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艾伯维泛基因型丙肝鸡尾酒疗法G/P进入英国药品早期获取计划(EAMS)

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  • Time of issue:2017-05-19 14:21
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(Summary description)英国药品及保健品管理局(MHRA)近日发布积极科学意见,将美国生物技术巨头艾伯维(AbbVie)开发的泛基因型丙肝鸡尾酒疗法G/P(glecaprevir/pibrentasvir,300mg/120mg)纳入英国的药品早期获取计划(EAMS),这也使得G/P成为首个入选该计划的慢性丙肝治疗药物。  G/P(300mg/120mg)由NS3/4A蛋白酶抑制剂glecaprevir(G)和NS5A抑

艾伯维泛基因型丙肝鸡尾酒疗法G/P进入英国药品早期获取计划(EAMS)

(Summary description)英国药品及保健品管理局(MHRA)近日发布积极科学意见,将美国生物技术巨头艾伯维(AbbVie)开发的泛基因型丙肝鸡尾酒疗法G/P(glecaprevir/pibrentasvir,300mg/120mg)纳入英国的药品早期获取计划(EAMS),这也使得G/P成为首个入选该计划的慢性丙肝治疗药物。  G/P(300mg/120mg)由NS3/4A蛋白酶抑制剂glecaprevir(G)和NS5A抑

  • Categories:最新消息
  • Author:
  • Origin:
  • Time of issue:2017-05-19 14:21
  • Views:
Information

  英国药品及保健品管理局(MHRA)近日发布积极科学意见,将美国生物技术巨头艾伯维(AbbVie)开发的泛基因型丙肝鸡尾酒疗法G/P(glecaprevir/pibrentasvir,300mg/120mg)纳入英国的药品早期获取计划(EAMS),这也使得G/P成为首个入选该计划的慢性丙肝治疗药物。

  G/P(300mg/120mg)由NS3/4A蛋白酶抑制剂glecaprevir(G)和NS5A抑制剂pibrentasvir(P)组成,开发用于全部6种基因型丙肝的治疗。该鸡尾酒疗法每日服药一次,一次服用3片药物。目前,G/P正在接受欧洲药品管理局(EMA)和美国食品和药物管理局(FDA)的审查。如果获批,G/P将为无肝硬化的全部基因型丙肝患者群体提供一种为期8周、全口服、每日一次、无利巴韦林(RBV)的治疗方案。

  入选EAMS,意味着在欧盟批准G/P之前,英国的丙肝患者可以提前获取G/P的治疗。据估计,在英国,目前大约有21.4万丙肝患者。

  在III期临床研究中,G/P 8周治疗方案在横跨全部6种基因型(GT 1-6)无肝硬化丙肝患者群体中实现了非常高的病毒学治愈率(SVR12,完成治疗后12周的持续病毒学应答);在伴有代偿性肝硬化的患者中,G/P 12周治疗方案也取得了非常高的病毒学治愈率。另外,G/P在治疗性选择有限的患者群体中也取得了非常高的治愈率,包括伴有严重慢性肾脏病(CKD)的患者。在历史上难以治疗的患者群体中,包括以前接受直接抗病毒药物(DAAs)未治愈的丙肝患者,G/P 12周治疗方案也取得了非常高的持续病毒学应答。

  G/P监管文件的提交,是基于艾伯维G/P临床开发项目中8个注册研究的数据,该项目在27个国家超过2300例丙肝患者中开展,评估了G/P治疗全部6种基因型丙肝的疗效和安全性,包括既往未接受治疗(初治)和既往接受治疗(经治)患者群体,伴有代偿性肝硬化和无肝硬化的患者群体,临床上极具挑战性的难治性患者群体,如伴有严重慢性肾脏病的患者及既往接受过直接作用抗病毒药物(DAAs)未治愈的患者。

  之前公布的数据显示,G/P 8周治疗方案在无肝硬化和初治基因型1-6丙肝患者群体中的病毒学治愈率(SVR12)达到了97.5%(n=693/711)。去年11月底,艾伯维在美国肝病研究协会年会(AASLD 2016)上公布的G/P临床项目的最新数据显示,G/P针对全部6种基因型丙肝治疗疗效均很高,包括伴有严重慢性肾脏疾病(CKD)的患者群体,同时该疗效与患者之前接受的治疗方案或是否伴有代偿性肝硬化均无关。

  慢性丙型肝炎(HCV)在伴有严重慢性肾脏疾病(CKD)的患者群体中很常见,在世界的一些区域甚至达到了80%。在美国,大约有50万人同时患有慢性丙型肝炎(HCV)和慢性肾脏疾病(CKD)。有些伴有严重CKD的丙肝患者,尤其是基因型2和基因型3(GT2,GT3)患者,目前没有可用的直接作用抗病毒(DAAs)药物。在这类患者中,在开发一种新的、安全有效的药物方面,仍存在着一个重要的未获满足的医疗需求。

  事实上2013年之后,全球对于丙肝相关专利申请量稍显下降趋势,说明目前全球抗丙肝创新药物技术已趋于成熟,热情正在冷却,纵观国际抗丙肝药物市场,自2013年以后,吉利德、艾伯维、默沙东等都先后推出了自己的疗效极佳的抗丙肝药物与组合(SVR12都达到90-100%),并逐渐统治市场。若想突出重围,还需另辟蹊径,从以上主流靶点以外的方向入手,开发出疗效优异的抗丙肝药物。

  在中国也出现了一些新的抗丙肝技术,如常州寅盛制药与四川大学联合申请的NS4B抑制剂化合物专利(WO2016045587),抗癌抗病毒活性的KDAC6抑制剂类(WO2015159097)、还有对于丙肝的免疫疗法相关专利等。期待未来这些技术能为中国的患者带来福音。

  新闻来源:http://news.bioon.com/article/6703572.html

  本新闻经华讯团队重新编辑整理并添加分析意见。

Electronic

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

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

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

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
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