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PATENT APPLICATION FOR CANCER DRUG

(ENZALUTAMIDE) REFUSED BY THE INDIAN

PATENT OFFICEive pre-grant oppositions against Indian patent 15 of US ‘981 and Enzalutamide is the FLUORO-
N-METHYLBENZAMIDE moiety at the first
application No. 9668/DELNP/2007, which nitrogen of the thiohydantoin moiety.

Fcovers an anti-cancer drug Enzalutamide,

were decided by the Controller of Patents vide order
dated 8th November 2016. The application was
rejected for lack of inventive step and patentability
under section 3(d) and 3(e) of the Patents Act. The
main claim (claim 1) of the application was directed
to the chemical compound, Enzalutamide:

Claims 2 and 3 were directed to a composition The Controller held that the invention is obvious
and method of preparation of said compound when US ‘981 is seen in view of D1 (J Med Chem.
respectively. 2004 Jul15; 47(15), 3765-16 ) or when US ‘981 is
seen in view of US 6518257 (US ‘257) in combination
with D1. US ‘257 describes a compound of the
following formula:

The highlights of the decision are as follows:-

Novelty: As per the Controller, none of the cited The Opponent contended cited document, J Med
documents, specifically discloses the structure of Chem. 2004 Jul15; 47(15), 3765-16, (D1) motivates
the compound, Enzalutamide in either a claim the selection of fluoro-N-methylbenzamide.
or in an example and therefore the same is novel.
The person skilled in the art will have to pick The Applicant argued that the Opponent’s
suitable substituents from the definition given in the suggestion was based on hindsight. It was alleged
Markush structures of the prior art and place them that the Opponent had incorrectly equated
suitably to arrive at the structure of the claimed the acetamido (-NHCOCH3 in D1) functional
compound, Enzalutamide. This type of picking and group with the methyl carbamoyl (-CONHCH3
placing is not allowable for determining the issue of in Enzalutamide) functional group. Further, it
novelty. The Controller therefor held the claims was argued that D1 teaches compounds having a
to be novel. bicalutamide core structure wherein the ‘SO2’
group is replaced with oxygen ‘O’ and different
Inventive step: US 5441981 (US ‘981), one of substitutions on the phenyl ring are introduced.
the prior art documents, cited by the Opponent
discloses a compound of example 15 which is
represented herein below:

The difference between the compound of example

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