Protection of Information in Three-Dimensional Protein Structures

January 20, 2004
Harakenzo World Patent ＆ Trademark
Patent Attorney Toshiro KURODA

Ⅰ．Introduction

The twentieth century is reputed to have been the age of electronics, and the twenty first century is said to be the age of bioscience, that is to say, life science. The Life science is a technical field expected to be applied in broad area of industries, such as pharmaceuticals, diet, chemicals and environment. At home, it is also referred to as one of the four major fields in "Basic Program for Science and Technology." (Reference (1))

In the previous history of life science, biochemistry analyzed living creatures and their components and utilized its asset until the late 1970s. Thereafter, genetic engineering altered them to a genetic level and created useful compounds. From the end of 1990s to the start of 2000, in order to have a thorough understanding of mechanism of living things and make use of it, comes the age of the more sophisticated genomic analysis that decodes the perfect genomic information, along with mapping DNA sequences constituting chromosomes of human being, plants, animals, and microorganism. Then, it was reported on the June 20thof 2000 that decoding the human genome was completed by both The International Human Genome Project and Celera Genomics (Company) in America. Furthermore, it was reported on the April 14th of 2003 that the high-precision decoding of the human genome was completed. Utilizing the genomic information based on the above-mentioned project as the foundation, at present, we have entered a past-genome era looking to analyze functions of a certain protein derived from the genes and gene products. (References (2), (3))

The research of protein based on genomic and gene information is considered to have a high possibility to generate immediate high economic value. An increasing number of researchers are embarking on Bio-Venture businesses relating to these results. An example of the researches with the aim of analyzing the structures and functions of such proteins is the "Protein 3000 Project," which is one of the researches that is primarily led by The institute of physical and chemical research and research institutes of universities at home.

With regard to such researches, structures and functions of protein understood and research tools developed for a breakthrough after investing an enormous amount of funds and intellectual activities are tremendously valuable economically. For that reason, how these research achievements as an intellectual property should be returned to society is a major issue. Among these, how the information in three-dimensional protein structures can be protected by the patent laws and then utilized is a serious question. (Reference (4))

Ⅱ．Patent Protection For Three-dimensional Structural Data of Protein
Three-dimensional structural data of protein is the fruit with considerable labor. It is the result obtained from intellectual production activities with the use of X-ray crystal structural analysis and Nuclear Magnetic Resonance (NMR). Therefore, many people voiced their opinions that the "result" should be protected as deserving right so as to prevent easy imitation and unfair use. This is based on the following reason: The acquisition of structural information of protein functional domains and pharmacopher require considerable cost and time. At the same time, they are utilizable in practical pharmaceutical planning, and the data in itself generates tremendous economic value.

However, trilateral patent offices, namely, Japan Patent Office, U.S Patent and Trademark Office, and Europe Patent Office determine protein three-dimensional structural information itself not to be protected as a patent because it is no more than disclosure of data contents. For instance, at home, the Patent Office releases case studies of "how the data and the like are handled in examination" as the "Collection of Cases relating to inventions to three-dimensional structures of protein." (Reference (5)) In this collection, the patent office at home, for instance, determines protein three-dimensional structural coordinate data and pharmacopher to be no more than presentation of information. Therefore, it is not considered to be an invention. (cases 1, 2) Moreover, computer screening methods using three-dimensional structural coordinate data, in other words a hypothetical screening claim, is considered to be an invention. This is because the handling of a kind covering chemical compound is not involved, and the disclosure as a software-related invention is inadequate. (case 3) As mentioned above, according to the decisions made by the Patent Office at home, the claims of "deliverables from Bio-informatics" are hardly protected by patent laws.

On the other hand, in order to clarify the existing patent law and examination criteria, there are reports on the problems where the protein three-dimensional structural data and pharmacopher are considered to be inventions and that they fulfill a number of requirements, which allow for them to be protected by the patent laws. (Reference (6))

According to the report, the problems on the "easiness of replication", "difficulty in presenting evidence of infringement", "absolute exclusive right", and "difficulty of examination" exist if protein three-dimensional structural data was to be considered to be an invention and be protected.

• As for "easiness of replication," the problem is that the data can be replicated very easily with the use of computer by the third person.
• As for "difficulty in presenting evidence of infringement," the problem is that it is difficult to verify the invasion when a third party uses the data stored in the computer.
• As for "absolute exclusive rights," the problem is that the data itself is knowledge, and granting that knowledge to be absolute exclusive rights can seriously hinder remarkable researches and developments of technologies using the knowledge.
• As for "difficulty of examination," when examining the progress of data, the data value varies depending on the kind and the nature of the data. Thus, the problem is that it is extremely difficult to have a proper protection after the value of each data is scrutinized at every examination phase.

Therefore, it is natural that only limited protection can be provided to the protein three-dimensional structural data by the existing patent laws.

Ⅲ．Non-patent protection
Again, the above-mentioned report (reference (6)) says that protecting the data itself by the patent laws is considered to be difficult. However, it is true that the data itself generates the substantial economic value. As a necessity of making the protection of the data put into effect in some form, "(i) Copymart Circulation" and "(ii)Unique Legislation" are the possible solutions brought up.

･As for "(i) Copymart Circulation," premised on the existing contract-based protection, the protein three-dimensional structural data and pharmacoper are circulated after being registered in the aggregated release and contract-typed electric rights management system of the digital-contents in a similar manner as Copymart ; Copyright market.

･As for "(ii) Unique legislation," premised on the registration in the unified "structural data rights management system" like "Coymart," the designated formal examination is conducted on the content registered. Further for the data registered, the exclusive rights (Relative Exclusive Rights) is granted, followed by the legal remedy to unauthorized copying. The problem can be solved by enacting the unique legislation that has the public disclosure system so as to release the data contents in a certain period of time from the date of grant.

Further for a solution of protecting the protein three-dimensional structural data, in addition to the above-mentioned solutions, what other protections are possible in accordance with the existing laws and ordinances is under consideration. For instance, in the above-mentioned report, five possible protections by the non-patent laws and ordinances are mentioned; ① Protection of trade secret, ② Protection of contract law, ③ Protection of general illegal act, ④ Protection of copyright law and ⑤ Protection of safeguard.

① Protection of trade secret : By meeting three requirements; secrets management, non-disclosure and usability, the protein three-dimensional structural data is protected as "Trade Secrets" regulated in the forth clause of the article 2 under the unfair competition prevention law. Corresponding to the "Trade secret," the injunction of intended acts and the right to damages on damages caused by intended acts are granted to the person who conducts illegal act by the unfair competition prevention law.

② Protection of contract law : As for the protein three-dimensional structural data, the contract is concluded between or among the parties concerned so that performing businesses with the authorized power allowing the utilization of the data can not be prevented.(Principle of the Freedom of Contract) Therefore, by allowing the only parties, who have concluded the contract on the utilization of the data, to utilize it, the data can be protected.

③ Protection of general illegal act : Recently, the precedent theory has arisen. It says that illegal act can be allowed under a certain requirement discussed for informational goods that is not granted explicit protection under the copyrights.(Decision on a case of vehicle database; Reference (7)) Accordingly, when four of the below-mentioned requirements are satisfied, illegal act can be enforced. (i) Making database with the information gathered and concluded by an indirect party's cost and labor, (ii) Performing businesses by producing and distributing the data concerned, (iii) in the territory where the seller thereof is competing (豳) Selling the database made by replicating the database concerned. However, the legal remedy can only correspond to the right to damage. Therefore, we need to take notice that the remedy by the injunction cannot be expected.

④ Protection of copyright law : The existing copyright law evaluates the information choice and systematic creativity. As for the accumulated database after cyclopaedically analyzing the protein three-dimensional structural data, except for the database that has the special compilation, such as the creativity of selection of subject matter and sequence, it is viewed that the protection as a copyright cannot be provided.

⑤ Protection of safeguard : When using the accumulated database of the three-dimensional structural data, the protection can be provided by establishing the safeguard for eliminating the utilization and access by the unauthorized party. Thus, the act of providing the equipment and program that disturbs the safeguard is enacted by the tenth Clause of the Article 2, and the eleventh Clause under the unfair competition prevention law.

Ⅳ．Conclusion
The above-mentioned three-dimensional structural data of protein is considered to be no more than the presentation of information. Therefore, the patent protection can not be provided to that by the existing patent laws. At the same time, the solutions of the protection by non-patent legislation and the others can be seen. However, they are far from the protection as powerful as the protection by the patent law.

The protein three-dimensional structural data is tremendously valuable in economy, and is intellectual property crucial to circulate the intellectual creativity and economic cycle. Therefore, it is viewed that the framework protecting the protein three-dimensional structural data properly and internationally should be made promptly. Moreover, the framework of protection is preferred to be the patent law like, which adopts the registration, limits the period and protection range, and regulates the balance in benefits between the parties receiving the protection and utilizing the information, not to be the copyright law like, which provides the almost indefinite protection right in informality.

Reference:
(1) "Basic Program for Science and Technology" ( http://www.mext.go.jp/a_menu/kagaku/kihon/ , http://www.mext.go.jp/b_menu/shingi/kagaku/kihonkei/kihonkei.htm )
(2) "Genetic Business and Genomic Patent" by Japan Society of Kansei Engineering and a society for the study of IP, published on March 10 of 2001, the first publication of the first edition, by Department of Publication, Incorporated Foundation of Investigation Committee of Business and Industries.
(3) "Investigation Report on the Patent Application of Technical Trend relating to Life Science", April 4th of 2003, Engineering Examination Section of the General Affairs Department at Japan Patent Office.
(4) "Scuttling Bio-informatics - Protect the Protein Structural Information −", NIKKEI BIO-BUSINESS, The September Issue of 2003, p66-p68.
(5) Japan Patent Office Patent and Utility Model Screening Criterion The Ⅶ Screening Criterion in the Specific Technical Field. http://www.jpo.go.jp/iken/pdf/3d_jirei.pdf
(6) The 2002 Report on the Problem Surveillance Study of system of Japan Patent Office Industrial Property Right by Sumioka and Kokubu "Surveillance Study relating to the way the emerging technical related inventions in Life Science should be protected", March of 2003.
(7) Tokyo District Court・May 25th of 2001・Interlocutory Judgment・THE HANREIJIHO・Page 132 of A case number 1774, Tokyo District Court・March 28th of 2002・Judgment as to the Principal Matter・Law Reports of Intellectual Property Right on the Supreme Court Home Page. ( http://www.court.go.jp )