Amgen has filed a complaint under the Biologics Price Competition and Innovation Act (BPCIA), asserting that a biosimilar application filed by Apotex, Inc. infringes two of its patents. Although several complaints have invoked the BPCIA, this may be the first one in which the patent dance provisions have been followed.
The Biosimilar Patent Dance
According to Amgen’s complaint filed in the U.S. District Court for the Southern District of Florida, Apotex filed a Biologic License Application (BLA) seeking FDA approval to market a biosimilar version of Amgen’s Neulasta® (pegfilgrastim) product. Amgen describes pegfilgrastim as “a recombinantly expressed, 175-amino acid form of … human granulocyte-colony stimulating factor (‘G-CSF’) conjugated to a 20 kD monomethoxypolyethylene glycol (m-PEG) at the N-terminus.”
Also according to the complaint:
Beginning in December 2014, the parties engaged in the exchange of information and statements as required by the BPCIA. As a result of these exchanges, the parties have agreed to the inclusion of two U.S. patents in this action: the ’138 Patent [U.S. 8,952,138] and the ’784 Patent [U.S. 5,824,784] (“Patents in Suit”)
(You can read more about the biosimilar patent dance in these articles.)
Independent claim 1 of the ‘138 patent recites:
1. 一种将非哺乳动物表达系统中表达的蛋白质进行重折叠的方法，该蛋白质存在于体积浓度为2.0 g/L或更高的溶液中，包括： (a) 将该蛋白质与重折叠缓冲液接触，该缓冲液包含具有最终硫醇对比值范围为0.001至100的氧化还原组分，其氧化还原缓冲强度为2 mM或更高，并包含以下一种或多种组分：(i) 变性剂； (ii) 聚集抑制剂；以及(iii) 蛋白质稳定剂；以形成重折叠混合物；(b) 培养重折叠混合物；以及(c) 从重折叠混合物中分离蛋白质。
(As a method of manufacture claim, this type of claim could not be listed in the Orange Book.)
Independent claim 1 of the ‘784 patent recites:
1. A substantially homogenous preparation of N-terminally PEGylated G-CSF or analog thereof, optionally in a pharmaceutically acceptable diluent, carrier or adjuvant, said preparation being essentially free of G-CSF or analog thereof PEGylated at sites other than the N-terminus.
The Notice of Commercial Marketing Standoff
Although Amgen and Apotex cooperated in the biosimilar patent dance, it appears that they disagree on the notice requirements of 42 U.S.C. § 262(l)(8)(A). According to Amgen, Apotex “purport[ed]” to give notice on April 17, 2015, even though its product had (and has) not yet been approved. As Amgen notes in its complaint, the Federal Circuit held in Amgen v. Sandoz that notice cannot be given before the biosimilar is approved. But, Sandoz has requested rehearing en banc of that finding, so the issue may not yet be finally resolved.
Patent Litigation Under The BPCIA
Although the BPCIA defines new acts of patent infringement and lays out rules for selecting the patents to be asserted, it does not address how patent litigation under the BPCIA should be conducted. Likely, it will proceed much like other patent litigation, but protective orders may prevent us from following along every step of the way.