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贝达药业抗癌药明星产品专利诉讼缠身

  • Categories:最新消息
  • Author:华讯知识产权
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  • Time of issue:2018-10-12 15:11
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(Summary description)在A股上市公司中,被称为“抗癌药第一股”的贝达药业惹上了一场马拉松式官司。贝达药业是一家由海归博士团队创办的以自主知识产权创新药物研究和开发为核心,集医药研发、生产、营销于一体的国家级高新技术企业,针对的领域为恶性肿瘤、糖尿病、心血管病等严重影响人们健康和生命的疾病。2011年,公司自主研发的国家1类新药埃克替尼(商品名称:凯美纳)获国家食品药品监督管理局颁发的新药证书和生产批文并开始上市销售,为

贝达药业抗癌药明星产品专利诉讼缠身

(Summary description)在A股上市公司中,被称为“抗癌药第一股”的贝达药业惹上了一场马拉松式官司。贝达药业是一家由海归博士团队创办的以自主知识产权创新药物研究和开发为核心,集医药研发、生产、营销于一体的国家级高新技术企业,针对的领域为恶性肿瘤、糖尿病、心血管病等严重影响人们健康和生命的疾病。2011年,公司自主研发的国家1类新药埃克替尼(商品名称:凯美纳)获国家食品药品监督管理局颁发的新药证书和生产批文并开始上市销售,为

  • Categories:最新消息
  • Author:华讯知识产权
  • Origin:
  • Time of issue:2018-10-12 15:11
  • Views:
Information

在A股上市公司中,被称为“抗癌药第一股”的贝达药业惹上了一场马拉松式官司。

贝达药业是一家由海归博士团队创办的以自主知识产权创新药物研究和开发为核心,集医药研发、生产、营销于一体的国家级高新技术企业,针对的领域为恶性肿瘤、糖尿病、心血管病等严重影响人们健康和生命的疾病。2011年,公司自主研发的国家1类新药埃克替尼(商品名称:凯美纳)获国家食品药品监督管理局颁发的新药证书和生产批文并开始上市销售,为公司的收入及利润带来了快速增长,并成为公司收入及利润的主要来源,据2018年半年报披露,2018年上半年凯美纳创造营收5.81亿元,占总营收的100%,该产品毛利率95.51%,销量同比增长28.54%,营业收入同比增长16.70%。

贝达药业是一家由海归博士团队创办的以自主知识产权创新药物研究和开发为核心,集医药研发、生产、营销于一体的国家级高新技术企业,针对的领域为恶性肿瘤、糖尿病、心血管病等严重影响人们健康和生命的疾病。2011年,公司自主研发的国家1类新药埃克替尼(商品名称:凯美纳)获国家食品药品监督管理局颁发的新药证书和生产批文并开始上市销售,为公司的收入及利润带来了快速增长,并成为公司收入及利润的主要来源,据2018年半年报披露,2018年上半年凯美纳创造营收5.81亿元,占总营收的100%,该产品毛利率95.51%,销量同比增长28.54%,营业收入同比增长16.70%。

目前,公司在中国境外涉及三宗未决诉讼事项,在中国境内涉及两宗未决诉讼事项。

 

埃克替尼专利纠纷始末

Ø  2000年

谢国建对记者表示,自己2000年4月应聘贝达化学公司。

Ø  2001年

谢国建称,其“主导研发出一个靶向治疗晚期肺癌的激酶抑制剂”。

Ø  2003年

王印祥、丁列明即此回国创业,贝达有限(贝达药业前身)成立,美国贝达以“EGFR酪氨酸激酶抑制剂”技术入股,成为贝达有限的股东。

Ø  2006年-2015

2006年,埃克替尼进入临床试验阶段。经过公司8年多的研发,2011年贝达药业1类新药埃克替尼(凯美纳)获批并实现产品上市。2011年度至2015年度,该产品销售收入年均复合增长率达到97.4%。

Ø  2014年

贝达药业及公司股东美国贝达就被曾是美国贝达员工的谢国建告上法庭。2017年年报披露,仍然是在审理中。

Ø  2016年

贝达药业开始迈向资本市场,最终在当年11月成功上市。

Ø  2017年7月31日

杭州市中级人民法院受理了GUOJIAN XIE(中文名:谢国建)诉贝达药业股权转让纠纷一案。

Ø  2018年9月25日

以贝达药业、贝达药业股东美国贝达等为被告的诉讼在杭州中级人民法院展开庭前会议。

 

早在2014年,贝达药业及公司股东美国贝达就被曾是美国贝达员工的谢国建告上法庭,此后案件一直无实质进展。上市后的2017年7月31日,杭州市中级人民法院受理了GUOJIAN XIE(中文名:谢国建)诉贝达药业股权转让纠纷一案。

原告谢国建在2017年8月向贝达药业、Beta Pharma Scientific, Inc.(美国贝达)和张晓东提起诉讼,称自己作为2002年美国临时专利“EGFR酪氨酸激酶抑制剂”(临时专利号:60/368.852)专利技术的发明人与申请人之一,与其他4名申请人享有该临时专利的所有权,美国贝达将该临时专利作为无形资产出资设立浙江贝达药业有限公司(贝达药业前身)侵犯了原告权利。

根据招股书披露(2003年3月28日),贝达有限在“EGFR酪氨酸激酶抑制剂”的基础上进行了进一步改造、研发,完成专利申请文件撰写后正式向中国知识产权局提交专利申请,成功申请并获得了埃克替尼对应化合物结构的发明专利“新型作为酪氨酸激酶抑制剂的稠合的喹唑啉衍生物”。在该专利的基础上,贝达有限进一步自主研发了埃克替尼的晶体结构、药物组合和制备方法等核心技术,并于2009年7月7日获得了发明专利“埃克替尼盐酸盐及其制备方法、晶型、药物组合物和用途”,这里研发出来的盐酸埃克替尼,正是贝达药业的明星产品凯美纳。

谢国建的律师对新京报记者表示,目前谢国建的诉求为获得赔偿、其对应专利本该获有的美国贝达股权。

 

谁的专利?

谢国建表示,自己于2000年4月应聘张晓东(在美国创办贝达化学公司,即美国贝达的前身,现通过美国贝达持有贝达药业部分股权)在美国开办的贝达化学公司,并主导研发出一个靶向治疗晚期肺癌的激酶抑制剂,研发成果经在耶鲁大学医学院做博士后的王印祥所在的实验室测试,发现特别的抗癌活性,王印祥透露给自己的研究生同学,也就是现任贝达医药董事长的丁列明,在试验图谱出来之后,张晓东即与王印祥、丁列明商议在中国开发该技术成果之市场。

2003年1月,王印祥、丁列明即此回国,一方面申报激酶抑制剂的临床试验和课题资金,一方面组建注册浙江贝达药业有限公司。

2003年1月,贝达有限成立,美国贝达以“EGFR酪氨酸激酶抑制剂”技术入股,成为贝达有限的股东(根据贝达药业的招股书,当时美国贝达的股权结构为只有张晓东一人持股,其持有美国贝达100%股权)。

谢国建认为,自己作为贝达有限核心研发团队成员之一为盐酸埃克替尼的研发作出了巨大贡献,贝达有限应依据前述合资投资协议的约定授予其部分贝达有限股权,但贝达有限除支付其工资外,没有向其发行过任何贝达有限股份。

根据贝达药业的公告,美国贝达已经和DON ZHANG(张晓东),GUOJIAN XIE(谢国建)等5位雇员签署《保密协议》,“上述雇员确认所有发现、发明、改进和技术革新的知识产权和商业利益归属于Beta Pharma Inc.(以下简称“BETA”)所有,所有相关的美国和国外专利申请权都属BETA所有”,这一主张也多次出现在贝达药业代理律师提出的质证意见中。贝达药业的代理律师多次提及谢国建为美国贝达的员工,不属于该专利的权利人;谢国建的律师回应称,“美国法律和中国法律不一样,美国法律强调的是发明人持有专利权”。

目前该案件仍然在审理中,双方争议的焦点从该专利的归属延展到多个问题。2018年10月10日,贝达药业发布早间公告称,“EGFR酪氨酸激酶抑制剂”的专利权权属纠纷案已在上市招股说明书中做了明确的说明,谢国建为BETA的员工,根据双方的协议约定,在职期间的所有职务行为产出的知识产权的所有权均归属于BETA,原告对涉案的专利或者技术成果不享有所有权,BETA享有该项专利的全部权利,并已在美国专利商标局办理了著录事项变更,依据当时法律、法规的规定,BETA有权通过协议约定以专利技术作价入股贝达药业。贝达药业在公司设立过程中,依法通过相应的法定核准和审批,程序完全合法。

 

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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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