Portola抗凝药物解毒剂Andexxa获美FDA加速批准

Categories:最新消息
Author:
Origin:
Time of issue:2018-05-24 10:16
Views:

(Summary description)5月3日，美国Portola制药公司宣布，美国FDA已批准Andexxa [凝血因子Xa(重组)，inactivated-zhzo]作为首个及唯一一个凝血因子Xa抑制剂（利伐沙班、阿哌沙班）的解毒药物，用于当出现危及生命或无控制出血后的抗凝的逆转。





Portola抗凝药物解毒剂Andexxa获美FDA加速批准

Categories:最新消息
Author:
Origin:
Time of issue:2018-05-24 10:16
Views:

Information

5月3日，美国Portola制药公司宣布，美国FDA已批准Andexxa [凝血因子Xa(重组)，inactivated-zhzo]作为首个及唯一一个凝血因子Xa抑制剂（利伐沙班、阿哌沙班）的解毒药物，用于当出现危及生命或无控制出血后的抗凝的逆转。

而就在去年12月份，FDA还再次表示要推迟对其的审批，将评审日期从2018年2月3日推迟到2018年5月4日，理由是要考证其要求该公司提供的额外信息，由于对生产上的担忧而最初部分驳回申请。

没想到好消息来的这么快。Andexxa的本次批准是基于FDA加速批准，加速批准认定则是基于健康志愿者抗Xa因子活性的基线变化数据而获得，同时该药物获得了FDA的突破性疗法及孤儿药资格认定。但该适应症的完全批准则可能取决于药物上市后的研究结果，仍需要证明病人的止血效果有所改善。

Andexxa是被开发用来治疗服用过apixaban（Eliquis的活性成分）或者rivaroxaban（Xarelto的活性成分）患者的失血过多。

由于Xa因子抑制剂相比依诺肝素和华法林在预防和治疗血栓栓塞症[如卒中、肺栓塞和静脉血栓栓塞症（VTE）]中的良好疗效及安全性，使得Xa抑制剂的使用正在迅速增长。而这种使用的快速增长伴随着出血相关的入院和与死亡的增加，这也是抗凝治疗的主要并发症。仅在2016年，美国就有约11.7万例因Xa抑制剂相关出血而住院的患者，每月有近2000人因出血而死亡。因此Andexxa具有的这种拯救生命的潜力，将有效帮助临床医生去治疗危及生命的出血事件，对全球公共卫生都将产生重大影响。目前Portola公司仍然致力于在血栓形成和血液瘤领域挖掘更多的潜力。”

本次Andexxa的批准主要基于两项临床3期研究ANNEXA（ANNEXA-R 与ANNEXA-A）的试验数据，具体数据已经刊登在《The New England Journal of Medicine》，研究评价了Andexxa逆转Xa因子抑制剂利伐沙班和阿哌沙班抗凝作用的安全性和有效性。结果显示，Andexxa可迅速而显着地逆转抗Xa因子的活性，与基线相比，抗因子Xa活性的中位数下降了97%（利伐沙班），而阿哌沙班活性则下降了92%。

作为其审查和批准的一部分，FDA也评估了正在进行的ANNEXA-4单臂开放标签研究中对大出血患者治疗的中期数据。185例可评估患者的数据显示，Andexxa在给药时迅速而显着地逆转了抗Xa因子的活性，并在120分钟后持续逆转。与基线相比，利伐沙班和阿哌沙班的平均活性降幅分别为90%和93%。

在专利布局方面，仅在美国与其相关的专利就多达9篇，目前大部分都尚未授权，下面例举了4篇，其中最相关的为2013年2月14日申请的US20160015793A1：

专利名称	专利号	申请日
Modulation of factor Xa inhibitor mediated blood loss by partial and transient administration of antidote	US20160015793A1	20130214
Antidotes for factor Xa inhibitors and methods of using the same in combination with blood coagulating agents	US20140134151A1	20130430
Lyophilized formulations for factor Xa antidote	US20160237420A1	20160422
Antidotes for factor Xa inhibitors and methods of using the same	US20170233711A1	20170216

Previous: 长虹 vs Sisvel，七年专利诉讼长跑终获胜

Next: 罗氏血友病重磅药Hemlibra诉讼获胜，未侵权Shire专利

Previous: 长虹 vs Sisvel，七年专利诉讼长跑终获胜

Next: 罗氏血友病重磅药Hemlibra诉讼获胜，未侵权Shire专利

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