A procedural note: the case was also distributed on November 21 for consideration at the Supreme Court’s private conference on December 9. Given the date when Amgen filed its opposition, the case would ordinarily have been considered in January, but was distributed early because Apotex waived the fourteen-day waiting period for distribution. This means that, even if the Acting Solicitor General files his long-awaited amicus brief in Sandoz v. Amgen soon, the Court will have the opportunity to consider Apotex’s petition at least once before Sandoz v. Amgen is ready for consideration again.
In its reply, Apotex argues that the case is not moot and the issues were properly preserved. Apotex also contends that the Federal Circuit’s decision was contrary to the text and purpose of the BPCIA and was not required by the Federal Circuit’s holding in Sandoz. Finally, Apotex offers several reasons why the case presents questions of significant national importance.
At the threshold, Apotex claims that the district court’s entry of a permanent injunction does not moot Apotex’s appeal—which stems from an earlier preliminary injunction—because the permanent injunction was based on the Federal Circuit’s holding affirming the original preliminary injunction. Apotex also points out that preliminary injunctions in this context would evade review given the pace of proceedings in the lower courts. Therefore, Apotex says, unless the Supreme Court addresses this case and the Federal Circuit’s precedent, biosimilar manufacturers will be subject to unjust preliminary injunctions and duplicative appeals. Apotex also maintains that its arguments have been “made clear from the commencement of this litigation.”
On the merits, Apotex argues that the Federal Circuit’s decision upsets the statutory balance by “placing a thumb on the scale in favor of reference product sponsors.” Essentially, Apotex says that the statute provides for notice either by information exchange or by notice of commercial marketing, and requiring both would be redundant. Apotex also draws comparison to the Hatch-Waxman framework to argue that forcing biosimilar applicants to wait for FDA approval before providing notice is an unnecessary delay, if notice is mandatory. As for Sandoz, Apotex contends that the Federal Circuit overreached in applying its earlier holding to a distinct factual situation under the BPCIA, because Apotex engaged in the information exchange under (l)(2)(A) while Sandoz did not. Lastly, Apotex says that “shall” in (l)(8)(A) should be read consistently with (l)(2)(A) from Sandoz as not creating a mandatory obligation.
Finally, Apotex makes a couple of policy arguments. According to Apotex, Congress expected that shorter exclusivity periods would drive cost savings, but in this case, Amgen’s exclusivity period has already lapsed. Responding to the notion that future biosimilar applications will likely come during the reference product’s twelve-year exclusivity period, Apotex says, the FDA cannot currently issue post-dated approvals to address potential exclusivity extensions. And new regulation addressing this issue is unlikely any time soon. Therefore, Apotex contends, requiring notice of commercial marketing creates an undue exclusivity extension beyond the proscribed twelve years.
Big Molecule Watch will continue to follow this case and other litigation involving the BCPIA, so check back for further updates.