Page 59 - A&A Patents&Design Rewind-2016
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APPLICATION FOR SOFOSBUVIR SEES LIGHT OF
THE DAYfter a roller coaster ride from the Patent the oppositions. The order was set aside and the
matter was remanded back for a fresh hearing by
Office to the High Court and back to the the Delhi High Court.
APatent Office, the application for Patent Dr. Rajesh Dixit heard the matter at length
between 23rd to 29th February, 2016 and, vide an
for the drug Sovaldi (Sofosbuvir) finally saw the sun order dated 9th May 2016, reversed the previous
on 9th May 2016. The Indian Patent Office upheld order refusing grant. The following are noteworthy
the patent application of Gilead for Sofosbuvir. findings in the decision of the Controller:-
The Deputy Controller of Patents and Designs,
Mr. Rajesh Dixit, in a 58 page order found the Novelty
application for patent to be novel, inventive and The application discloses (2’R)-21-deoxy-2’-fluoro
outside the prohibitory ambit of Section 3(d). (down)-2’-C-methyl (up) nucleosides, as well as
their corresponding monophosphate, diphosphate
The Controller held that the claimed and triphosphate forms. The claimed compounds
compounds which have not be exemplified in require methyl group at the 2’ (up) position and a
any prior art cannot be deemed to be a part fluorine at the 2’ (down) position of the sugar ring
of the prior art. Cherry picking of substituents and a cytosine or uracil base attached to the sugar
from the prior art is not allowed and the ring at 1 position nitrogen in the base ring. The
substituent in the Markush formulae provided Controller noted that this substitution is unique
in the prior arts have to be understood in and there is neither exemplification nor enabling
the context of the invention contained in the disclosure in any of the cited prior art documents,
examples, process for preparation and overall including the closest prior art.
teaching of the document. It was further held
that arbitrary selection of the substituents The Controller held that the claimed compounds
to arrive at hypothetical compounds is not which have not be exemplified in any prior art
possible without hindsight. cannot be deemed to be a part of the prior art.
Cherry picking of substituents from the prior
In January 2015, the Indian Patent office had art is not allowed and the substituent in the
rejected the same application under Section 3(d) Markush formulae provided in the prior arts have
of the Patents Act. Instead of appointing hearings to be understood in the context of the invention
on the pre-grant oppositions, the erstwhile contained in the examples, process for preparation
Controller appointed a hearing under Section and overall teaching of the document. It was further
15. The Controller did not consider the data on held that arbitrary selection of the substituents to
reduced toxicity and rejected Gilead’s patent arrive at hypothetical compounds is not possible
application under Section 3(d). Gilead filed a Writ without hindsight.
Petition before the Delhi High Court against the
order of the Controller stating that the same was Inventive Step
biased and was largely influenced by the opposition The Controller held that the compounds enabled
filed to the extent that typographical errors in the by the prior art do not have 2’-fluoro (down)-2’-
oppositions were incorporated as it is in the order. C-methyl (up) substitution pattern, which has been
Gilead further claimed that the order was biased claimed in the present application. The Controller
as no opportunity of being heard was given to the
Petitioner with regard to the grounds raised in
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