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浅析药品知识产权中的试验数据保护制度

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  • Time of issue:2018-08-13 14:11
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(Summary description)谈到药品知识产权,即便是在专业从事知识产权工作的人中,大多数人能想到的也就只有“专利”而已。然而,专利仅仅是药品知识产权保护中的一种形式,除此之外,还有许多不同类型的知识产权保护形式,这其中越来越受到国内医药企业关注的一种就是“药品数据保护制度”。

浅析药品知识产权中的试验数据保护制度

(Summary description)谈到药品知识产权,即便是在专业从事知识产权工作的人中,大多数人能想到的也就只有“专利”而已。然而,专利仅仅是药品知识产权保护中的一种形式,除此之外,还有许多不同类型的知识产权保护形式,这其中越来越受到国内医药企业关注的一种就是“药品数据保护制度”。

  • Categories:最新消息
  • Author:
  • Origin:
  • Time of issue:2018-08-13 14:11
  • Views:
Information

谈到药品知识产权,即便是在专业从事知识产权工作的人中,大多数人能想到的也就只有“专利”而已。然而,专利仅仅是药品知识产权保护中的一种形式,除此之外,还有许多不同类型的知识产权保护形式,这其中越来越受到国内医药企业关注的一种就是“药品数据保护制度”。

 

试验数据保护制度的起源及意义

药品作为一种特殊的商品,关乎人们健康,甚至可以说是性命攸关,因此绝大多数现代国家都选择施行严格的药品行政审批和管理制度。在这种制度下,一种药品若要获准上市,必须提交大量的临床前、临床试验数据,种类繁多、要求严格、并且过程漫长。在这个过程中,药物厂商要投入大量的人力物力财力,相比于其他行业而言,制药行业的产品上市周期长的可怕。有经济学家研究后指出,对于一个新的生物药而言,至少需要13-16年的数据独占期才能使得原研药厂商收回研发过程中的巨额成本,如果没有足够的药品数据独占保护期的支持,在专利保护不力的情况下,很难想象原研药厂商会有动力去开发新的生物药。

对于新药而言,在审批程序中,药品制造商必须向行政审批机构提交多种类型的药品试验数据(包括临床试验数据)来证明药品的有效性和安全性;而对于仿制药,则无需重复提交临床试验数据,而只需提交证明其与原研药具有相同质量和疗效的生物等效性数据,例如按照中国《药品注册管理办法》的规定,对于化学药来说,如果已有国家药品标准的原料药或制剂要进行上市审批,那么只需要提交生物等效性试验数据以及国内外相关的临床试验资料综述,而无需自行进行临床试验。这样的规定可以大大加快仿制药的审批上市,显然有益于减少垄断和降低药品价格。但是,从另外一个角度来看,原研药厂商付出巨大努力和成本开发出新药,而仿制药厂商反而无需进行昂贵且耗时的临床试验,似乎有失公平,且对原研药研发动力有所打击。同时,由于新药研发周期越来越长,新药上市时,二十年的专利保护期往往所剩无几,长此以往,势必严重地影响原研药厂商研发新药的热情。为了更好地推动药品研发,各个发达国家采取了多种措施来进一步加强对原研药的保护力度,其中之一就是药品数据保护(Data protection)制度,也有人称其为药品试验数据独占权(Pharmaceutical Test Data Exclusivity)。

试验数据保护制度最早源于美国1984年《药品价格竞争与专利补偿法》,是为了原研药厂商与仿制药厂商之间利益的平衡而生,从某种程度上来说,就是为了弥补由于仿制药审批过程的简化而对原研药厂商所造成的潜在损失,因此,药品数据保护对原研药厂商的积极意义是毋庸置疑的。

试验数据保护制度与专利保护制度并行不悖、互为补充,但侧重点不同。它一方面集中体现了对以临床试验为核心的新药开发成果的保护和奖励,另一方面也有效地保障了新开发上市药品能够享受与专利保护大体相当的市场独占期。美国实施试验数据保护制度至今的实践表明,这一制度确实较好地平衡了新药开发商、仿制药商、社会公众等各方的利益,所以乐为利害相关各方所接受。

 

药品数据保护的具体内涵

到目前为止,药品数据保护并不像专利保护那样具有相对统一且明确的定义和保护客体,从当前TRIPS以及世界各国的实践来看,大致可以概括为:药品制造商(尤其是原研药制造商)对于在药品研发过程中应药品监管机构的要求提交的试验数据享有一定期限的独占权,在该期限内药品监管机构不得基于该数据授予仿制药的上市许可,药品监管机构应当防止该数据不被不正当的商业使用。除此之外,根据各个国家不同的规定,药品数据保护还会有一些其他要求,例如药品监管机构不得披露该数据等等。

中国的药品数据保护的具体内涵涉及以下层面:

(1)保护主体:药品监管机构,在我国则是国家食品药品监督管理总局。

(2)保护客体:药品试验数据,在我国具体规定为未披露数据或其他数据。

(3)保护范围:针对创新药物,包括新化学实体(New Chemical Entity,NCE)、新剂型、新适应症、生物制品等等,在我国只保护新化学实体。

(4)保护期限:各国对保护期限的规定差别很大,在我国为6-12年。

(5)保护方式:我国及各发达国家以不允许第三方依赖该数据申请仿制药上市为主要保护方式,另有一些国家主要以防止针对该数据的不正当商业使用为主要方式。

 

中国的试验数据保制度护现状

中国药品试验数据保护起步较晚,虽然在2001年加入TWO时承诺承担包含TRIPs协议在内的《马拉喀什建立世界贸易组织协定》框架中所规定的义务,同时,在《中国加入WTO工作组报告》中的282~284段对于试验数据保护也有明确的规定,也于2002年颁布的《药品管理办法实施条例》第35条首次设立了药品数据保护制度,并以此为依据在2007年制定的《药品注册管理办法》第20条对药品数据提供6年的数据保护期,但目前尚无实施方法和细则。

为进一步促进药品创新和仿制药发展,完善药品试验数据保护制度,国家药品监督管理局近日起草了《药品试验数据保护实施办法(暂行)(征求意见稿)》,改革意见将试验数据保护的对象范围从原来仅有的“含有新型化学成分的药品”扩展到“创新药、罕见病用药、儿童专用药、改良型新药的罕见病用药和儿童专用药、创新的治疗用生物制品”,其具体保护年限如下表所示:

试验数据的保护范围

试验数据的保护年限

创新药

6年

属于创新药且属于罕见病用药

6年

属于创新药且属于儿童专用药

6年

创新的治疗用生物制品

12年

改良型新药的罕见病用药

3年

改良型新药的儿童专用药

3年

 

可见,未来罕见病用药、儿童专用药、治疗用生物制品的创新研发将得到较大助力。

 

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.
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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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