION™ thus solves a major barrier to distributing vaccines in developing countries. LION™ also makes saRNA safe in humans,” HDT says in the lawsuit.

HDT has said that Emcure recently announced that it intends to go public on the strength of its so-called “proprietary mRNA platform,” which includes a COVID-19 vaccine. “But that mRNA platform and vaccine belong to Plaintiff HDT Bio Corp,” the lawsuit says.

It goes on to add: “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. The truth is mundane: Emcure stole HDT’s technology, which HDT had licensed to its subsidiary Gennova for manufacture and distribution in India.”

The background
HDT has alleged that Emcure got its hands on a saran vaccine in a ‘faster way: by stealing it from HDT.”

HDT goes on to elaborate that Emcure Director (and Gennova Chief Executive Officer) Dr Sanjay Singh visited HDT’s headquarters in Seattle in January 2020. There, Dr Singh met with HDT Chief Executive Officer Dr Steven Reed, whom he had befriended over a decade earlier. Dr Singh proposed a partnership to bring HDT’s then-incipient COVID-19 vaccine to market in India: HDT would provide the technology, and Dr Singh and his team would manufacture the product at scale and shepherd it through the regulatory approval process, the US firm narrates in the lawsuit.

After Reed agreed, HDT and Emcure subsidiary Gennova then entered into various contracts, culminating in the Exclusive License Agreement that gave Gennova a limited license to use HDT’s technology to develop and sell a COVID19 vaccine in India. In exchange, HDT would receive payments and royalties along with an unrestricted license to use Gennova’s data to develop and sell the vaccine everywhere else.

“The Agreement also specified that HDT retained all rights in the transferred technology, and that HDT would jointly own any improvements that Gennova might make to HDT’s inventions,” the lawsuit mentions.

The US firm says that at first Emcure and its subsidiary acted like a partner. Emcure publicly acknowledged that its vaccine was developed “in collaboration with” HDT. “Dr Singh coined a name for the vaccine—“HGCO19”—in which “H” stood for “HDT.” HDT said.

And when Emcure and Gennova—together—sought regulatory approval to conduct clinical trials in India, they promised that the characteristics, specifications, dosage, and storage temperature would be “the same as that of HDT 301 vaccine developed by HDT.

By late 2021, HDT alleged that Emcure was proclaiming HDT-301 and the LION technology behind it as its own. The company further alleged that Emcure and/or Gennova have sought two Indian patents on HDT’s technology over the summer. In a draft red herring prospectus (DRHP), Emcure has described the Covid19 vaccine as indigenously developed and touts Emcure’s “proprietary mRNA platform,” and does not mention HDT,” the US firm alleged.

In fact, by fall of 2021, Emcure and Gennova had been refusing to share clinical data on the vaccine’s safety and efficacy with HDT, it said.

“HDT demanded an explanation during Dr Singh’s next visit to Seattle in November 2021. Caught red-handed, Dr Singh denied that the Emcure and Gennova’s vaccine was based on HDT’s technology at all. He falsely claimed that Gennova had independently developed the vaccine that Emcure and Gennova are testing in phase III clinical trials, which on information and belief is the same as HDT-301 except that it removes one immunologically inactive component,” HDT has noted.

The US firm says that Singh asserted that Emcure and Gennova could sell their vaccine without paying HDT royalties. Gennova then terminated the License Agreement. Business Standard