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药品专利链接制度概况及其意义

  • Categories:最新消息
  • Author:华讯知识产权
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  • Time of issue:2020-05-15 12:37
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(Summary description)近年来,加强药品专利保护已成为各大国家和地区监管机构和制药产业的共识,建立药品专利链接制度(PatentLinkage)更是备受关注。药品专利链接制度是什么?药品专利链接制度是指仿制药上市批准与创新药品专利期满相“链接”,即仿制药注册申请应当考虑先前已上市药品的专利状况,从而避免可能的专利侵权。该制度最早是在美国产生的,1984年美国通过了《药品价格竞争与专利恢复法》(Hatch-Waman法案)

药品专利链接制度概况及其意义

(Summary description)近年来,加强药品专利保护已成为各大国家和地区监管机构和制药产业的共识,建立药品专利链接制度(PatentLinkage)更是备受关注。药品专利链接制度是什么?药品专利链接制度是指仿制药上市批准与创新药品专利期满相“链接”,即仿制药注册申请应当考虑先前已上市药品的专利状况,从而避免可能的专利侵权。该制度最早是在美国产生的,1984年美国通过了《药品价格竞争与专利恢复法》(Hatch-Waman法案)

  • Categories:最新消息
  • Author:华讯知识产权
  • Origin:
  • Time of issue:2020-05-15 12:37
  • Views:
Information

近年来,加强药品专利保护已成为各大国家和地区监管机构和制药产业的共识,建立药品专利链接制度(Patent Linkage)更是备受关注。

药品专利链接制度是什么?

药品专利链接制度是指仿制药上市批准与创新药品专利期满相链接,即仿制药注册申请应当考虑先前已上市药品的专利状况,从而避免可能的专利侵权。该制度最早是在美国产生的,1984年美国通过了《药品价格竞争与专利恢复法》(Hatch-Waman法案),开创性的建立了药品专利链接制度,又经历多次修改调整。这是药品审评审批与药品专利保护互相链接的一项制度设计,在平衡原研药(专利药)企业和仿制药(学名药)企业之间的利益上有着良好的效果。

构建药品专利链接制度有什么意义

1、对于原研药企业来说,保护原研药专利权,提高原研药企业开发创新药的积极性,助力原研药创新。例如通过专利声明制度和桔皮书制度,可以及时发现可能发生的侵权行为。再例如,通过专利保护期延长制度,为原研药企业利用专利垄断地位收回成本提供法律支持。原研药企业可以在可能侵权的仿制药获得上市许可前提起诉讼,意味着在专利有效期内原研药被侵权产品侵占市场的风险降低,同时在调查取证,诉讼周期等环节上,原研药企业的诉讼成本将大大降低。原研药企业为了自己的药品专利不会轻易被挑战成功,药品专利权人在研发过程中会更加注重创新,以及完善的专利布局。

2、对于仿制药企业来说,。制度给予仿制药企业专利挑战的机会,专利挑战成功可以让仿制药提前上市,也有可能获得首仿药奖励,在给自身带来巨大经济利益之外,也会使得自己有机会转型成研发型药企,提高仿制药企业创新的积极性。毕竟,在未来的市场中,创新才是王道。再例如通过Bolar例外,缩短仿制药临床实验和审批时间,削减原研药在专利期届满后仍然享受的实质垄断的时间。

3、规范药品准入制度,原研药企业和仿制药企业之间的竞争规则变得明确化,促进双方有序竞争。例如通过45天诉讼期制度和30个月遏制期制度,将可能产生的专利侵权纠纷解决在药品上市之前的萌芽阶段这无疑会大大缩减司法资源。

基于药品专利保护的重视以及与美国之间的自由贸易协定,中国、韩国、加拿大、澳大利亚等国家都跟进了美国做法,并结合自身实际情况在具体适用范围(例如是否包括生物制剂)和规则(例如程序启动方式、相关期间长度)上进行了不同程度的调整或改变。同时,不仅由于各国国情不同,药品专利链接制度不存在通用模式,部分国家或地区还对该制度持否定态度,例如印度、欧盟和日本。印度作为仿制药大国,通过法院判例明确了在专利法规定了Bolar例外的情况下,药品上市审批机构只需审核药品的安全性和有效性,无须考虑专利纠纷的因素。在欧洲,药品专利权人要想阻止仿制药的上市审批程序,首先需要拿到法院的临时禁令,这显然要比美国的门槛高不少。日本干脆规定在新药活性成分专利届满前,禁止提仿制药申请。

中国的专利链接制度如何?

对于中国国内是否已经建立了药品专利链接制度,主要有两种意见:一种认为中国已经有了药品专利链接的规定。其依据是中国200551日正式施行的《药品注册管理办法及其修正案》(2007101日生效,以下简称28号局令)中对药品专利情况的说明条款,包括第八条(信息公示)、第十八条(药品专利状况和不侵权声明)、第十九条(仿制药申请限制)、第二十条(数据独占)和第六十六条(监测期保护条款)。这些都类似于美国药品申请的专利链接规定和桔皮书所公布的药品专利信息。而另一种意见认为,中国还未真正在药品注册过程中建立专利链接。其依据是,尽管28号局令分别对(药品专利状况和不侵权声明)(仿制药申请期限限制)进行了规定,但是由于中国没有像桔皮书那样具有法律效力的专利信息列表,药品主管部门与专利主管部门也没有职能上的相互协作,仿制药企业在药品注册过程中没有明确的法律环境,使得国家食品药品监督管理局(SFDA)在处理如美国那样的包含专利挑战的ANDA时无法可依。

即使是支持中国已设立药品专利链接制度的学者也承认,药品专利链接在中国现在还基本上停留于形式,在实际操作中存在如专利不侵权声明内容可信度差、SFDA在药品注册审查过程中对相关专利纠纷无审查能力、SFDA和国家知识产权局(SIPO)各司其职,无法实现职能的链接等诸多问题,而对于药品注册信息审查和药品专利审查又对专业性有极高的要求,所以不可能由一个部门独立解决所有问题,必须靠每个部门发挥各自的优势,协同配合,因此在亟待解决的问题中最重要的说是如何在药品注册过程。

2017101日,中办国办印发《关于深化审评审批制度改革鼓励药品医疗器械创新的意见》,提出探索建立药品专利链接制度。这是我国知识产权保护领域的重要制度创新。今年初签署的《中华人民共和国政府和美利坚合众国政府经济贸易协议》提出建立"专利纠纷早期解决的有效机制",其核心内容就是药品专利链接制度。科学把握药品专利链接制度的要义、价值、功能、关键、前提、实质和艺术,有利于审时度势,趋利避害,最大限度地发挥这一制度的潜力和优势。药品专利链接制度既涉及诉讼制度,也涉及行政管理制度,两者的有效衔接,是药品专利链接制度运行的条件。

台湾地区的专利链接制度如何?

台湾地区的专利链接制度是在美国专利链接制度上进行的修改和调整,主要区别在于将在美国只针对化学药品扩大到了适用于生物类似药和化学药品并将首仿药的市场独占期从美国的180天延长到了台湾地区的12个月以及仿制药获批的停滞期方面,美国为30个月,而台湾地区为12个月。在生物药处于医药领域的重要性愈来愈凸显的背景下,台湾地区将专利链接制度适用于生物类似药的举动,无疑可以更好地刺激本土生物医药企业进行技术创新,并保证原研药生产商的经济利益,同时鼓励仿制药生产商为争夺首仿的优势地位而加快后续改进研发。

总之,这项制度会激励仿制药企业挑战专利,而原研药企业为维护专利权和保持市场竞争力,也会积极考虑提起专利诉讼。无论是对于原研药企业还是对于仿制药企业,药品专利链接制度的执行和变革都会带来巨大的市场变革。随着各项制度在多个国家和地区不断被完善,全球的药企可以参考美国专利链接制度,提前进行布局和准备,在未来充分竞争的市场上占据一席之地。

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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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