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On 16 October 2008, the Intellectual Property Office held a public
hearing to discuss proposed amendments to its Patent Examination Guidelines on Patent
Term Extension under Chapter 8. The
main content of the proposed amendments is as follows: |
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The types of invention patents
to which patent term extension (PTE) may be sought will be expressly defined, and
unqualified patent cases enumerated. |
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The subject matters and scope
of rights of PTE will be expressly defined. |
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With regard to clinical trials
conducted in
Taiwan
, the IPO proposes to introduce provisions on acceptance of bridging studies and
their limitations, based on the announcement of the Department of Health dated 12
December 2000 on the scope of pharmaceutical products for which bridging studies
are required. |
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With regard to applications for
PTE sought based on the duration of clinical trials of pharmaceutical products conducted
in foreign countries, additional provisions will be introduced to define the limiting
conditions as well as the evidentiary documents to be submitted. |
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With regard to applications for
PTE sought based on the duration of trials conducted overseas of agrochemical products,
provisions will be introduced to define the limiting conditions as well as the evidentiary
documents to be submitted, and to expressly define the term "country of manufacture." |
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It will be expressly provided
that when identifying a "first license", the determination criteria shall be based
on a combination of active ingredient and application stated in the license. |
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To adapt to the implementation
of the amendments to the Act of Administering Agrochemical Products as of 18 July
2007, examination of field trials of agrochemical products has been changed to one
based on documents, and such trials are no longer conducted by the Council of Agriculture
(COA) but instead are conducted by COA designated entities.
In response to these changes, amendments are proposed to related
aspects of the PTE regime, such as the documents to be submitted when seeking PTE
for a patent covering an agrochemical product or a patent covering its manufacturing
process, the determination of the date of commencement of trials of an agrochemical
product, and the calculation of the "period required to obtain a license." |
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With regard to the method of calculating
the period of a PTE, in the case of a pharmaceutical product, since the implementation
of a bridging study does not require prior DOH evaluation, it should not be included
in the "period required to obtain a license".
In the case of an agrochemical product, the field trials are mainly conducted
within
Taiwan
and data generated from overseas field trials are used merely for reference. In addition, testing of the physical
and chemical properties of agrochemicals mainly focuses on basic analysis, and therefore
should be conducted during the product development stage.
The time needed for the above should not be included in the calculation of
the period during which the patent cannot be practiced. |
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We will monitor the progress of the proposed amendments and keep
our readers updated. |
