FDA voices concerns around drug patents and competition

Generics and biosimilars Initiative

Building trust in cost-effective treatments

Inscribirse
eng / esp

FDA voices concerns around drug patents and competition

INICIO/Políticas y legislación | Posted 08/10/2021 0 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.

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.

Related articles
A new dawn for China’s patent law

US Supreme Court rejects Enbrel patent challenge from Sandoz

Federal court maintains decision on infliximab patent validity

FDA issues final guidance on petitions delaying generics

LATIN AMERICAN FORUM The new section of the ‘Latin American Forum’ on GaBI has been launched. The objective of this new section is to provide you with all the latest news and updates on developments of generic and biosimilar medicines in Latin America in Spanish. View this week’s headline article: Requisitos de certificación de BPF en Chile, Cuba y Venezuela Browse the news in the Latin American Forum! Register to receive the GaBI Latin American Forum newsletter. Inform colleagues and friends of this new initiative. LATIN AMERICAN FORUM Se ha lanzado la nueva sección del ‘Foro Latinoamericano’ sobre GaBI. El objetivo de esta nueva sección es brindarle las últimas noticias y actualizaciones sobre desarrollos de medicamentos genéricos y biosimilares en América Latina en español. Vea el artículo principal de esta semana: Requisitos de certificación de BPF en Chile, Cuba y Venezuela Explore las noticias en el Foro Latinoamericano! Regístrese para recibir el boletín informativo GaBI Foro Latinoamericano. Informe a colegas y amigos sobre esta nueva iniciativa.

Reference
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

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.