Wednesday, June 17, 2015

Teva case arises in Cephalon v. Celgene

Acusphere, Inc. is the assignee of U.S. Reissued
Patent No. RE40,493 (“the ’493 patent”), titled “Porous
Paclitaxel Matrices and Methods of Manufacture
Thereof.” Acusphere, Inc., and its exclusive licensee
Cephalon, Inc., sued Celgene for infringement of the ’493
patent based on Celgene’s Abraxane drug product, which
contains a fast-dissolving form of paclitaxel.
Following the district court’s construction
of a number of disputed claim terms,
see Cephalon, Inc. v. Celgene Corp.
, 985 F. Supp. 2d 171 (D. Mass. 2013), Acusphere
stipulated to noninfringement. Acusphere appeals the
district court’s claim constructions of: (1) “nanoparticles”
and “microparticles”; (2) “nanoparticles and
microparticles of a taxane”; and (3) “wherein upon
exposure to an aqueous medium, the matrix dissolves to
leave the taxane nanoparticles and microparticles.”
See Appellants’ Br. 2–3. Acusphere stipulated that if any of
the district court’s claim constructions are affirmed, it
cannot sustain its burden of proving infringement of the
’493 patent. J.A. 29.

Of definitions:

The district court construed the term “nanoparticles”
to mean “particles that have a mean diameter of between
about 1 to 1000 nanometers and less than that of
microparticles,” and construed “microparticles” to mean
“particles that have a diameter of betwee
n about 1 to 1000 microns and greater than that of nanoparticles.”
J.A. 28–29;
see also Cephalon, 985 F. Supp. 2d at 175–78. The
district court found these constructions supported by the
“widely accepted definition” of the terms nanoparticles
and microparticles.Cephalon,
985 F. Supp. 2d at 176.

Teva is mentioned:

Acusphere first argues the “‘widely accepted
definition[s]’” of the disputed terms are “not standard
usage.” Appellants’ Br.18 (quoting Cephalon, 985 F.
Supp. 2d at 176). As the United States Supreme Court
has recently instructed, “‘how the art underst[ands] [a]
term . .. [is] plainly a question of fact.’” Teva, 135 S. Ct.
at 838 (quoting Harries v. Air King Prods., Co.
, 183 F.2d 158, 164 (2d Cir. 1950) (Hand, C.J.)). Technical words
“may give rise to a factual dispute” that, “like all other
factual determinations, must be reviewed for clear error.” 837 – 38. The terms “microparticles” and
“nanoparticles” are technical words, and how the relevant
scientific community understands them is therefore a
question of fact reviewable for clear error.
Acusphere fails to establish clear error



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