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Top legal experts explain why laws like Bayh-Dole and Section 1498 should not be used to control prices, and Novavax becomes the third updated COVID shot cleared for use in the U.S. as cases surge. (553 words, 2 minutes, 19 seconds) |
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Top legal experts: Laws promoting innovation and IP aren’t drug pricing ‘tools’ |
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Laws to support innovation and protect patents cannot be used to enable price controls, leading patent experts tell lawmakers.
Who, what, when: A high-profile group of former judges, federal officials, and legal scholars sent a letter to lawmakers saying strong IP makes America a global leader in drug development, and refute activists “inaccurately claiming that Congress has endorsed” drug price controls.
Bayh-Dole promotes innovation by allowing inventors, like universities and small businesses, to own and commercialize inventions made with federal funding support. The government can "march in" and give licensing rights to a third party—in limited circumstances—if an IP holder does not commercialize an invention that could benefit society.
But Bayh-Dole is clear: “March in” rights have nothing to do with drug prices, the experts explain. Furthermore, drugs are developed with private funding and multiple patents, so the federal government can’t claim IP rights.
A law protecting patent holders—28 U.S.C. § 1498—has also been mistakenly promoted by activists as a price control “tool,” the letter says. Section 1498 allows patent holders to sue if the government uses a patent without authorization.
But § 1498 “does not grant the government any power to infringe patents, let alone to ‘break’ them to impose price controls,” the letter says.
The bottom line: Activists cannot use these IP laws as a “quick-and-easy path to an unprecedented regulatory policy for imposing price controls on prescription drugs.”
Read more in Bio.News.
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Novavax COVID vaccine gets FDA authorization, CDC recommendation |
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The BIO member’s updated COVID-19 vaccine becomes the third vaccine officially recommended for use this year against COVID.
The news: The Food and Drug Administration (FDA) authorized Novavax’s updated vaccine for emergency use. A Centers for Disease Control and Prevention (CDC) advisory committee recommended it on Sept. 12; with yesterday’s authorization, it’s officially recommended for individuals 12+.
3 updated shots: Novavax joins Pfizer-BioNTech and Moderna, both of which received traditional approval on Sept. 11, updated to target the XBB.1.5 coronavirus subvariant. Novavax said it’s ready to roll out vaccines in the coming days.
Why it matters: All three vaccines were found to be effective against currently circulating subvariants—and vaccines remain the best defense against COVID-19, currently the fourth-leading cause of death in the United States.
What they’re saying: “COVID-19 is once again on the rise with infections and hospitalizations increasing, so it's important that individuals get vaccinated,” said Novavax CEO John Jacobs. “Novavax's authorization today means people will now have the choice of a protein-based non-MRNA option to help protect themselves.”
Take your shots: CDC recommended everyone six months and older get an updated COVID shot. With fall respiratory virus season approaching, influenza vaccines and RSV immunization for some populations are also recommended. More Health News: Axios: Pharma industry plays defense on merger guidelines
“[T]he new coalition, the Partnership for the U.S. Life Science Ecosystem, argues the antitrust proposal would choke off a key source of innovation, since mergers and acquisitions are often the only way for biopharma startups to advance their treatments.”
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