On Nov 15, 2017, Court of appeal for the federal circuit in a
non-precedential opinion affirmed the decision of paten trial & appellate
board (PTAB) which found formulation patent of Teduglutide (Gattex) invalid.
Previously PTAB found NPS pharmaceutical’s U.S.
Patent Number 7,056,886 invalid under obviousness in two IPR proceedings
(IPR2015-00990 & IPR2015-01093).
US’886 claims GLP-2 (teduglutide) composition with
histidine, phosphate buffer &
mannitol /sucrose. PTAB in its decision held that use of histidine &
mannitol was well known in protein formulation and experimentation needed to
confirm successful application with GLP-2 analog was nothing more than routine practice.
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