E-drug: Registration of nearly-off-patent drugs? (cont'd)
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Dear E-Druggers,
1. In my opinion, regulations about registrations are independent from
regulations on patents. A Drug Regulatory Authority would not breach
any patent law by examining a file established by a company. Only a
company can breach a patent law (by manufacturing a patented drug).
2. If patent regulations are different between countries, it is possible,
according the TRIPS Agreement (World Trade Organisation), to allow a
national legislation to let a company test a patented product for
registration and market it after the patent expires (Article 30:
"Exceptions to exclusive rights"). According Carlos Correa (The
Uruguay Round and Drugs, Geneva, World Health Organisation Task
Force on Health Economics, WHO/TFHE/97.1, "the following exceptions
may be deemed legitimate pursuant to Article 30":
(...)
c) use of invention for research and experimentation or for
teaching purposes; (...)
f) experiments carried out in order to obtain health approval before
marketing a drug.
With regard to the latter, The United States Drug Price Competition
and Patent Term Restoration Act permits the carrying out of tests to
establish bio-equivalence of generic products before the relevant
patent expires. This is to help producers of generic drugs to market
their products as soon as the patent expires" (p 8).
So, a national law or a national provision can allow "registration of
their products to occur ahead of the day that the original patent
expires", without breaking international regulations.
Jerome Dumoulin
Institut de Recherche Economique sur la Production et le
Developpement
Universite Pierre Mendes France
BP 47
F-38040 GRENOBLE Cedex 09, France
tel 33 4 76 82 54 50
fax 33 4 76 82 59 89
e-mail: jerome.dumoulin@upmf-grenoble.fr
http://www.upmf-grenoble.fr/irepd
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