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24 August 2021Big PharmaAlex Baldwin

Regeneron asks court to dismiss COVID-19 tech patent suit

Regeneron wants a Manhattan district court to toss a lawsuit that claims it infringed on patents in the development and testing of COVID-19 treatments.

The US pharmaceutical company filed a motion to dismiss plaintiff Allele Biotechnology’s amended complaint with the US District Court for the Southern District of New York on Friday, August 20.

Allele claims that Regeneron infringed its patent mNeonGreen—a “novel monomeric yellow-green fluorescent protein” derived from a marine invertebrate called the Branchiostoma lanceolatum.

According to the complaint, the protein is commonly used as a “fusion tag” for imaging technologies.

The technology is protected under US patent 10,221,221, issued by the US Patent and Trademark Office on March 5, 2019. More than 250 different biotechnology companies and Universities have licensed the patent, according to Allele’s website.

In a document supporting its motion to dismiss, Regeneron claims that its use of Allele’s “mNeonGreen” technology was protected by safe harbour, despite Allele’s insistence that the technology is a “research tool” and therefore not eligible for the protection.

Regeneron said: “Allele misreads the statute and overlooks clear Congressional intent: companies making new drugs need not await [the] expiration of relevant patents before completing the necessary testing to demonstrate safety and efficacy, and obtain Food and Drug Administration (FDA) approval.”

Regeneron’s arguments

Regeneron claims that its use of mNeonGreen was “reasonably related” to the FDA submission process, and is therefore immune from infringement litigation.

It also cites the New York court’s prior ruling in Teva v Sandoz (2015) as evidence of its safe harbour claims. Regeneron claims that the case, where the alleged infringement involved the defendant’s use of a laboratory test to generate data for a new drug product, was a “nearly identical” situation.

In response to Allele’s research tool argument, Regeneron claims that the “clear” wording of the safe harbour statute covers “all inventions”.

In the amended complaint, Allele claimed that Regeneron had made “post-approval marketing uses mNeonGreen”, arguing that Regeneron used the technology to secure two further US patents unrelated to the disputed FDA submission.

“Regeneron’s product is not currently approved by the FDA, so there can be no such post-approval uses,” Regeneron argued.

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More on this story

Big Pharma
8 March 2021   On June 24, 2020, a seven-year long legal battle between two biotech companies finally concluded in the UK.
Americas
29 August 2019   A US judge yesterday, August 28 ruled in favour of Sanofi and Regeneron in the pharmaceutical companies’ long-running patent dispute with Amgen over the cholesterol drug Praluent.
Big Pharma
11 November 2021   The US Patent Trial and Appeal Board will review the validity of two Regeneron Pharmaceuticals patents related to its Eylea (aflibercept) medication.

More on this story

Big Pharma
8 March 2021   On June 24, 2020, a seven-year long legal battle between two biotech companies finally concluded in the UK.
Americas
29 August 2019   A US judge yesterday, August 28 ruled in favour of Sanofi and Regeneron in the pharmaceutical companies’ long-running patent dispute with Amgen over the cholesterol drug Praluent.
Big Pharma
11 November 2021   The US Patent Trial and Appeal Board will review the validity of two Regeneron Pharmaceuticals patents related to its Eylea (aflibercept) medication.