Granisetron – USA

Granisetron – USA

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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