Post-genome research and patent system for such research

September 7, 2000
HARAKENZO World Patent & Trademark
Patent Attorney Toru TUBURAYA

(1) Post-genome research
(2) Patent system for such research

(1) Post-genome research
1) The decoding
work of the human genomes is now about to be complete. On June 26, 2000, an international team of a human genome project and a U.S. private enterprise Celera Genomics, both had been engaging in the decoding of the human genomes, jointly made an announcement, where the international team announced that approximately 90 % of the entire human genomes had been decoded, while Celera declared the completion of the decoding of the entire human genomes.

2) Of course, the clarification of the entire base sequence of the human genomes does not immediately leads to its industrialization such as the development of treatment drugs. Further developed research needs to be done using the obtained genomic information. Now the target is shifted from the clarification of the whole human genomes, to post-genome research using the genomic information.

Specifically, the focus is on those areas such as "proteomics" for analyzing the structure and function of protein that each gene codes, and "transcriptomics" for studying the transcriptional control of genes, and further new academic areas such as "bioinformatics" and "In silico biology" for analyzing life system on the computer by the analysis or use of genetic information.

3) Under these circumstances, research environment in Japan is also widely changing.
In the "Millenium Project", started this year, more than 120 billion yen of public fund will be spent in the post-human genome studies.

The Institute of Physical and Chemical Research will open the Genomic Sciences Center in Yokohama city this fall, where the structural analysis of genomes, genes, and proteins will be extensively carried out. For the structural analysis of proteins, 20 pieces of nuclear magnetic resonance apparatus will be equipped, thereby making one of the biggest institutes for analyzing proteins in the world.

Also in the Kansai area, Osaka University will found a future medical center and newly establish a future medical major provided with five groups including post-genome studies at a graduate school in 2001. Further, the Ministry of Health and Welfare decided to newly establish an institute in Osaka Prefecture, aiming to develop new drugs for cancer or dementia and to put regenerative remedy to practical use, based on the analytic information of the genomes. This institute will open in 2004.

As described above, as the new research environment for the post-genome is being established in Japan, a number of important research results in the post-genome research are expected to be produced in Japan.

(2) Patent system for such research
1) How to
properly protect such research results with the patent system is important for accelerating and activating the future research. For this reason, the patent system must be clear in particular to researchers and research institutes.

2) The Patent Office studied a variety of cases on the inventions related to genes and opened the results, thereby showing more specific judgement standards for unity of invention, enablement requirement, and inventive step. This makes patent requirements more understandable and clearer, which is worth mentioning.

3) The results of the case study, however, must be clearer in the future. For example, in the cases of ESTs, the case 7 describes the case where the enablement requirement does not meet as to the invention of a DNA fragment, when the function or biological activity of the protein encoded by the corresponding full-length DNA is not described and cannot be assumed. The reality is, however, most of the cases its function can be deduced through peripheral information such as homology search, and thus a case where its function is completely unknown seems to be extremely rare. Further, based on this deduced function, inventive step may be easily granted.

As a result, how to judge a "specific function" that is described in the results of the case study needs to be clearer in the future.

4) The effects of an established patent right also must be clear. For example, in a gene-related patent, its specification is required to include a description about a specific function and use of the claimed gene. However, is the patent right only effective for the specific function or use described in the specification?

Moreover, when ESTs are merely used as a probe to obtain a full-length cDNA as its specific use, the acquisition of their patent right may end up virtually meaningless since "the effects of the patent right shall not extend to the working of the patented invention for the purposes of experiment or research (Patent Law 69. (1))".

5) Therefore, in the future, it is desirable to show some examples of use of rights to the researchers and the research institutes, indicating what kind of right can be exerted or not by the acquisition of rights on the gene-related inventions. This will restrict unnecessary patent applications, while patents will properly protect research results that would make a remarkable contribution to technology and industry.

There was once a story that a public institute in Japan gave up the acquisition of patent rights because such monopoly would harm the public interest. It is regrettable that such important research results were not protected with the patent system. From now, good harmonization between the post-genome research and the patent system will be further required, by making the patent system clearer, and properly protecting the research results with patents.