Page 62 - A&A Patents&Design Rewind-2016

The Controller, disagreeing with the Applicant, held
that although D1 does not talk about methylcarbamoyl
group and instead suggests acetamido group, D1
suggests that only a moderately sized group can be
accommodated at the para position. Further, it was
held that as per the teachings of D1 groups such
as acetamido (molecular formula C2H4NO) hold
preference in accommodating them at the afore-
mentioned para position. Therefore, in view of the
teachings of D1, the Applicant has selected aryl ring
substituted with methylcarbamoyl particularly for
the para-position. Further, in light of the teachings
of D1, a person skilled in the art will be motivated to
replace the moiety of the US ‘257 compound shown
in rectangle with the hydrogen attached to N of
hydantoin moiety of compound 15 of US ‘981. The
invention was therefore considered obvious.
Section 3(d): As per the Controller, the claimed
compound Enzalutamide is lacking novelty (which is
contrary to the Controller’s finding in respect of the
ground of novelty) and inventive step and therefore
the argument of the Applicant that Section 3(d) is
not applicable as the claimed compound is a new
chemical entity is not acceptable. Accordingly, it was
held that claim 1 falls under the prohibitory ambit of
section 3(d).
Section 3(e): As per the Controller, the invention
fails to show any surprising synergistic effect when
the said compound is used in a composition.
Therefore, the Opponent’s objection of section 3(e)
of the Patents Act was found acceptable.
Insufficiency of disclosure: The ground of lack of
sufficient disclosure was refused as the Controller
found that the impugned invention was sufficiently
disclosed in the patent application. Enzalutamide and
its process for preparation was specifically disclosed
in example 56 . In-vivo data in clinical trials was also 4. That the patent applicant had filed evidence
found to have been provided in the specification.
Section 8: The Controller refused this ground
of opposition and held that the requirements of
Section 8(1) and 8(2) have been complied with. An
objection was also raised by one of the Opponents
on payment of insufficient fees for the claims at
62 | Patents & Design
the time of filing of the application. The Controller
rejected this ground and held that at the time of
entering national phase in India, the Applicant is
allowed to delete claims and pay the fees only for
the remaining claims.
The Applicant filed a writ against the order of the
Controller refusing the grant of the their application.
On 2nd March 2017 As per the Controller, the claimed
the matter was listed compound Enzalutamide is lacking
before the Delhi High novelty (which is contrary to the
Court (DHC) and the
petitioner, made the Controller’s finding in respect
following arguments on of the ground of novelty) and
behalf of the Petitioner:- inventive step and therefore, the
1. That the said order argument of the Applicant that
has been passed in Section 3(d) is not applicable as
gross violation of the the claimed compound is a new
principles of Natural chemical entity, is not acceptable.
Justice; Accordingly, it was held that claim
1 falls under the prohibitory ambit
2. That the Patent of section 3(d).
Application which is the
subject matter of the Writ Petition has been granted
Patent in around 50 countries;
3. Further, the marketing approval has been
granted in around 75 countries;
affidavits of three witnesses including the two
inventors. However, the impugned order grossly
erred in not considering or even referring to the
evidence filed by the patent applicant.
In view of the above, the Hon’ble Judge has issued
notice in the Writ Petition, returnable on 2nd May
2017.
The decision can be accessed at: -
http://ipindiaservices.gov.in/decision/9668-DELNP-
2007-24746/9668delnp2007.pdf