As per patent office journal dated 12/11/2021, patent number 381262 has been granted to JINA PHARMACEUTICALS, INC. that is titled IMPROVED PHARMACEUTICAL COMPOSITION OF ENDOXIFEN & PREPARATION THEREOF.
The primary independent claim of this patent states a pharmaceutical composition comprises a core, wherein said core comprises endoxifen or pharmaceutically acceptable salt thereof, a sub-coat surrounding the core, an enteric coat surrounding the sub-coat and optionally a color coat surrounding the enteric coat.
During the patent prosecution, the patent examiner objected to this patent under section 3(d) of the Indian Patents Act. The patent applicant responded to this objection by stating that the claimed compound does not pertain to mere forms/derivatives of known compounds. The applicant further submits that the method of preparing the dosage form of endoxifen is also not known. Further, it has been shown that the claimed compositions show enhanced efficacy when compared to endoxifen generated upon tamoxifen administration. Therefore, the present invention does not fall under section 3(d) of the Patents Act.
This patent falls under the category of Pharmaceuticals. Overall, this patent covers a pharmaceutical composition comprising a core, wherein said core comprises endoxifen or pharmaceutically acceptable salt thereof, a sub-coat surrounding the core, an enteric coat surrounding the sub-coat and optionally a color coat surrounding the enteric coat.
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