Regeneron, Pfizer and BioNTech Slapped with Patent Lawsuits for COVID-19 Therapies

Allele Biotechnology and Pharmaceuticals filed lawsuits claiming the companies infringed on Allele’s patented mNeonGreen technology in the development of their COVID-19 treatments.

Allele Biotechnology and Pharmaceuticals filed lawsuits against Regeneron Pharmaceuticals, as well as Pfizer and Germany’s BioNTech, claiming the companies infringed on Allele’s patented mNeonGreen technology in the development of their COVID-19 treatments.

In its announcement, Allele said its mNeonGreen protein was patented in 2019. The company claims the protein is considered “the world’s brightest monomeric fluorescent protein.” The company said the protein has been touted in scientific journals “as the gold standard for use in assays testing neutralizing antibody and vaccine candidates.”

The mNeonGreen technology is being used by the three companies as a reagent in therapeutics programs aimed at halting COVID-19, Allele said in its announcement. On Monday, San Diego-based Allele filed the lawsuits, one in New York and one in California. Regeneron, Pfizer and BioNTech used mNeonGreen commercially without authorization from Allele, the company said.

Allele said it reached out to New York-based Regeneron on multiple occasions to negotiate a license on reasonable terms. Regeneron never responded, according to Allele. Regeneron’s monoclonal antibody therapeutic for COVID-19, REGN-COV2, was recently administered to President Donald Trump under compassionate use to treat his infection with the novel coronavirus.

In addition, neither Pfizer nor BioNTech sought permission to use mNeonGreen to develop and test their vaccine candidate, Allele said. Pfizer and BioNTech’s vaccine candidate BNT162b2 is now under rolling review for authorization in the European Union. The companies anticipate data from their Phase III vaccine study later this month.

Jiwu Wang, founder and chief executive officer of Allele, said he is pleased that mNeonGreen is playing a pivotal role in the battle against COVID-19 and he does not want the lawsuits to prohibit or slow down the development of vaccines or therapeutics that were discovered using the technology. Rather, Wang said he wants the three companies to respect Allele’s research. Wang went on to note that there are hundreds of active licenses using Allele’s mNeonGreen technology. However, none of the three companies in the lawsuits have one.

“Our goal is to have these companies recognize, as many others have before them, the hard work that went in to developing this technology and to respect our intellectual property,” Wang said in a statement.

Dan Catron, Allele’s head of Licensing and Business Development, said the lawsuits are to maintain Allele’s patent rights and to also ensure that an agreement can be put in place to protect the rights of current and future licensees.

According to The Motley Fool, Regeneron said it would vigorously defend itself against the accusation. Neither Pfizer nor BioNTech have yet responded to the allegations.

Perkins Coie LLP is representing Allele in the New York filing. Troutman Pepper Hamilton Sanders LLP is representing Allele in the California lawsuits.