FDA voices concerns around drug patents and competition

Home/Policies & Legislation | Posted 08/10/2021 post-comment0 Post your comment

On 10 September 2021, acting US Food and Drug Administration (FDA) commissioner Janet Woodcock, sent a letter to the US Patent and Trademark Office (PTO), outlining the agency’s concerns around drug patents and competition.

Patent 1 V13E17

The letter, addressed to US PTO Director Andrew Hirshfield, outlined a number of specific concerns related to anti-competitive behaviour.

Anti-competitive patent activities
The FDA acting commissioner highlighted the issue of ‘continuation patents’, where a company can add follow-on patents to a patented drug which can block competition.

Dr Woodcock stated, ‘the existence of multiple patents increases litigation burdens and potentially delays the approval of generics and the launch of generics and biosimilars and interchangeable biological products’.

AbbVie, the pharmaceutical company that owns the patent for Humira, has been accused of a variety of anti-competitive tactics, including the creation of of ‘patent thickets’, to block competition to their multi-billion dollar drug [1].

In addition, Dr Woodcock highlighted that the practice of patenting slight tweaks to a new drug (such as formulation changes, new delivery systems, or patents claiming additional methods of use) should come under scrutiny.

Product hopping
Dr Woodcock also highlighted the anti-competitive process of ‘product hopping’ whereby some companies effectively switch a drug’s entire market to a new dosing regimen, e.g. immediate to extended release. This can block generics competition and can then create monopolies with new patents.

For example, Actavis (now owned by Teva Pharmaceuticals) and its subsidiary, Forest Laboratories, were found to have launched an extended-release version of their Alzheimer’s drug Namenda and simultaneously delisted the immediate-release version. They have been accused of being anti-competitive under the Sherman Act.
Dr Woodcock highlighted that almost 80% of drugs in the Orange Book for which new patents were listed between 2005–2015, were not new drugs.

PTO-FDA information exchange
In the letter, Dr Woodcock offered that PTO examiners and staff become acquainted with FDA’s databases and expertise so that patent term extensions can be accurately and fairly granted in the future. She also requested further information on the Patent Trial and Appeal Board, specifically regarding post grant and inter partes reviews and their impact on patents listed in the Orange Book or biologicals.

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1. GaBI Online - Generics and Biosimilars Initiative. AbbVie accused of anticompetitive tactics to stop Humira biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Oct 8]. Available from: www.gabionline.net/policies-legislation/AbbVie-accused-of-anticompetitive-tactics-to-stop-Humira-biosimilars

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