--- Begin Message ---
http://www.essentialinventions.org/docs/eppa/
ESSENTIAL INVENTIONS, INC
Po Box 19405, Washington, DC 20036
Voice +1.202.387.8030, fax +1.202.234.5176
http://www.essentialinventions.org
January 17, 2005
WHO
UNAIDS
The Global Fund
Essential Inventions, Inc. proposes the creation of an Essential Patent
Pool for AIDS (EPPA) as a tool to facilitate the sustainable scaling up
on treatment for AIDS. The proposal draws from the US experience in
creating the Manufacturers Aircraft Association (MAA) patent pool. The
MAA was created in 1917 to overcome barriers for the scaling up of
aircraft manufacturing, in response to a crisis -- the US decision to
enter World War I. The creation of the EPPA is motivated by the crisis
in access to essential treatments for AIDS.
A patent pool is an arrangement for the collective management of patent
rights. Most patent pools today are based upon voluntary agreements,
including for example patent pools involving the manufacture of DVDs,
radios and other consumer electronic products, or patent pools on
agriculture products or SARS. Patent pools can focus on upstream (R&D)
or downstream (product) markets. There are also some patent pools which
have been created with legislation, including as noted, the MAA aircraft
patent pool, which was mandated with threats of compulsory licenses in
1917.
The rationale for creating a patent pool for essential treatments for
AIDS is as follows:
1.1 The high cost of patented medical products, when marketed by a
monopoly, is a barrier to providing access to medicines for all.
1.2 Patents on essential medical inventions restrict innovation and
adaptation of medicines and devices to fit the needs of patients such as
different formulations, combinations, dosages and medicine forms.
Innovation and adaptation is necessary to cope with the differing viral
strains, changing immunities, related infectious diseases, local health
system conditions and local patient customs, and to enhance patient
compliance with treatment regimes.
1.3 Patients suffering from AIDS benefit from an efficient competitive
global market for essential medical products used in the treatments of
AIDS, and economies of scale and access to manufacturing know-how are
important for for efficient manufacturing of essential medical
treatments and devices.
1.4 The multitude of patents, potential claims of infringement, variance
of national laws, complexity of international treaties and national
patent laws, and patent restrictions on the export of essential medical
technologies, have presented barriers for access to medicines for all.
The EPPA would address these problems, and work as follows.
2.1 The patent pool would be created as a standalone non-profit entity.
2.2 The EPPA would identify essential patents for the treatment of AIDS
in developing countries.
2.3 The EPPA would simultaneously negotiate agreements with patent
holders and national governments.
2.4 Patent owners would be asked to voluntarily license patents to the
EPPA, for use in countries not designed as high income by the World Bank.
2.5 In cases where the EPPA failed to obtain voluntary licenses, it
would seek compulsory licenses.
2.6 Licensing by the EPPA, under voluntary or non-voluntary
arrangements, would follow "best practice" models, including:
i. Consistency with national patent laws and trade agreements on patents,
ii. Non-discriminatory "open" license to any qualified party,
iii. Rights to manufacture, export, import and sell,
iv. Adequate remuneration using transparent and predictable royalty
guidelines,
v. Requirements that patent owners met appropriate standards of quality.
The benefits of the EPPA to various parties can be summarized as follows:
3.1 Patients. The EPPA would promote competition and lower prices,
particularly for newer regimes which do not currently have a significant
generic market. The EPPA would also provide enhanced access to
follow-on innovations, such as new FDCs, better heat stabilization, or
other delivery mechanisms. Licenses would be tied to appropriate
standards for product quality.
3.2 National governments. The EPPA would provide technical assistance,
and a creditable and politically acceptable approach to the granting of
compulsory licenses.
3.3 Patent owners. The EPPA would provide a predictable and fair system
for remuneration, and would comply with national patent laws and trade
agreements on patent rights.
3.4 Donors. The EPPA would ensure that the "solution" to the patent
problem was focused on (a) the rule of law, (b) open competition, and
(c) efficiency.
We wish to review with you several options to turn the EPPA into a
reality, including:
a. Directly fund the establishment of the EPPA.
b. Endorse establishment of the EPPA
c. Join a consortium of sponsors to establish the EPPA.
We look forward to reviewing the EPPA with your staff.
Sincerely,
Terry Gardiner
CEO
Essential Inventions, Inc.
Attachments:
Draft Memorandum of Understanding between the EPPA and Company A
Draft Memorandum of Understanding between the EPPA and Country A
_______________________________________________
Ip-health mailing list
[EMAIL PROTECTED]
http://lists.essential.org/mailman/listinfo/ip-health
--- End Message ---
