On February 15, 2017, Genentech
filed suit against Amgen accusing Amgen of failing to adequately disclose its
manufacturing process to Genentech despite agreeing to engage in the biosimilar "patent dance.” After the FDA accepted Amgen’s aBLA for a biosimilar version of
Avastin®, Amgen gave notice of the acceptance to Genentech within
the 20 day statutory period. Amgen further
produced only its aBLA, and announced that doing so “satisfie[d] Amgen’s
production obligations under 42 U.S.C. § 262(l)(2)(A),” and took the position
that the sixty-day countdown for Genentech to prepare its list of patents under
§ 262(l)(3)(A) had begun to run. In the
Complaint, Genentech states that it is unable to prepare a list of patents that
Amgen infringes without additional information from Amgen, particularly “information that describes the process or
processes used to manufacture the biological product that is the subject of
such application.” 42 U.S.C. §262(l)(2)(A).
Genentech seeks immediate relief from
the court since “if Genentech fails to list a patent, it could be barred
permanently from asserting that patent against Amgen’s biosimilar Avastin®.”
Genentech
further states that it identified for Amgen the following categories of
information relevant to antibody manufacturing patents in Genentech’s portfolio,
and provided Amgen with exemplary Genentech patents that were potentially implicated:
•
Characterization of the complete genome and phenotype of host cells used to
manufacture bevacizumab;
• Composition of
all cell culture media, including the amounts of each component of the media;
• For each
attempt by Amgen to culture cells transformed with DNA encoding bevacizumab,
all information concerning the extent and nature of glycosylation of
bevacizumab (for example, relative percentages of different glycoforms of bevacizumab);
• Parameters
monitored during any attempt by Amgen to culture cells transformed with DNA
encoding bevacizumab;
• All
information concerning any sparging of the pre-harvest or harvested culture
fluid;
• Protein A
chromatography parameters, including the compositions and properties of all
buffers used in the process;
• From each
attempt by Amgen to purify bevacizumab using Protein A chromatography,
information concerning the temperature of the material loaded onto the column
and the temperature of the column;
• Cation
exchange chromatography parameters, including the compositions and properties
of all buffers used in the process, the amount of antibody loaded onto the
cation exchange resin, the volume of the cation exchange resin, and column
regeneration procedures;
• Anion exchange
chromatography parameters, including the compositions and properties of all
buffers used in the process;
• From each
attempt by Amgen to purify bevacizumab, measurements of the amount of
bevacizumab monomer and amounts of bevacizumab dimers and multimers, before and
after cation or anion exchange chromatography;
• All parameters
concerning any viral inactivation steps or protocols, including all information
concerning the effects of such processes on the stability of bevacizumab;
• All
information concerning the ABP 215 formulation and its development, including
any experiments performed with excipients other than those found in ABP 215;
• All
information concerning the filling of vials to manufacture the ABP 215 drug
product; and
• All
information concerning the use of tangential flow filtration, including the
processes used to adjust buffer concentrations.
Genentech seeks information from Amgen regarding the
above manufacturing processes before it provides Amgen a list of patents that Amgen possibly infringes.
According to Genentech, the issue in this case is
different from Amgen Inc. v. Sandoz Inc., 794 F.3d 1347 (Fed. Cir. 2015), cert.
granted, ___ U.S. ___, 2017 WL 125662 (Jan. 13, 2017), where the Supreme Court
will decide whether a biosimilar applicant can opt out of the BPCIA information
exchanges altogether, and if so what are the consequences.
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