On Dec. 11, 2019, Federal Circuit (Rule 36 judgment) upheld
a Texas court’s decision that Actavis' proposed generic version of Sancuso®
infringes the transdermal composition patent.
The sole patent at issue, US 7,608,282 covered the
transdermal patch which enabled the administration of granisetron through an
acrylic adhesive of certain specifications.
Claim 1 reads:
1. An adhesive patch suitable for the transdermal administration of
granisetron to a subject in need thereof, said patch comprising: an acrylic
adhesive consisting essentially of:
50 to 98% w/w of a primary acrylate monomer wherein said primary acrylate
monomer is either 2-ethylhexyl acrylate
or butyl acrylate, and 0.5 to 20% w/w of a monomer containing non-acidic hydroxyl moieties, and a
physiologically effective amount of granisetron loaded in the acrylic adhesive,
wherein the granisetron content of said patch remains substantially unchanged
when stored at 250C for six weeks.
District court decision summary:
Plaintiffs ProStrakan, Inc. and Strakan International (“ProStrakan”)
filed suit against Defendant
Actavis Laboratories UT,
Inc. (“Actavis”) for infringement of US ‘282 patent as Actavis sought approval of
its ANDA. Actavis used Duro-Tak® 387 2287 acrylic adhesive in its patch.
Duro-tak is a random copolymer of
2-ethylhexyl acrylate (68.2%),
vinyl acetate (26.5%),
2-hydroxyethylacrylate (5.2% ) and glycidyl methacrylate (0.15%). The 2-ethylhexyl acrylate (68.2%) present
in the Duro-Tak® 387-2287 of Actavis’s Accused Product satisfies the feature of
claim 1 that requires “50 to 98% w/w of a primary acrylate monomer wherein said
primary acrylate monomer is either 2-ethylhexyl acrylate or butyl acrylate.” The 2-hydroxyethyl acrylate
(5.2%) present in
Duro-Tak® 387-2287 that
is used to prepare Actavis’s Accused Product satisfies the feature of
claim 1 that requires “0.5 to 20% w/w of a monomer containing non -acidic
hydroxyl moieties.”
Actavis argued that
its Accused Product
does not infringe
claim 1 of the
’282 Patent because Actavis’s Accused Product: (1) administers granisetron at a
greater or lesser rate than disclosed in
the ’282 Patent; (2) has a greater or lesser granisetron stability than that disclosed
in the ’282 Patent; and/or (3) provides less than the complete release of
granisetron. However, Court said that Actavis’s Accused Product does not show
a substantial difference
in any of
the rate of transdermal delivery
of granisetron, the stability of granisetron, and/or the
complete release of granisetron as compared to either the data set forth in the
’282 Patent and/or Sancuso®. Court also said that there is no evidence to
support Actavis’s argument that its Accused Product does not infringe claim 1
of the ’282 Patent because the acrylic adhesive used in its Accused Product includes additional unclaimed monomers (or
other materials) that materially affect
the basic and
novel properties of its
patch Accused Product. As
construed by the
Court, the term
“consisting essentially of”
merely requires that no additional materials present in the acrylic
adhesive have a material effect on the basic and novel properties of the
claimed invention. Last, there is neither evidence to support a finding, nor
did Actavis assert, that any additional unlisted ingredients such as ethanol,
ethyl acetate, the release liner, or backing layer used in Actavis’s Accused
Product materially affect the basic and novel properties of the claimed patch, as
construed by the Court. Thus, Actavis product infringes the asserted claims.
The Court with respect to Invalidation concluded
that the prior art neither anticipated certain claims of the patent nor
rendered them obvious.
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