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4-Patents: Japan Bioindustry Association rejects patentibility of DNA fragments



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TITLE:  JBA opinions concerning patentability of DNA fragments
SOURCE: Japan Bioindustry Association, sent by PATNEWS, U.S.
        http://www.jba.or.jp/katudou/topics/news990419e.html
DATE:   April 7, 1999

----------------- archive: http://www.gene.ch/ ------------------


JBA opinions concerning patentability of DNA fragments

The US Patent and Trademark Office, on October 6, 1998, issued a
patent for Human Kinase Homologs (USP5817479), a type of
expressed sequence tags (ESTs). We are worried that if patenting
of this type of invention becomes common practice it will
seriously affect the entire global bioindustry. Consequently, we
recently studied the issues involved in the patenting of EST
related inventions and came up with the following opinions:

1.ESTs are cDNA fragments selected at random from cDNA libraries
  derived from mRNA expressed in cells of organs, etc. Sequencing
  of ESTs can easily be done using automated DNA sequencer, and
  this method has been generalized within the concerned technical
  field.

2.Although it is possible that the function of a gene from which
  an ESTs isderived can be assumed by conducting homology
  searching of the nucleotide sequences of the ESTs, it is
  present status in a large number of cases that patent
  applications are made without corroborating or clarifying the
  types of function that the gene in question possesses.

3.It is not particularly difficult to prepare ESTs or determine
  their structure; therefore, this type of invention lacks
  inventive step. Furthermore, since, in similarity to an
  invention of a compound of unknown function, this type of
  invention cannot demonstrate particular industrially applicable
  utility, it is thought that they make little significant
  technological contribution to the society. For these reasons,
  we in Japan Bioindustry Association consider that applications
  in relation to this type of ESTs inventions should not be
  patented.

4.Moreover, if an ESTs is patented, it is not clear according to
  the present judicial cases whether the scope of the right would
  be limited to the ESTs having the specific sequence or would
  further encompass cDNAs including the full length nucleotide
  sequence of which the structure and function were unknown a
  the time of the ESTs application. From this standpoint, the
  patenting of ESTs inventions of unknown function presents a
  very significant problem.

5.With respect to an ESTs invention indicated to have usefulness
  as diagnostic probe for a specific disease where the
  association with the disorder is clearly established, we do
  not oppose conferring a patent to it. However, ESTs of this
  type are only invaluable as a diagnostic probe for a disease;
  and in comparison with inventions that present genes encoding
  proteins having some functions, their technological
  contribution to the society, we believe, is small and limited.

Therefore, even in the patenting of this type of cases, the
technical scope of the right allowed should be limited to ESTs
having the specific nucleotide sequences in accordance with the
disclosure.



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