Gilead Sciences, the leading maker of
HIV drugs, is to share intellectual property rights on its medicines in a
patent pool designed to make treatments more widely available to the poor.
The
California-based group is the first drugmaker to sign up to the new Medicines
Patent Pool, whose organizers now expect other major pharmaceutical manufacturers
to join the initiative.
Ellen `t
Hoen, the pool`s executive director, told Reuters she was negotiating terms for
similar deals with ViiV Healthcare -- a
GlaxoSmithKline and Pfizer joint venture -- as well as with Bristol-Myers
Squibb, Roche, Boehringer Ingelheim and Sequoia Pharmaceuticals.
"This
is not just a one-off. The whole field is changing ... there will be more to
follow," she said.
Around
33 million people worldwide have the human immunodeficiency virus (HIV) that
causes AIDS. Most live in Africa and Asia, where medicines have to be very
cheap to allow those who need them to be able to afford them.
The
Medicines Patent Pool, launched by the UNITAID health financing system that is
funded by a tax on airline tickets, aims to address this problem by creating a
system for patent holders to license technology to makers of cheap generics in
exchange for modest royalties.
In the
case of Gilead, the agreement allows for the production of generic copies of
tenofovir, emtricitabine, cobicistat and elvitegravir, as well as a combination
of these products in a single HIV pill known as the "Quad."
Significantly,
cobicistat, elvitegravir and the Quad are still in clinical development, and
their inclusion in the deal should speed the flow of new treatments
in poor countries.
"Through
systematic licensing of intellectual property related to HIV products, people
in developing countries will have access to low-cost versions of those products
almost at the same time that people in rich countries do," `t Hoen said.
Traditionally,
patients in developing countries have to wait for years before they can get
access to new drugs.
CHANGE
IN ATTITUDE
Gilead
will receive a 3 percent royalty on generic sales of tenofovir, which is also
approved for use in hepatitis B, and 5 percent on the other products.
The
licenses will allow for the supply of tenofovir and emtricitabine in 111
countries, for cobicistat in 102 countries, and for elvitegravir and the Quad
in 99 countries.
Assuming
other companies come on board, the patent pool could save poor countries more
than $1 billion a year in drug costs.
But the
revenue stream to Gilead and other patent holders is likely to be small, since
generic drug prices in Africa could be just 1 or 2 percent of those in
high-income countries.
The
decision by Gilead and others to work with UNITAID on the new patent pool marks
an evolution in thinking by Big Pharma toward the thorny problem of drug access
in the developing world.
Ten
years ago, the world`s pharmaceutical industry took a very different stance
when it sued South Africa over legislation that was passed by former President
Nelson Mandela and which favored generics.
That
battle proved a public relations disaster, and since then individual companies
have struck a series of voluntary licensing deals, allowing generic copies of
HIV products on a case-by-case basis.
The
patent pool system, however, goes beyond this by providing an effective
"one-stop shop" for generic firms to secure rights to manufacture
patent-protected drugs.
The
U.S. National Institutes of Health became the first organization to sign up to
the pool last September. The concept has been harder for some drugmakers to
swallow.
ViiV,
for example, was initially unwilling to consider pooling its patents -- and
Abbott Laboratories, Merck & Co and Johnson & Johnson have yet to enter
formal negotiations, although `t Hoen said her team was now discussing the idea
with all three companies.