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5年才有1次机会 药品如何才能挤进新医保目录?

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  • Time of issue:2016-12-02 13:30
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(Summary description)人力资源和社会保障部近日发布《2016年国家基本医疗保险、工伤保险和生育保险药品目录调整工作方案(征求意见稿)》。时隔7年,医保目录调整将再次启动。《征求意见稿》更是明确提出2016年年底前将完成本轮医保药品目录调整工作。  这次调整,预计将有约300款药品新增纳入国家医保目录,其中临床价值较高的新药,地方乙类增补较多的药品,重大疾病、儿童、急抢救、职业病用药品种也有望调入新版医保目录。  据人社

5年才有1次机会 药品如何才能挤进新医保目录?

(Summary description)人力资源和社会保障部近日发布《2016年国家基本医疗保险、工伤保险和生育保险药品目录调整工作方案(征求意见稿)》。时隔7年,医保目录调整将再次启动。《征求意见稿》更是明确提出2016年年底前将完成本轮医保药品目录调整工作。  这次调整,预计将有约300款药品新增纳入国家医保目录,其中临床价值较高的新药,地方乙类增补较多的药品,重大疾病、儿童、急抢救、职业病用药品种也有望调入新版医保目录。  据人社

  • Categories:最新消息
  • Author:
  • Origin:
  • Time of issue:2016-12-02 13:30
  • Views:
Information

  人力资源和社会保障部近日发布《2016年国家基本医疗保险、工伤保险和生育保险药品目录调整工作方案(征求意见稿)》。时隔7年,医保目录调整将再次启动。《征求意见稿》更是明确提出2016年年底前将完成本轮医保药品目录调整工作。

  这次调整,预计将有约300款药品新增纳入国家医保目录,其中临床价值较高的新药,地方乙类增补较多的药品,重大疾病、儿童、急抢救、职业病用药品种也有望调入新版医保目录。

  据人社部医保部门官员透露,本次医保目录调整分三个阶段。第一阶段是确定备选药物的名单。人社部将咨询专家,确定调入和调出医保目录的备选药品名单以及谈判药品备选范围。咨询专家约400人左右,由相关学术团体和行业协会推荐。

  第二阶段由专家通过电子投票的方式遴选调入与调出医保目录的品种,这些专家将随机抽取,共两万名。

  第三阶段由专家根据投票结果确定调入和调出品种,争取2016年年底前完成医保药品目录调整工作。

  截至目前,医保目录调整工作处于确定备选名单的第一阶段,2017年上半年公布调整结果,2017-2018年各省陆续完成省医保目录增补。

  “本次目录调整由专家全权负责,人社部等行政部门不会干涉评审。评审时中西药兼顾,二者数量增幅基本平衡,以临床需求为导向,根据基金承受能力和参保人负担水平,合理确定用药范围和水平。报销比例上,甲类目录全额报销,乙类自付一定比例。”前述人社部官员表示。

  对于企业来说,大家关注的或者担心的问题不外乎3点:

  一是原来在三个目录中的药品能否在合并后的新目录里继续保留;

  二是原来没有进目录的如何才能挤进新目录;

  三是专利药品进入目录的可能性有多大。

  扩展开来说:

  一,能否继续留在目录里。因为总体来说本次调整后,新目录里的数量是增加的,所以只要不存在以下三种情况,就应该不会被无辜“踢”出来了。

  (1)是药品质量不过关,发生过用药安全问题。

  (2)是药品疗效确实不行,或者同类品种中出现疗效更高的品种。

  (3)是遴选专家一定要“踢”的品种。

  二. 关于对于如何挤进新“目录”的问题,网上盛行一个观点:看到“征求意见稿”才做准备的企业,已经较信息灵通的企业落后一大步了。信息灵通者前期沟通都做完了,目录也已基本确定后再征求意见,时间当然要短,为免得节外生枝,最好把不懂做沟通工作的人甩掉,这就是竞争。

  但是,“基本确定”并不是最后确定,如果确实有不合理的地方,或者明显不完善的环节,修正的可能性还是有的;而且,真正信息灵通、且做了前期沟通的企业并非大多数,虽然竞争激烈,但众言汹汹,效果说不定会更好。

  况且,有400人的专家咨询团队,对药品分类与数据分析提供咨询、论证药品评审技术要点、论证提出备选药品范围意见。而遴选专家的数量达2万人。征求意见稿要求,参与遴选的专家中来自二级及以下医疗机构的不少于30%;每个药品组别的专家原则上不少于50人。如此看来,前期的沟通充其量只是顶层沟通。如果遴选专家们不通过,或者有不少遴选专家提出异议,“后来居上”的可能性还是挺大的。

  三.专利药品进入目录的可能性有多大。按照普通人的认知,专利药品肯定是价格高的药品,当然也是疗效比较好的药品。拒预测此次专利药进入新“目录”有可能,但难度依旧很大,理由有三个。

  (1)是由新医改的目的和基本要求所决定。新医改的基本要求是“低水平、广覆盖”,主要目的是用有限的医保经费,让更多的人看得起病。尽管专利药疗效好,可能从药物经济学的角度看更应该进入医保目录。但是,从单次费用报销及区域总体把控的角度看,医保支付肯定会首选低价的非专利药。

  (2)是前面提到的药物经济学问题,政府相关部门很清楚这一点,所以才下大力气主推仿制药的一致性评价工作。目的也非常明确:在医保目录中选用低价格的非专利药,尽量收到跟原研药差不了多少的疗效。

  (3)是目前我国的医保基金额确实还承受不了价格高的专利药品的广泛使用。此前就曾有媒体报道说,北京、天津、湖北、重庆、贵州和新疆建设兵团六个地区的医保统筹基金累计结余不足6个月支出。

  专利药进入医药也并非不可能,办法有两种,一种是降价,降到比非专利药高不了多少,那么在价格相差无几的前提下,相信大多数人是会优先选用质量疗效更为可靠的专利药。但如此一来,势必损伤专利药生产公司的经济利益。还有一种办法就是将专利药做到无可替代,对某种疾病只有某种专利药能治,那么没有其他选择的前提下,想必此时进入医保的可能性就大大提高了,且不会使企业利益受损。

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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