(~'21/09/30) Patent Act Article 93: Award for the Grant of a Non-Exclusive License for the Public Interest (Public Interest Award)

I am updating the article. Links to past articles are provided at the bottom of the page.

1. Purpose of the System

　Article 93 of the Patent Act is a system that forcibly grants a non-exclusive license through an award by the Minister of Economy, Trade and Industry when the working of a patented invention is particularly necessary for the public interest.

　Since a patent right is an exclusive right, the existence of a patent right may harm the public interest and cause significant damage to the public. In such cases, some measures are necessary, but restrictions on private rights should be kept to the minimum necessary even for the purpose of protecting the public interest, and the grant of a non-exclusive license can meet the requirements in all cases, so the Patent Act provides for the award system under Article 93.

2. Reason for the Minister of Economy, Trade and Industry to make the award

　This is because it is necessary to judge whether it is particularly necessary for the public interest, and requests from other administrative agencies (e.g., the Minister of Health, Labour and Welfare, etc.) are expected.

　As of now (September 22, 2021), there is no record of an award having been made, but it is considered important to determine what criteria will be used to judge whether it falls under the category of "when it is particularly necessary for the public interest."

3. Relationship with other awards

　In the case of an award for non-working (Article 83), if there is a justifiable reason for the non-working, an award for the grant of a non-exclusive license will not be made. However, this provision is not applied mutatis mutandis in this article. This is because, for example, in the case of a patent for a miracle drug for a highly lethal malignant infectious disease, if it is "particularly" necessary to work it for the public interest, it is necessary to use all available pharmaceutical factories to produce the miracle drug. This example is a case of a national emergency due to a malignant infectious disease, and it is because the patentee's justifiable reasons should not be considered even in such cases.

4. Specific examples

　The specific examples of when it is particularly necessary for the public interest described in the commentary on the articles are the following two cases: ① An invention related to power generation where, if the invention is worked, the cost of power generation will be significantly reduced and the burden on consumers will be halved. ② An invention related to the gas business where, if the invention is worked, gas leaks will be eliminated and the number of gas poisoning victims will be significantly reduced.

5. Other

・It is deemed that an agreement has been reached upon service of the transcript.

・Note that as of September 22, 2021, there has been no instance of an award being made under the provisions of Article 93 of the Patent Act.　To the extent I have confirmed, the following statement was found in the
materials of the Patent System Subcommittee of the Intellectual Property Policy Committee of the Industrial Structure Council held on March 3, 2004.

5. Track record of awards
To date, a total of 23 requests for awards have been made for patent rights, utility model rights, and design rights combined (9 for non-working, 14 for utilization relationships), but all were withdrawn before reaching an award, and there are no cases where a non-exclusive license was granted by an award.

5.1. I had an explanatory illustration drawn!

・I asked Ossan Patent Attorney (@ossan_tokkyo) to draw an explanatory illustration regarding the award!

5.2. Regarding tweets about public interest awards from around 21/09/21

　From around 21/09/21, some tweets about public interest awards were seen. These seem to have been triggered by the following tweet by Dr. Masayo Takahashi (@masayomasayo).

　To the extent I have confirmed, I believe the joint patent rights of RIKEN and Helios are the following two: Patent No. 6518878 (Invention Title: Method for producing retinal pigment epithelial cells) and Patent No. 6850455, which is a division of Patent No. 6518878. Also, Dr. Masayo Takahashi, who tweeted the above, is one of the inventors of these patents. More specifically, Patent No. 6518878 has three inventors: Dr. Masanori Sawada, Dr. Masayo Takahashi, and Dr. Kiyotoshi Sekiguchi, and the patent holders are three parties: Helios Techno Holding Co., Ltd., RIKEN, and Osaka University.

It seems that Helios had entered into a joint development agreement with Sumitomo Dainippon Pharma. Furthermore, according to the announcement dated June 13, 2019, the terms of this agreement were changed, and it was decided to establish a joint venture, CiGen Co., Ltd., to manufacture and promote RPE cell pharmaceuticals (Source 1).

On the other hand, according to the Vision Care Inc. website (Source 2), Dr. Takahashi was originally affiliated with RIKEN, and it appears she has been the representative of Vision Care Inc. since August 2019 (Source 2).

Inferring from this information alone, it looks as though Dr. Takahashi was not satisfied with the policy led by RIKEN and others to change the development of RPE cell pharmaceuticals to development by an external organization, and moved to a different organization (company).

5.2.1. Personal speculation

Since the medical field is outside my area of expertise, the descriptions in this block are based on speculation. According to the tweet by Dr. Masayo Takahashi (@masayomasayo) mentioned above, the effectiveness of the manufacturing methods for retinal pigment epithelial cells (Patent No. 6518878, Patent No. 6850455) has
not been 'confirmed' in clinical trials. If effectiveness has not been confirmed in clinical trials, then for a patent where it is unclear whether it is actually effective, I believe it is unlikely that the working of the patented invention will be certified as being particularly necessary for the public interest (Patent Act Article 93).

Also, while this case is a result of industry-academia collaborative research and development, it appears that the research and development costs (including actual development costs, clinical trial costs, etc.) are being borne by an organization/company, and a former member is requesting a public interest award. While this point does not seem to have much to do with the 'particularly necessary for the public interest' requirement of Article 93 of the Patent Act, it is hard to imagine the request being granted.

5.2.2. Summary

Ultimately, I do not know what the outcome of this request will be, but I hope that as a result, the spread of licensing awards (non-working awards) to NPEs (Non-Practicing Entities) will further accelerate technological progress. Note that NPE might be more familiar under the term patent troll.

6. Related articles, etc.

Dr. Kurihara and Dr. Dokugaku wrote articles on this, so I will provide the links.

・Patent Act Article 93

(Award for the Grant of a Non-Exclusive License for the Public Interest) Article 93 (1) When the working of a patented invention is particularly necessary for the public interest, a person who intends to work the patented invention may request the patentee or the exclusive licensee to hold consultations regarding the grant of a non-exclusive license. (2) If the consultations referred to in the preceding paragraph are not reached or cannot be held, the person who intends to work the patented invention may request an award from the Minister of Economy, Trade and Industry. (3) The provisions of Article 84, Article 84-2, Article 85(1), and Article 86 through Article 91-2 shall apply mutatis mutandis to the award referred to in the preceding paragraph.

●Article History
・(~'21/09/21) Patent Act Article 93: Award for the Grant of a Non-Exclusive License for the Public Interest (Public Interest Award)

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