[e-farmacos] Check-List para licencias obligatorias

[e-farmacos@usa.healthnet.org]

E-farmacos: Check-List para licencias obligatorias
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[Este mensaje aparecio en la lista de discusion 'e-drug'; se ha
traducido parcialmente por su interes potencial para los suscriptores de
e-farmacos. Gracias!, AF]

"Check-List para la rapida obtencion de licencias obligatorias

En relacion con la autorizacion del uso involuntario de patentes, esta
nota pretende dar respuesta a la cuestion sobre que es lo que deberia
incluirse en cualquier legislacion nacional de un pais en desarrollo que
desee aprovachar al maximo la flexibilidad de los Acuerdos WTO-TRIPS.

He escrito algo sobre el tema para la UNDP:

http://www.cptech.org/ip/health/cl/recommendedstatepractice.html

y no voy a repetirlo de manera extensa en este foro, sino que quisiera
poder llegar a un consenso sobre los puntos que deberian contemplar los
paises.

A continuacion adjunto check list inicial, confio poderlo mejorar con
vuestras sugerencias.

James Love
Consumer Project on Technology
P.O. Box 19367, Washington, DC 20036
http://www.cptech.org, mailto:love@cptech.org
voice: 1.202.387.8030 fax 1.202.234.5176 mobile
1.202.361.3040

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CHECK LIST FOR FAST TRACT COMPULSORY LICENSING

1.  In countries where the costs of litigation is an important barrier
to the use of compulsory licensing, the system should be upon an
administrative process, to the extent permitted under the national legal
system. This of course is allowed under Articles 31h, 31j, 31k, and 44.2
of the TRIPS. 

2.   The government should have at least as strong as rights to
authorize use for public purposes as does the US government under 28 USC
1498. That is, government should have the right to use any patent, and
to authorize any third party to use any patent, for any government
purpose, without a hearing, with a finding, without
a license, subject only to the payment of compensation. 

3.   In no cases of the government authorizing non-voluntary use of a
patent should the patent owner have the right to enjoin the government
or a private party from acting. This no-injunction policy is permitted
under Article 44.2 of the TRIPS.

4.   Compensation should be determined by an administrative process, and
should be guided by royalty  guidelines, which set out recommended
royalty rates, based upon net sales of the generic product. The royalty
guidelines should be a range of possible royalties. CPT has recommended
0 to 8 percent, depending upon a
range of factors (see attachment below). The fact that the government
has to choose the rate satisfies the case by case requirement in Article
31.a of the TRIPS.

5.   Compensation decisions should be forward looking, including
revisions based upon appeals, to lower the risks by third parties using
non-voluntary authorizations. 

6.   The compensation system should permit the consolidation of multiple
patents on the same product, in such a way that the generic company pays
into a single fund, and the various patent owners have to resolve, at
their own expense, who gets what share of the proceeds. Arbitration can
settle intra-patent owner disputes.

7.   For non-voluntary licenses that are for the commercial market, and
require prior negotiation, the procedure should have as a guideline no
more than six months to negotiate a voluntary license. This period
should not be binding on either party, however, and with good cause, a
generic company should be able to proceed with a request before the
period.

8.   Where the government determines there is an urgent public health
crisis and the patents address a public health concern, the government
should have the right to waive requirements for prior negotiation for
even commercial uses, as is permitted under 31.b. 

9.   The government should have an Article 31.k administrative
proceedure that can be used when the product cannot be efficiently
produced for a single market, and exports are needed to achieve
economies of scale. 
(This note concerns only those uses authorized by Article 31 of the
TRIPS. I'll shortly post a separate note on the checklist for Article 30
exceptions to patent rights.)  
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Attachment on Royalty Guidelines

(f) ROYALITY GUIDELINES. In order to provide guidance to patent owners,
investors and competitive suppliers of health care inventions, regarding
the range of royalties on licenses for patents on medicines that would
normally be considered reasonable, and are also consistent with adequate
access to medicines, the Minister 
shall publish royalty guidelines. Such guidelines should include
recommendations for compensation as a percent of net sales of products.
The initial guidelines, which may be modified by the Minister as needed,
are as follows. 

(1) two to three percent for a product that does not represent a
significant advance in therapeutic benefits, 

(2) five percent for an innovative product that provides a significant
advance in therapeutic benefits;

(3) for products that are particularly innovative, based upon
therapeutic evidence, or for which there was a significantly higher than
average investment in R&D, based upon economic evidence, an additional
royalty premium or up to three percent.

(4) one percent or less for patents that represent minor contributions
to a product, such as a formulation patent,

(5) in cases of multiple patents on the same product, the amounts in (1)
through (4) are the combined compensation for all patents, allocated
fairly among the various patent owners in accordance with the relative
significance and benefits of the inventions. 
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Attachment on 28 USC 1498
US Code as of: 01/05/99
Sec. 1498. Patent and copyright cases 

(a) Whenever an invention described in and covered by a patent of the
United States is used or manufactured by or for the United States
without license of the owner thereof or lawful right to use or
manufacture the same, the owner's remedy shall be by action against the
United States in the United States Court of Federal Claims for the
recovery of his reasonable and entire compensation for such use and
manufacture.  

For the purposes of this section, the use or manufacture of an invention
described in and covered by a patent of the United States by a
contractor, a subcontractor, or any person, firm, or corporation for the
Government and with the authorization or consent of the Government,
shall be construed as use or manufacture for the
United States."

[NOTA: Mensaje sin acentos ni caracteres especiales.]
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