[Ip-health] Under pressure, Gilead expands Sovaldi licensing deal to four middle-income countries

Priti Krishtel priti at i-mak.org
Thu Aug 24 17:39:32 PDT 2017

Under pressure, Gilead expands Sovaldi licensing deal to four middle-income

*By* ED SILVERMAN <https://www.statnews.com/staff/ed-silverman/> @Pharmalot

AUGUST 24, 2017

Under pressure to widen access to a pricey hepatitis C medicine, Gilead
Sciences (GILD
<https://www.google.com/finance?q=gild&ei=WdqdWcnnKcHSeIG8sfAN>) has
expanded a licensing deal that will allow generic companies to now sell
lower-cost versions in four middle-income countries – Ukraine, Belarus,
Thailand and Malaysia.

The move comes amid an ongoing and far-reaching battle over the cost of
Sovaldi, which has threatened to strain government budgets around the world
since becoming available nearly four years ago. The Gilead decision, in
fact, comes after heated skirmishes in at least two of those countries.

Earlier this year, advocacy groups noted the Malaysian government
considered issuing a license to override a Gilead patent, while in Ukraine,
the company successfully threatened legal action if the government did not
revoke marketing authorization granted a generic manufacturer.

“This is a welcome move, but in some ways too late, because many more
people could have been treated much earlier,” said Rohit Malponi, director
of policy and advocacy at Doctors Without Borders. “Decisions to expand
licenses can only come when companies are held accountable for their

In statement, Gregg Alton, executive vice president for corporate and
medical affairs at Gilead, said the company is “committed to widening
access to our lifesaving medicines around the world.”

Here’s the back story: After encountering pushback over pricing in the U.S.
and some other well-to-do countries, Gilead subsequently struck licensing
deals <http://freepdfhosting.com/d49e199c47.pdf> with seven large generic
drug makers based in India, or with operations there, to sell lower-cost
versions in 101 developing countries.

The move was designed to provide wider access to 185 million people and
forestall further criticism over its pricing. By doing so, Gilead hoped to
avoid the reputational damage the pharmaceutical industry sustained a
decade earlier in South Africa over litigation surrounding access to costly
AIDS medications.

But from the start, the licensing deals generated still more criticism.
Patient groups complained the company excluded middle-income countries
where governments and individuals may not be able to afford Sovaldi, which
has since become the linchpin in the Gilead hepatitis C product franchise.

The generic drug makers are allowed to make and supply countries that were
excluded from the 101-nation deal — even if a patent does not exist in a
country that was not named in the agreement. But the deal would be breached
if a generic maker attempted to sell a copycat version in any of the
excluded countries — if a patent is still pending in India and that
excluded country.

But the red tape has proven problematic. Last month, the World Health
Organization sanctioned
<https://www.statnews.com/pharmalot/2017/07/21/who-generic-sovaldi-gilead/> use
of a generic version of Sovaldi by the United Nations and other agencies in
hopes of widening access. The WHO took this step in response to concerns
that access has been impeded by bureaucratic delays to the Gilead licensing

Meanwhile, some patient groups have filed challenges to Gilead patents on
Sovaldi in numerous countries, including India
Brazil, Thailand, Egypt, and Russia, and have succeeded in having patents
revoked in China and Ukraine.

Gilead, however, has consistently pushed back.

In Ukraine
years ago, the company went to court to force generic Sovaldi off the
market. The company challenged government registration of the cheaper
version by arguing it was entitled to market exclusivity until October
2020, and asked to have the registration revoked.

Gilead lost the court case, but filed an appeal and then, citing a
U.S.-Ukraine treaty, threatened to file
<http://freepdfhosting.com/ddf50698c1.pdf> an investor state dispute
settlement in hopes of having the generic removed from the market,
according to Doctors Without Borders. Under international trade treaties,
such a move allows companies to initiate claims against foreign governments.

In Malaysia, the Ministry of Health last year began price negotiations with
Gilead in 2016, but the company was reportedly unwilling to lower Sovaldi
pricing below $12,000 for a complete course of 12-week treatment, according
to Fifa Rahman of the HCV Access & Affordability for the Malaysian AIDS
Council. She noted the average Malaysian household income is slightly more
than $1,200 a month.

“The Malaysian Cabinet has only recently given approval for a
government-use license application, and Gilead may have decided to
circumvent this, in the nick of time, to prevent the possible mushrooming
of other [licenses] in neighboring countries or countries in the same
income bracket who were excluded from the Gilead voluntary license,” she
wrote on the Intellectual Property Watch blog

“The decision to include these countries, however, no doubt is a response
to increasing pressure from within these countries to issue a compulsory
license or a government use license, invalidate the Sovaldi patents, or
block data exclusivity for the drug,” she continued. “The threat of a
government-use license in Malaysia may have been particularly instrumental.”

“At this stage, the details the voluntary license that will be offered by
Gilead remains unknown and unclear,” Sangeeta Shashikant, a Third World
Network legal advisor, wrote us. “And it also remains unclear whether the
voluntary license will facilitate access to at prices affordable to the
Malaysian Ministry of Health.” She urged the government to “seriously
consider” issuing a government use license.

“Gilead didn’t do this because it wanted to,” said Tahir Amin, co-director
of the Initiative for Medicines, Access & Knowledge, which has challenged
Sovaldi patents in several countries.
“Threats to Gilead’s unjustified patents on hepatitis C drugs in key
countries have put pressure on the number one thing the company needs to
make billions and keep its decades-long monopoly in place. Gilead knows
that public pressure is building against it and so it’s creating deals to
try to wiggle its way out.”

*Priti Radha Krishtel*
Co-Founder and Director of Treatment Access
Initiative for Medicines, Access & Knowledge (I-MAK)
Website: www.i-mak.org
Email: priti at i-mak.org <martine at i-mak.org>
Skype: pritiwho
Tel: +1 9177032876

*Priti Radha Krishtel*
Co-Founder and Director of Treatment Access
Initiative for Medicines, Access & Knowledge (I-MAK)
Website: www.i-mak.org
Email: priti at i-mak.org <martine at i-mak.org>
Skype: pritiwho
Tel: +1 9177032876

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