Biosimilars ruling has implications for future patent challenges

Biosimilars/News | Posted 15/11/2013 post-comment0 Post your comment

Biosimilars manufacturers may not be able to make early challenges on biologicals patents according to a ruling which rejected Sandoz’s request to invalidate patents for Amgen’s blockbuster autoimmune disease treatment Enbrel (etanercept). This appears to be the first court decision interpreting the patent litigation provisions of the Biologics Price Competition and Innovation Act (BPCI Act).

Patent 2 V13E31

Enbrel is a tumour necrosis factor (TNF) inhibitor that is approved to treat rheumatoid, juvenile rheumatoid and psoriatic arthritis, plaque psoriasis and ankylosing spondylitis. Sandoz is carrying out clinical trials on a biosimilar version of Enbrel [1], but has not yet sought US Food and Drug Administration (FDA) approval. Sandoz filed a lawsuit in June 2013 seeking a declaratory judgment that its biosimilar would not infringe Amgen’s patents for Enbrel (US Patent Nos. 8,063,182 and 8,163,522) and that the two patents are invalid and unenforceable. Amgen responded by filing a motion to dismiss for lack of subject matter jurisdiction, arguing that the complaint was premature as Sandoz has not yet submitted its application to FDA and that no case or controversy currently existed.

The US District Court for the Northern District of California granted Amgen’s motion to dismiss Sandoz’s declaratory judgment complaint concerning the Enbrel patents on 12 November 2013. The court argued that Sandoz had not provided a ‘notice of commercial marketing’ because its etanercept product is not yet licensed. Sandoz had argued that it had provided notice of commercial marketing in its opposition brief to the court.

In addition, the court determined that Sandoz failed to establish a ‘case or controversy’, adding that ‘Sandoz’s allegation that it intends in the future to file an application with the FDA is insufficient to create a case or controversy’.

The court’s interpretation of the BPCI Act in this case is significant, particularly since it is the first of its kind. If other district courts interpret the BPCI Act in the same way, it could prevent biosimilars manufacturers from making early challenges on biologicals patents.

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1.  GaBI Online - Generics and Biosimilars Initiative. Sandoz to start phase III etanercept trial []. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Nov 15]. Available from:

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Source: Law360

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