By Ed Silverman
In a setback for Gilead Sciences, India's patent office has
rejected an application for its Sovaldi hepatitis C treatment. The
decision means that locally-based drug makers can sell lower-cost
generic versions of the medicine, which costs $1,000-a-day in the
U.S. for a 12-week regimen.
The patent application had been opposed by Natco Pharma, an
Indian generic drug maker, and the Initiative for Medicines, Access
& Knowledge, a non-profit. They argued that Sovaldi was not a
significant improvement compared with an earlier compound developed
by another company, according to the ruling issued by the Indian
patent office.
The patent office noted that a "molecule with minor changes, in
addition to the novelty, must show significantly enhanced
therapeutic efficacy" compared with a prior compound. In other
words, Gilead had to prove its compound offered improved efficacy
over that earlier compound, but the application failed to pass this
threshold, according to the ruling. A Gilead spokeswoman declined
to comment.
The decision may have broad implications for patients and drug
makers. For the pharmaceutical industry, the ruling may be seen as
another instance in which intellectual property protection in India
is lacking. A recent report by the U.S. International Trade
Commission found that 28% of drug makers feel India fails to
sufficiently protect patents. The Obama administration has been
pressing India to make changes.
For patients, the decision is expected to spur other drug makers
to produce low-cost versions of Sovaldi, even though Gilead last
fall signed agreements with seven large generic drug makers--all
based in India--to sell cheaper versions in 91 developing
countries. Those countries have an average per capita income of
less than $1,900 and account for about 54% of those with hepatitis
C.
"The move to reject Gilead's patent application really opens up
the playing field, so we hope to now see many other generic
companies that did not take licenses from Gilead starting to
produce more affordable versions of this drug," says Tahir Amin,
director of intellectual property at IMAK, which advocates for
changes in patent systems to widen access to drugs.
"The bottom line here is that India's patent law doesn't give
monopolies for old science, for compounds that are already in the
public domain. Gilead's strategy of charging as much as $84,000 per
treatment for a drug that is predicted to be simple and cheap to
produce, and is now un-patentable in India, has been exposed for
what it is--seeking to squeeze as much profit out of the sick as
possible."
Doctors Without Borders noted that a Liverpool University study
showed Sovaldi could be produced for as little as $101 for a
three-month regimen. "Getting [Sovaldi] out of the stronghold of
Gilead's monopoly will be crucial to expanding treatment for people
with hepatitis C globally," says Manica Balasegaram, who heads the
group's access to medicines campaign.
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