2023.09.26
EXTENSION OF DURATION OF PATENT RIGHTS FOR PHARMACEUTICAL PRODUCTS ETC.
PATENT
EXTENSION OF DURATION OF PATENT RIGHTS FOR PHARMACEUTICAL PRODUCTS ETC.
1. Introduction
In Japan, the duration of a patent right expires after 20 years from the filing date of the patent application concerned. However, in the case of a pharmaceutical product etc., a considerable period is required for tests and examination etc. necessary for the pharmaceutical product to be approved under provisions of laws for securing safety etc., and thus, the duration of the patent right may be extended by filing an application for registration of the extension of the duration, by a period not exceeding five years. In this Newsletter, we report requirements for the extension of the duration of patent rights (hereinafter, referred to as “patent term”) for pharmaceutical products etc. and effects of the patent rights registered for the extension, including the revision of the Order for Enforcement of the Patent Act related to the newly established emergency approval system of pharmaceutical products etc., and precedents of the Intellectual Property High Court.
2. Outline of System of Patent Term Extension for Pharmaceutical Products etc.
Regarding the patent term extension system, the Patent Act stipulates as follows:
(Article 67(4) of the Patent Act)
“If there is a period during which a person cannot work a patented invention due to the need to obtain a permission or other such disposition under the provisions of the law which is intended to ensure safety in the working of the patented invention or accomplish a similar objective, and which Cabinet Order prescribes as one that it requires considerable time to properly arrive at due to things such as the purpose of the disposition and the procedures that are involved, the patent term…may be extended, upon the filing of an application to register an extension, for a maximum of 5 years.”
The patentee is required to file the application for registration of the extension under Article 67(4) of the Patent Act within three months from the date of the disposition prescribed by the Cabinet Order under Article 67(4) of the Patent Act, provided that the application may not be filed after the expiration of the patent term.
3. Subjects of Patent Term Extension for Pharmaceutical Products Etc.
If there is a period when a patented invention cannot be worked due to the need for a disposition prescribed by Cabinet Order under Article 67(4) of the Patent Act, the patent right concerned is subject to the patent term extension. As the disposition described above, the following two dispositions are prescribed:
(1) registration related to agricultural chemicals based on the provisions of the Agricultural Chemicals Regulation Law; and
(2) approval and certification based on the Law for Ensuring the Quality, Efficacy, and Safety of Drugs and Medical Devices (hereinafter, referred to as “Pharmaceutical and Medical Device Law”) concerning pharmaceutical products, in vitro diagnostics, products for regeneration medicine, etc.
Therefore, patent rights related to pharmaceutical products, in vitro diagnostics, products for regeneration medicine, etc. for human and non-human animals, and agricultural chemicals are subject to the system. At present, medical devices are not subject to the system.
4. Clarification of Subjects of Patent Term Extension after Establishment of Emergency Approval System of Pharmaceutical Products Etc.
As a result of the spread of the new coronavirus infectious disease (COVID-19), in order to promptly approve and supply therapeutic drugs and vaccines in emergencies, “the partly revised Law for Ensuring the Quality, Efficacy, and Safety of Drugs and Medical Devices” (hereinafter, referred to as “the revised Pharmaceutical and Medical Device Law”) was enacted on May 20, 2022, and a system for expedited pharmaceutical approval in emergencies (hereinafter, referred to as “the emergency approval system”) was newly established, which approves, conditionally and for a limited period, pharmaceutical products etc. with the efficacy estimated on the premise of confirming the safety.
If a pharmaceutical product etc. is granted for the emergency approval, the pharmaceutical product is to be approved by newly filing an application for approval within the time limit for the approval, after it is granted for the emergency approval. The Order for Enforcement of the Patent Act expressly prescribes that not both of these two approvals but only the emergency approval falls under the disposition which may be grounds for the registration of the patent term extension as described above. This is because the emergency approval is “approval of manufacturing and sales” under the Pharmaceutical and Medical Device Law, which makes possible the working of the patented invention, and thus the emergency approval is deemed to fall under the disposition required for the working of the patented invention under the Patent Act. Therefore, it should be understood that the approval by the additional application for approval within the time limit for the approval after the emergency approval does not fall under the disposition as the grounds for the registration of the patent term extension as described above.
5. Requirements in Examination of Extension Registration Application Related to Pharmaceutical Products Etc., and Effects of Patent Right Registered for Extension
Regarding effects of the patent right registered for extension, the Patent Act stipulates in Article 68-2 that the effect is limited to the working of the patented invention related to a product subject to the disposition which is prescribed by the Cabinet Order described above and constitutes the grounds for the registration of the extension (if a specific use of the product is designated in the disposition, the product used for such a use). Various judgments were made on the requirements in the examination of the extension registration application related to pharmaceutical products and the effects of the extended patent right. We will introduce some of them.
5-1. Oxaliplatin Case (Intellectual Property High Court Decision Made on January 20, 2017; 2016 [Administrative Litigation Case, the Second Instance] No. 10046; Appeal for Seeking an Injunction of Patent Infringement)
The effect of the patented invention related to the patent right with the term extended covers not only a “product” (pharmaceutical product etc.) specified by configuration with “ingredient, dose, administration, dosage, efficacy, and effect” in the disposition under Cabinet Order but also a product which is substantially the same as the pharmaceutical product etc. Thus, even if the above configuration determined in the disposition under the Cabinet Order includes a part different from the subject pharmaceutical product etc., when the part is just a small difference or a formal difference from overall, the subject pharmaceutical product etc. falls within what is substantially the same as the product subject to the disposition under the Cabinet Order, as a pharmaceutical product, and belongs to the coverage of the effect of the patent right with the term extended.
In detail, according to the judgment, in the following cases, the difference between the subject pharmaceutical product etc. and the “product (pharmaceutical product etc.)” specified by the “ingredient, dose, administration, dosage, efficacy, and effect” determined in the disposition under the Cabinet Order falls under the small difference or the formal difference from overall, and the subject pharmaceutical product etc. is included as the matter substantially the same as the product subject to the disposition under the Cabinet Order, as a pharmaceutical product.
(1) A case of a patented invention characterized only by an active ingredient of a pharmaceutical product etc., where the subject pharmaceutical product etc. additionally or alternatively contains, as “an ingredient” not active, an ingredient which is partly different from the patented invention, based on the well-known and common arts as of the application for the disposition under the Cabinet Order;
(2) A case of a patented invention concerning to safety or a dosage form of a pharmaceutical product related to a publicly known active ingredient, where the subject pharmaceutical product etc. additionally or alternatively contains an ingredient which is partly different, based on the well-known and common arts as of the application for the disposition under the Cabinet Order, and the both products have identity in the technical feature and the operation and effects, in view of the contents of the patented invention.
(3) A case where there is only a difference not numerically significant in the “dose” or “dosage and administration” specified in the disposition under the Cabinet Order.
(4) A case where the products are different in the “dose” specified in the disposition under the Cabinet Order, but are deemed to be identical when “the dosage and administration” are also taken into consideration.
5-2. Nalfurafine Case: (Intellectual Property High Court Decision Made on March 25, 2021; 2020 [Administrative Litigation Case, the First Instance] No. 10063; Request for Reversal of Appeal Decision)
The decision judges as follows: Whether it was necessary to receive a disposition under Cabinet Order for working the patented invention should be determined in light of the gist of the Patent Act instituting the system for extending a patent term, and whether the extension registration is granted should be determined substantially from such a perspective. Therefore, it should not be determined formally only on the basis of what is described as the “active ingredient” in a certificate in application for marketing approval of the pharmaceutical product.
In detail, the subject patented invention is to protect a free form of “nalfurafine,” and on the other hand, the certificate subject to the disposition under the Cabinet Order describes “nalfurafine hydrochloride” as “an active ingredient.” The decision judges as follows: It is inappropriate to determine formally that the active ingredient of the pharmaceutical product subject to the disposition under the Cabinet Order is “nalfurafine hydrochloride,” which was described in the certificate; rather, it is appropriate to find that the active ingredient of the subject pharmaceutical product includes both “nalfurafine,” which is a free base that attracted attention in the examination for approval of the subject pharmaceutical product as an ingredient substantially exerting efficacy and effects, and “nalfurafine hydrochloride,” which is its active pharmaceutical ingredient blended in the subject pharmaceutical product.
6. Conclusion
For an invention related to a pharmaceutical product etc., registration of patent term extension is permitted, because it requires a considerable period of time for tests and examination etc. necessary for the pharmaceutical product to be approved under provisions of laws for securing safety etc., which often results in a period during which the patented invention cannot be worked, and such a period is long, as compared to inventions pertaining to other technical fields. Further, it is necessary to define requirements in the examination of the extension registration application related to a pharmaceutical product etc., and effects of the patent right with the term extended, based on the revision of the Pharmaceutical and Medical Device Law etc., the interpretation of the active ingredient, efficacy, effect, etc. under the Pharmaceutical and Medical Device Law, etc. In this regard, various judgments will be made in the future.
In Japan, the duration of a patent right expires after 20 years from the filing date of the patent application concerned. However, in the case of a pharmaceutical product etc., a considerable period is required for tests and examination etc. necessary for the pharmaceutical product to be approved under provisions of laws for securing safety etc., and thus, the duration of the patent right may be extended by filing an application for registration of the extension of the duration, by a period not exceeding five years. In this Newsletter, we report requirements for the extension of the duration of patent rights (hereinafter, referred to as “patent term”) for pharmaceutical products etc. and effects of the patent rights registered for the extension, including the revision of the Order for Enforcement of the Patent Act related to the newly established emergency approval system of pharmaceutical products etc., and precedents of the Intellectual Property High Court.
2. Outline of System of Patent Term Extension for Pharmaceutical Products etc.
Regarding the patent term extension system, the Patent Act stipulates as follows:
(Article 67(4) of the Patent Act)
“If there is a period during which a person cannot work a patented invention due to the need to obtain a permission or other such disposition under the provisions of the law which is intended to ensure safety in the working of the patented invention or accomplish a similar objective, and which Cabinet Order prescribes as one that it requires considerable time to properly arrive at due to things such as the purpose of the disposition and the procedures that are involved, the patent term…may be extended, upon the filing of an application to register an extension, for a maximum of 5 years.”
The patentee is required to file the application for registration of the extension under Article 67(4) of the Patent Act within three months from the date of the disposition prescribed by the Cabinet Order under Article 67(4) of the Patent Act, provided that the application may not be filed after the expiration of the patent term.
3. Subjects of Patent Term Extension for Pharmaceutical Products Etc.
If there is a period when a patented invention cannot be worked due to the need for a disposition prescribed by Cabinet Order under Article 67(4) of the Patent Act, the patent right concerned is subject to the patent term extension. As the disposition described above, the following two dispositions are prescribed:
(1) registration related to agricultural chemicals based on the provisions of the Agricultural Chemicals Regulation Law; and
(2) approval and certification based on the Law for Ensuring the Quality, Efficacy, and Safety of Drugs and Medical Devices (hereinafter, referred to as “Pharmaceutical and Medical Device Law”) concerning pharmaceutical products, in vitro diagnostics, products for regeneration medicine, etc.
Therefore, patent rights related to pharmaceutical products, in vitro diagnostics, products for regeneration medicine, etc. for human and non-human animals, and agricultural chemicals are subject to the system. At present, medical devices are not subject to the system.
4. Clarification of Subjects of Patent Term Extension after Establishment of Emergency Approval System of Pharmaceutical Products Etc.
As a result of the spread of the new coronavirus infectious disease (COVID-19), in order to promptly approve and supply therapeutic drugs and vaccines in emergencies, “the partly revised Law for Ensuring the Quality, Efficacy, and Safety of Drugs and Medical Devices” (hereinafter, referred to as “the revised Pharmaceutical and Medical Device Law”) was enacted on May 20, 2022, and a system for expedited pharmaceutical approval in emergencies (hereinafter, referred to as “the emergency approval system”) was newly established, which approves, conditionally and for a limited period, pharmaceutical products etc. with the efficacy estimated on the premise of confirming the safety.
If a pharmaceutical product etc. is granted for the emergency approval, the pharmaceutical product is to be approved by newly filing an application for approval within the time limit for the approval, after it is granted for the emergency approval. The Order for Enforcement of the Patent Act expressly prescribes that not both of these two approvals but only the emergency approval falls under the disposition which may be grounds for the registration of the patent term extension as described above. This is because the emergency approval is “approval of manufacturing and sales” under the Pharmaceutical and Medical Device Law, which makes possible the working of the patented invention, and thus the emergency approval is deemed to fall under the disposition required for the working of the patented invention under the Patent Act. Therefore, it should be understood that the approval by the additional application for approval within the time limit for the approval after the emergency approval does not fall under the disposition as the grounds for the registration of the patent term extension as described above.
5. Requirements in Examination of Extension Registration Application Related to Pharmaceutical Products Etc., and Effects of Patent Right Registered for Extension
Regarding effects of the patent right registered for extension, the Patent Act stipulates in Article 68-2 that the effect is limited to the working of the patented invention related to a product subject to the disposition which is prescribed by the Cabinet Order described above and constitutes the grounds for the registration of the extension (if a specific use of the product is designated in the disposition, the product used for such a use). Various judgments were made on the requirements in the examination of the extension registration application related to pharmaceutical products and the effects of the extended patent right. We will introduce some of them.
5-1. Oxaliplatin Case (Intellectual Property High Court Decision Made on January 20, 2017; 2016 [Administrative Litigation Case, the Second Instance] No. 10046; Appeal for Seeking an Injunction of Patent Infringement)
The effect of the patented invention related to the patent right with the term extended covers not only a “product” (pharmaceutical product etc.) specified by configuration with “ingredient, dose, administration, dosage, efficacy, and effect” in the disposition under Cabinet Order but also a product which is substantially the same as the pharmaceutical product etc. Thus, even if the above configuration determined in the disposition under the Cabinet Order includes a part different from the subject pharmaceutical product etc., when the part is just a small difference or a formal difference from overall, the subject pharmaceutical product etc. falls within what is substantially the same as the product subject to the disposition under the Cabinet Order, as a pharmaceutical product, and belongs to the coverage of the effect of the patent right with the term extended.
In detail, according to the judgment, in the following cases, the difference between the subject pharmaceutical product etc. and the “product (pharmaceutical product etc.)” specified by the “ingredient, dose, administration, dosage, efficacy, and effect” determined in the disposition under the Cabinet Order falls under the small difference or the formal difference from overall, and the subject pharmaceutical product etc. is included as the matter substantially the same as the product subject to the disposition under the Cabinet Order, as a pharmaceutical product.
(1) A case of a patented invention characterized only by an active ingredient of a pharmaceutical product etc., where the subject pharmaceutical product etc. additionally or alternatively contains, as “an ingredient” not active, an ingredient which is partly different from the patented invention, based on the well-known and common arts as of the application for the disposition under the Cabinet Order;
(2) A case of a patented invention concerning to safety or a dosage form of a pharmaceutical product related to a publicly known active ingredient, where the subject pharmaceutical product etc. additionally or alternatively contains an ingredient which is partly different, based on the well-known and common arts as of the application for the disposition under the Cabinet Order, and the both products have identity in the technical feature and the operation and effects, in view of the contents of the patented invention.
(3) A case where there is only a difference not numerically significant in the “dose” or “dosage and administration” specified in the disposition under the Cabinet Order.
(4) A case where the products are different in the “dose” specified in the disposition under the Cabinet Order, but are deemed to be identical when “the dosage and administration” are also taken into consideration.
5-2. Nalfurafine Case: (Intellectual Property High Court Decision Made on March 25, 2021; 2020 [Administrative Litigation Case, the First Instance] No. 10063; Request for Reversal of Appeal Decision)
The decision judges as follows: Whether it was necessary to receive a disposition under Cabinet Order for working the patented invention should be determined in light of the gist of the Patent Act instituting the system for extending a patent term, and whether the extension registration is granted should be determined substantially from such a perspective. Therefore, it should not be determined formally only on the basis of what is described as the “active ingredient” in a certificate in application for marketing approval of the pharmaceutical product.
In detail, the subject patented invention is to protect a free form of “nalfurafine,” and on the other hand, the certificate subject to the disposition under the Cabinet Order describes “nalfurafine hydrochloride” as “an active ingredient.” The decision judges as follows: It is inappropriate to determine formally that the active ingredient of the pharmaceutical product subject to the disposition under the Cabinet Order is “nalfurafine hydrochloride,” which was described in the certificate; rather, it is appropriate to find that the active ingredient of the subject pharmaceutical product includes both “nalfurafine,” which is a free base that attracted attention in the examination for approval of the subject pharmaceutical product as an ingredient substantially exerting efficacy and effects, and “nalfurafine hydrochloride,” which is its active pharmaceutical ingredient blended in the subject pharmaceutical product.
6. Conclusion
For an invention related to a pharmaceutical product etc., registration of patent term extension is permitted, because it requires a considerable period of time for tests and examination etc. necessary for the pharmaceutical product to be approved under provisions of laws for securing safety etc., which often results in a period during which the patented invention cannot be worked, and such a period is long, as compared to inventions pertaining to other technical fields. Further, it is necessary to define requirements in the examination of the extension registration application related to a pharmaceutical product etc., and effects of the patent right with the term extended, based on the revision of the Pharmaceutical and Medical Device Law etc., the interpretation of the active ingredient, efficacy, effect, etc. under the Pharmaceutical and Medical Device Law, etc. In this regard, various judgments will be made in the future.
