《药品管理法》修订，“药神”可以存在么？

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Author:华讯知识产权
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Time of issue:2019-09-12 14:08
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(Summary description)8月26日，十三届全国人大常委会第十二次会议表决通过了新修订的《药品管理法》，自2019年12月1日起施行。本次修订是《药品管理法》时隔18年后第一次全面修改，对进口药、创新药、网络售药等社会矛盾突出的问题进行了调整，主要表现在以下几个方面：一是对网售药品做出规定，药品网络销售第三方平台提供者应当向药品监督管理部门备案，并且对申请进入平台经营的药品上市许可持有人、药品经营企业资质进行审查，并对发生

《药品管理法》修订，“药神”可以存在么？

Categories:最新消息
Author:华讯知识产权
Origin:
Time of issue:2019-09-12 14:08
Views:

Information

8月26日，十三届全国人大常委会第十二次会议表决通过了新修订的《药品管理法》，自2019年12月1日起施行。本次修订是《药品管理法》时隔18年后第一次全面修改，对进口药、创新药、网络售药等社会矛盾突出的问题进行了调整，主要表现在以下几个方面：一是对网售药品做出规定，药品网络销售第三方平台提供者应当向药品监督管理部门备案，并且对申请进入平台经营的药品上市许可持有人、药品经营企业资质进行审查，并对发生在平台的药品经营行为进行管理；二是建立了上市许可人制度，规定药品上市许可持有人依法对药品研制、生产、经营、使用全过程中药品的安全性、有效性和质量可控性负责，将生产许可和上市许可的分离；三是加大了处罚力度，多个涉及处罚的条款中，都将处罚力度较大幅地上调。比如，生产、销售劣药的，没收违法所得，并处药品货值金额十倍以上二十倍以下的罚款，而在原《药品管理法》中的罚款为一倍以上三倍以下；四是未获批进口药不再以「假药」论处，对假药的范畴进行了新的定义，并规定对于未经批准进口少量境外合法上市的药品，可以减轻或者免予处罚。

南京华讯知识产权顾问有限公司

2018年由真实故事改编的《我不是药神》，引发了社会对“假药”、“代购”未经国家批准进口药品等问题的广泛探讨。《我不是药神》的主人翁原型是陆勇，他在02年的时候却得了白血病，国内药物的价格难以承受，后来陆勇在网上了解到在印度有一款跟药效相同的药品，价格非常便宜，但没有出口中国的一些相关证件，只能靠一些渠道偷偷买进来，陆勇还帮其他病友代购此款药品。2015年初，陆勇以涉嫌”销售假药”被抓捕，在这期间病友联合发起抗议，恳求司法机关免除刑事处罚，最后检察院作出不起诉决定。

此前未经批准进口的药品，按假药论处并根据相关规定对相应的行为人作出处罚。全国人大常委会法制工作委员会行政法室主任袁杰在新闻发布会上表示，这次对假劣药的范围进行修改，没有再把未经批准进口的药品列为假药，这是回应了民众的关切。新《药品管理法》第九十八条规定“禁止生产（包括配制，下同）、销售、使用假药。有下列情形之一的，为假药:1. 药品所含成份与国家药品标准规定的成份不符；2. 以非药品冒充药品或者以他种药品冒充此种药品；3. 变质的药品；4. 药品所标明的适应症或者功能主治超出规定范围。”与此前发布的《药品管理法》中对“假药”的定义相比，新《药品管理法》中移除了“依照本法必须批准而未经批准生产、进口，或者依照本法必须检验而未经检验即销售的”这一项。另外第一百二十四条更新指出“未经批准进口少量境外已合法上市的药品，情节较轻的，可以依法减轻或者免予处罚”。

药物是一种关于生命健康的商品，未经批准进口的药物不按假药处理，是顺应公众的迫切需求，像陆勇这样的“药神”不会再因为自己的热心而受到处罚。这意味着，自用的药品可以去国外购买，但是如果为他人代购牟利，代购量大，可能涉及非法经营罪或走私罪的违法犯罪行为。

南京华讯知识产权顾问有限公司

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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

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Types of patents that are easily overlooked- Design Patent

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