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 The drug, which has a list price of $1,000 a pill in the United
States, was rejected for a patent by the Indian patent authority in
January 2015 on the basis it represented only minor changes to a
previous formulation, and the company already had licensing deals
with manufacturers in India.
After an appeal by Gilead, the Indian Patent Office of New Delhi on
Monday approved its application for the drug saying it found its
compounds to be "novel" and "inventive."
Gilead, in a statement, welcomed the move, but said it will have no
impact on availability of the compound, which is already licensed to
11 generic manufacturers in India for distribution in 101 developing
countries.
Patents guarantee drugmakers exclusive sales for a decade or more,
before generic competition is allowed, so the companies can recoup
their investment and use profits to then develop new medicines.
Gilead said the goal of its voluntary licensing program, and
"partnership" with Indian manufacturers, is to enable access to
medicines for as many people as possible, as quickly as possible.
But patient groups said Gilead's licensing deals do not serve
patients and the patent approval could prevent exports of raw
materials to other countries seeking to make the drug, hailed by
some as a breakthrough in the global fight against hepatitis.
"Like unmerited patents, these schemes manipulate the market,
violate patients' rights and block millions of people from getting
the medicines they need," the Initiative for Medicines, Access &
Knowledge said in a statement.
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Gilead said eight of its licensees have launched sales in India and
other licensed territories under the company's program for supplying
its hepatitis C, hepatitis B and HIV drugs to "resource-challenged
countries." Licenses have also been granted to two manufacturers in
Egypt and one in Pakistan.
Sovaldi was first launched in the United States in 2013 at a list
price of $28,000 for a 28-tablet bottle, or $1,000 a pill.
The list price in India as of April 26, according to the Asia
Pacific Network of People Living with HIV, was $384 per bottle, or
about $14 per pill.
The liver-destroying hepatitis C virus infects as many as 150
million people globally, according to the World Health Organization.
(Reporting By Deena Beasley; Editing by Andrew Hay)
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