Amgen loses at CAFC in filgrastim case

Sandoz prevailed against the appeal of Amgen at the CAFC:


Amgen Inc. and Amgen Manufacturing Ltd. (collectively, “Amgen”)
appeal from two decisions of the United
States District Court for the Northern District of California
in two patent infringement actions brought by Amgen under
the Biologics Price Competition and Innovation Act
(“BPCIA”), 42 U.S.C. § 262 (2012). The court construed
claims of U.S. Patents 6,162,427 (the “’427 patent”) and
8,940,878 (the “’878 patent”), Amgen Inc. v. Sandoz Inc.,
No. 14-CV-04741-RS, 2016 WL 4137563 (N.D. Cal. Aug. 4,
2016) (“Claim Construction Order”), and granted summary
judgment of noninfringement of claim 7 of the ’878 patent
by Sandoz’s filgrastim biosimilar and its proposed pegfilgrastim biosimilar,
Amgen Inc. v. Sandoz Inc., 295 F. Supp.
3d 1062, 1064 (N.D. Cal. 2017) (“Decision”). We conclude
that the district court correctly construed the claims and
granted summary judgment of noninfringement of claim 7.
The judgment of the district court is therefore affirmed.



The technical area:


Amgen created and commercialized two related biologic products,
filgrastim (marketed as Neupogen®) and
pegfilgrastim (marketed as Neulasta®), indicated for treating neutropenia,
a deficiency of white blood cells. Neutropenia often results from exposure to certain
chemotherapeutic regimens or radiation therapy during
cancer treatment. Filgrastim is a recombinant analog of
granulocyte-colony stimulating factor (“G-CSF”), a naturally-occurring
human glycoprotein that stimulates the
production of neutrophils and stem cells and their release
into the bloodstream.



A legal issue was "sequence of steps":


We reject this [Amgen's] argument for two reasons.

First, as in Mformation, the claim language logically requires that the process steps,
lettered (a) through (g), be performed in sequence.
For example, expressing the protein in a nonmammalian cell
(limitation (a)) obviously must occur before the step of lysing
that cell (limitation (b)). There is no
indication on the face of claim 7 that the washing and
eluting steps are any different. Second, washing and eluting
are consistently described in the specification as separate
steps performed by different solutions. See ’878 patent col.
10 ll. 44–46 (“After the separation matrix with which the
protein has associated has been washed, the protein of interest is eluted from the matrix using an appropriate solution.”), c