Amgen wins biosimilars case against Apotex at Federal Circuit

The US Court of Appeals for the Federal Circuit ruled yesterday in the Amgen v Apotex case that bisoimilars companies must always notify brand name rivals 180 days before launching their products.

The appeal was an outcome of Amgen suing Apotex under the Biologics Price Competition and Innovation Act (BPCIA) of 2009, after Apotex had applied for permission to begin marketing a biosimilar of Amgen’s Neulasta (pegfilgrastim), used to prevent the risk of infection when undergoing chemotherapy.

Amgen sought a preliminary injunction to enforce a provision of the BPCIA requiring a biosimilar product applicant to give 180 days’ notice before commercially marketing its US Food and Drug Administration (FDA)-licensed product.

Following the recent Amgen v Sandoz case, the court agreed with Amgen as it held that the 180-day period runs from giving notice of FDA approval.

The court affirmed in the Amgen v Sandoz case that the commercial marketing provision is mandatory, with the 180-day period beginning only after giving notice, but that the patent dance was not obligatory.

Apotex argued in the latest case that the commercial marketing provision is not mandatory and may not be enforced by an injunction because it, unlike Sandoz, did launch the statutory process for exchanging patent information.

The court, however, disagreed, and stated that the commercial marketing provision is mandatory and enforceable by an injunction.

“In Amgen v Apotex, the Federal Circuit stood by its interpretation of the 180-day pre-marketing notice requirement of the BPCIA, holding that the requirement applies to all biosimilar applicants, even those who participated in the ‘patent dance’ process,” said Courtenay Brinckerhoff, partner at law firm Foley & Lardner.

Brinckerhoff added: “The court emphasised that the BPCIA created a ‘two stage’ patent litigation process, and found that the 180-day pre-marketing notice is essential to the second stage, because it ‘gives the reference product sponsor time to assess its infringement position for the final FDA-approved product as to yet-to-be-litigated patents’, and ‘gives the parties and the district court the time for adjudicating such matters without the reliability-reducing rush that would attend actions for requests for relief against immediate market entry that could cause irreparable injury’.”

She continued: “It will be interesting to see if the FDA interprets and implements § 262(k)(7)(A) [of 42 USC] in line with the Federal Circuit’s suggestion, and if that interpretation is upheld by the US Court of Appeals for the District of Columbia, which is the appellate court most likely to review the FDA’s interpretation of that statute.”