Protection of Intellectual Property and Infringement Risk
First written in FY2016. 4 of 14 entries say "Mitigated", first in FY2017-Q3. Latest entry: FY2024.
Ono Pharmaceutical moved to the "Worse" side of this theme in 2019, 6 years before the typical company in this theme (2025).
The whole theme swung hardest in 2025: 9 of 59 companies on the "Worse" side.
127 other companies' latest entry also says "Restated".
- FY2024RestatedAnnual report
「The Company, Bristol-Myers Squibb Company (United States; hereinafter, “BMS”), AstraZeneca (United Kingdom), MedImmune (United Kingdom) and their affiliates entered into an agreement dated 24 July 2023 to fully settle worldwide the disputes, including patent litigation, concerning patents related to anti-PD-L1 and anti-CTLA-4 antibodies to which the Company and BMS have rights.」
The worldwide settlement of disputes concerning patents related to anti-PD-L1 and anti-CTLA-4 antibodies and the resulting upfront payment income have been reaffirmed as a material agreement and source of revenue. - FY2024-Q1MitigatedAnnual report
「The Company, Bristol-Myers Squibb Company (United States; hereinafter, “BMS”), AstraZeneca (United Kingdom), MedImmune (United Kingdom) and their affiliates entered into an agreement dated 24 July 2023 to fully settle worldwide the disputes, including patent litigation, concerning patents related to anti-PD-L1 and anti-CTLA-4 antibodies to which the Company and BMS have rights. Under the settlement, the Company will receive approximately US$140 million in total.」
The parties entered into a worldwide full settlement agreement concerning disputes over patents related to anti-PD-L1 and anti-CTLA-4 antibodies, and the Company will receive approximately US$140 million. - FY2023MitigatedAnnual report
「Dana-Farber Cancer Institute — Settlement agreement concerning PD-1 patent litigation — upfront payment — royalties — from April 2023 through the expiration year of the applicable patent」
The settlement agreement concerning the ongoing PD-1 patent litigation with Dana-Farber Cancer Institute is disclosed as a material business agreement. - FY2023-Q3RestatedAnnual report
「In July 2020, an appellate judgment upholding the trial court decision was issued, and in May 2021 the Company’s appeal to the Supreme Court was also dismissed, making the judgment final. / In June 2019, Dana-Farber Cancer Institute, which had acquired rights and interests relating to the invention from Dr. Gordon J. Freeman, filed suit in the U.S. District Court for the District of Massachusetts. It claimed that, as the party entitled to receive a share of the license income obtained when the Company and Bristol-Myers Squibb Company, as exclusive owners of the above patents, brought patent infringement actions against competitors and entered into settlements or license agreements, it was entitled to a share of the related benefits.」
The final disposition of the litigation concerning the anti-PD-1 and anti-PD-L1 antibody patents and the ongoing action by Dana-Farber Cancer Institute seeking a share of license income have been reaffirmed. - FY2023-Q2RestatedAnnual report
「In July 2020, an appellate judgment upholding the trial court decision was issued, and in May 2021 the Company’s appeal to the Supreme Court was also dismissed, making the judgment final. / In June 2019, Dana-Farber Cancer Institute, which had acquired rights and interests relating to the invention from Dr. Gordon J. Freeman, filed suit in the U.S. District Court for the District of Massachusetts. It claimed that, as the party entitled to receive a share of the license income obtained when the Company and Bristol-Myers Squibb Company, as exclusive owners of the above patents, brought patent infringement actions against competitors and entered into settlements or license agreements, it was entitled to a share of the related benefits.」
The final disposition of the litigation concerning the anti-PD-1 and anti-PD-L1 antibody patents and the ongoing action by Dana-Farber Cancer Institute seeking a share of license income have been reaffirmed. - FY2022-Q3MitigatedAnnual report
「An action seeking payment of a share of amounts related to third-party litigation concerning the PD-1 patent, filed by Dr. Tasuku Honjo in the Osaka District Court in June 2020, had been ongoing. Following a recommendation to settle by the court, a settlement was reached on 12 November 2021.」
The action brought by Dr. Honjo seeking payment of a share of proceeds related to the PD-1 patent was settled, with ¥5.0 billion paid as a settlement amount and ¥23.0 billion donated to Kyoto University. Litigation concerning Dana-Farber Cancer Institute remains ongoing. - FY2021WorsenedAnnual report
「The Company appealed because it disagreed with the judgment, but in July 2020 a judgment was issued upholding the trial court decision. The petition for rehearing by the appellate court was also dismissed. In March 2021, the Company appealed to the Supreme Court, but the petition was dismissed in May 2021 and the judgment became final.」
The patent litigation concerning anti-PD-1 antibodies and other matters progressed through an appellate judgment upholding the trial court decision, dismissal of the petition for rehearing, and dismissal of the appeal to the Supreme Court, with the judgment becoming final, indicating an escalation in the dispute. - FY2021-Q2WorsenedAnnual report
「The Company appealed because it disagreed with the judgment, but on 14 July 2020 a judgment was issued upholding the trial court judgment. The Company petitioned the appellate court for a rehearing, but the petition was dismissed, and it is currently considering an appeal to the Supreme Court. Similar litigation has also been filed in Europe. In addition, on 19 June 2020, Dr. Tasuku Honjo filed an action in the Osaka District Court seeking payment of a share of amounts related to third-party litigation concerning the PD-1 patent, and the proceedings are ongoing.」
In the patent litigation concerning anti-PD-1 antibodies and other matters, the appellate court upheld the trial court judgment and dismissed the petition for rehearing. In addition to the European litigation, the action brought by Dr. Tasuku Honjo seeking payment of a share of proceeds is also ongoing. - FY2021-Q1WorsenedAnnual report
「On 14 July 2020, a judgment was issued upholding the trial court judgment. The Company is considering a petition for rehearing or an appeal to the Supreme Court. Similar litigation has also been filed in Europe. In addition, on 19 June 2020, Dr. Tasuku Honjo filed an action in the Osaka District Court against the Company seeking payment of a share of amounts related to third-party litigation concerning the PD-1 patent, and the Company received the complaint.」
In litigation concerning patents for anti-PD-1 antibodies and other matters, a judgment upholding the trial court judgment was issued, European litigation was also disclosed, and Dr. Tasuku Honjo filed a new action seeking payment of a share of proceeds. - FY2020-Q1MaterialisedAnnual report
「On 21 June 2019, Dana-Farber Cancer Institute, which had acquired rights and interests relating to the invention from Dr. Gordon J. Freeman, filed suit in the U.S. District Court for the District of Massachusetts. It claimed that, as the party entitled to receive a share of the license income obtained when the Company and Bristol-Myers Squibb Company, as exclusive owners of the above patents, brought patent infringement actions against competitors and entered into settlements or license agreements, it was entitled to a share of the related benefits.」
In addition to the appeal against the trial court judgment concerning patents for anti-PD-1 antibodies and other matters, Dana-Farber Cancer Institute filed a new action claiming entitlement to a share of license income. - FY2019MaterialisedAnnual report
「On 17 May 2019, a trial court judgment was issued allowing Dr. Clive R. Wood and Dr. Gordon J. Freeman of Dana-Farber Cancer Institute to be added as inventors. The Company appealed because it disagreed with the judgment. The impact of the judgment on the Group’s operating results and other matters cannot currently be estimated.」
In litigation concerning patents for anti-PD-1 antibodies and other matters, a trial court judgment allowed additional inventors to be named, and the Company appealed, marking the occurrence of a specific litigation event. - FY2018RestatedAnnual report
「If the Group is unable to protect its various intellectual property rights, or infringes third-party intellectual property rights without being aware of it, its operating results and financial position may be materially affected.」
The risk of failure to protect the Company’s intellectual property and infringement of third-party intellectual property has been reaffirmed as a general risk. - FY2017-Q3MitigatedAnnual report
「The Company and Bristol-Myers Squibb Company (United States; hereinafter, “BMS”) held a use patent for anti-PD-1 antibodies jointly with Dr. Tasuku Honjo, Visiting Professor at the Graduate School of Medicine, Kyoto University, and a substance patent for anti-PD-1 antibodies jointly with BMS. The parties had been involved in patent infringement litigation in Japan, the United States, Europe and other jurisdictions concerning the sale and other activities related to Keytruda® (generic name: pembrolizumab, MK-3475), an anti-PD-1 antibody product sold by Merck & Co., Inc. (United States) and its affiliates (hereinafter, “Merck”). On 20 January 2017, the Company and BMS reached a settlement with Merck and entered into a license agreement. Under the agreement, after confirming the validity of the use and substance patents held by the Company and BMS, the parties agreed to authorize Merck to sell Keytruda®. Merck also agreed to pay the Company and BMS an upfront payment of US$625 million and royalties equal to 6.5% of worldwide Keytruda® sales from 1 January 2017 through 31 December 2023 and 2.5% from 1 January 2024 through 31 December 2026.」
After patent infringement litigation concerning anti-PD-1 antibodies had become an active dispute, the litigation in each country was concluded through a settlement and license agreement with Merck. The agreement also specifies a US$625 million upfront payment and royalty terms for separate periods. - FY2016First statedAnnual report
「If the Group is unable to protect its various intellectual property rights, or infringes third-party intellectual property rights without being aware of it, its operating results and financial position may be materially affected.」
Failure to protect the Group’s intellectual property and infringement of third-party intellectual property are identified as risks that could affect operating results and financial position.