浅谈药品专利链接制度

Categories:最新消息
Author:华讯知识产权
Origin:
Time of issue:2021-04-16 13:46
Views:

(Summary description)浅谈药品专利链接制度药品是与公众健康和社会福利息息相关的重要产品，也是知识产权冲突的集中领域之一。药品市场中存在原研药企与仿制药企之争，集中体现在其专利侵权纠纷上。药品专利链接制度是指将申请审批上市的仿制药与其所仿原研药的专利“链接”起来。简单来说，就是在仿制药上市审评审批期间确认仿制药的技术方案是否落入原研药的专利保护范围，从而在仿制药上市前提前解决其可能存在的专利侵权问题。 2020年10月17日，全国人大通过了中国专利法第四次修改，将于2021年6月1日生效，其中第四十二条和第七十六条，分别对药品专利有效期补偿及药品专利链接做出了原则性规定。对于在中国获得上市许可的新药发明专利，国务院专利行政部门可以应专利权人的请求给予期限补偿。对因申请注册的药品相关的专利权产生纠纷的，相关当事人可以向人民法院起诉，国务院药品监督管理部门会同国务院专利行政部门制定药品上市许可审批与药品上市许可申请阶段专利权纠纷解决的具体衔接办法，报国务院同意后实施。这是我国专利法中首次出现药品专利有效期补偿及建立药品专利衔接制度的法律条文，为我国逐步建立药品专利链接及配套制度迈出了重要的一步。药品专利链接制度有什么作用和意义呢？药品专利链接制度是药品监管部门的行政审批与司法裁判的相互链接。药品专利链接制度设定目标在于以更有效率的方式在药品上市批准前明确是否侵权或作出侵权预警，尽量避免药品批准后发生侵权纠纷，避免造成双方的实质性损失。构建合乎国情的药品专利链接制度通常具有以下4个方面的重要意义：保护原研药专利权；鼓励仿制药专利挑战；建立规范的药品市场准入秩序，防止恶意竞争；将专利纠纷解决在既定侵权事件发生前，有利于降低社会违法成本。药企如何应对医药专利制度的变化？对于原研药企业，要做好高价值专利布局工作，形成严密高效的专利保护网。建立预警与防控机制，定期关注中国上市药品专利信息登记平台，及时对仿制药企业登记信息进行侵权与否的判断，若确定仿制药品侵权，按照药品专利链接制度提起诉讼或行政裁决。对于仿制药企业，做好充分的信息调研准备工作，专利侵权风险评估是最为重要的环节之一，仿制药企业应核查清所仿制药物的所有相关专利状态，确定这些专利是否会对产品上市构成障碍，并根据评估结果结合制度，选择合适的策略。药品专利期限补偿与药品专利链接制度的实施，对医药企业的专利工作提出了更高的要求，无论原研药企业还是仿制药企业，都要更加重视专利的创造、运用、保护及管理。

浅谈药品专利链接制度

(Summary description)浅谈药品专利链接制度

药品是与公众健康和社会福利息息相关的重要产品，也是知识产权冲突的集中领域之一。药品市场中存在原研药企与仿制药企之争，集中体现在其专利侵权纠纷上。药品专利链接制度是指将申请审批上市的仿制药与其所仿原研药的专利“链接”起来。简单来说，就是在仿制药上市审评审批期间确认仿制药的技术方案是否落入原研药的专利保护范围，从而在仿制药上市前提前解决其可能存在的专利侵权问题。

2020年10月17日，全国人大通过了中国专利法第四次修改，将于2021年6月1日生效，其中第四十二条和第七十六条，分别对药品专利有效期补偿及药品专利链接做出了原则性规定。对于在中国获得上市许可的新药发明专利，国务院专利行政部门可以应专利权人的请求给予期限补偿。对因申请注册的药品相关的专利权产生纠纷的，相关当事人可以向人民法院起诉，国务院药品监督管理部门会同国务院专利行政部门制定药品上市许可审批与药品上市许可申请阶段专利权纠纷解决的具体衔接办法，报国务院同意后实施。

这是我国专利法中首次出现药品专利有效期补偿及建立药品专利衔接制度的法律条文，为我国逐步建立药品专利链接及配套制度迈出了重要的一步。

药品专利链接制度有什么作用和意义呢？

药品专利链接制度是药品监管部门的行政审批与司法裁判的相互链接。药品专利链接制度设定目标在于以更有效率的方式在药品上市批准前明确是否侵权或作出侵权预警，尽量避免药品批准后发生侵权纠纷，避免造成双方的实质性损失。

构建合乎国情的药品专利链接制度通常具有以下4个方面的重要意义：保护原研药专利权；鼓励仿制药专利挑战；建立规范的药品市场准入秩序，防止恶意竞争；将专利纠纷解决在既定侵权事件发生前，有利于降低社会违法成本。

药企如何应对医药专利制度的变化？

对于原研药企业，要做好高价值专利布局工作，形成严密高效的专利保护网。建立预警与防控机制，定期关注中国上市药品专利信息登记平台，及时对仿制药企业登记信息进行侵权与否的判断，若确定仿制药品侵权，按照药品专利链接制度提起诉讼或行政裁决。

对于仿制药企业，做好充分的信息调研准备工作，专利侵权风险评估是最为重要的环节之一，仿制药企业应核查清所仿制药物的所有相关专利状态，确定这些专利是否会对产品上市构成障碍，并根据评估结果结合制度，选择合适的策略。

药品专利期限补偿与药品专利链接制度的实施，对医药企业的专利工作提出了更高的要求，无论原研药企业还是仿制药企业，都要更加重视专利的创造、运用、保护及管理。

Categories:最新消息
Author:华讯知识产权
Origin:
Time of issue:2021-04-16 13:46
Views:

Information

浅谈药品专利链接制度

药品是与公众健康和社会福利息息相关的重要产品，也是知识产权冲突的集中领域之一。药品市场中存在原研药企与仿制药企之争，集中体现在其专利侵权纠纷上。药品专利链接制度是指将申请审批上市的仿制药与其所仿原研药的专利“链接”起来。简单来说，就是在仿制药上市审评审批期间确认仿制药的技术方案是否落入原研药的专利保护范围，从而在仿制药上市前提前解决其可能存在的专利侵权问题。

2020年10月17日，全国人大通过了中国专利法第四次修改，将于2021年6月1日生效，其中第四十二条和第七十六条，分别对药品专利有效期补偿及药品专利链接做出了原则性规定。对于在中国获得上市许可的新药发明专利，国务院专利行政部门可以应专利权人的请求给予期限补偿。对因申请注册的药品相关的专利权产生纠纷的，相关当事人可以向人民法院起诉，国务院药品监督管理部门会同国务院专利行政部门制定药品上市许可审批与药品上市许可申请阶段专利权纠纷解决的具体衔接办法，报国务院同意后实施。

这是我国专利法中首次出现药品专利有效期补偿及建立药品专利衔接制度的法律条文，为我国逐步建立药品专利链接及配套制度迈出了重要的一步。

药品专利链接制度有什么作用和意义呢？

药品专利链接制度是药品监管部门的行政审批与司法裁判的相互链接。药品专利链接制度设定目标在于以更有效率的方式在药品上市批准前明确是否侵权或作出侵权预警，尽量避免药品批准后发生侵权纠纷，避免造成双方的实质性损失。

构建合乎国情的药品专利链接制度通常具有以下4个方面的重要意义：保护原研药专利权；鼓励仿制药专利挑战；建立规范的药品市场准入秩序，防止恶意竞争；将专利纠纷解决在既定侵权事件发生前，有利于降低社会违法成本。

药企如何应对医药专利制度的变化？

对于原研药企业，要做好高价值专利布局工作，形成严密高效的专利保护网。建立预警与防控机制，定期关注中国上市药品专利信息登记平台，及时对仿制药企业登记信息进行侵权与否的判断，若确定仿制药品侵权，按照药品专利链接制度提起诉讼或行政裁决。

对于仿制药企业，做好充分的信息调研准备工作，专利侵权风险评估是最为重要的环节之一，仿制药企业应核查清所仿制药物的所有相关专利状态，确定这些专利是否会对产品上市构成障碍，并根据评估结果结合制度，选择合适的策略。

药品专利期限补偿与药品专利链接制度的实施，对医药企业的专利工作提出了更高的要求，无论原研药企业还是仿制药企业，都要更加重视专利的创造、运用、保护及管理。

Keyword:

Previous: 华讯诚邀您参加世界知识产权日——市场专利布局IPO论坛

Next: 如何加强对职务发明人的奖酬保护？

Previous: 华讯诚邀您参加世界知识产权日——市场专利布局IPO论坛

Next: 如何加强对职务发明人的奖酬保护？

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