A Writ Petition has been filed before the Delhi High Court,
challenging the grant of patent for Gilead's megahit anti
Hepatitis-C virus (HCV) drug, sofobuvir which is known commercially
everywhere as "Sovaldi". The company charges a super hike
price of $1,000 per pill in the USA. Though the price of the
treatment in India is not expected to be very high due to local
competition, with the generic version priced at a around $13.71 per
pill in India, where domestic drugmakers may have planned to export
the key raw material or others planning to launch the drug in the
country are bound to be hit, argued by whom have decided to take
the patent office to court.
The petition has been jointly filed by the non-for-profit group
based in United States, Initiative for Medicines, Access &
Knowledge (I-MAK) and the human rights group, Delhi Network of
Positive People (DNP+). The challenge contends that the Indian
Patent Office's judgment is contrary to public interest, and
that it fails to appraise the full scientific and legal evidence
presented. The challenge further submits that the decision ignores
key judicial precedents.
On May 9, 2016, the Indian Patent Office (IPO) granted a patent
to Gilead Pharmasset, LLC (Gilead) holding that the invention was
novel, inventive and did not fall within the preclusion of Section
3(d) of the Indian Patents Act. The heavy 58 page order rejected
six pre-grant oppositions that had been filed and ordered the
granting of the application.
The key arguments presented by the pre-grant opponents were: (i)
lack of novelty, (ii) lack of inventive step and (iii)
non-patentability in view of section 3(d). Considering the
arguments of all the parties, the Controller in a very detailed
technical analysis, held that the invention involved both novelty
as well as inventive step and overcame the patentability barrier
set by section 3(d). Specifically, The Controller observed that
with respect to novelty, the prior art neither exemplified nor
provided an enabling disclosure with respect to the claimed
compound. Therefore, an arbitrary selection without the use of
hindsight was impossible. As a result, he held that the claimed
compounds were not anticipated by the cited prior art. Regarding
inventive step, the Controller agreed with Gilead that the cited
prior art documents failed to provide a clear teaching for a person
skilled in the art to arrive at a substitution pattern as recited
in the claims. With regard to non-patentability under section 3(d),
the Controller held that it was difficult to accept that claimed
compounds were derivatives of known compounds when such compounds
having anti-HCV activity were simply not exemplified in any of the
cited prior art documents. This was an ambo given to the
"Sovaldi" by the patent office smashing a bundle of
pre-grant oppositions. The battle still has scenes to show.
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This article enunciates the recent, much awaited, and landmark judgment delivered on September 16, 2016 by Hon'ble Delhi High Court throwing light on the important provisions of the Copyright Act, 1962.
Department of Industrial Policy and Promotion recently issued an office memorandum pursuant to receiving representations from various stakeholders for guidance with respect to the applicability of the provisions of Section 31D of the Copyright Act, 1957.
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The Patents Act 1970, along with the Patents Rules 1972, came into force on 20th April 1972, replacing the Indian Patents and Designs Act 1911. The Patents Act was largely based on the recommendations of the Ayyangar Committee Report headed by Justice N. Rajagopala Ayyangar. One of the recommendations was the allowance of only process patents with regard to inventions relating to drugs, medicines, food and chemicals.
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