HDT Bio Corp accuses Emcure of trade secret theft, seeks $950 million in damages.

  • March 29, 2022
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US-based firm HDT Bio Corp has filed a $950 million lawsuit against Pune-based Emcure Pharmaceuticals for stealing HDT Bio Corp’s mRNA technology to use in developing a Covid Vaccine.

Indian maker of mRNA vaccine faces charges of trade secret theft, IP rights violations
Infringement Suit between HDT Bio Corp and Emcure

Earlier in March 2022, Gennova Pharmaceuticals (a subsidiary of Emcure Pharmaceuticals) which is making the country’s first mRNA vaccine has submitted its final vaccine trial data to the Drugs Controller General of India (DCGI) for evaluation.

HDT Bio Corp had signed an agreement with Gennova Pharmaceuticals for jointly developing a potential Covid-19 using the mRNA technology as per reports from TOI.

The lawsuit stated that HDT Bio Corp and Gennova Pharmaceuticals entered into various contracts in 2020, one of them being giving Gennova a limited license to use HDT’s technology to develop and sell the Covid-19 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. 

HDT Bio Corp has filed a lawsuit in Seattle federal court alleging 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 Technology in question:

The technology is related to developing the Covid-19 vaccine using mRNA (Messenger Ribonucleic acid). Messenger RNA is a type of RNA that is necessary for protein production. In cells, mRNA uses the information in genes to create a blueprint for making proteins. Messenger RNA (mRNA) vaccines work by teaching cells to make a protein that will trigger an immune response inside the body to combat diseases like Covid-19.

The HDT bio said that its innovative vaccine uses a proprietary delivery platform Lipid InOrganic Nanoparticle (LION) formulation to deliver immune-stimulating RNA fragments to target cells (Source: TOI).

HDT Bio corp says that their 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. 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 temperature, a vaccine with LION can be stored in standard refrigerators or even freeze-dried and stored at temperatures exceeding 100 degrees Fahrenheit. Plaintiff HDT developed an mRNA vaccine against Covid-19 that is safer, cheaper, more portable and likely more effective than the mRNA vaccines on the market, which are themselves extraordinary feats built on decades of research”, the lawsuit says. 

The suit, says “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.” 

Emcure applied for two Indian patents on HDT’s technology and filed for an IPO in India that falsely describes its “indigenously developed” vaccine with a “proprietary mRNA platform,” the lawsuit said (Source: Reuters).

Reuters also reports “Gennova allegedly terminated its license agreement with HDT at Emcure’s request shortly after its CEO told HDT it would not pay royalties on vaccine sales”. 

In response to the allegations, Emcure spokesperson told The Times of India (TOI): “The License Agreement, which is the subject matter of the suit, is between Gennova Biopharmaceuticals 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.”

A Gennova spokesperson told The Times of India “We state that there is no legal merit in the suit. We assert that there is no contravention of breach on any contractual obligations or provisions of law and will shall defend such frivolous litigation vigorously.”

The case is HDT Bio Corp v. Emcure Pharmaceuticals Ltd, U.S. District Court for the District of Washington, No. 2:22-cv-00334.

The HDT Bio Corp v. Emcure pharmaceuticals case joins the recent string of lawsuits related to mRNA-based vaccines. Earlier Moderna and Pfizer both have faced infringement allegations for using lipid nanoparticles in developing their Covid-19 shots.

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