SUMMERVILLE — A local nonprofit has close ties to the COVID-19 treatment President Donald Trump received in October, and the relationship between drugmaker Regeneron Pharmaceutical and Nexton development-based Advanced Technology International has raised some eyebrows at a consumer protection group.
The U.S. government is using ATI to contract with drug companies, including Regeneron, to purchase coronavirus vaccines and treatments on behalf of the Defense Department and Health and Human Services. The taxpayer-funded contracts include a $450 million deal between ATI and Regeneron, which developed the experimental antibody treatment Trump received.
The Food and Drug Administration this month gave Regeneron’s drug “cocktail” emergency authorization for use as a coronavirus treatment.
The ATI contract includes a clause that would let Regeneron retain exclusive rights to produce the treatment for commercial use, even though its development was funded, at least in part, with public money. Similar language is being used in other ATI contracts with drugmakers — including a $1 billion deal with Johnson & Johnson —according to Knowledge Ecology International, a Ralph Nader-founded group that focuses on consumer-related intellectual property and health issues.
The consumer group says the clause bypasses the 1980 Bayh-Dole Act. That legislation was meant to ensure the government protects the public’s interests by obtaining sufficient rights to federally funded technology patents. The act also allows the government to force the patent holder to make its technology available to others to bring the invention to market at potentially cheaper prices.
However, Regeneron’s contract with ATI states: “This license does not include the right to use or allow others to use the subject invention for commercial purposes,” unless Regeneron can’t or won’t produce the treatment. It also explicitly states “the Bayh-Dole statute does not apply” to the deal. The contract was disclosed as part of Regeneron’s third-quarter financial statement released this month.
“This is a massive contract, with very limited public rights in inventions it has funded, compared to the standard government rights in patents set out in the Bayh-Dole Act,” Knowledge Ecology International said of the Regeneron deal. The group said the federal government has given up any leverage it might have had to keep the treatment affordable.
ATI’s corporate legal counsel could not be reached for comment. Regeneron has said the contract provides adequate protections.