South Korean biotechnology company Celltrion filed a lawsuit on 31 March 2014 in a federal court in Massachusetts seeking a declaratory judgement that Janssen Biotech’s (Janssen) remaining patents on the reference drug Remicade (infliximab) are invalid and unenforceable.
The move comes in anticipation of Celltrion filing a marketing approval application for its biosimilar drug Remsima (infliximab) with the US Food and Drug Administration (FDA), which is expected to happen in the first half of 2014. Celltrion expects Remsima to ‘become the first biosimilar of an antibody drug ever approved in the United States’, with FDA approval expected by early 2015.
In its complaint Celltrion argues that ‘Janssen and its affiliates, including its parent company Johnson & Johnson and its predecessor company Centocor, have aggressively sought patents relating to Remicade’. Centocor filed the first patent application related to Remicade back in 1991. Celltrion also claims that Janssen has ‘engaged in manipulative and deceptive practices’ in order to ‘improperly extend the length of its patent monopoly for Remicade’.
Celltrion gained European approval for the world’s first monoclonal antibody biosimilar Remsima/Inflectra (infliximab) in September 2013 as part of its collaboration with US-based generics major Hospira [1]. Since then Celltrion has also gained approval for Remsima in South Korea [2] and Colombia [3], and has applied for approval in Japan [4].
Sandoz filed a similar lawsuit against Amgen and F. Hoffman-La Roche on 24 June 2013 in the Northern District of California. Sandoz was seeking a declaratory judgement of invalidity and non-infringement of two patents relating to Amgen’s psoriasis and arthritis blockbuster Enbrel (etanercept), also before filing a licensure application with FDA. The court, however, granted a motion to dismiss on the basis that ‘neither a reference product sponsor such as Amgen, nor an applicant such as Sandoz, may file a lawsuit unless and until they have engaged in a series of statutorily-mandated exchanges of information’ under the Biologics Price Competition and Innovation Act (BPCIA).
Despite this precedent, Celltrion is hoping to get a decision before it files its biosimilar application for Remsima with FDA. The company is arguing that ‘denying Celltrion the opportunity to litigate declaratory judgement claims now would delay Celltrion’s access to the judicial system for about 10–12 months (and perhaps even longer)’. This, Celltrion argues, would delay the launch of Remsima, and would ‘harm the public interest’ by keeping healthcare costs related to diseases for which Remicade is currently the only available treatment high.
At least three US patents for Remicade ‘purportedly’ extend beyond 2014. Janssen has also ‘publicly asserted’ that its monoclonal antibody has patent protection into 2018 even though the first patents for Remicade were filed ‘more than 27 years [ago] (in 1991)’.
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References
1. GaBI Online - Generics and Biosimilars Initiative. EC approves first monoclonal antibody biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 May 16]. Available from: www.gabionline.net/Biosimilars/News/EC-approves-first-monoclonal-antibody-biosimilar
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilar monoclonal antibody approved in Korea [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 May 16]. Available from: www.gabionline.net/Biosimilars/News/Biosimilar-monoclonal-antibody-approved-in-Korea
3. GaBI Online - Generics and Biosimilars Initiative. Remsima approved in Colombia [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 May 16]. Available from: www.gabionline.net/Biosimilars/News/Remsima-approved-in-Colombia
4. GaBI Online - Generics and Biosimilars Initiative. Celltrion applies for biosimilar infliximab approval in Japan [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 May 16]. Available from: www.gabionline.net/Biosimilars/News/Celltrion-applies-for-biosimilar-infliximab-approval-in-Japan
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