CN  /  EN

imgboxbg

NEWS

经典胃药深陷致癌风波,药品安全值得持续关注

  • Categories:最新消息
  • Author:华讯知识产权
  • Origin:
  • Time of issue:2020-04-17 16:23
  • Views:

(Summary description)2020年4月1日,美国食品和药物管理局(FDA)发布消息,要求制造商立即从市场上撤回所有处方和非处方(OTC)雷尼替丁(ranitidine,也译为雷尼得定)药物。这是FDA针对雷尼替丁药物(通常以商标名Zantac(善胃得)为人们所知)中的N-亚硝基二甲胺(NDMA)污染物的研究的最新步骤。FDA已确定,某些雷尼替丁产品中的NDMA会随时间推移以及在高于室温下储存而增加,并可能导致消费者暴露于

经典胃药深陷致癌风波,药品安全值得持续关注

(Summary description)2020年4月1日,美国食品和药物管理局(FDA)发布消息,要求制造商立即从市场上撤回所有处方和非处方(OTC)雷尼替丁(ranitidine,也译为雷尼得定)药物。这是FDA针对雷尼替丁药物(通常以商标名Zantac(善胃得)为人们所知)中的N-亚硝基二甲胺(NDMA)污染物的研究的最新步骤。FDA已确定,某些雷尼替丁产品中的NDMA会随时间推移以及在高于室温下储存而增加,并可能导致消费者暴露于

  • Categories:最新消息
  • Author:华讯知识产权
  • Origin:
  • Time of issue:2020-04-17 16:23
  • Views:
Information

202041日,美国食品和药物管理局(FDA)发布消息,要求制造商立即从市场上撤回所有处方和非处方(OTC)雷尼替丁(ranitidine,也译为雷尼得定)药物。这是FDA针对雷尼替丁药物(通常以商标名Zantac(善胃得)为人们所知)中的N-亚硝基二甲胺(NDMA)污染物的研究的最新步骤。FDA已确定,某些雷尼替丁产品中的NDMA会随时间推移以及在高于室温下储存而增加,并可能导致消费者暴露于不可接受量的NDMA

南京华讯知识产权顾问有限公司

雷尼替丁是一种H2(组胺2)阻断剂。非处方雷尼替丁被批准用于预防和缓解因食酸和胃酸而引起的烧心;处方雷尼替丁被批准用于多种适应症,包括治疗和预防胃和肠溃疡以及治疗胃食管反流疾病。雷尼替丁原研药由Allen & Hanburys有限公司开发,最早于198110月在英国上市。历史资料显示,雷尼替丁是全球第一个销售超过10亿美元的重磅炸弹,同时也是制药史上第一个累计销售额达500亿美元的药物,曾多次位居全球药品销售额第一的宝座。雷尼替丁上市近40年曾风光无限,是全球使用广泛的经典胃药。

南京华讯知识产权顾问有限公司

专利方面,Allen & Hanburys197684日申请了标题为“Aminoalkyl furan derivatives(氨基烷基呋喃衍生物)”的专利GB1565966A,并于1980423日获得授权。该专利应为雷尼替丁化合物原研专利,在全球三十多个国家和地区拥有一百多个同族专利,当然这些专利早已相继期限届满。此后数十年,来自不同国家的众多药企争相研究雷尼替丁的不同盐形式、晶型、剂型以及制备工艺,并进行专利申请和布局。

这一事件可追溯至2019913日,FDA发表声明称,基于实验室测试,在雷尼替丁样品中发现了少量NDMA。当时FDA表示,尽管NDMA可能会造成大量伤害,但FDA初步测试发现,雷尼替丁含量几乎不超过在普通食品中可能发现的含量。

针对FDA发出的这一安全警告,最先作出反应的是山德士公司(Sandoz Inc.),924日,山德士自愿召回其生产的14批雷尼替丁处方药胶囊。此后直至2020227日,陆续有多家跨国药企自愿召回多种雷尼替丁片剂、胶囊、糖浆等,召回事件波及的其他药企包括赛诺菲(Sanofi)、葛兰素史克(GSK)、印度雷迪博士药厂(RDY)、加拿大Apotex制药公司、印度Strides制药等等。

其间,在2019102日,FDA建议使用LC-HRMS测试方案测试雷尼替丁样品,并开始测试其他H2阻滞剂和质子泵抑制剂的样品。1023日,FDA发布第二种液相色谱-质谱(LC-MS)方法以供检测和定量雷尼替丁中的NDMA111日,FDA发布了药物评估和研究中心(CDER)关于雷尼替丁中NDMA杂质的新测试结果。124日,FDA宣布,已要求雷尼替丁和尼扎替丁产品的制造商扩大对NDMA的测试至包括所有批次的药物,若测试显示NDMA超过可接受的每日摄入量限制(每天96 ng0.32 ppm),则制造商必须通知FDA,并不得将其投放市场。20201月,独立实验室Emery Pharma测试确认,即使雷尼替丁药物包装完好,但若储存于高温环境,其可疑致癌物NDMA亦会增加。202041日,NDMA杂质风险升级,FDA终于要求所有处方和非处方(OTC)雷尼替丁药物撤市。

与此同时,在美国以外的其他国家和地区,各大药监机构也积极表态。2019913日,在FDA发出警示的同一天,由于检验显示有些药品中含有NDMA杂质,欧洲药品管理局(EMA)表示,将根据欧盟委员会(EC)的要求开始对雷尼替丁药品进行审核。新加坡当局似乎对于民众的安全更加谨慎,917日,新加坡卫生科学局在一份声明中表示,新加坡将立刻暂停8种相关药品的销售和供应。台湾方面,据《联合报》报道,因含致癌成分,台湾食药署于920日通知各药厂,要求台湾贩卖的含雷尼替丁(ranitidine)38款胃药,全数于23日午夜12时止完成预防性下架;还表示检验合格并提供食药署确认后,始可恢复上架。925日,应加拿大卫生部要求,加拿大销售雷尼替丁产品的公司已停止任何进一步的分销,直到提供证据证明它们所含的NDMA含量不超过可接受的水准为止。926日,韩国食品药品安全部(MFDS)已发现7种雷尼替丁原料中的NDMA含量超标,向药企通报要求暂停使用雷尼替丁,禁止相关药品的生产、进口和销售。另外,意大利药品监管局则宣布,撤回多批次由Saraca Laboratories Limited药厂生产的含有雷尼替丁成分的药物。129日,中国药典委发布《关于盐酸雷尼替丁及其制剂国家药品标准修订草案的公示》和《关于枸橼酸铋雷尼替丁、枸橼酸雷尼替丁片、枸橼酸雷尼替丁胶囊国家药品标准修订草案的公示》,对雷尼替丁相关的药品标准进行了修订,雷尼替丁标准拟增加NDMA杂质控制。

N-亚硝基二甲胺(NDMA)是一种曾用于制造火箭燃料的有机化学物质,同时也是某些化学反应的非预期副产品。在世界卫生组织(WHO)下属机构国际癌症研究机构(IARC)公布的致癌物清单中,NDMA被归为2A类致癌物质。NDMA可能使人罹患癌症,经消化道、呼吸道吸收迅速,经皮肤吸收缓慢,主要引起肝脏损害。据不完全统计,近年来药品中发现NDMA杂质已有三起:20186月华海药业在降压药缬沙坦原料药中检测出NDMA20199FDA在胃药雷尼替丁样品中检出NDMA201912月新加坡公布3款降血糖药“二甲双胍(metformin)”检出微量NDMA

南京华讯知识产权顾问有限公司

尽管近年来替丁类药物市场份额逐渐被质子泵抑制剂蚕食,但作为经典胃药,雷尼替丁仍使用广泛。然而,自20199月以来,雷尼替丁致癌风波持续蔓延,此次FDA对雷尼替丁全部撤市标志着致癌风波进一步升级,对雷尼替丁而言是危机四伏,也许再难翻身;对我们亦是一种提醒,痕量的NDMA引起了大事件,显示出杂质对药品质量的影响不可忽视,药品安全值得药企、监管机构甚至医护人员和患者的持续关注!

 

 

Keyword:

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
Previous page
1
2
136
底部
这是描述信息

2001, 20th Floor, Block B, Ascendas Building, No. 88 Jiangmiao Road, Jiangbei New District, Nanjing City, Jiangsu Province

Copyright ◎Nanjing Huaxun Intellectual Property Consultant Co., Ltd.

苏ICP备xxxxxx号-1     Powered by: www.300.cn

这是描述信息
这是描述信息
这是描述信息
这是描述信息
这是描述信息