Page 60 - A&A Patents&Design Rewind-2016
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held that a person skilled in the art would not be Further, the claimed compounds are not derivatives
motivated to select a compound for further research of any known compounds. The process for
from prior art unless the same is enabled or listed preparation of the claimed compounds shows
as a promising compound. Selecting a hypothetical that the claimed compounds are not derived from
compound requires some motive and the Opponent the prior art compounds having 2’methyl (up) or
has not provided any motivation for selecting said 2’-hydroxyl (down) substitutions.
imaginary compound for the inventive step analysis.
The Controller highlighted from prior publications In addition, the
that the person skilled in the art was well aware
of the unpredictability of fluorination on drug Applicant has provided The compounds argued to be
metabolism and the unpredictability of fluorination known substances for the present
using reagents such as DAST and substantial comparative activity case are hypothetical compounds
experimentation would have been required at the which are not exemplified. The
priority date to arrive at the claimed compounds and toxicity data vis- processes described in the prior
which therefore, cannot be obvious. art will not lead to the claimed
à-vis compounds compounds and the Opponent has
Section 3(d) visualized the claimed compounds
The Controller held that the compounds claimed having 2’methyl (up) in the prior art based on hindsight.
are outside the prohibitory ambit of Section 3(d). It A comparison with compounds
was observed that nucleosides and other analogues substitution and which were not in existence on
are known in the art and there is bound to be the priority date is not required.
similarity in core structure of any new nucleoside 2’-hydroxyl (down)
analogue invented by future research. This is not the
same as structural similarity in the field of chemistry. substitution i.e.
Further, if such compounds are considered to be
structurally similar to a known substance or a 2’-C-methylcytidine and
derivative of a known substance then the question
is which substance is the known substance against 2’-C-methyladenosine.
which enhanced therapeutic efficacy has to be
shown. The drug covered
The compounds argued to be known substances for by the claims of the
the present case are hypothetical compounds which
are not exemplified. The processes described in the present application has
prior art will not lead to the claimed compounds and
the Opponent has visualized the claimed compounds shown excellent efficacy
in the prior art based on hindsight. A comparison
with compounds which were not in existence on the as against all known
priority date is not required.
medicines for HCV.
Insufficiency
The Opponents’ arguments on insufficiency remain
unsupported. The specification provides examples,
schemes of synthesis, experimental data, figures,
comparative activity and toxicity data. Therefore,
a person skilled in art will able to perform the
invention in view of the description of the patent
application.
The decision can be accessed at:-
http://ipindiaservices.gov.in/decision/6087-
DELNP-2005-17472/order%206087DELNP2005.pdf
60 | Patents & Design
