Revision of Examination Standards of"Industrially Applicable Inventions"and "Medicinal Inventions"
November 27, 2009
Harakenzo World Patent&Trademark
By M. NAKAO, Patent Attorney
1. Introduction
On May 29, 2009, the Panel on Enhancement of Competitiveness through Intellectual Policy Advanced Medical Patents Committee at the Intellectual Property Strategy Headquarters summarized "On Patent Protection in the Field of Advanced Medicine". As a result, the examination standards of "industrially applicable inventions" and "medicinal inventions" were revised. These revisions also include the changes of the scope of invention to be protected. Below we will take a closer look at these revisions.
2. Revision of Examination Standards for "Industrially Applicable Inventions"
The most important revision in the examination standards for industrially applicable inventions is the change of scope in the "Methods of Diagnosis of Humans".
Described below is a comparison between the former examination standards and the revised examination standards with regard to the methods of diagnosis of humans.
Former Examination Standards:
"Diagnosis methods practiced on the human body" include methods for gathering various kinds of data by measuring the structures or functions of each organ in the human body for medical purposes, such as detecting diseases, recognizing/judging the physical condition of a human body, or methods of judging the condition of such human diseases.”
(Examination Standard §2, Chapter I, 2.1.1.1(3))
Revised Examination Standards:
"Methods of diagnosis of humans" include methods of judging for medical purposes the physical condition of a human body such as diseases and physical health, the mental condition, or prescription/ treatment/surgery plans based on these conditions” (Examination Standard §2, Chapter I, 2.1.1.1(3))
The important point is that the revised standards do not include "methods of gathering various kinds of information" mentioned in the former examination standard, and therefore, the methods in the revised standards are limited to "methods of judging for the medical purpose…". In this regard, the following description was incorporated to the revised examination standards.
"The following methods for gathering various kinds of information, e.g., by measuring the structures and functions of various organs of the human body, is not considered to be a method of diagnosis of humans unless it includes steps to judge for medical purposes the physical condition of a human body, such as diseases and physical health, mental condition, or prescription/treatment/surgery plans based on these conditions.” (Examination Standard §2, Chapter I, 2.1.1.2(3))
As such, in the former examination standards, "methods for gathering various kinds of information for the medical purpose…" were regarded as methods of diagnosis of humans. However, in the revised examination standards, it explicitly states that "the following methods for gathering various kinds of information, e.g., by measuring structures and functions of various organs of the human body, is not considered to be a method of diagnosis of humans unless it includes steps for judging for medical purposes the physical condition of a human body such as diseases and physical health, mental condition, or prescription/treatment/surgery plans based on these conditions".
Therefore, the scope of the invention to be protected has been enlarged so that the methods of gathering various kinds of information for medical purposes, which were not protected before, are protected as an invention unless it includes "the steps of judging for medical purposes…".
Such revision aims for the harmonization of patent systems with other developed countries. In the US and Australia, the methods of gathering various kinds of information for medical purpose is originally protected as an invention since the medicinal methods are regarded as patent objects to be protected. In Europe, the Enlarged Board of Appeal issued the final decision of appeal on December 16, 2005 declaring that the information gathering methods for supporting final diagnosis (measurement of human body excluding surgery, treatment and diagnosis) were defined as patentable objects to be protected. Also in Korea, the examination standards were revised after this decision was made and the same action was taken (January 2008). Given that the methods for gathering various kinds of information have been protected as patent rights in other developed countries, Japan also revised the examination standards.
From my point of view, however, there is some doubt on how the rights are enforced (or is it even possible in the first place?). Essentially, on humanitarian grounds, it is not allowed to grant patent rights for medicinal acts (e.g. 2000 (gyo-ke) No.65, Tokyo High Court, Judgment of April 1, 2002), while in most cases it is considered that the invention comprising the above methods will be performed as a part of medicinal acts at medicinal scenes. In view of such circumstances, when a doctor enforces the method at a medicinal scene, it is necessary to make it clear whether or not the act is considered to be an infringement on a patent right. In this regard, the JPO said, "it is possible that a doctor implements the protected methods, but at this stage, we have not yet reached a conclusion that an exemption of a doctor should be legislated”. I suppose that this statement implies that the medicinal act of the doctor is not an infringement, but it should be further clarified in the future.
3. Revision of Examination Standards for "Medicinal Inventions"
The most important revision of the examination standards for medicinal inventions is "the novelty of the claimed invention is not denied when there is a difference between the claimed medicinal invention and the cited invention in medicinal use of applying to a specific disease with a specific dosage and administration". Thus, this revision also enlarged the scope of the invention to be protected.
In the former examination standard, even if a particular medicinal product specified by a specific dosage, and dosage interval, etc., was described as an invention of a "product", i.e., "medicinal product with a specific dosage and administration", it was considered to lack novelty except that the application of the medicinal product was confirmed to be different in the following (a) and (b).
(a) Where there are clear differences in target patient groups (e.g., where a medicinal product administered to a group of patients of general hepatitis C with a certain dosage interval and dosage is verified to be effective to a group of patient of hepatitis C having a particular type of gene when applying with a specific dosage interval and dosage).
(b) Where the application site differs (e.g., where a specifically effective application site has been discovered).
※Even if a medicinal invention was not valid to (a) and (b), the novelty of the medicinal invention was permitted when it could be distinguished from known medicinal products by reflecting the aspect of the treatment on its dosage form.
In "methods of judging novelty" (Examination Standard §7, Chapter III, 2.2.3 (3)) of the revised examination standard, the chapter "with regard to aspects of treatment such as dosage interval, dosage, etc." was replaced with the following description.
"Even if compounds etc. of a claimed medicinal invention do not differ from those of a cited invention and there is no difference in the applied disease, the novelty of the claimed invention is not denied when there is a difference between the claimed medicinal invention and the cited invention in medicinal use of applying to a specific disease with a specific dosage and administration based on the attribute of compounds etc. thereof.” (Examples 4-6)(Examination Standard §7, Chapter III, 2.2.2(3-2-2))
Therefore, the novelty came to be permitted when there is a difference in a specific dosage and administration, even if there was no difference in the groups of patients, application parts, and/or the dosage forms.
This revision stems mostly from the nation's needs and provision of incentive with the exploitation of pharmaceutical companies, rather than harmonization with international patent systems such as "Methods of Diagnosis of Humans" as described above.
According to the improvement of the standard of living of the nations and the standard of public health and medical treatment, patients and doctors are requiring the development of medicinal products which enable the maintenance and improvement of a patient's quality of life (QOL), in which the patients and doctors can use the medicinal products more safely and at ease due to fewer side effects and strains.
Further, if the dosage and administration of the medicinal product for human use changes drastically, the research and development will involve high risks, and incur high costs. Under Pharmaceutical Affairs Law, it is necessary to conduct a clinical trial to change the dosage and administration, which given the importance thereof, must also be authorized. In other words, despite that the change of dosage and administration incurred a large amount of developmental costs despite an applicable patient and/or an applicable part being same, the improved product was not able to obtain a patent right. Therefore, it became possible for the medicinal product with improved dosage and administration to be protected as a patent right in order to provide incentive for development in changing the dosage and administration.
Additionally, listed below for your reference is how different dosage and administration is protected in other countries as a medicinal invention.
In the US and Australia, it is protected as an invention of a medical treatment method, i.e., "a method for providing medical treatment using a specific medicinal product with a specific dosage and administration". In Europe, the convention has not yet made a final decision on whether or not it is protected as a "product" invention, i.e., "a medicinal product with a specific dosage and administration" and protected as a patent right, and the final judgment has yet to be declared. In New Zealand, it is protected as in Switzerland. In Canada and Korea, it is not protected as a patent right.
Meanwhile, you may doubt that the difference in dosage and administration can actually be regarded as a different product. When I first read the revised examination standard, I was interested in how to verify the difference of the dosage and administration in executing the patent right. With respect to this matter, the government considers that "in the actual trading, medicinal products are sold with information of dosage and administration (under Pharmaceutical Affairs Law, Rule 52, there is an obligation to describe the dosage and administration on an appended paper (commonly known as a package leaflet) or the package (box) of the medicinal product. Therefore, the dosage and administration are considered to be a part of the medicinal product and an element thereof."
Simply, I believe this means the description of the appended package leaflet etc., not only the tablet or powder itself, is considered to be an element of the product. Based on such point of view, I think that the novelty of products with different dosages and administrations should have been admitted. Anyway, the revision is significant in that the description of the appended package leaflet etc. is considered to be an element of the product in understanding the configuration of the product.
4. Conclusion
Described above are particularly important parts of the revision of the Examination Standard, which are related to the enlargement of protected items. It can be said that this revision makes it possible to develop a wider range strategy, and provides a benefit particular to the pharmaceutical industry.
(References)
・"On Patent Protection in the Field of Advanced Medicine", Intellectual Property Strategy Headquarters, Panel on Enhancement of Competitiveness through Intellectual Policy, Advanced Medical Patents Committee
http://www.ipr.go.jp/e_materials.html
・Opinion on Revision of Examination Standards (plan) "Industrially Applicable Invention" and "Medicinal Invention", Japan Patent Office website
http://www.jpo.go.jp/iken/sangyouhatumei_iyaku_kekka.htm
STAFF
大阪本部
