The US Court of Appeals for the Federal Circuit on Tuesday affirmed a district court’s ruling that a biosimilar applicant must provide a reference product sponsor with 180 days’ notice before commercial marketing of a biosimilar begins, regardless of whether the applicant provided notice of US Food and Drug Administration (FDA) review.
The ruling has major implications for when biosimilars can be launched and it follows the US Supreme Court’s request in late June that the solicitor general provide more information on whether the highest court in the US should review the terms of this so-called “patent dance,” the rules of which govern how biosimilar and reference product manufacturers must work out their patent issues as established by the Biologics Price Competition and Innovation Act of 2009 (BPCIA).
"With this ruling, regardless of participation, the biosimilar
applicant is required to provide 180-days’ notice prior to first commercial
marketing," Stacie Ropka, an intellectual property attorney with Axinn Veltrop & Harkrider, told Focus. "And, this ruling affirms that effective notice cannot be given
until the biosimilar applicant receives approval (licensure) from FDA.
Since the applicant has some control over the number of patents litigated in
the first phase, which will impact the number of patents that are available for
the second phase of litigation, applicants may have another strategic decision
regarding whether to litigate early or late."
The case at hand – pitting biologic reference product sponsor Amgen against biosimilar developer Apotex, which is developing a version of a treatment that can help patients make white blood cells after receiving cancer treatment, known as Neulasta (pegfilgrastim) – centered around Apotex’s argument that by complying with the manufacturing and patent information exchanges under the BPCIA, which are part of the so-called “patent dance,” Apotex was allowed to opt out of providing Amgen with the 180-day notice of marketing.
The Generic Pharmaceutical Association’s Biosimilars Council sided with Apotex, arguing that Congress never meant for the 180-day notice provision to add six months of exclusivity to biologics.
And though a prior ruling found that the patent dance is optional, the court also said 180-days’ pre-marketing notice can only be applied after a 351(k) application (required for a biosimilar’s approval) has been approved by FDA.
On 4 February, Amgen filed its reply brief, noting that the 180-day period is designed to allow the reference product sponsor that the biosimilar is based on a discrete period in which to seek preliminary injunctive relief.
“Apotex cannot avoid the requirement of a statute by the specifics of this particular case. Sandoz, too, touted the peculiarities of its own position as a reason not to give 180 days’ notice, but the panel majority rejected this: ‘A statute must be interpreted as it is enacted, not especially in light of particular, untypical facts of a given case,’” Amgen said.
“The 180-day notice period would apply to Apotex even if it were right that Amgen had no additional patents on which to seek a preliminary injunction. It is, as this Court held in Amgen v. Sandoz, a standalone provision,” Amgen said.
Industry group BIO also filed an amicus curiae brief in support of Amgen, noting: “The BPCIA’s provision requiring biosimilar applicants to provide notice of commercial marketing following 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.”
Tuesday’s opinion from the Federal Circuit further affirms Amgen’s stance against Apotex.
“In Amgen v. Sandoz, we held that the commercial-marketing provision is mandatory, with the 180-day period beginning only upon post-licensure notice, and that an injunction was proper to enforce the provision against Sandoz, a biosimilar-product applicant that had entirely skipped the statutory process of information exchange and patent-litigation channeling,” the opinion says. “Apotex argues that a different result is required here—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 and channeling patent litigation. We reject the asserted distinction. We hold that the commercial-marketing provision is mandatory and enforceable by injunction even for an applicant in Apotex’s position.”
The court also says that Apotex’s argument that the decision effectively extends, by six months, the 12-year exclusivity period given to a reference product sponsor has no merit, and that the statute “establishes the 12-year date only as an earliest date, not a latest date, on which a biosimilar license can take effect.”
And the court seems to believe that this additional six months of exclusivity will be slowly reduced as more biosimilar applications are filed.
“Moreover, it is implicit in the Biologics Act that any such delay beyond 12 years should occur less and less as time goes by. Doubtless, there will be some exclusivity periods beyond 12 years in the early years of the Biologics Act, as biosimilars are introduced for reference products licensed well before the Act was adopted in 2010. But as time passes, more and more of the reference products will be newer, and a biosimilar-product applicant, entitled to file an application a mere four years after licensure of the reference product, § 262(k)(7)(B), can seek approval long before the 12-year exclusivity period is up,” the opinion says.
“In such circumstances, we have been pointed to no reason that the FDA may not issue a license before the 11.5-year mark and deem the license to take effect on the 12-year date—a possibility suggested by § 262(k)(7)(A)’s language about when the FDA approval may ‘be made effective.’ And we read (8)(A) [the provision of the BPCIA that requires a biosimilar applicant to give notice 180 days before commercially marketing its FDA-licensed product] as allowing the 180-day notice of commercial marketing to be sent as soon as the license issues, even if it is not yet effective, because it is at the time of the license that ‘the product, its therapeutic uses, and its manufacturing processes are fixed,’” the court adds.
United States Court of Appeals for the Federal Circuit AMGEN INC., AMGEN MANUFACTURING LIMITED, Plaintiffs-Appellees v. APOTEX INC., APOTEX CORP., Defendants-Appellants