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Application of Inventions related to Medical Activity to the Patent Law

June 24, 2003
HARAKENZO WORLD PATENT & TRADEMARK
Patent & Trademark Attorney
Yoshinori SAKAI

1. Report presented by the Patent System Subcommittee of the Industrial Structure Council Intellectual Property Committee A report entitled "Application of Methods related to Medical Activity to the Patent Law" of the Medical Activity Working Group of the Patent System Subcommittee of the Industrial Structure Council Intellectual Property Committee was put on the homepage of the Japanese Patent Office on June 12, 2003.
( http://www.jpo.go.jp/shiryou/toushin/toushintou/pdf/iryou_report.pdf )
The following is the conclusion of the report:
In regard to the current patent examination guidelines of excluding the "methods for treatment of extracted samples are performed on the presumption that they will be returned to the same human body (e.g. a treatment of blood by dialysis)" from the scope of patent granting on the basis that it falls under the "methods of surgery, therapy or diagnosis of humans", we believe it is appropriate to promptly amend the standard to define that "manufacturing methods for medicines or medical equipment made from human parts (e.g. cultured epidermal sheets and artificial bones)" are within the scope of patent granting. It may be appropriate to continue monitoring possible influences in application trends, research and development activities, and magnitude of enforcement regarding patents granted in the future resulting from such amendments concerning the handling of methods related to medical activity under the Patent Law, including the necessity of future discussion.
In accordance with this, the JPO would amend the examination standards so that "manufacturing methods for medicines or medical equipment made from human parts (e.g. cultured epidermal sheets and artificial bones)" can be included in the scope of patent granting. As a result, in the field of technology related to regenerative medicine and gene therapy, the methods of cultivating skin and processing cells would be included in the scope of patent granting, thereby promoting the development of new technology for business use.
On the other hand, according to the report, they considered it necessary to continue reviewing the political necessity, actual consequences, etc. of deciding whether methods related to medical activity in general should fall under the scope of patents, as they did not reach an agreement at this stage.
Prior to the presentation of this report, the JPO invited public comments on the draft report from April 21, 2003 to May 20, 2003 and received comments from nine individuals. The summary of the comments is as follows:
( http://www.jpo.go.jp/iken/sankosin_iryou_pub.htm )
- A majority of them is for the conclusion that manufacturing methods for medicines or medical equipment made from human parts should be within the scope of patent granting.
- Some of them request the scope of patent granting be expanded not by amending the patent examination standards but by revising the laws.
- Many of them request that other medical activities be included in the scope of patent granting. They also state that sufficient caution is necessary to prevent influence on medical activities carried out by doctors when this issue is considered.
2. Administration based on the current patent examination guidelines
With regard to handling of inventions in methods related to medical activity, the patent examination standards stipulate in "Chapter 1, Industrially Applicable Inventions of Part ‡U, Requirements for patentability" as follows:
2.1 Industrially Inapplicable Inventions
(1) Methods for treatment of the human body by surgery or therapy and diagnostic methods practiced on the human body Methods for treatment of the human body by surgery or therapy and diagnostic methods practiced on the human body have been termed "medical act" and are normally practiced by physicians (or persons directed by them).
An instrument or apparatus for use in such methods, or a pharmaceutical substance is a product, and is not included in "methods for treatment of the human body by surgery or therapy and diagnostic methods practiced on the human body." On the other hand, an operating procedure on human body by means of such an instrument (e.g. scalpel) or a method for treating of the human body with a pharmaceutical substance is considered as "methods for treatment of the human body by surgery or therapy and diagnostic methods practiced on the human body."
Methods for treatment of samples that have been removed from the human body (e.g. blood, urine, tissues, or hairs), or methods of gathering data by analyzing the same, are not included in "methods for treatment of the human body by surgery or therapy and diagnostic methods practiced on the human body." However, if the methods for treatment of these samples are performed on the presumption that they will be returned to the same human body (e.g. a treatment of blood by dialysis), then, such methods are considered as "methods for treatment of the human body by surgery or therapy and diagnostic methods practiced on the human body."
Furthermore, methods for contraception or delivery are also included in "methods for treatment of the human body by surgery or therapy and diagnostic methods practiced on the human body."
In short, inventions in methods related to medical activity are excluded from the scope of patent granting for the reason that they do not fall under "industrially inapplicable inventions" (the main paragraph of Article 29(1), the Patent Law). The basis for this judgment includes the fact that there is no strong need to provide incentives under the patent system because such inventions are made at universities and large hospitals. Furthermore, a political reason is that research and development competition is not suitable in medical research, and a humanistic reason is that it would be inappropriate to require approval of the patent holder when urgent treatment is necessary.
3. A recent court decision for a medical activity
The Tokyo High Court made a decision for a suit against an appeal/trial decision concerning inventions in methods related to medical activity in April 2002 (2002, (gyo ke) Suit against an appeal/trial decision No.65, decided by the Tokyo High Court on April 11, 2002). The Tokyo High Court supported the appeal decision by the Japanese Patent Office that the decision of refusal should be maintained, dismissing the demand by the plaintiff. The decision by the Tokyo High Court is worthwhile considering.
The plaintiff did not further appeal to the Supreme Court. Therefore, the decision of the Tokyo High Court became final and conclusive.
One of the issues discussed in the suit against an appeal/trial decision is "whether or not medical activity falls under industries" (other issues omitted). The summary of the suit is as follows (See the court decision for detail):
The claim of the plaintiff
The defendant has been dealing with financial industry and insurance industry as "industries", interpreting "industries" in the Patent Law in a broad sense. Under the above circumstances, it is nothing but unreasonable in terms of interpretation that only medical activity is excluded from "industries" without exception for the reason that it is a medical activity.
The claim of the defendant
The courts have been supporting the view that an invention that requires human bodies as a component does not fall under the category of "industrially applicable invention" (The Tokyo High Court, December 22, 1970 (Showa 45), See Decision Times vol. 260, page 334).
The plaintiff claimed that "industries" should be interpreted in a broad sense and "medical industry" should be also dealt with as one of the "industries". The defendant agrees with the plaintiff in that "industries" should be interpreted in a broad sense.
The defendant has been handling mining industry, agriculture, fishery, transportation industry, communication service and the like as included in this "industries". It is obvious that industries related to medical equipment and medicines are also included in the "industries".
As shown in the decision, however, the viewpoint that medical activities that "require human bodies as a component" should be interpreted not as an industry and methods for treatment of the human body by surgery or therapy and diagnostic methods practiced on the human body (medical activity) do not fall under the category of "industrially applicable inventions" has been taken in the examination standards.
The court decision
The Patent Law stipulates that the purpose of this Law shall be to encourage inventions by promoting their protection and utilization so as to contribute to the development of industry. From this point of view, there are no fundamental grounds, in general, to interpret the term "industries" in a narrow sense. The defendant agreed in this regard.
The opinion stating that medical activity should be excluded from the scope of patent granting and open to the public for the benefit of human beings because it is closely related to human existence and ethics has been cited as a main reason for denying the patentability of medical activity.
However, this opinion is not necessarily persuasive.
Medical activity, on the contrary, should be promoted to develop by being included in the scope of patent granting for the very reason that it is such an essential invention that is closely related to the human existence and required to be open to the public for the benefit of human beings.
At least, the opinion in which inconsistency between patentable medicines/medical equipment and unpatentable medical activity is pointed out seems to be quite reasonable.
As long as inventions related to medicines and medical equipment are included in the scope of patent granting, those related to medical activity should also be included in the scope on the basis that it falls under "industrially applicable invention." The opinion stating that there is no ground found to exclude those related to medical activity from the scope of patent granting is worth considering.
As mentioned above, the court considered it is appropriate to interpret a medical activity as "an industrially applicable invention".
However, there is a significant difference that cannot be ignored between medicines/medical equipment and medical activity when deciding whether they have patentability or not. Furthermore, a patent system that might force physicians to fear possible infringement of patents would be inappropriate, considering the fundamental nature of medical activity. Therefore, as long as there are no special provisions in the Patent Law, there is no choice but to decide that inventions in medical activity do not fall under the scope of inventions capable of industrial application.
Stated reversely, this means that the court implies as follows:
Medical activity should be interpreted as an industrially applicable invention as long as a patent system ensures that physicians can carry out medical activities without any fear of infringement of patents.
4. Conclusion
The patent examination standards are to be amended so that a part of inventions related to medical activity can be included in the scope of patent granting as a result of the report presented by the Patent System Subcommittee of the Industrial Structure Council Intellectual Property Committee. However, it seems impossible to continue to handle medical activity as an invention that does not fall under "industrially applicable invention" as shown in the above court decision. Furthermore, there has been a request on the industry side that inventions related to medical activity should be included in the scope of patent granting like other inventions.
The discussion about the inventions related to medical activity and application thereof is likely to continue for a while before reaching a conclusion.
However, the legislation where medical activity is included in the scope of patent granting in the condition that the patent rights do not influence on medical activities carried out by physicians is likely to be established in the future as in the United States.
5. Reference
(1) The Medical Activity Working Group of the Patent System Subcommittee of the Industrial Structure Council Intellectual Property Committee, "Application of Methods related to Medical Activity to the Patent Law", June 2003
( http://www.jpo.go.jp/shiryou/toushin/toushintou/pdf/iryou_report.pdf )
(2) Industrial Property Legislation Office of General Administration
Division of the Japanese Patent Office, "Summary of the comments on the draft report of the Medical Activity Working Group of the Patent System Subcommittee of the Industrial Structure Council Intellectual Property Committee", June 2003
( http://www.jpo.go.jp/iken/sankosin_iryou_pub.htm )
(3) The Tokyo High Court, Heisei 12 (gyo ke) Suit against an appeal/trial decision No. 65, decided by the Tokyo High Court on April 11, 2002
(4) Takayuki HIROSE, "Protection for medical activity by the Patent Law", Patent vol.56, No.4, 69-78, 2003

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