PERU
tHE fREE tRADE AGREEMEnt WItH tHE Us
BRoUGHt IMPoRtAnt DYnAMIsM to tHE EConoMY
Data protection • Applicants may request a two-month extension of the original 12-month
• Law 1072 on pharmaceutical products and Law 1074 on agrochemicals,
term for fi ling a patent with a priority claim. For that purpose, the
which obligate health authorities, under certain conditions, not to disclose
applicant must fi le a sworn declaration explaining the reasons why the
confi dential product testing data submitted to them as part of mandatory
application could not be fi led within the 12-month original term and
product approval processes.
providing evidence to show that it was not possible despite the applicant’s
due diligence
Implementation of the free trade agreement with
• A provision has been approved allowing manufacturers of generic drugs
the Us
to use a patented ingredient in experiments and test marketing, as
required, for the sole purpose of obtaining approval by health authorities
• Law 29316, which amends, adds and regulates several provisions in order
and aimed at the commercialisation of the generic drug in the market
to implement the FTA with the United Sates.
aft er the expiration of the patent
Th e most important changes and developments brought by this legislation are: • Th e scope of non-patentable subject matter has been broadened to
biological materials which, in whole or in part, exist in nature. Earlier
Patents legislation was less precise, and it was understood that it referred only to
• Th e patent offi ce, at the request of an interested party, will adjust and
biological materials existing in nature as a whole
extend the term of the patent (except in the case of pharmaceutical • When a patented product or process has been developed from genetic
products and processes) when an unreasonable delay in the granting resources or traditional knowledge originated in the country, failure
process occurs. An unreasonable delay is one of more than fi ve years from by the patentee to have obtained the corresponding Access Contract
the fi ling date or more than three years from the applicant’s request for or License of Use, as required by Andean and local laws, will result in
patentability examination. Th e adjustment must be requested within 30 a number of possible sanctions. Th ese include a fi ne of up to 1,000 Tax
days of the grant Units (approximately $1.3 million), the payment of compensation or
www.worldipreview.com World Intellectual Property Review Digest 2009 123
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