阿斯利康奥希替尼作为NSCLC的一线疗法已在国内获批，必将进一步造福国内患者

Categories:最新消息
Author:华讯知识产权
Origin:
Time of issue:2019-09-19 11:22
Views:

(Summary description)2019年8月31日，国家药品监督管理局（NMPA）官网显示，阿斯利康研发的奥希替尼用于表皮生长因子受体（EGFR）基因突变阳性的局部晚期或转移性非小细胞肺癌（NSCLC）患者的一线治疗的上市申请（JXHS1800054/5）审批完毕，进入了制证阶段，标志着奥希替尼正式作为NSCLC的一线疗法在国内获批。甲磺酸奥希替尼片（泰瑞沙®，AZD9291）是阿斯利康的第3代口服、不可逆的选

阿斯利康奥希替尼作为NSCLC的一线疗法已在国内获批，必将进一步造福国内患者

Categories:最新消息
Author:华讯知识产权
Origin:
Time of issue:2019-09-19 11:22
Views:

Information

2019年8月31日，国家药品监督管理局（NMPA）官网显示，阿斯利康研发的奥希替尼用于表皮生长因子受体（EGFR）基因突变阳性的局部晚期或转移性非小细胞肺癌（NSCLC）患者的一线治疗的上市申请（JXHS1800054/5）审批完毕，进入了制证阶段，标志着奥希替尼正式作为NSCLC的一线疗法在国内获批。

甲磺酸奥希替尼片（泰瑞沙®，AZD9291）是阿斯利康的第3代口服、不可逆的选择性EGFR突变抑制剂，是全球首个上市，也是中国首个获批的用于EGFR T790M突变阳性的局部晚期或转移性非小细胞肺癌的靶向肿瘤药物。

在我国，肺癌是发病率和死亡率较高的恶性肿瘤，每年新发病的肺癌患者超过73万人。中国的非小细胞肺癌患者约有30-40%发生EGFR突变，而接受过EGFR-TKI药物（如吉非替尼、厄洛替尼、埃克替尼）治疗的EGFR突变患者约有三分之二会由于T790M突变而产生耐药，导致疾病再次进展，患者亟需得到新的治疗方案。相比第一代和第二代EGFR-TKI，第三代EGFR奥希替尼有两个显著的优点：1. 对导致第一代EGFR-TKI药物失效的T790M突变依然有效；2. 第三代TKI的特异性提高，产生有效的精准抑制，副作用减小。

近年来，基于严谨的询证医学证据，奥希替尼从17年3月在国内上市成为唯一批准用于EGFR-T790M突变的非小细胞肺癌治疗药物，到18年10月进入我国医保，以及到如今跻身为EGFR突变的转移性非小细胞肺癌的一线用药，已逐渐成为我国EGFR基因阳性突变肺癌治疗的主力武器。

南京华讯知识产权顾问有限公司

全球范围内，几大权威临床实践指南均强烈推荐奥希替尼作为一线治疗EGFR阳性的晚期NSCLC的首选药物。2018年美国食品药品管理局（FDA）基于FLAURA研究结果，批准奥希替尼用于一线治疗EGFR阳性的非小细胞肺癌患者。2019年初美国国立综合癌症网络（NCCN）指南进一步推荐奥希替尼作为EGFR阳性非小细胞肺癌患者一线用药为首选推荐，且排在吉非替尼、厄洛替尼等之前。2018年10月欧洲肿瘤内科学会（ESMO）的临床实践指南也将奥希替尼纳入EGFR阳性非小细胞肺癌患者一线用药。2018年日本发布的肺癌诊疗指南将奥希替尼高级别推荐为EGFR阳性非小细胞肺癌患者一线用药。2019年初ESMO官方期刊《肿瘤学年鉴（Annals of Oncology）》发布的“泛亚洲转移性NSCLC临床实践指南”优先推荐奥希替尼作为一线首选治疗。

抗癌药最关键的疗效评估指标是药物延长患者的总生存期（OS）、提高生活质量，OS目前被广泛接受作为评价抗癌药疗效的金标准。2019年8月9日，阿斯利康宣布FLAURA研究达到了OS的次要终点，奥希替尼一线治疗EGFR突变阳性晚期NSCLC患者相比标准TKIs治疗显示出具有统计学和临床意义的OS改善，使得奥希替尼成为美国FDA认可的首个延长总生存的EGFR靶向药。FLAURA研究OS结果巩固了奥希替尼一线治疗的地位。

自2015年11月获美国FDA批准上市以来，奥希替尼已在美国、欧洲、日本、中国、加拿大、瑞典、以色列、墨西哥、澳大利亚等47个国家及地区上市。市场销售额稳步增长，2017年销售额9.55亿美元，2018年前9月销售额12.66亿美元（+94%），2019年H1业绩销售额14.14亿美元（增长86%）。

南京华讯知识产权顾问有限公司

目前，我国获批上市的三代EGFR-TKIs仅有奥希替尼一个，这也是目前FDA、EMA唯一批准的三代EGFR-TKIs。此次奥希替尼在中国正式获批作为NSCLC的一线疗法意味着：30年来唯一可真正延长生存时间的EGFR靶向药将进一步造福国内患者，可谓中国EGFR肺癌治疗的一大里程碑！

药品简介

通用名称：甲磺酸奥希替尼片

商品名称：Tagrix®（泰瑞沙®）

分子式：C28H33N7O2·CH4O3S

化学式：

南京华讯知识产权顾问有限公司

Keyword:

Previous: 吉利起诉威马侵犯其商业秘密，索赔21亿并要求追回专利！

Next: 《药品管理法》修订，“药神”可以存在么？

Previous: 吉利起诉威马侵犯其商业秘密，索赔21亿并要求追回专利！

Next: 《药品管理法》修订，“药神”可以存在么？

Electronic Arts pledges free use for five accessibility patents

Electronic Arts pledges free use for five accessibility patents Recently, Electronic Arts (EA) announced a patent pledge that gives other companies and developers free access to five of its current accessibility-related patents and technology. The company promised not to enforce against any party for infringing any of the listed patents. Instead, EA hopes to encourage “innovation” and build new features that make video games more inclusive on a much larger scale by opening up the patents. Electronic Arts (EA) is an American video game company founded in 1982. The company owns many popular and famous games, such as The Sims, SimCity, Apex Legends, Madden NFL and FIFA. Each of the games has more than 30 or 50 million sales volume. Significantly, esports involves FIFA and Apex Legends into the event list. Apex Legends has up to 1 billion players, and it is so popular that it has a Switch version. Within the freely available patents, one of which grabs everyone’s attention -- Apex Legends’ ping system (patent No. US 11097189). The ping system in Apex Legends, which excellently allows players to make communication and teamwork quick and easy without hearing or speaking, has been praised both as an impressive alternative to voice chat and as a great accessibility feature for players with a variety of disabilities. The other patents include the technology widely used in the FIFA and Madden NFL. The innovations can automatically detect and modify colors (patent No. US 10118097 and CN 107694092) and contrast ratios (patent No. US 10878540) to improve gamers’ visibility with colorblindness and low vision. Furthermore, one of the patents relates to personalized sound technology, helping players with hearing issues by modifying or creating music based on their preferences (patent No. US 10790919). The code of the mentioned technology is published on EA’s GitHub, and it is open to all developers. Thus, the developers can use it or adapt it for their games without spending the costs to research. It is good that EA shares the patents for free use and aims to create an accessibility-increased gaming environment for players. However, it is not “unconditional” to use the listed patents. In the pledge, EA mentioned that it may terminate the promise for a specific party which files a patent infringement lawsuit or other patent proceedings against EA. We can see parts of EV’s ambition behind the announcement—to build a large game developer league and a community of shared interests. Reference: https://www.ea.com/commitments/positive-play/accessibility-patent-pledge https://iknow.stpi.narl.org.tw/Post/Read.aspx?PostID=14562 https://www.polygon.com/22639469/apex-legends-electronic-arts-patent-pledge-accessibility-developers https://www.theverge.com/2021/8/24/22638535/ea-accessibility-patent-pledge-apex-legends-ping-system https://www.gamesradar.com/ea-secures-a-patent-for-the-apex-legends-ping-system-and-its-giving-it-away-for-free/ https://dotesports.com/apex-legends/news/apex-legends-ping-system-is-now-patent-free-for-accessibility https://www.nintendolife.com/news/2021/08/apex_legends_ping_system_now_patent-free_as_ea_announces_accessibility_pledge Recently, Electronic Arts (EA) announced a patent pledge that gives other companies and developers free access to five of its current accessibility-related patents and technology. The company promised not to enforce against any party for infringing any of the listed patents. Instead, EA hopes to encourage “innovation” and build new features that make video games more inclusive on a much larger scale by opening up the patents. Electronic Arts (EA) is an American video game company founded in 1982. The company owns many popular and famous games, such as The Sims, SimCity, Apex Legends, Madden NFL and FIFA. Each of the games has more than 30 or 50 million sales volume. Significantly, esports involves FIFA and Apex Legends into the event list. Apex Legends has up to 1 billion players, and it is so popular that it has a Switch version. Within the freely available patents, one of which grabs everyone’s attention -- Apex Legends’ ping system (patent No. US 11097189). The ping system in Apex Legends, which excellently allows players to make communication and teamwork quick and easy without hearing or speaking, has been praised both as an impressive alternative to voice chat and as a great accessibility feature for players with a variety of disabilities. The other patents include the technology widely used in the FIFA and Madden NFL. The innovations can automatically detect and modify colors (patent No. US 10118097 and CN 107694092) and contrast ratios (patent No. US 10878540) to improve gamers’ visibility with colorblindness and low vision. Furthermore, one of the patents relates to personalized sound technology, helping players with hearing issues by modifying or creating music based on their preferences (patent No. US 10790919). The

2021-10-22

The forum on "China's Intellectual Property-related Reform Measures and New Trends in Patent Litigation" will be held successfully!

The forum on "China's Intellectual Property-related Reform Measures and New Trends in Patent Litigation" will be held successfully! In response to the call for building a strong country with intellectual property rights, at 2 o'clock in the afternoon of October 21, the forum on "China's reform measures related to intellectual property rights and new trends in patent litigation" will be successfully held in Nanjing Jiangbei New District Industrial Technology Research and Innovation Park. The event was hosted by the Science and Technology Innovation Bureau of Nanjing Jiangbei New Area Management Committee, Nanjing Jiangbei New Area Industrial Technology Research and Innovation Park, Nanjing Intellectual Property Rights Protection Assistance Center Jiangbei New District Center, Nanjing Huaxun Intellectual Property Consultant Co., Ltd., Nanjing Intellectual Property Co-organized by the Protection Center (Nanjing Intellectual Property Rights Protection Assistance Center), Taiwan Pharmaceutical Development Association, and Gene Online. The director of Nanjing Intellectual Property Protection Center, Mou Xiaojian, delivered a speech. Director Mu expressed his warm congratulations on the holding of this event and introduced in detail the new pattern of intellectual property protection in Nanjing. He said: At present, Nanjing has implemented a rights protection assistance network in the municipal area. With full coverage, Nanjing Intellectual Property Protection Center is willing to closely communicate and interact with Nanjing's innovation entities, and provide relevant public welfare services such as rapid pre-review, rapid rights protection, and comprehensive utilization for enterprises in need. In addition, Huang Funan, CEO of Gene Online, was unable to come to congratulate due to the epidemic, and recorded a congratulatory video. In the video, he said: China Innovative Pharmaceuticals has already made many outstanding achievements on the international stage, and these are inseparable from intellectual property rights. The support of the company can also show the importance of intellectual property rights to biotechnology and pharmaceutical companies. This event invites four industry experts to focus on China's reform measures related to intellectual property rights and new trends in patent litigation, discuss with companies and universities, and make arrangements in advance. Dr. Qingchen Hou, general manager of Nanjing Huaxun Intellectual Property Consulting Co., Ltd., introduced the "Guidelines for Building a Powerful Country with Intellectual Property Rights (2021-2035)" and explained his views from four aspects: background, strategic layout, overall requirements, and organizational guarantees. . Subsequently, a detailed analysis of China's patent linkage system was carried out, and compared with the same types of cases at home and abroad, questions were raised: Why should we reward the first person who successfully challenged patents? Not the first person to file a P4 application? And have a series of discussions with you. Director Jiang Haijun of the Intellectual Property Protection Legal Committee of the Nanjing Lawyers Association gave a speech on three points: the problems after the amendment of the patent law, the enforceability of the amount of compensation, and the legal conflicts related to service inventions. Regarding the patent right evaluation report, he emphasized that the patentee, interested party or accused infringer can also proactively issue a patent right evaluation report. "Patent is a work of art that combines technology and law" is a message shared by Mr. Feng Tao from Jiangsu Junbo Law Firm at this event. Mr. Feng analyzes the big data of Chinese patent litigation cases through graphs and examples. Explore. The last topic of the event was shared by Guo Huangying, Intellectual Property Manager of Nanjing Huaxun Intellectual Property Agency (General Partnership)-China's Patent Infringement Judgment Principles and New Developments. Manager Guo explained to everyone the principles of patent infringement judgment and the necessity of patent infringement search and analysis before producing and selling products. In the intellectual property industry, ECCOM has been providing high-quality and professional comprehensive intellectual property services to enterprises and universities one step at a time. It also hopes that under the leadership of the state and the government, it will contribute to the building of a strong intellectual property nation in China. Make a contribution.

2021-10-22

Types of patents that are easily overlooked- Design Patent

Types of patents that are easily overlooked- Design Patent In recent years, as the public’s awareness of intellectual property has increased, people have begun to consciously use the patent law to protect their intellectual property rights. However, in the process of implementation, they often only focus on invention patent and utility model patent, and tend to ignore the protection of design patent. Recently, Midea sued Haotaitai for two models of CXW-300-D998 and CXW-300-D908 Haotaitai brand range hoods In the case of suspected infringement of its design patent (patent number: ZL201930621598.X), the Guangzhou Intellectual Property Court made a first-instance judgment after hearing that it determined that the two products of Haotaitai constituted infringement, and ordered it to immediately stop the infringement and compensate Midea, The company's economic losses and reasonable expenses totaled 360,000 yuan. In fact, appearance infringement cases have occurred from time to time before, such as: "Molly" blind box design patent case, "Siemens" switch design patent infringement dispute case received a compensation of 6 million yuan, three Casio watch design patents were infringed Received a compensation of 8.8 million yuan and so on. The reason why people ignore the protection of design patents, in the final analysis, is that they have insufficient knowledge of design patents. Today, let's take a look at what is protected by design patents and what rights protections can we apply for? Design patent definition: Article 2 of the "Patent Law", design patent, refers to a new design that is aesthetically pleasing and suitable for industrial applications based on the shape, pattern, or combination of products, and the combination of color, shape, and pattern. Protected range: The shape of the product; the pattern of the product; the shape and pattern of the product; the shape and color of the product; the pattern and color of the product; the shape, pattern and color of the product. Protection period: The term of protection for design patent rights is 15 years, calculated from the date of filing. What are the conditions for applying for a design patent? The design should be aesthetically pleasing Appearance patents should be suitable for industrial applications The design patent application should be novel The design patent application should be inventiveness What are the advantages and functions of design patents? Protect the rights and interests of enterprises in product designs and fight against infringements in market competition. To enhance brand value, the quality and quantity of patents are the embodiment of the company's innovation ability and core competitiveness. Receive consumer recognition. If a company's new product appearance is filed for a patent in a timely manner, its appearance design will enjoy the exclusive right. Nowadays, consumers often choose products with trendy and beautiful appearance when buying their products. Applying for a design patent is a necessary condition for applying for a high-tech enterprise.

2021-09-26

Colopl Settles Patent Infringement Lawsuit with Nintendo by Paying $30 Million

Colopl Settles Patent Infringement Lawsuit with Nintendo by Paying $30 Million This August, Nintendo and a game developer Colopl announced that they have settled for patent infringement regarding White Cat Project (Shironeko Project in Japanese), a smartphone game developed by Colopl. Although both companies did not publicly share exact details of the settlement, at least it is sure that Colopl agreed to pay 3.3 billion yen (about US$30.2 million) as the settlement fee for the proceedings, including the future license of Nintendo's patents. How did the battle begin? Being developed and published by a Japanese game developer, Colopl, White Cat Project is a free-to-play action role-playing game for Android and iOS systems. The mobile game was launched in July 2014 as well as got a television anime adaptation in 2020. It is incredibly popular to have more than 50 million downloads. Furthermore, the game is set to receive a Switch version titled "Shironeko New Project". In September 2016, Nintendo noted the Colopl's game and considered that the game had infringed on several of Nintendo's technology patents. The two companies communicated with each other for over a year; however, Nintendo did not accept the explanations from Colopl, and Nintendo filed a lawsuit against Colopl at the beginning of 2018. Nintendo claimed that Colopl infringed 6 of its patents. These patents protect touch-screen joystick functionality (patent no. JP3734820), multiplayer connectivity (patent no. JP5595991, JP6271692), confirmation screens in sleep mode (patent no. JP4010533), character attacks based on touch input locations (patent no. JP4262217), and a shadow effect placed on characters hidden behind the game geometry (patent no. JP3637031). These patents almost cover various ways of game technology, especially the patent JP5595991 and JP6271692. Their patent family is wide-reaching, and many divisional applications of the family are pending in Japan. They protect a communication game system and its related devices. It is not easy to detect the patent's existence and boundary since this kind of hardcore technique is so common in the gaming field and our daily lives. The five-year patent war has been settled. After a five-year dispute, the situation appeared to turn in Nintendo's favor as the Switch maker increased its monetary demands, which convinced Colopl to strike a deal that lets it use the disputed patents. Furthermore, a Switch version of White Cat Project remains in the works at Colopl. With the extraordinary losses of Colopl, the legal battle between the two companies came to an end.

2021-09-09