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7 July 2022Big Pharma

USPTO and FDA unite to tackle drug pricing

The US Patent and Trademark Office (USPTO) and Food and Drug Administration (FDA) have partnered to facilitate access to affordable drugs.

In a press release shared yesterday, July 6, the USPTO said that the agencies had recently completed an exchange of letters outlining numerous initiatives to execute on the US President’s agenda.

In July last year, US President Biden outlined a multipoint plan to increase access and reduce the cost of prescription drugs in his executive order on “promoting competition in the American economy”. Within the order, the President called on the two agencies to collaborate.

A letter sent by chief USPTO Katherine Vidal to Robert Califf, commissioner of the FDA, also outlined the new initiatives.

"Through these initiatives, the USPTO will protect against the patenting of incremental, obvious changes to existing drugs that do not qualify for patents. This effort can lead to lower drug prices because drug companies will not be able to unjustifiably delay generic competition based on trivial changes to a drug product,” said the USPTO’s press release.

Last month, a bipartisan group of six US senators urged the US Patent and Trademark Office (USPTO) to address ‘patent thickets’, a tactic that pharmaceutical companies allegedly use to stifle competition.

Additionally, the USPTO has said it will work to ensure that patent examiners have the “time and resources” needed to conduct a thorough review of patent applications for pharmaceutical inventions.

The office added that it will provide new tools for patent examiners to search global databases of technical information—including publicly available sources maintained by the FDA—to determine whether similar innovations already exist.

On the FDA front, the administration will assist by providing patent examiners with training on the state of the art in the pharmaceutical and biologics fields.

Further collaboration will come in the form of “developing policies aimed at protecting and promoting US innovation while advancing competition that can lower drug prices for all Americans”. In particular, the agencies will explore the policies surrounding the use of ‘skinny labels’.

The agencies have invited the public to participate in this process through upcoming outreach events and listening sessions.

“Our intent is to ensure our government’s innovation system strikes the appropriate balance, encouraging meaningful innovation in drug development while not unduly delaying competition that provides relief from the high cost of medicines,” said the USPTO’s press release.

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Americas
3 August 2020   The US government has agreed to pay up to $2.1 billion to Sanofi and GSK for the development and delivery of 100 million doses of a COVID-19 vaccine.
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6 September 2022   Web page reveals information concerning patent term extension applications | President Joe Biden urged collaboration between USPTO and FDA.

More on this story

Americas
9 June 2022   A bipartisan group of six US senators have asked the US Patent and Trademark Office to address ‘patent thickets’, a tactic that pharmaceutical companies allegedly use to stifle competition.
Americas
3 August 2020   The US government has agreed to pay up to $2.1 billion to Sanofi and GSK for the development and delivery of 100 million doses of a COVID-19 vaccine.
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