Risks from changes in legal regulations, intellectual property infringement and product liability
First written in FY2016. 7 of 13 entries say "Restated". Latest entry: FY2026-H1.
No other company in this theme has enough history to compare yet.
- FY2026-H1MitigatedAnnual report
「Regarding the company's response to the jury verdict, it is considering post-trial motions and all available options, including an appeal. Regardless of the first-instance outcome, the company believes that the U.S. patents held by Sarepta are likely to be found invalid on appeal and considers the likelihood of being ordered to pay damages to be low. Accordingly, it has not recognized a provision for damages relating to infringement of the relevant U.S. patent.」
Regarding the U.S. patent litigation over Viltepso, the company states that it is considering responses including post-verdict motions and an appeal, and that it has not recognized a provision because it considers the likelihood of paying damages to be low. - FY2025MaterialisedAnnual report
「Following a jury trial held at the same court in December 2024, the jury found that the patent Sarepta had obtained from the University of Western Australia (UWA) was valid and awarded Sarepta damages of $115.2 million based on the company's sale of Viltepso, a treatment for Duchenne muscular dystrophy. The jury also found that the company's patent was invalid.」
Regarding intellectual property risks, the company states that an actual jury verdict was issued in the U.S. litigation over Viltepso, awarding $115.2 million in damages and finding the company's patent invalid. It also states that the Japanese litigation ended when Sarepta abandoned its claim. - FY2025-H1RestatedAnnual report
「During the interim consolidated accounting period, there were no new business or other risks, nor any significant changes to the business or other risks described in the annual securities report for the previous fiscal year.」
The company states that there have been no new business risks or significant changes to existing risks. - FY2024MitigatedAnnual report
「The company protects and makes strategic, multifaceted use of intellectual property rights, including patents, for pharmaceuticals and functional foods it develops internally. It also regularly investigates third-party rights relating to its products and appropriately conducts intellectual property due diligence in licensing-in and licensing-out activities, including the evaluation of candidate products and potential partner companies.」
In response to intellectual property risks, the company identifies rights protection and third-party rights investigations, as well as intellectual property due diligence and candidate product and partner evaluations in licensing-in and licensing-out transactions. - FY2024-Q3RestatedAnnual report
「During the cumulative third quarter of the current consolidated fiscal year, there were no new business or other risks, nor any material changes to the business and other risks described in the annual securities report for the previous fiscal year.」
The company states that there have been no new business risks or significant changes to existing risks. - FY2024-Q2RestatedAnnual report
「During the cumulative second quarter of the current consolidated fiscal year, there were no new business or other risks, nor any material changes to the business and other risks described in the annual securities report for the previous fiscal year.」
The company states that there have been no new business risks or significant changes to existing risks. - FY2024-Q1RestatedAnnual report
「During the cumulative first quarter under review, there were no new business or other risks, nor any material changes to the business or other risks described in the annual securities report for the previous fiscal year.」
The company states that there have been no new business risks or significant changes to existing risks. - FY2023RestatedAnnual report
「If the group's business activities infringe the intellectual property rights of a third party, this could lead to disputes, damages claims or the discontinuation of the relevant business, and could materially affect the group's operating results, financial position and other matters.」
The company reiterates the risks that legal regulations, intellectual property rights and litigation could affect operating results and financial position. - FY2023-Q2RestatedAnnual report
「During the cumulative second quarter of the current consolidated fiscal year, there were no new business or other risks, nor any material changes to the business and other risks described in the annual securities report for the previous fiscal year.」
The company states that there have been no new business risks or significant changes to existing risks. - FY2021RestatedAnnual report
「If a risk materializes, the company has established a framework for working with external attorneys and/or patent attorneys to take the best possible action.」
The company reiterates the risks involving regulations, intellectual property rights and litigation, as well as its framework for responding in cooperation with external specialists. - FY2020MitigatedAnnual report
「If a risk materializes, the company has established a framework for working with external attorneys and/or patent attorneys to take the best possible action.」
The company describes its framework for working with external attorneys and patent attorneys if intellectual property risks materialize. - FY2019ReframedAnnual report
「In connection with the business activities of the corporate group, lawsuits may be brought in the future concerning pharmaceutical side effects, product liability, environmental matters, labor issues, fair trade and other matters. Depending on how such matters develop, they could affect operating results.」
In addition to existing regulatory, intellectual property and product liability risks, litigation risks involving environmental, labor and fair-trade matters are also identified. - FY2016First statedAnnual report
「Changes to these laws and regulations may require product recalls or the suspension of sales, which could affect operating results. There are also risks relating to intellectual property infringement, product liability and other matters, and their occurrence could, in some cases, affect operating results.」
Regulations concerning pharmaceuticals and functional foods, intellectual property rights and product liability are identified as factors that could affect operating results.