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美国的药品专利期延长制度

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  • Time of issue:2017-03-03 15:10
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(Summary description)1984年美国国会通过了《食品、药品和化妆品法》FoodDrugandCosmeticsAct简称FDCA的一项重要修正案《药品价格竞争和专利期恢复法》DrugPriceCompetitionandPatentTermRestorationAct也称为Hatch-WaxmanAct。在该法案中对药品的专利期延长做出了明确的规定。  1.1药品专利期延长的条件可获得专利期延长的药品专利包括产品专

美国的药品专利期延长制度

(Summary description)1984年美国国会通过了《食品、药品和化妆品法》FoodDrugandCosmeticsAct简称FDCA的一项重要修正案《药品价格竞争和专利期恢复法》DrugPriceCompetitionandPatentTermRestorationAct也称为Hatch-WaxmanAct。在该法案中对药品的专利期延长做出了明确的规定。  1.1药品专利期延长的条件可获得专利期延长的药品专利包括产品专

  • Categories:最新消息
  • Author:
  • Origin:
  • Time of issue:2017-03-03 15:10
  • Views:
Information

  1984年美国国会通过了《食品、药品和化妆品法》FoodDrug and Cosmetics Act简称FDCA的一项重要修正案《药品价格竞争和专利期恢复法》Drug Price Competition and Patent Term Restoration Act也称为Hatch-Waxman Act。在该法案中对药品的专利期延长做出了明确的规定。

  1.1 药品专利期延长的条件 可获得专利期延长的药品专利包括产品专利和方法专利。方法专利为使用方法专利或制备方法专利。

  药品的某项专利保护期延长需满足以下条件:

  专利尚未过期。

  以前从未获得过专利期延长。

  药品在上市销售之前已经过了FDA的注册批准并且是经FDA批准的首次上市销售、使用或在该制备方法专利下生产的药品。

  声明该产品在上市销售使用之前经过FDA强制审查期。

  必须在FDA 批准上市后60天内向USPTO递交专利期延长申请即使该药品还未做好上市准备。

  提出药品专利期延长的申请人必须USPTO 记录的该项专利的持有人且参与了该药品注册的强制审查。

  1.2 药品专利期延长的期限药品专利期延长的期限受到以下两方面的限制:

  (1)延长期不得超过5 年。

  (2)药品通过FDA批准后剩余的基本专利期加上延长期不得超过14年。例如一个已批准的药品按要求可以获得5年的专利期延长但其在批准上市时还有10年的基本专利期剩余则该药品只能获得4年的专利期延长。

  在此限定条件下药品专利延长期确定的基础是FDA对药品注册的强制审查期Regulatory Re- view Period简陈RRP。强制审查期通常由两部分构成,即试验阶段和审批阶段。试验阶段指的是临床试验阶段即从调研性新药申请(Investigational New Drug Application,简称INDA,又称为“临床研究申请”)被批准到新药申请New Drug Application,简称 NDA。首次递交之间的时间间隔审批阶段即为 NDA被接收到通过FDA的批准的时间间隔。FDA 将查阅其纪录并咨询专家以确认申请的试验阶段和审批阶段的时间长短。如果在任一个阶段由于申请人未能尽责undue diligence而造成了时间的延误则该阶段减去这部分延误时间。一旦强制审查期确定FDA将通知USPTO和申请人同时抄送FDA文件摘要管理处

  Dockets Man- agement Branch并在《联邦注册》Federal Regis- ter杂志上公布。 《联邦注册》上将注明申请人的姓名、产品的商品名和通用名、专利号、确定的强制审查期包括试验阶段和审批阶段各为多长时间及各阶段的尽责决定。

  1.3 药品专利期延长中的异议处理在公布强制审查期决定后180 d内任何人都可以向FDA提出尽责申诉due diligence petition申诉的目的是改变FDA因申请人未能尽责而减少专利期延长期限的决定。同时任何人都可以在FDA公布尽责决定后的60 d内要求FDA对此举行非正式的听证即尽责听证due diligence hearing。

  FDA在下列情况之一即认定强制审查期为最终结果:

  (1)180 d期限届满而无尽责申诉。

  (2)对及时提出的关于强制审查期的异议通过尽责申诉或尽责听证得到了解决。

  1.4 药品专利期延长的程序及审批中的职责分工药品专利期延长的程序是:

  (1)申请人在收到FDA 批准函60 d内向USPTO递交专利期延长申请。

  (2)USPTO在收到申请的60 d内将申请送交至FDA

  (3)负责计算强制审查期并将计算结果通知 USPTO。

  (4)FDA公布强制审查期结果并主持尽责申诉和尽责听证。

  (5)USPTO审查专利期延长申请并确定最终的专利期延长期限。

  美国药品专利期延长制度显著的一个特点就是实现了USPTO和FDA的职责的联接和分工。FDA 的主要职责是协助USPTO考察提出申请的药品专利期延长的资格、提供有关该产品依法审批期限的信息计算强制审查期并负责随后的尽责诉讼和尽责听证。而USPTO负责接收药品专利期延长申请并有专利延长期限最终的确定权。FDA在所有涉及专利解释和有效性方面与USPTO保持一致。

  1.5 药品专利期延长的权利限制只有通过FDA 批准的药品、药品的使用方法或药品的制备力法的专利才能够获得专利期延长每项专利只能获得1 个专利期延长即使在该项专利下有多个被FDA批准的药品每个被FDA批准的药品只能有1项专利获得专利期延长即使该药品享有多项专利如第一项专利是药品专利第2项专利是使用方法或制备方法专利。

  为何在中国没有药品专利延期制度?

  我国没有制度专利保护期延长制度,虽然改革开放之初,我国作为发展中国家,经济和科技水平相对比较落后,我国对创新药的保护力度比较弱,总体人均收入比较低,如果对专利药进行保护,药价就比较高,势必加重国家和患者的经济负担。然而进入 21 世纪以来,人们生活水平有了很多的提高,特别是 2005 年以后,随着我国对科技的不断重视,科技水平和自主创新能力有了很多的提高,客观上要求给予我国医药企业更多的发展空间,需要在制度上给予自主创新更多的制度支持。因此,也有很多学者呼吁我国建立完善药品专利延期制度,然而实际的制度实行和落实,还有很长的路要走。

  http://www.docin.com/p-778323706.html

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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