A federal judge has declined to dismiss a patent infringement case against Regeneron Pharmaceuticals over unlicensed use of a chemical agent that was used to develop a coronavirus drug.
U.S. District Judge Philip M. Halpern denied Regeneron’s motion for summary judgement, on Oct. 4, on the issue of using Allele Biotechnology’s patented chemical agent for testing the REGEN-COV Covid-19 antibody cocktail.
The drug is used to treat people who are at high risk of serious consequences from Covid-19 infections. President Trump was given REGEN-COV when he became ill in 2020 under a compassionate use request, when the drug was still classified as an experimental treatment.
Allele Biotechnology, of San Diego, received a patent for its mNeonGreen protein in 2013. The bright fluorescent material is used in biotechnology research to test, for example, the potency and effectiveness of Covid-19 antibodies.
In 2020, Allele sued Regeneron, of Tarrytown, for unlicensed use of mNeonGreen.
Regeneron argued that Allele is not entitled to compensation for patent infringement because it had failed to mark the patent number on the product or the packaging, or to notify Regeneron of the patent.
Judge Halpern noted that the policy goal of marking is to notify the public of a patented product in commerce. But mNeonGreen is not an ingredient in Regeneron’s drug, he found, so Allele was not obligated to mark its invention.
Allele also accused Regeneron of intentionally infringing the patent. A senior scientist at Regeneron, for example, had cited a published paper about mNeonGreen. An Allele official testified that he repeatedly tried to contact Regeneron about licensing the invention “but could not get past reception.” Messages sent to Regeneron’s business development email were ignored.
A rational jury, Halpern found, could infer that Regeneron knew about the patent.
Regeneron argued that the FDA’s safe harbor rule allows drug-makers to use patented inventions to develop and submit required information to the FDA before a drug is approved.
For example, scientists may use research tools, such as lab equipment and methods, to develop information for the FDA.
Halpern found that mNeonGreen is a research tool that is not covered by the safe harbor rule.
He directed the companies to submit pretrial materials by Nov. 4.
