Intellectual Property Committee
Interview with Chairman Okumura
The IP strategy of the pharmaceutical industry has reached a major turning point, as the government's "Intellectual Property Promotion Plan 2025" includes a pharmaceutical data protection system for the first time. In addition, the rapid development of AI technology is reexamining the very framework of intellectual property. In the midst of these changes, the IP Committee has begun to take on challenges in new areas in addition to its traditional activities. We interviewed Mr. Hiroya Okumura, Chairperson of the Committee, about the Committee's efforts and future prospects.
Realizing an IP system that supports co-creation and innovation
Aiming to create an attractive business environment
Three key issues: "Pharmaceutical Data Protection," "Patent Linkage," and "Patent Term Extension
The activities of the Intellectual Property Committee have had four pillars so far. The four pillars of the IP Committee's activities have been "solving domestic IP system issues," "harmonizing international IP systems," "addressing international IP issues such as global health," and "disseminating IP information.
However, now that AI technology is developing at an astonishing speed and open innovation is accelerating, IP is no longer just an IP issue. Therefore, in addition to the four existing pillars, we have begun to address "boundary areas" where multiple areas overlap, such as "R&D and intellectual property" and "industrial policy and intellectual property," as our fifth new pillar. This is our new challenge to meet the demands of the current era.
Our ongoing challenge is to improve the IP system. In particular, "pharmaceutical data protection," "patent linkage," and "patent term extension" are important issues that can be regarded as a "three-part set.
Drug data protection is a system to protect, for a certain period of time, test data submitted to the regulatory authorities for marketing authorization from use by third parties. Japan's current reexamination system functions in substantially the same way, but because it is not a legal right, no countermeasures can be taken against infringement. In addition, foreign countries sometimes mistakenly believe that Japan has no data protection system, which has been a major disadvantage for the drug discovery environment in Japan.
This longstanding issue has made progress this year. In the "Intellectual Property Promotion Plan 2025" compiled by the Japanese government, the need for a data protection system was clearly stated for the first time as a "recognized issue. This is a "first step" that opens the door to a broader discussion in the future. We would like to seize this opportunity to gather the opinions of the pharmaceutical industry and take the next step, which is to upgrade the "direction of measures," and link this to future revisions of the law.
Patent linkage" is a system whereby the pharmaceutical authorities take into account the valid patents related to the brand name drug when approving a generic drug, in order to avoid problems with the stable supply of the generic drug due to patent infringement lawsuits or other problems related to the brand name drug. Currently, information is disclosed only after the generic is approved, which means that there is not enough time for prior coordination. We are calling for improvements to the system so that information is disclosed at the generic drug application stage and so that there is an early opportunity for prior coordination.
Expanding the Possibilities for Co-Creation through the Establishment of a New "Innovation Promotion Task Force
Our activities in the fifth pillar, "Boundary Area," are also moving forward in concrete terms. We have newly established an "Innovation Promotion Task Force" within the committee and are exploring the possibility of collaboration with other committees such as the Research and Development Committee and the Industrial Policy Committee. For example, there are many ways we can contribute, such as holding study sessions to support IP strategies for venture companies and supporting contracts in industry-academia-government consortiums.
The issue of AI and intellectual property is also unavoidable. Fundamental discussions such as "Can AI be an inventor? In the pharmaceutical industry, it may be some time before AI can autonomously create drugs, but we need to advance the discussion with researchers now and prepare for the coming future.
Our activities are not limited to the domestic market. International institutional harmonization is also an important mission. For example, in China, the IP system has changed drastically in recent years, and we can see some differences from international standards. We continue to encourage the government to improve the system through various consultation forums.
We believe that the development of such an IP system will ultimately benefit patients. If the drug data protection system becomes law, it may encourage investment in drugs (drug-lag/loss) that have so far been kept out of development in Japan. This will improve the drug development environment in Japan and bring new treatment options to patients.
Now that the world is changing at such a rapid pace, there are fewer issues that can be completed only by intellectual property. We will continue to promote activities that support innovation through co-creation, with a strong awareness of the fifth pillar, "borderline areas," while deepening the four existing pillars.
The structure and activities of the Intellectual Property Committee are posted on the website of the Pharmaceutical Manufacturers Association of Japan. Please visit the site.
[Intellectual Property Committee website]
Intellectual Property Committee | Information from the Committee | Japan Pharmaceutical Manufacturers Association