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The March-In Drug Price Control Narrative Crumbles While Its Damage to American Innovation Grows

It was little more than a month ago when the Biden Administration unleashed its draft guidelines for applying the march-in provisions of the Bayh-Dole Act.

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America wants to waive patent protection for vaccines


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MERICA HAS long been the global protector-in-chief of intellectual property. But on May 5th it sought to tear up the rule book. “The extraordinary circumstances of the covid-19 pandemic call for extraordinary measures,” said Katherine Tai, the United States Trade Representative. To help battle the pandemic, the administration of President Joe Biden said it supported waiving some intellectual-property protections for vaccines. Jaws dropped—along with the share prices of vaccinemakers.
Investors shuddered at the idea that other manufacturers might pounce on unprotected intellectual property. Only a day earlier, Pfizer forecast vaccine revenues of $26bn in 2021, with profits around $7bn. Splitting such spoils could blunt the incentive to invest and undermine innovation. And if firms fear that their know-how can be pilfered with impunity, it could undermine collaborative efforts. Just as bad, botched imitations by generic manufacturers could fuel vaccine hesitancy.

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"Monumental Moment": U.S. Backs Waiving COVID Vaccine Patent Rights After Months of Blocking Talks


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The Biden administration has announced it now supports temporarily waiving the intellectual property rights for COVID vaccines, in what the World Trade Organization is calling a “monumental moment.” India and South Africa first proposed the waiver in October, but the United States and other wealthy nations blocked the WTO from even opening negotiations on the proposal. Supporters say the waiver is critically needed to increase the rate of vaccine production for the Global South as COVID-19 rapidly spreads in India, Latin America and other regions where few vaccines are available. Biden’s support for the waiver is “an incredibly pleasant surprise” and “late, but still welcome,” says Achal Prabhala, coordinator of the AccessIBSA project, which campaigns for access to medicines in India, Brazil and South Africa. “The proposal is monumental because what it does is it allows for more vaccines to be manufactured in the world,” Prabhala says. “The whole world faces a crippling shortage of coronavirus vaccines.”

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