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6 October 2020BiotechnologyMuireann Bolger

Regeneron sued over antibody protein used to treat Trump’s COVID-19 symptoms

Regeneron Pharmaceuticals is facing claims that its “antibody cocktail”, which was administered to  President Donald Trump to treat his COVID-19 symptoms, was developed with the unauthorised use of a fluorescent protein.

Allele Biotechnology and Pharmaceuticals sued Regeneron at the US District Court of the Southern District of New York, yesterday, October 5, alleging that Regeneron did not have permission to use its m NeonGreen protein. It is also seeking royalties for the use of the protein in Regeneron’s development of the experimental treatment to combat COVID-19.

The company filed a separate federal lawsuit in San Diego against Pfizer and BioNTech SE, accusing the companies of using the same protein without its authorisation.

The disputed fluorescent protein works by being injected into cells so researchers can monitor and evaluate how a virus reacts to an antibody. According to Allele, the patent for mNeonGreen, issued in March 2019, has been referred to by scientific journals as the “gold standard” for testing the efficacy of antibody and vaccine candidates.

According to Allele’s founder, chief executive Jiwu Wang, mNeonGreen is so bright when used in testing that the camera can detect changes in a split second, which enables researchers to look at different antibodies to see which works best in less time. The fluorescent protein was developed without funding from the federal government and most of its licences are academic and non-transferable, Wang added in a statement.

Allele said it reached out to Regeneron on many occasions to negotiate a license, but received no reply.

According to a report in Bloomberg, Regeneron surged as much as 9.8% in New York trading following news that Trump had received the treatment. Early studies indicate Regeneron’s treatment, which Trump received on Friday, may help suppress the virus.

Further commenting on the suits, Wang said: “I am pleased that mNeonGreen has played a pivotal role in the fight against COVID-19. In no way does Allele want to prohibit, or slow down development of vaccines or therapeutics discovered using this technology. Our goal is to have these companies recognise, as many others have before them, the hard work that went into developing this technology and to respect our IP.”

LSIPR has approached Regeneron, Pfizer and BioNTech SE for comment.

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Americas
9 April 2019   Pharmaceutical companies Alnylam and Regeneron will collaborate on the development and commercialisation of RNA interference therapeutics.
Americas
19 October 2020   Kilpatrick Townsend & Stockton has strengthened its life sciences expertise with the addition of a patent litigation team, that includes four litigators from DLA Piper.
Big Pharma
23 October 2020   The English High Court has lifted a stay on Amgen’s lawsuit which accused Sanofi-Aventis and Regeneron of infringing a patent covering pharmaceuticals which treat elevated cholesterol levels.