BPCIA Notification Provision Takes Center Stage in Two Federal Cases

Notification requirements under the federal biosimilars law are getting renewed attention with two recent court filings: one, a petition to the U.S. Supreme Court, and the other an amicus brief before the U.S. Court of Appeals for the Federal Circuit.

The high court petition comes from generic drugmaker Sandoz, which is asking the court to settle its patent dispute with Amgen over requirements under the Biologics Price Competition and Innovation Act. The amicus brief comes from the Biotechnology Innovation Organization in support of Amgen in a patent dispute with Apotex that focuses on a related issue under the BPCIA.

Sandoz’ Feb. 16 petition asks the Supreme Court to overturn a lower court ruling that requires the drugmaker to obtain FDA approval for a biosimilar before it can go to market. The petition argues that a three-judge panel from the federal circuit erred in concluding that FDA approval was a prerequisite for fulfilling the notification requirements under the Biologics Price Competition and Innovation Act.

While the BPCIA mandates that Sandoz give Amgen six months advance notice before marketing a biosimilar of the company’s bone marrow drug Neupogen (42 U.S.C. §262(l)(8)(A)) — which the company did in July 2014 — the appellate panel interpreted the law to mean that the six months’ notice must come after Sandoz secures FDA approval.

Sandoz objects to the panel’s interpretation, saying that it automatically gives reference product holders an additional six months of exclusivity and disregards “the only remedy provided by Congress: the right to initiate patent litigation.”

Sandoz has since secured FDA approval for the biosimilar — named Zarxio — but has a vested interest in speeding biosimilars’ entry to market, with five biosimilar products currently in its pipeline, according to its website.

High Court Unlikely to Hear Case

An intellectual property attorney says that in spite of the industry-wide implications of the case, the high court is unlikely to accept Sandoz’ petition. Timothy Shea Jr., a director at Sterne, Kessler, Goldstein & Fox, says the Supreme Court usually doesn’t accept petitions on statutory cases unless they involve transformative issues or there are conflicting rulings in the lower courts.

“The court may just let this issue stand and percolate until there does become a clear need for the Supreme Court to rule on it,” he tells Generic Line.

If the court does refuse to hear the petition, he says that will reinforce the importance of the appellate panel’s decision and ensure that the court’s mandate for FDA approval prior to notification will become “the law of the land.”

He adds that while this will hit biosimilars producers the hardest, such an outcome would be something of a double-edged sword for industry, given that many branded drugmakers also are dabbling in biosimilars.

In an amicus brief filed Feb. 18, BIO sides with Amgen in a patent dispute with Apotex, arguing that the generic drugmaker should give notice of FDA acceptance of an application when attempting to produce a biosimilar that mimics an Amgen product.

BIO: Revisit Panel Decision

BIO contends that the federal circuit should revisit the panel decision in the Sandoz case, which concluded in part that a requirement for biosimilar makers to warn patent holders before they attempt to market a competing biosimilar is merely optional (42 U.S.C. § 262(l)(2)(A)).

At issue is a lawsuit Amgen filed in August, contending that Apotex’s plans to market a generic version of Neulasta infringes two of the company’s patents for the drug. Apotex initially followed the BPCIA by informing Amgen that it was filing an aBLA to market a biosimilar of Neulasta. However, it refused to give Amgen notice when it received FDA approval on the grounds that Apotex considers that provision within the law to be merely optional.

In its brief, BIO argues that the notification provision post-FDA approval “is an integral part of the balance achieved by the BPCIA, and it furthers Congress’ goal of ensuring that the parties can resolve any patent disputes prior to the launch of the biosimilar product.”

“The commercial marketing notice provision cannot meaningfully serve its intended function, however, if, as Apotex argues in this case, applicants are in many circumstances free to ignore it,” the brief states.

BIO’s brief also references the six-month window, but in the context of companies that have flouted the 20-day disclosure requirement, noting that “(l)(8)(A) on its face does not differentiate between applicants who have complied with paragraph (l)(2)(A) and those who have not.”

Read Sandoz’ petition here: www.fdanews.com/02-17-16-Petition.pdf.

Read BIO’s brief here: www.fdanews.com/02-17-16-AmicusBrief.pdf. — Cameron Ayers



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