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7 March 2022Big PharmaAlex Baldwin

Regeneron can’t dodge Allele’s COVID patent suit

Regeneron has failed to convince a Manhattan district court to drop a lawsuit claiming that it developed COVID-19 treatments using Allele’s fluorescent protein invention without its permission.

Allele sued Regeneron in the US District Court for the Southern District of New York in August last year, alleging that Regeneron infringed its mNeonGreen “novel monomeric yellow-green fluorescent protein”.

According to the complaint, the protein is used as a “fusion tag” for imaging technologies in drug development. The technology is protected under US patent 10,221,221, issued by the US Patent and Trademark Office on March 5, 2019.

Regeneron filed a motion to dismiss the lawsuit on August 20, saying that Allele had failed to state a claim and that its usage of the invention was protected by the “safe harbour” provision of the Hatch-Waxman Act, which allowed it to utilise the invention “solely” to develop its drug

But on March 2, district court judge Philip Halpern shot down the bid to drop the suit and ordered Regeneron to file its answer to Allele's complaint by March 16, 2022.

Regeneron’s motion

In response to Allele’s complaint, Regeneron did not deny its usage of the invention, rather choosing to argue that its usage in developing COVID-19 treatments was protected under the Hatch-Waxman Act.

It stated that the provision allowed it to use the fluorescent protein “solely for uses reasonably related to the development” of drugs.

Regeneron also cited the New York court’s prior ruling in Teva v Sandoz (2015) as evidence of its safe harbour claims. It argues 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.

However, Allele claims that Regeneron had made “post-approval marketing uses” of mNeonGreen to secure two further US patents unrelated to its initial Food and Drug Administration (FDA) submission.

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

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4 May 2021   Pharmaceutical company Novartis has abandoned its attempt to halt US imports of Regeneron’s Eylea pre-filled syringes amid concerns that such a ban could hinder public access to essential treatments.