Product Liability Act and Litigation Risks
First written in FY2016. 22 of 29 entries say "Restated". Latest entry: 2026-05-12.
Fuso Pharmaceutical Industries moved to the "Worse" side of this theme in 2024.
1 other company's latest entry also says "Materialised".
- 2026-05-12MaterialisedEarnings
「As a result of the ¥8,744 million payment of advances paid, cash outflows totaled ¥6,224 million.」
The payment of advances paid related to patent infringement litigation was reflected in full-year cash flows. - FY2026-H1MaterialisedAnnual report
「Although pretax interim net income was recorded and trade receivables declined, operating cash flow was an outflow of ¥5,367 million due to the payment of ¥8,744 million in an advance payment related to the above litigation.」
The ¥8,744 million advance payment related to the patent infringement litigation with TORAY INDUSTRIES,INC. was made, resulting in an operating cash flow outflow of ¥5,367 million. - FY2025MaterialisedAnnual report
「On 27 May 2025, the Intellectual Property High Court issued a partially favorable judgment on TORAY INDUSTRIES,INC.’s claims and ordered us to pay a total of ¥7,472,878,838 plus late-payment damages. In connection with the judgment, we recorded ¥8,744 million as an extraordinary loss for the provision for litigation-related losses, and net loss for the period was ¥3,288 million, compared with net income of ¥1,377 million in the same period of the previous year. We had maintained, among other positions, that the Product did not infringe patents held by TORAY INDUSTRIES,INC. We deeply regret and cannot accept the fact that our arguments were not accepted on appeal, and on 6 June 2025 we filed an appeal to the Supreme Court and a petition for acceptance of the final appeal.」
In the patent infringement litigation with TORAY INDUSTRIES,INC. that had been pending, the Intellectual Property High Court issued a partially favorable judgment and ordered payment of ¥7,472,878,838 and other amounts. The company recorded a ¥8,744 million provision for litigation-related losses and has filed an appeal and other petitions with the Supreme Court. - FY2025-H1WorsenedAnnual report
「On 13 December 2018, TORAY INDUSTRIES,INC. filed a lawsuit with the Tokyo District Court against us seeking an injunction against patent infringement and damages relating to the oral antipruritic drug Nalfurafine Hydrochloride OD Tablets 2.5 μg “Fuso” (the “Product”) [reference originator product: Remitch OD Tablets 2.5 μg]. The Tokyo District Court subsequently dismissed TORAY INDUSTRIES,INC.’s claims, and TORAY INDUSTRIES,INC. appealed to the Intellectual Property High Court, where the case was pending. On 22 March 2024, however, a motion to amend the complaint was filed seeking to increase the amount of damages claimed against us in this litigation from ¥40 million plus late-payment damages to ¥8,224,008,843 plus late-payment damages.」
With respect to the pending patent infringement litigation, the damages claim was specifically disclosed as having been increased from ¥40 million and other amounts to ¥8,224,008,843 and other amounts. It is also stated that the company believes the claim is excessive and will not be upheld. - FY2024MaterialisedAnnual report
「Details of material pending litigation are provided in “V. Financial Information, 1. Financial Statements, (1) Financial Statements, Notes to Financial Statements (Balance Sheet), 6. Contingent Liabilities.”」
In addition to the previously disclosed possibility of litigation, it is stated that material litigation is pending. - FY2024-Q3RestatedAnnual report
「During the first three quarters of the current fiscal year, there were no new occurrences of the major risks that management recognises could materially affect the filing company's financial position, operating results or cash flows among the matters relating to business conditions, financial conditions and other matters described in the quarterly report, and no material changes to the "Business and Other Risks" described in the annual securities report for the previous fiscal year.」
It is stated that there have been no material changes in the major risks, including product liability and litigation. - FY2024-Q1RestatedAnnual report
「There were no new major risks during the three months ended 30 June, and no material changes to the business and other risks described in the annual securities report for the previous fiscal year.」
It is stated that there have been no material changes in the major risks, including product liability and litigation. - FY2023-Q3RestatedAnnual report
「During the first three quarters of the current fiscal year, there were no new occurrences of the major risks that management recognises could materially affect the filing company's financial position, operating results or cash flows among the matters relating to business conditions, financial conditions and other matters described in the quarterly report, and no material changes to the "Business and Other Risks" described in the annual securities report for the previous fiscal year.」
It is stated that there have been no material changes in the major risks, including product liability and litigation. - FY2022RestatedAnnual report
「We may face lawsuits relating to infringement of intellectual property rights, violations of the Product Liability Act, environmental pollution, labor issues, fair trade and other matters. If we are sued and lose, we could incur substantial damages and suffer a material impact on our operating results and social reputation.」
The risks of litigation relating to intellectual property rights, product liability, environmental matters, labor issues, fair trade and other matters, as well as the possibility of substantial damages and loss of trust in the event of an adverse judgment, continue to be identified. - FY2022-Q2RestatedAnnual report
「During the cumulative second quarter under review, there were no new major risks that management recognizes could have a material impact on the financial condition, operating results or cash flows of the filing company, and no material changes to the “Business and Other Risks” described in the annual securities report for the previous fiscal year.」
It is stated that there have been no material changes in the major risks, including product liability and litigation risks. - FY2021WorsenedAnnual report
「We may face lawsuits relating to infringement of intellectual property rights, violations of the Product Liability Act, environmental pollution, labor issues, fair trade and other matters. If we are sued and lose, we could incur substantial damages and suffer a material impact on our operating results and social reputation.」
The risk items have been expanded from the previously disclosed litigation risks under the Product Liability Act and other laws to include intellectual property rights, environmental pollution, labor issues and fair trade, with the potential for substantial damages and loss of trust in the event of an adverse judgment explicitly stated. - FY2021-Q3RestatedAnnual report
「During the first three quarters of the current fiscal year, there were no new occurrences of the major risks that management recognises could materially affect the filing company's financial position, operating results or cash flows among the matters relating to business conditions, financial conditions and other matters described in the quarterly report, and no material changes to the "Business and Other Risks" described in the annual securities report for the previous fiscal year.」
It is stated that there have been no material changes in the major risks, including product liability and litigation risks. - FY2021-Q2RestatedAnnual report
「During the cumulative second quarter under review, there were no new major risks that management recognizes could have a material impact on the financial condition, operating results or cash flows of the filing company, and no material changes to the “Business and Other Risks” described in the annual securities report for the previous fiscal year.」
It is stated that there have been no material changes in the major risks, including product liability and litigation. - FY2021-Q1RestatedAnnual report
「There were no new major risks during the three months ended 30 June, and no material changes to the business and other risks described in the annual securities report for the previous fiscal year.」
It is stated that there have been no material changes in the major risks, including product liability and litigation risks. - FY2020-Q3RestatedAnnual report
「During the cumulative third quarter of the current fiscal year, there were no occurrences of matters concerning the business situation, accounting situation or other matters described in the quarterly report that could have a material impact on investors’ decisions, and no material changes to the “Business and Other Risks” described in the annual securities report for the previous fiscal year.」
It is stated that there have been no material changes in business and other risks, including product liability and litigation. - FY2020-Q2RestatedAnnual report
「During the cumulative second quarter of the current fiscal year, there were no occurrences of matters concerning the business situation, accounting situation or other matters described in the quarterly report that could have a material impact on investors’ decisions, and no material changes to the “Business and Other Risks” described in the annual securities report for the previous fiscal year.」
It is stated that there have been no material changes in business and other risks, including product liability and litigation. - FY2020-Q1RestatedAnnual report
「During the cumulative first quarter of the current fiscal year, there were no occurrences of matters concerning the business situation, accounting situation or other matters described in the quarterly report that could have a material impact on investors’ decisions, and no material changes to the “Business and Other Risks” described in the annual securities report for the previous fiscal year.」
It is stated that there have been no material changes in business and other risks, including product liability and litigation. - FY2019RestatedAnnual report
「Litigation risks relating to the Product Liability Act (PL Act) and other matters」
Litigation risks relating to the PL Act and other matters continue to be listed. - FY2019-Q3RestatedAnnual report
「During the cumulative third quarter of the current fiscal year, there were no occurrences of matters concerning the business situation, accounting situation or other matters described in the quarterly report that could have a material impact on investors’ decisions, and no material changes to the “Business and Other Risks” described in the annual securities report for the previous fiscal year.」
It is stated that there have been no material changes in business and other risks, including product liability and litigation. - FY2019-Q2RestatedAnnual report
「During the cumulative second quarter of the current fiscal year, there were no occurrences of matters concerning the business situation, accounting situation or other matters described in the quarterly report that could have a material impact on investors’ decisions, and no material changes to the “Business and Other Risks” described in the annual securities report for the previous fiscal year.」
It is stated that there have been no material changes in business and other risks, including product liability and litigation. - FY2019-Q1RestatedAnnual report
「During the cumulative first quarter of the current fiscal year, there were no occurrences of matters concerning the business situation, accounting situation or other matters described in the quarterly report that could have a material impact on investors’ decisions, and no material changes to the “Business and Other Risks” described in the annual securities report for the previous fiscal year.」
It is stated that there have been no material changes in business and other risks, including product liability and litigation. - FY2018RestatedAnnual report
「Litigation risks relating to the Product Liability Act (PL Act) and other matters」
Litigation risks relating to the PL Act and other matters continue to be listed. - FY2018-Q3RestatedAnnual report
「During the cumulative third quarter of the current fiscal year, there were no occurrences of matters concerning the business situation, accounting situation or other matters described in the quarterly report that could have a material impact on investors’ decisions, and no material changes to the “Business and Other Risks” described in the annual securities report for the previous fiscal year.」
It is stated that there have been no material changes in business and other risks, including product liability and litigation. - FY2018-Q1RestatedAnnual report
「During the cumulative first quarter of the current fiscal year, there were no occurrences of matters concerning the business situation, accounting situation or other matters described in the quarterly report that could have a material impact on investors’ decisions, and no material changes to the “Business and Other Risks” described in the annual securities report for the previous fiscal year.」
It is stated that there have been no material changes in business and other risks, including product liability and litigation. - FY2017RestatedAnnual report
「Litigation risks relating to the Product Liability Act (PL Act) and other matters」
Litigation risks relating to the PL Act and other matters continue to be listed. - FY2017-Q3RestatedAnnual report
「During the cumulative third quarter of the current fiscal year, there were no occurrences of matters concerning the business situation, accounting situation or other matters described in the quarterly report that could have a material impact on investors’ decisions, and no material changes to the “Business and Other Risks” described in the annual securities report for the previous fiscal year.」
It is stated that there have been no material changes in product liability and litigation risks. - FY2017-Q2RestatedAnnual report
「During the cumulative second quarter of the current fiscal year, there were no occurrences of matters concerning the business situation, accounting situation or other matters described in the quarterly report that could have a material impact on investors’ decisions, and no material changes to the “Business and Other Risks” described in the annual securities report for the previous fiscal year.」
It is stated that there have been no material changes in product liability and litigation risks. - FY2017-Q1RestatedAnnual report
「During the cumulative first quarter of the current fiscal year, there were no occurrences of matters concerning the business situation, accounting situation or other matters described in the quarterly report that could have a material impact on investors’ decisions, and no material changes to the “Business and Other Risks” described in the annual securities report for the previous fiscal year.」
It states that there have been no material changes to the risks described in the previous fiscal year. - FY2016First statedAnnual report
「Litigation risks relating to the Product Liability Act (PL Act) and other matters」
The possibility of litigation relating to the PL Act and other matters is listed as a risk.