Federal Court maintains decision on infliximab patent validity

Home/Policies & Legislation | Posted 23/04/2021 post-comment0 Post your comment

On 21 January 2021 and following appeal, the US Federal Court again found that the patent held by The Kennedy Trust for Rheumatology Research regarding the use of infliximab (Janssen’s Renicade) is valid and infringed by Hospira’s biosimilar, Inflectra.

Patent 1 V13E17

The UK’s Kennedy Trust holds a patent for the combined use of infliximab with methotrexate (MTX) for the treatment of rheumatoid arthritis in patients whose disease was not previously controlled by methotrexate treatment alone. In a litigation that concluded in 2018, the US Federal Court found that Kennedy’s patent was valid and infringed by Hospira Healthcare Corporation’s biosimilar, Inflectra. Following this, the Federal Court of Appeal remitted issues of anticipation and obviousness for reconsideration to the trial judge. However, following this reconsideration, the Federal Court has again found that Kennedy’s infliximab Canadian 630 patent is valid.

During the reconsideration, the Federal Court re-examined three specific matters identified by the Court of Appeal. These related to Anticipation, Obviousness and Obvious to try.

The Court of Appeal raised two concerns regarding the analysis of anticipation in the initial trial. These included the rejection of two prior art references (referred to as ‘the 94 Kennedy Report’ and ‘Higgins’) which were said to be speculative and not focusing on the essential elements of the claims and, the fact that analysis did not address disclosure and enablement distinctly. However, on reconsideration, the Court held that neither piece of prior art disclosed certain essential elements of certain claims. Regarding enablement, the Federal Court held that arriving at the claims was not routine and it would be necessary to undertake a clinical trial to administer infliximab and MTX, and ‘combining MTX with a biologic was risky and something not done’.

The court of Appeal raised concerns over the obviousness of the invention due to the existence of two excluded pieces of prior art – Higgins and an FDA Workshop. However, the Court concluded that the prior art did not render the invention obvious.

Obvious to try
The Court of Appeal highlighted that certain pieces of prior art appeared to suggest that it was an obvious decision to try the invention. However, the Federal Court concluded that Hospira had not shown that the invention was obvious to try.

Despite the negative outcome of the reconsideration, Hospira has appealed the decision and the trial recommenced on 1 February 2021.

Related articles
Canada approves infliximab biosimilar Remsima SC

Infliximab biosimilars for IBD patients – experience from Italy

Five key questions about the patent dance answered

Biosimilars of infliximab

Biosimilars approved in the US


To further enhance the objectives of GaBI in sharing information and knowledge that ensure policies supportive of safe biosimilars use, we are pleased to announce that we will be launching a new section on GaBI Online and GaBI Journal, the ‘Latin American Forum’ (in Spanish) featuring the latest news and updates on research and developments in generic and biosimilar medicines in Latin America.

Register to receive the GaBI Latin American Forum newsletter. Inform colleagues and friends of this new initiative.



Para fomentar los objetivos de GaBI sobre la difusión de información y conocimiento sobre las políticas de apoyo que garantizan el uso seguro de medicamentos biosimilares, nos complace anunciar el lanzamiento de una nueva sección en GaBI Online y GaBI Journal, el ‘Latin American Forum’ (en español), que presentará las últimas noticias y actualizaciones en investigación y desarrollo sobre medicamentos genéricos y biosimilares en Latinoamérica.

Regístrese para recibir el boletín informativo GaBI Latin American Forum. Informe a colegas y amigos sobre esta nueva iniciativa. 

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.

Copyright – Unless otherwise stated all contents of this website are © 2021 Pro Pharma Communications International. All Rights Reserved.

comment icon Comments (0)
Post your comment
Related content
Medicare drug price negotiation: implications
pill bottles V14K20
Home/Policies & Legislation Posted 04/05/2023
New guidance for Medicare Drug Price Negotiation Program
79 MD002389
Home/Policies & Legislation Posted 20/04/2023
FDA and FTC join forces to promote competition in the biological market
23 AA011020
Home/Policies & Legislation Posted 14/04/2023
Most viewed articles
About GaBI
Home/About GaBI Posted 06/08/2009
EU guidelines for biosimilars
EMA logo 1 V13C15
Home/Guidelines Posted 08/10/2010