[Ip-health] KEI reaction to GSK announcement on patent pool for neglected diseases

[James Love]

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[ Picked text/plain from multipart/alternative ]
http://www.keionline.org/blogs/2009/02/19/gsk-patent-pool/

KEI reaction to GSK announcement on patent pool for neglected diseases
By James Love, on February 19th, 2009

As an early proponent of the use of patent pools to expand access to
medical technologies, our initial reaction to the GSK announcement is
that GSK is responding to several new developments.

One is the creation of the U.S. FDA priority review voucher (PRV).  This
legislation creates a large incentive to register new chemical entities
for the treatment of the =E2=80=9Cmost neglected=E2=80=9D diseases =E2=80=
=94 what the WHO calls
=E2=80=9CType III diseases=E2=80=9D are those that almost exclusively conce=
rn poor
people living in developing countries.  While the program is new and
there are no PRV=E2=80=99s traded yet, some estimate a PRV may be worth mor=
e
than $ 300 million.

Second, UNITAID is creating a patent pool for medicines.  While the
initial scope of the UNITAID patent pool is for second generation AIDS
drugs, there is considerable interest in expanding it to other diseases
and conditions.

Third, the new WHO Global Strategy And Plan Of Action On Public Health,
Innovation And Intellectual Property (Wha 61.21) calls for the creation
of new patent pools for both upstream and downstream uses.

GSK is, on the one hand, seeking to benefit from the new interest in
Type III disease research, in order to benefit from the PRV, and on the
other hand, seeking to manage the conversation about patent pools.   The
UNITAID patent pool is not yet set up, but so far it is designed as
something new =E2=80=94 a patent pool controlled by people who pay for drug=
s and
other technologies, rather than by people who sell them.  The UNITAID
Patent Pool has the potential to solve both upstream and downstream
problems in access to medicines, with an important focus on improving
generic competition in the developing world.

Three companies, Gilead, J&J and Merck have agreed to negotiate with
UNITAID.  GSK has taken a low profile on the UNITAID proposal.  The fact
that GSK is explicitly excluding HIV/AIDS in their announcement and are
limiting their proposal to an upstream R&D proposal is being read by
some public health experts as an attempt to undermine the model
presented in the UNITAID patent pool.

Gilead and J&J have also expressed a willingness to support something
even more interesting, which is to create a prize fund from Global Fund,
PEPFAR or UNITAID budgets to reward entities that license patents to the
patent pool.  If the patent pool and the prize fund mechanisms are
linked, it is the beginning of a new business model for drug
development, one that breaks the link between drug prices and R&D
incentives, and one that gets rid of monopolies for products.  So far,
GSK has aggressively opposed this.

The governments of Barbados and Bolivia have asked the WHO Expert Group
on R&D Financing to consider the prize fund/patent pool model.  A
meeting where this will be discussed will probably happen in June or
July of this year.  A growing number of NGOs and experts support the
prize fund/patent pool model.

There are several pharma friendly alternatives being explored now, to
blunt the more fundamental and transformative reforms.  These include
the Gates backed Advanced Marketing Commitment R&D subsidies, which work
with monopolies, the Pogge/Hollis effort to co-op the prize fund/patent
pool model by creating a prize fund that works with monopolies, and the
Barton/Pfizer proposal to regulate drug prices in middle income
countries. Now we also have the GSK announcement about an upstream
patent pool, seeking again to change the conversation.

In our opinion, none of the co-opting efforts will succeed.  While they
offer some benefits, they are quite incomplete, particularly in the
important area of designing R&D incentives that work when the products
people use are free of intellectual property claims, and they fail to
provide a sustainable model for innovation and access for all.

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James Love, Director, Knowledge Ecology International
http://www.keionline.org | mailto:james.love at keionline.org
Wk: +1.202.332.2671 | US Mobile +1.202.361.3040 | Geneva Mobile +41.76.413.=
6584
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