On Mar 25, 2020, Federal Circuit affirmed-in part infringement of
Chang patents & revesed-in part district court’s decision of Ashley
II Patents.
In March 2016, Plaintiffs Galderma filed suit against Defendants
Amneal as defendants sought to bring to market a generic version of Plaintiffs’
Oracea® Capsules, a once-daily 40 milligram administration of doxycycline for
the treatment of the papules and pustules of acne rosacea. Plaintiffs alleged
infringement of U.S. Patent Nos. 8,206,740 (“Chang ’740 patent”); 8,394,405
(“Chang ’405 patent”); 8,470,364 (“Chang ’364 patent”); 7,749,532 (“Chang ’532
patent”) (collectively, the “Chang
patents”); 7,211,267 (“Ashley ’267 patent”); 7,232,572 (“Ashley ’572
patent”); (collectively, the “Ashley I patents”);
8,603,506 (“Ashley ’506 patent”); and 9,241,946 (“Ashley ’946 patent”)
(collectively, the “Ashley II patents”).
The Chang and Ashley patents are generally directed to low-dose doxycycline
formulations for the treatment of the papules and pustules of acne rosacea.
Specifically, the Chang patents describe “pharmaceutical composition[s] of
doxycycline that contain[] an immediate release (IR) component of the drug and
a delayed release (DR) component of the drug, which are combined into one
dosage unit for once-daily dosing.” The asserted claims of the Ashley patents
generally cover methods of treating acne or rosacea by oral administration of a
low daily dose doxycycline. Following bench trial District court found
infringement of Chang patents & Ashley II patents & non-infringement of
Ashley I patent. You can read the summary “reported here” on this blog.
Chang
patents:
Claim 1 of the ’740 patent is illustrative:
1. An oral pharmaceutical composition of doxycycline, which
at a once-daily dosage will give steady state blood levels of doxycycline of a
minimum of 0.1 μg/ml and a maximum of 1.0 μg/ml, the composition consisting of
(i) an immediate release (IR) portion comprising 30 mg doxycycline; (ii) a
delayed release (DR) portion comprising 10 mg doxycycline; and optionally,
(iii) one or more pharmaceutically acceptable excipients.
During appeal, Amneal argued that Galderma’s arguments
during the ’740 inter partes review proceedings clearly and unmistakably
surrendered subject matter and therefore preclude a finding that Amneal’s
products infringe the Chang patents under the doctrine of equivalents. Federal
Circuit said that “statements made by a patent owner during an IPR proceeding
can be considered during claim construction and relied upon to support a
finding of prosecution disclaimer” so long as the statements are “both clear
and unmistakable.” [Aylus Networks, Inc.
v. Apple Inc., 856 F.3d 1353, 1361–62 (Fed. Cir. 2017)]. Federal Ciruit said
that what Galderma argued with respect
to “delayed release” construction during IPR was rejected by board. Board
clearly put the public on notice that the meaning of delayed release with
respect to the Chang Patents is not limited to formulations requiring that
there be no substantial release in the stomach. Accordingly, Federal Ciruit saw
no error in the district court’s conclusion that Galderma was not precluded by
these statements from asserting the doctrine of equivalents.
Now turning to the merits, Federal Circuit said that Amneal’s
product is manufactured by layering doxycycline such that doxycycline releases
at various intervals. Because a portion is prevented from releasing
immediately, such later-releasing portion of doxycycline occurs “at a time
other than immediately following oral administration” as construed by District
court with respect to term “delayed release”. Therefore, this later-releasing
portion, “in combination with [the DR portion of doxycycline], is
insubstantially different from the 10 mg DR portion claimed in Chang.” Thus, district
court did not clearly err in finding infringement under the doctrine of
equivalents with respect to the Chang Patents.
The Ashley
II patents:
Claim 15 of the ’506 patent is illustrative:
15. A method for treating papules and pustules of rosacea in
a human in need thereof, the method comprising administering orally to said
human doxycycline, or a pharmaceutically acceptable salt thereof, in an amount
of 40 mg per day, wherein the amount results in no reduction of skin
microflora during a six-month treatment, without administering a
bisphosphonate compound.
The district court construed “wherein the amount results in
no reduction of skin microflora during a six-month treatment” as “wherein the
amount results in no reduction of skin microflora vis-à-vis a placebo control
during a sixmonth treatment, with microbiological sampling at baseline and
month six.” It found that Amneal’s product infringes the asserted claims of the
Ashley II Patents under the doctrine of equivalents.
Amneal argued that allegations of infringement under the
doctrine of equivalents require “particularized testimony and linking argument
as to the ‘insubstantiality of the differences’ between the claimed invention and
the accused . . . process, or with respect to the function, way, result test .
. . evidence must be presented on a limitation-by-limitation basis.” Amneal said
that argument presented by Galderma was related to the “sub-antibacterial
amount” limitation of the Ashley I patents and the record does not support that
it “applies equally to the overlapping subject matter of the ‘skin
microflora’ terms” here. Galderma did not present particularized testimony
and linking argument as to the reduction in skin microflora term. Rather, it
presented testimony with respect to the “sub-antibacterial amount” limitation
of the Ashley I patents and, now attempting to link it to the “skin microflora”.
Because the record wholly lacked the requisite particularized testimony
required to find infringement under the doctrine of equivalents, Federal
Circuit reversed the district court’s judgment.
