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老药新用能申请专利保护吗?

  • Categories:最新消息
  • Author:华讯知识产权
  • Origin:
  • Time of issue:2019-04-13 14:54
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(Summary description)老药新用的“老药”其实不仅限于现有已上市药物,还应该包含曾/现处于临床前或临床研究中的潜在候选物,虽然不是什么新概念了,但是老药新用可以降低失败率和研发成本,鉴于近年来新药临床研究的高失败率,寻找现有药物的新适应症成为极具吸引力及优化药企成本/效益的新策略;更重要的是,老药新用非常适用于罕见疾病的治疗,由于罕见病患者数量少,市场空间有限,在传统药物开发框架内很难盈利,大多数企业不愿意进入这些领域,

老药新用能申请专利保护吗?

(Summary description)老药新用的“老药”其实不仅限于现有已上市药物,还应该包含曾/现处于临床前或临床研究中的潜在候选物,虽然不是什么新概念了,但是老药新用可以降低失败率和研发成本,鉴于近年来新药临床研究的高失败率,寻找现有药物的新适应症成为极具吸引力及优化药企成本/效益的新策略;更重要的是,老药新用非常适用于罕见疾病的治疗,由于罕见病患者数量少,市场空间有限,在传统药物开发框架内很难盈利,大多数企业不愿意进入这些领域,

  • Categories:最新消息
  • Author:华讯知识产权
  • Origin:
  • Time of issue:2019-04-13 14:54
  • Views:
Information

老药新用的“老药”其实不仅限于现有已上市药物,还应该包含曾/现处于临床前或临床研究中的潜在候选物,虽然不是什么新概念了,但是老药新用可以降低失败率和研发成本,鉴于近年来新药临床研究的高失败率,寻找现有药物的新适应症成为极具吸引力及优化药企成本/效益的新策略;更重要的是,老药新用非常适用于罕见疾病的治疗,由于罕见病患者数量少,市场空间有限,在传统药物开发框架内很难盈利,大多数企业不愿意进入这些领域,而老药新用策略可以很好的弥补这一领域的新药开发不足。

然而,老药新用面临的挑战主要来自三个方面:

1.  专利问题

老药新用首先面临的是知识产权的门槛,新适应症的专利申请和实施是激励制药公司开发老药新用的关键原因,因为它对产品收益有很大影响。如果一种已知药物的新用途是具有创造性的,那么在全球大多数市场上这种药物都会受到保护,但是大多数情况下新适应症都已有文献报道或研究发现,除非专利所有人能够证明他开发的适应症不在已有专利范围内,否则这种老药新用很难获得专利保护,因此,尽早确定目标适应症和专利保护力度就显得格外重要。

2.  监管政策

美国NDA一类、六类(新适应症)和补充新药申请(sNDA,新适应症)都适用于老药新用的申请,三类(新剂型)和四类(新联用)适用于老药新用或者新剂型,大部分老药新用的获批都是在原研药物专利到期前。另外,FDA对那些治疗新适应症的老药新用给予3年独占期。

3.  行业中的组织障碍

如果某一项目不属于该公司核心研发方向,那很有会因为资金等问题导致项目中止开发,这对于针对新适应症的药物再开发十分不利,可以通过资金筹措,借助CRO公司平台和政策支持完成公司内部无法完成的项目。另外,当前企业之间对于药物机制信息和临床药物警戒情报的共享还是非常保守的,如果能进一步共享进行中的老药新用成果会非常有帮助。

 

药品新用途是否是可专利的客体?

具备新用途的药品是否可申请专利?答案是肯定的,这种情况可以申请新适应症(新用途)专利,当然是否能获批还得考察三性,其中新颖性主要关注这种新用途是否有被实质性披露,我国专利《审查指南》指出,“对于涉及化学产品的医药用途发明,其新颖性审查应考虑以下方面:

(1)新用途与原已知用途是否实质上不同。仅仅表述形式不同而实质上属于相同用途的发明不具备新颖性。

(2)新用途是否被原已知用途的作用机理、药理作用所直接揭示。与原作用机理或者药理作用直接等同的用途不具有新颖性。

(3)新用途是否属于原已知用途的上位概念。已知下位用途可以破坏上位用途的新颖性。

(4)给药对象、给药方式、途径、用量及时间间隔等与使用有关的特征是否对制药过程具有限定作用。仅仅体现在用药过程中的区别特征不能使该用途具有新颖性。”

创造性主要考察此用途是否有足够的科学证据支撑(如临床前及临床数据),实用性则是要避开“疾病的诊断与治疗方法”这个坑。

对于该类药物的专利保护,原研公司有两种应对方式,即:(1)申请延长该类药物已有的化合物专利的保护期限,或(2)为该类药物申请新的专利。实践中,很多医药公司倾向于采取第二种策略,即为该类药物申请新的专利,这种新型专利策略最大化了药品专利的生命周期,为公司扩大了专利保护范围,但也遇到了专利法和审查实践的诸多限制。

在美国,尽管化合物本身可能是无专利保护的,但该化合物用于新的适应症,即已知药品的新用途(或第二适应症),如果确实是新的、出乎意料的,通常是可能受到专利保护的;美国专利申请的实践中,可获得授权的新用途专利的权利要求范围很广,它甚至还包括对病人的范围,如性别、种族或年龄等影响治疗效果的因素的限定特征。许多其他国家的专利局认为第二适应症的专利在没有新药品产生的情况下不适当地延伸了药品的保护,因而对这种权利要求拒绝授予专利权。

 

结语

在特定情况下,药用化合物的新用途/新适应症是可以受到专利保护的客体,但得到专利授权需要跨越新颖性和创造性的挑战,这需要药品企业在研发过程中就注意到专利法和审查实践的要求。在生产和市场的国际化趋势下,药品专利的国际申请已经是不可不为的战略需要,利用各个国家对化合物新用途的权利要求的不同规定制定不同的专利申请策略是高水平的专利法律服务的必备内容,一个受专利保护的已知药品的新用途可以有巨大的利润回报。因此,医药企业一旦发现已知药物的新适应症,即使不拥有该化合物的专利权,也应尽快提出该要物新用途专利的国际申请,并针对各个国家的不同规定确定进入该国家的国家阶段申请的权利要求形式和范围。

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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
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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.
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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 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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