Federal Circuit rejects Amgen biosimilar discovery request
The US Court of Appeals for the Federal Circuit has rejected a request by Amgen to compel discovery from Hospira over a biosimilar.
In a precedential decision, handed down yesterday, August 10, the Federal Circuit dismissed the appeal, finding that Amgen had failed to satisfy the prerequisites for mandamus and that the court didn’t have jurisdiction.
The dispute arose from the disclosure requirements under the Biologics Price Competition and Innovation Act (BPCIA).
These provisions were recently addressed by the US Supreme Court in Sandoz v Amgen.
For a biosimilar product based on an existing reference biologic product that is already approved, a party may submit an “abbreviated” application under subsection (k) of the statute.
In exchange for this abbreviated pathway, the applicant must fulfil certain obligations, including providing the sponsor with “a copy of the application submitted” under subsection (k), “and such other information that describes the process or processes used to manufacture the biological product that is the subject of such application”.
Hospira filed its application with the Food and Drug Administration in December 2014, seeking approval of a biosimilar of Epogen (epoetin alfa).
Epogen, developed by Amgen, is used to treat anaemia caused by chronic kidney disease in patients on dialysis to reduce or avoid the need for red blood cell transfusions.
Hospira provided a copy of its application to Amgen, but didn’t separately provide information concerning the manufacturing process (Hospira argued that such information was disclosed in its application).
Although the parties disagreed over Hospira’s compliance, the parties proceeded to the next phase of the BPCIA’s information exchange by identifying patents subject to suit.
Amgen listed patents that related to the biological product and methods of producing the biological product, rather than the specific cell-culture medium used during its manufacturing process.
Amgen claimed that without information on the cell-culture medium used by Hospira, “Amgen [could not] assess the reasonableness of asserting claims for infringement” with respect to other patents owned by Amgen “that claim processes for culturing cells used in manufacturing biological products”, according to the Federal Circuit.
Hospira was then accused of infringing US patent numbers 5,756,349, and 5,856,298, both owned by Amgen, in a patent infringement lawsuit brought by Amgen at the US District Court for the District of Delaware.
Amgen sought discovery on the composition of Hospira’s cell-culture medium in its suit, but the district court denied Amgen’s motion.
The court concluded that the cell-culture information sought by Amgen had “essentially no relevance to the patents that are asserted”.
Amgen appealed against the district court’s interlocutory order to the Federal Circuit, while Hospira asked the court to dismiss Amgen’s appeal for lack of jurisdiction.
Hospira’s motion was denied, but the court asked the parties to brief “whether this court has jurisdiction pursuant to the collateral order doctrine or under the All Writs Act”.
The doctrine allows “appeals from interlocutory rulings so long as those rulings conclusively decide an issue separate from the merits of the case and would be effectively unreviewable after final judgment”, explained Cornell Law School.
However, the Federal Circuit found that it lacked jurisdiction over Amgen’s appeal under the collateral order doctrine.
“Amgen argues that unless discovery of Hospira’s process is allowed, its right to sue on its cell-culture patents under the BPCIA will be thwarted,” said Circuit Judge Timothy Dyk.
In finding that Amgen hadn’t satisfied the prerequisites for mandamus, Dyk said that the “district court correctly denied Amgen’s motion to compel on the ground that the composition of Hospira’s cell-culture media was of ‘no relevance to the patents that are asserted’”.
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