[Ip-health] Pharmalot: Gilead Licenses AIDS Drug To Medicines Patent Pool

Krista Cox krista.cox at keionline.org
Tue Jul 12 13:32:19 PDT 2011


http://www.pharmalot.com/2011/07/gilead-licenses-aids-drug-to-medicines-patent-pool/

Gilead Licenses AIDS Drug To Medicines Patent Pool
By Ed Silverman // July 12th, 2011 // 7:33 am

In a groundbreaking move, Gilead Sciences has agreed to license four AIDS
medicines to the Medicines Patent Pool, which is an initiative designed to
streamline patent licensing for producing generics of patented HIV meds and
lower prices in poor countries. The deal marks the first time that a
drugmaker has taken this step and follows more than a year of criticism from
patient advocacy groups and non-government organizations that the
pharmaceutical industry for failing to embrace the MPP concept.

The licensing agreement between Gilead and MPP is also significant because
it involves two AIDS meds, Viread and Emtriva, that are important in
treating the virus. To date, most poor countries only have access to older,
less effective treatments. The deal also includes two more Gilead drugs that
are under development, cobicistat and elvitegravir, along with a combination
of all four meds known as the Quad. Viread, by the way, is also licensed for
use in treating hepatitis B.

“Today marks a milestone in managing patents for public health. The license
agreement with Gilead Sciences will help make medicines available at a
lower-cost and in easier to use formulations without delays,” MPP executive
director Ellen ‘t Hoen says in a statement. “People in developing countries
often have to wait for years before they can access new health technologies.
Today’s agreement changed that.”

Not everyone was as laudatory, though. Medicines Sans Frontieres, also known
as Doctors Without Borders, praised the agreement as a welcome step forward,
but cautioned that certain terms are lacking, such as limits placed on
access to people living in middle-income countries. The group complains
there are limits on “price-busting competition” by confining manufacturing
to India and there are narrow supply options for active pharmaceutical
ingredients needed to make the drugs (here is the license agreement and the
sublicensee agreement.)

“This agreement is an improvement over what other big pharma companies are
doing to ensure access to their patented AIDS medicines in developing
countries,” Michelle Childs, Policy and Advocacy Director at MSF’s Campaign
for Access to Essential Medicines says in a statement. “But some caution is
needed because in several key areas, Gilead is not going beyond the status
quo. More needs to be done to fulfil the vision of the Patent Pool to
provide a solution to all people living with HIV, so this licence should not
become the template for future agreements…If voluntary measures like the
Patent Pool are unable to ensure people access to the medicines they need,
countries that are left out will need to aggressively pursue non-voluntary
paths like compulsory licenses.”

The deal comes three years after the MPP was launched by UNITAID with an eye
toward convincing multi-national drugmakers to license their AIDS meds,
which would, in turn be licensed to select generic makers that would pay
inventors a small royalty and sell copycats only in certain developing
countries. The goal is to lower prices substantially, although inventors
would still get some revenue (read here).
“UNITAID has worked for four years to develop the Medicines Patent Pool
concept. Today, we are proud to see that it is becoming a tangible reality,”
UNITAID executive board chair Philippe Douste-Blazy says. “I salute this
first important step by Gilead and urge other pharmaceutical companies to
place their intellectual property at the service of global public health.”

The initiative gained needed steam when the National Institutes of Health in
October 2010 joined the MPP by agreeing to license a patent stemming from
research undertaken by the National Cancer Institute and the University of
Illinois at Chicago (see this). However, none of the brand-name drugmakers
had similarly agreed to a licensing deal, prompting mounting criticism and
protests.

In late 2010 letters were sent to senior executives at large drugmakers
(look here) imploring them to enter or accelerate nascent negotiations to
license meds to the MPP. Activists, meanwhile, camped outside Johnson &
Johnson offices after the healthcare giant struck its own deal with several
generic drugmakers, causing critics to call the move an end run around the
MPP (see here, here and here).

Gilead, however, was among the first drugmakers to enter talks and some say
its deals may add pressure on other drugmakers. “The pool has widened the
door for generic competition and lower prices for AIDS drugs in developing
countries,” writes Jamie Love of Knowledge Ecology International, a
non-profit advocacy group that focuses on intellectual property issues that
affect access to medications. “Gilead is the first, and should not be the
last, to recognize the importance of embracing the pool to formally share
its technology to address this public health crisis. The licenses are not
perfect, and there will be justifiable criticism of the geographic scope and
several of the terms in the agreement. That said, the agreement seems to be
an important step forward.”

Adds Diarmaid McDonald, coordinator of the Stop AIDS Campaign: “This deal is
very welcome but it excludes countries with serious poverty and HIV
epidemics like Brazil and China. This deal is a floor, not a ceiling, and we
now need to see all other companies reach agreement which exceed these
terms. Alongside this, countries which have been excluded must utilise their
legal right to issue compulsory licences to get the drugs their people
need.”

The terms will preserve the ability of generic drugmakers to supply
countries if those governments issue compulsory licenses, as well as waive
data exclusivity rights where they exist, according to the MPP, which vows
to promote “transparency in licensing practices” and, toward that end, will
publish licenses on its website.

The licenses will allow Viread and Emtriva to be supplied in 111 countries,
while cobicistat will be available in 102 countries, elvitegravir and the
Quad will be supplied to 99 countries. However, the licenses do not include
all developing countries. Royalties, by the way, will range from 3 percent
to 5 percent of generic sales, with royalties waived for any new pediatric
formulations.

“We believe the pool is an innovative mechanism to increase access to
patented medicines in a way that works for the pharmaceutical industry and
people living with HIV,” Gilead exec vp Gregg Alton says in the statement.
“And we hope to see the pool become an effective mechanism for providing
access to an increasingly broader range of antiretrovirals to treat HIV in
resource-limited parts of the world.”Welcome to EditPad.org - your online
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-- 
Krista Cox
Staff Attorney
Knowledge Ecology International
www.keionline.org
(202) 332-2670



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