Brinckerhoff Quoted on Amgen v Sandoz Ruling

23 July 2015 Intellectual Property News

Intellectual Property

Partner Courtenay Brinckerhoff was quoted in an Intellectual Property magazine article, “Amgen v Sandoz: BPCIA is a ‘Mystery Inside an Enigma,’” on July 23, 2015. The article discussed the Amgen v Sandoz decision, which ruled that biosimilar applicants can opt out of the U.S. Biologics Price Competition and Innovation Act’s patent resolution procedures and information disclosure/notice-of-commercial-marketing provisions.

Brinckerhoff was quoted saying, “It will be interesting to see if any biosimilar applicants go all in, ante up their biosimilar applications and play along. The court held that 42 USC § 262 (l)(8)(A) is a ‘standalone notice provision’ that requires a biosimilar applicant to give 180-days prior notice of commercial marketing to the reference product sponsor, but must wait to do so until after its biosimilar application is approved.”

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