Amgen Rejects Sandoz’s Offer to Dance Out of Step Under the Biosimilars Act

By Joanna T. Brougher and David A. Fazzolare


Amgen and Sandoz are back at it again, with Amgen filing a complaint in the United States District Court for the Northern District of California, alleging that Sandoz failed to comply with certain “patent dance” provisions under the Biologics Price Competition and Innovation Act (“Biosimilars Act”).

On July 24 2014, Sandoz announced that the FDA had accepted its application for review of a biosimilar version of Amgen’s Neupogen® (filgrastim) drug. Under § 262(l) of the Biosimilars Act, once the FDA accepts a biosimilar application for review, the biosimilar applicant must provide the reference product sponsor with “information that describes the process or processes used to manufacture the biological product” that is subject to FDA review. Amgen’s complaint alleges that Sandoz failed to provide any information regarding the manufacturing process of Sandoz’s biosimilar drug.  In particular, Amgen alleges that Sandoz sent a letter to Amgen on July 8, 2014 proposing an alternative method to the patent dance that would not require Sandoz to supply Amgen with any manufacturing process information. Amgen rejected Sandoz’s offer for an alternative patent dance procedure and did not receive the manufacturing process information from Sandoz by the July 28, 2014 deadline.  On October 20, 2014, Sandoz sent Amgen a letter reminding Amgen that Sandoz’s July 8 letter served as a 180-day notice of commercial marketing for the biosimilar drug, which is required under the Biosimilars Act.

Amgen’s lawsuit against Sandoz included patent infringement, unfair competition and conversion claims. Among other forms of relief, Amgen is seeking to obtain an injunction that would prevent the FDA from approving Sandoz’s biosimilar drug for marketing until Sandoz has complied with the patent dance requirements.

On October 29, 2014, just five days after Amgen filed its complaint against Sandoz, Amgen also filed a Citizen Petition with the FDA requesting that biosimilar applicants be required to certify that they will comply with the patent dance procedures under the Biosimilars Act.  In the petition, Amgen emphasizes that failure to comply with the patent dance framework “vitiates the entire scheme that Congress created.” However, Amgen’s Citizen Petition only applies to biosimilars that have not yet been accepted by the FDA for review, which means that the petition would not apply to Sandoz’s biosimilar Neupogen® application since that application has already been accepted by the FDA for review.

Regardless, Amgen’s recent complaint against Sandoz and Amgen’s Citizen Petition both have the potential to significantly impact the fate of generic biologic drug approvals in the United States going forward.

For more information on this topic, contact David or Joanna

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