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14 September 2021AmericasMuireann Bolger

FDA urges USPTO to tackle rising drug costs

The US Food and Drug Administration (FDA) has urged the US Patent and Trademark Office (USPTO) to curb drug costs in the wake of President Joe Biden’s plan to promote competition in the pharmaceutical sector.

President Biden’s executive order, number 14036, “Promoting Competition in the American Economy”, identified a lack of competition as one of the barriers to creating and sustaining a healthy economy.

The FDA’s acting commissioner, Janet Woodcock, sent a letter on Friday, September 10, asking the under secretary of commerce for IP and acting director of the USPTO, Andrew Hirschfeld, to address some key issues in the patenting field.

She noted that even when patents do not directly delay FDA’s approval of generic products, the launch of those products is routinely delayed by related patent litigation.

‘Litigation burdens’

In particular, she criticised the practice of some companies to file “continuation” patent applications, enabling them to create a blockade of patents around one drug to deter any potential future competition.

“The existence of multiple patents increases litigation burdens and potentially delays the approval of generics and the launch of generics and biosimilar and interchangeable biological products,” she wrote.

In the letter, Woodcock cited 2018 statistics from the Journal of Law and the Biosciences, that found 78% of drugs for which new patents were listed in the Orange Book from 2005-2015 were for existing (rather than new) drugs.

She also flagged the FDA’s issues with product hopping, pointing to the propensity of some companies to swap one drug’s entire market to a completely different dosing regimen, when it was unnecessary to do so.

‘Forestalling competition’

Woodcock said that product hopping “has the practical effect of forestalling competition notwithstanding the fact that the prior product (for which generic, biosimilar, or interchangeable competition has become available) remains safe and effective”.

To combat these failings, Woodcock suggested that the USPTO foster greater collaboration with the FDA to support its “ability to accurately and fairly grant patent term extensions”.

She also urged patent examiners to spend more time assessing complex pharmaceutical patents and suggested that the USPTO become more transparent when providing information about its decision-making.

Woodcock wrote that the FDA was particularly keen to gather data on the effect of USPTO  proceedings on Orange Book-listed patents and/or patents covering biological products.

This intervention comes in the wake of a similar entreaty by the health and human services secretary, Xavier Becerra, who sent a letter to the USPTO addressing the issue of soaring drug costs on Thursday, September 9.

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