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4-Patents: Study on patentibility of DNA fragments



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TITLE:  Comparative study on biotechnology patent practices
        Patentability of DNA fragments
SOURCE: Japan Bioindustry Association, sent by PATNEWS, U.S.
DATE:   June 17, 1999

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Dear GENET-news readers,

to read the full text of the study please go to
http://www.jpo-miti.go.jp/saikine/tws/sr-3-b3b.htm

Yours,
Hartmut Meyer

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Trilateral Project B3b 
Comparative study on biotechnology patent practices
Theme: Patentability of DNA fragments


1. Introduction

In the face of rapid progress of biotechnology including areas
relating to DNA fragments, updating and improving the comparative
study (project 24.1) done by the three offices is valuable. DNA
fragments are most interesting issue as DNA fragments reveal very
interesting and challenging aspect of patentability and attract
public attention through a potential deep impact on the academy
and industry. Therefore, at the last Trilateral Meeting in Miami,
the Trilateral Offices agreed to continue the comparative study
in biotechnology focusing on selected areas covered in the
previous comparative study, including DNA fragments, in an
efficient manner in a shorter period of time.

[...]

Following points are revealed through this comparative study.

1.A mere DNA fragment without indication of a function or
  specific asserted utility is not a patentable invention.
2.A DNA fragment, of which specific utility, e.g. use as a probe
  to diagnose a specific disease, is disclosed, is a patentable
  invention as long as there is no other reasons for rejection.
3.A DNA fragment showing no unexpected effect, obtained by
  conventional method, which is assumed to be part of a certain
  structural gene based on its high homology with a known DNA
  encoding protein with a known function, is not a patentable
  invention. (EPO, JPO) The above-mentioned DNA fragment is
  unpatentable if the specification fails to indicate an asserted
  utility. (USPTO)
4.The mere fact that DNA fragments are derived from the same
  source is not sufficient to meet the requirement for unity of
  invention.



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