Among the first generation of biosimilar litigation under the Biologics Price Competition and Innovation Act (BPCIA) is a dispute between Amgen and Apotex over Apotex’s proposed biosimilar versions of Amgen’s Neupogen (filgrastim) and Neulasta (pegfilgrastim). That dispute has resulted in the first final judgment in a BPCIA lawsuit. Earlier this month, Judge James Cohn of the Southern District of Florida ruled after a consolidated bench trial addressing both products that Apotex’s biosimilar applications did not infringe Amgen’s sole remaining patent, U.S. Patent No. 8,952,138 (the ‘138 patent). Meanwhile, Apotex, which remains subject to an injunction prohibiting it from marketing its biosimilar products for 180 days after they are approved, has filed a petition for a writ of certiorari to the United States Supreme Court challenging that injunction.
The Amgen v. Apotex litigation began with Amgen’s successful motion for a preliminary injunction requiring Apotex to observe the BPCIA’s 180-day notice of commercial marketing period (42 U.S.C. § 262(l)(8)(A)) and remain off the market for 180 days after its biosimilar applications are approved. In July, the Federal Circuit affirmed that injunction, holding that the 180-day notice of commercial marketing period is always mandatory, even when the biosimilar applicant complies with the information-exchange provisions of the BPCIA. As a result, Apotex is prohibited from marketing its proposed biosimilar products for 180 days after they are licensed for sale. The FDA has not yet approved either of Apotex’s proposed biosimilars.
Meanwhile, while Apotex’s appeal of the injunction was before the Federal Circuit, the district court litigation between Amgen and Apotex proceeded on an expedited basis, culminating in a bench trial in July. Because one of the two then-remaining patents expires in December 2016, the Federal Circuit’s 180-day ruling narrowed trial to a single patent, the ‘138 patent. The ‘138 patent is directed to methods for refolding proteins made in non-mammalian cells at high concentrations. After hearing testimony from both sides’ expert witnesses and reviewing the manufacturing information contained in Apotex’s biosimilar applications, the district court issued a decision earlier this month concluding that Apotex manufacturing processes did not infringe the patent. The district court found that the protein concentrations in Apotex’s processes were not as high as those required by the patent and therefore did not infringe the elements of the asserted claims requiring specific protein concentrations. The court also found that Apotex’s redox buffer, which the parties agreed did not literally meet the redox element of the ‘138 patent, was not equivalent to the claimed redox component. Having found that Apotex did not infringe the ‘138 patent, the court dismissed Apotex’s invalidity counterclaim without prejudice.
With its loss at the Federal Circuit on the 180-day injunction and its victory at the trial court level on patent infringement, Apotex will be able to market its filgrastim and pegfilgrastim biosimilar products 180 days after they are approved.
On September 9, Apotex filed a petition for writ of certiorari in the Supreme Court challenging the Federal Circuit’s interpretation of the BPCIA’s notice of commercial marketing provision. Apotex’s petition asks the Supreme Court to hear its case along with Sandoz’s pending challenge to the Federal Circuit’s earlier decision in Amgen v. Sandoz, which held that Sandoz, which had failed to follow the BPCIA’s “patent dance” procedures, had to observe the 180-day post-approval notice of commercial marketing period. As it did in its appeal to the Federal Circuit, Apotex contends in its petition that that the 180-day period should not be mandatory when the biosimilar applicant follows the statutory procedures, as Apotex did.
Last June, the Supreme Court called for the views of the Solicitor General on Sandoz’s petition. The Solicitor General has not yet weighed in. Although the two petitions are on different timetables, it is likely that the Solicitor General will address (or be asked to address) Apotex’s petition in its submission.