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On July 21 the US Court of Appeals for the Federal Circuit ruled in Amgen v Sandoz that biosimilar applicants can opt out of the ‘patent dance’. Courtenay Brinckerhoff of Foley & Lardner considers the decision’s implications for the biosimilars framework and highlights the questions that remain unanswered.
When Congress enacted the Biologics Price Competition and Innovation Act (BPCIA) in 2009 to create an abbreviated pathway for biosimilar product approval, it included complicated provisions for resolving patent infringement disputes. In March this year, the US Food and Drug Administration (FDA) approved the first biosimilar product, and the US Court of Appeals for the Federal Circuit then had to decide whether those provisions are mandatory or optional.
On July 21, in Amgen v Sandoz, the federal circuit held that the provisions are optional, although a biosimilar applicant that opts out may be subject to an immediate patent infringement suit. The court also held that biosimilar applicants must give 180 days prior notice of commercial marketing, and cannot do so until the biosimilar product has been approved by the FDA.
The Neupogen biosimilar dispute
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Amgen v Sandoz, biosimilar, Foley & Lardner, BPCIA, FDA, DNA, RPS,