|
每日IP英文第288期：
本文较好的概括了中国专利、商标和商业秘密保护的最新进展，推荐学习。
China’s Intellectual Property System: Important Changes for Medtech CompaniesNovember 11, 2019 | Morgan Lewis Nathan Smith Jensen Xu Shaobin Zhu
China has recently made significant strides in amending its intellectual property (IP) laws in a manner that provides substantial benefits and protections for medtech IP owners. As of November 1, 2019, China has taken another step in changing several aspects of its patent examination guidelines, along with the amendments to its trademark, trade secret, and unfair competition law. This LawFlash discusses these important changes to Chinese IP law and their implications for medtech companies.Updates to Chinese Patent ExaminationThe amendment to China Guidance for Patent Examination (Amended Guidance) took effect on November 1 and involves a series of changes that will alter the course of patent prosecution in China. Below we provide some of the key takeaways from the Amended Guidance that medtech companies should consider in their Chinese patent portfolio strategies.Deferred examination for up to three yearsWhile most applicants are eager to urge the examination process forward to obtain patents as soon as possible, medtech companies—especially in the early stages—must balance the desire to aggressively pursue issued patents with other constraints, such as financing or changes in product development. As such, medtech companies can benefit by controlling how quickly prosecution of their application proceeds.The Amended Guidance enables an applicant to request deferred examination of its application for a period of one, two, or three years either (1) at the time of requesting substantive examination for invention applications or (2) at the time of filing the application for utility model and design applications. Applicants should note that there is no cost to apply for deferred examination. However, the notice on the Form of Substantive Examination Application updated in November 2019 by the China Patent and Trademark Office states that “the deferral period cannot be altered and the deferral application cannot be withdrawn once it is submitted.” Therefore, applicants should be careful in preparing and submitting the application for deferred examination.As an important reminder, although applicants may delay examination for invention applications, the request for deferred examination does not delay publication of invention applications.Patenting of inventions related to embryonic stem cells allowedOne of the significant changes under the Amended Guidance relates to the protection of embryonic stem cells. Inventions related to the use of human embryos were previously impermissible under Chinese patent law and denied for the reason of “violation of social morality.” However, medtech companies are now able to pursue patent protection for inventions that satisfy the “14-day rule”: a human embryo research limitation that permits research of human embryonic stem cells for a maximum of 14 days after the point of fertilization. Although the Amended Guidance does not permit in vivo development, this change presents a major opportunity for medtech and biomedicine companies.Consistent use of applicant name in divisional applications, assignment documents, and power of attorney documentsMedtech companies must be wary of the new emphasis on applicant-naming requirements under the Amended Guidance. Often, whether through acquisition, merger, or other corporate events, medtech companies must develop and integrate new patent families into their existing patent portfolios. However, under the Amended Guidance, if the applicant named in a divisional application is different from the applicant named in the parent application, the divisional application will be considered to have not been filed ab initio. This incurable defect can be avoided by filing the divisional application in the name of the currently named applicant in the parent application (whether or not a name change has been recorded in the parent application). Further, medtech companies must also be wary of the requirement that the patent assignment bear the same signature as the power of attorney when the application is filed. The practice of having a single “company representative” that signs all assignment and power of attorney documents on behalf of the company is not as common in the United States as it is, for example, in Japan, China, and Korea, where company representatives may often use company stamps. In fact, given that the fast-moving world of medtech startups often produces high turnover in company leadership, medtech companies will need to be especially careful and, where possible, strive to maintain signatory consistency for formal documents.Correcting the loophole of ‘unlimited divisional applications’Under Chinese patent law, if the claims of a patent application are not directed to a single patentable or technical concept, a patent examiner should reject the claims as lacking “unity.” Pursuant to the Amended Guidance, with respect to a first divisional application where a notice of further division is issued by examiner ex officio or the examiner rejects the claims as lacking unity in an office action (collectively, unity rejection), the applicant may apply for a second divisional application only if the first divisional application receiving unity rejection (or the parent application of the first divisional application) is still pending. Otherwise, a second divisional application will not be permitted.This is a change from the prior guidance, which allowed the filing of a second divisional application after a first divisional application received a unity rejection as long as there was a related, pending application in the patent family (co-pendency with the first divisional application was not required). Some practitioners considered that the prior guidance permitted the filing of unlimited further divisional applications. The Amended Guidance closes this perceived loophole and now requires that medtech applicants more carefully develop and implement strategies to pursue divisional applications in their patent portfolios.Prioritized examination for key technologiesThe Amended Guidance now makes it possible for medtech applicants to request prioritized examination if the technology (1) is related to the industry advocated by the government; (2) has a significant effect on national or public interests; or (3) has certain market demand. Generally, applications that concern green technology, electric automobiles, new generation of information technology, and biomedicine technology might fall into this scope. However, as health and medical issues become increasingly important to the Chinese government, medtech companies may benefit from the new opportunity to access prioritized examination. Generally, applications allowed to enter the prioritized examination queue should expect examination to begin within a period of months, not the current one- to two-year delay period.Substantive issues can be discussed by calling the examinersPrior to the Amended Guidance, telephone communication with patent examiners was only possible to discuss formal defects that were of minor significance and unlikely to cause misunderstandings. The Amended Guidance now enables examiners and applicants to discuss substantive issues, including their understanding of the claimed inventions and related prior art references, by telephone. This change allows medtech companies valuable access to Chinese patent examiners and facilitates improved advocacy in protecting critical technology.Easier to initiate interviews with examinersThe Amended Guidance removed certain criteria that were previously necessary when initiating an examiner interview. For example, an applicant can now initiate an examiner interview (1) before the examiner has issued the first office action in the application; and (2) at times other than the time of issuance of the first office action or when the examiner offers an interview. As such, under the Amended Guidance, the patent applicant or the examiner can request or offer an interview at any time during the substantive examination proceeding. This important change allows medtech companies to more easily access Chinese patent examiners and will likely lead to improved communication and efficiency in the examination process.Increased patent examiner burden of proof in showing that a claimed feature was “well-known knowledge in the art”The Amended Guidance enhances patent examiners’ burden of proof when they issue rejections that are in any way based upon “well-known knowledge in the art.” Examiners are now required to provide evidence that supports their reliance on such “knowledge” while also being vulnerable to challenge by applicants if such evidence is not provided or is otherwise insufficient. Even in the absence of an applicant’s objection, the Amended Guidance still requires examiners to provide relevant evidence in the office action if they identify the key technical features of the invention as being “well-known knowledge in the art.” This important evidentiary requirement will certainly aid medtech applicants given that such technology often requires a specific, nuanced scientific or biological understanding that may be unappreciated or oversimplified by nonapplicants.Updates to Chinese Trademark, Trade Secret, and Unfair Competition LawsIn addition to these changes to patent examination standards, medtech companies should also be aware of other changes to the trademark, trade secret, and unfair competition laws in China. Indeed, with a growing domestic need for a fairer market and international trade pressures, China has made important amendments to its IP laws regarding trademark, trade secrets, and other unfair competition. The following select points will be important for medtech companies to be aware of when protecting nonpatent Chinese IP rights.Refusing trademark registrations if ‘bad faith’ is shownThe amended Chinese trademark law also took effect on November 1, 2019. The new trademark law will benefit medtech companies that have been targeted by others who filed “copycat” trademark applications without a genuine desire to use the trademarks in commerce. Under the amendment, such “bad faith” in a trademark application now constitutes practical grounds in all examination, opposition, and invalidation proceedings. The amendment also requires trademark agencies to reject an application if they know or have reason to know that the application was filed in bad faith; otherwise, the trademark agency may be subject to administrative or even criminal liability.Enhanced statutory and punitive damage awards in trademark litigationThe amendment to the trademark law also enhances the upper limit of statutory damages from the previous limit of RMB 3 million (approximately $426,000) to RMB 5 million (approximately $710,000). Because a statutory damages award is widely applied in civil trademark litigations in China, brand owners are now expected to be even more active in protecting their brands.In addition, the amendment increases the punitive damage award from up to three times the damage award that is determined by a statutory formula (i.e., determined by one of these three methods: (1) the trademark owner’s actual losses; (2) the gains of the infringer; or (3) the reasonable multiples of the underlying trademark licensing fee, if neither method (1) nor (2) works) to up to five times the damage award.However, given that punitive damages were very rarely awarded in the past—punitive damages can only be awarded under a finding of malicious infringement or other severe conditions—China has also made additional amendments and judicial interpretations to make the punitive damages determination clearer and more effective. Medtech brand owners will certainly benefit from these additional limits and greater clarity when pursuing damages awards.Changes to trade secret damage awards and the burden of proofChina also amended its anti-unfair competition law in April 2019 to strengthen the protection of trade secrets. Similar to the revisions of the trademark law, the amendment of the trade secret law increased the statutory damages award limit to RMB 5 million (approximately 710,000 USD), and prescribed punitive damages of up to five times the damages calculated by a statutory formula. As before, punitive damages can only be awarded under a finding of malicious infringement or other severe conditions.The 2019 Anti-Unfair Competition Law also prescribed a shift in the burden of proof for establishing infringement of a trade secret. To prove trade secret misappropriation, a plaintiff must show that (1) the plaintiff owned a valid trade secret; (2) the information acquired, disclosed, used, or licensed by the defendant is the same as or substantially identical to the trade secret; and (3) the defendant used an improper means to acquire, disclose, use, or license the trade secret. Under the new law, the burden shifts to the defendant to show that it is using a different means that is not the trade secret. This change in the burden of proof will allow medtech companies to more closely guard their trade secrets in litigation, while making it more difficult for defendants to manipulate their way out of an otherwise valid trade secret claim.TakeawaysThese many changes demonstrate China’s commitment to evolving and improving its IP protection for medtech companies. As these changes are factored into portfolio strategies, medtech companies may thereby improve their effectiveness in achieving their goals in and out of the Chinese marketplace.
Google翻译：中国的知识产权制度：医疗技术公司的重要变革November 11, 2019 | Morgan Lewis Nathan Smith Jensen Xu Shaobin Zhu中国最近在修改其知识产权（IP）法律方面取得了重大进展，以为医疗技术IP所有者提供实质性利益和保护的方式。截至2019年11月1日，中国已采取进一步措施来改变其专利审查指南的几个方面，以及对其商标，商业秘密和不正当竞争法的修正。本LawFlash讨论了中国知识产权法的这些重要变化及其对医疗技术公司的影响。中国专利考试最新动态《中国专利审查指南》（修订指南）的修正案于11月1日生效，涉及一系列变更，这些变更将改变中国的专利起诉程序。下面，我们提供了修订指南中的一些重要内容，这些内容是医疗技术公司应在其中国专利组合战略中考虑的。尽管大多数申请人都渴望敦促尽快推进审查程序以获取专利，但医疗技术公司（尤其是在早期阶段）必须在积极寻求已发行专利的愿望与其他约束（例如融资或产品开发变更）之间取得平衡。这样，医疗技术公司可以通过控制对其申请进行起诉的速度而受益。经修订的指南使申请人可以请求延期审查一，两年或三年，期限为（1）在请求对发明申请进行实质审查时或（2）在提交申请时实用新型和设计应用程序。申请人应注意，申请延期检查没有任何费用。但是，中国专利商标局于2019年11月更新的《实质审查申请表》中的通知规定：“延期不得更改，延期申请一经提交也不得撤回。”因此，申请人应谨慎行事。准备和提交延期审查的申请。一个重要的提醒是，尽管申请人可能会延迟发明申请的审查，但延期审查的请求并不会延迟发明申请的发布。经修订的指南中的重大变化之一涉及胚胎干细胞的保护。此前，根据中国专利法，与人类胚胎相关的发明是不允许的，但由于“违反社会道德”而被拒绝。但是，医疗技术公司现在能够为满足“ 14天规则”的发明寻求专利保护。：人类胚胎研究的局限性，允许在受精后最多进行14天的人类胚胎干细胞研究。尽管经修订的指南不允许进行体内开发，但此更改为医疗技术和生物医学公司提供了重大机遇。医疗技术公司必须警惕修订指南中对申请人命名要求的新强调。通常，无论是通过收购，合并还是其他公司活动，医疗技术公司都必须开发新专利家族并将其整合到现有专利组合中。但是，根据修订后的指南，如果分案申请中指定的申请人与母案申请中指定的申请人不同，则该分案申请将被视为从头开始提交。可以通过以父申请中当前指定的申请人的名义提交分案申请来避免这种无法治愈的缺陷（无论母申请中是否记录了名称更改）。进一步，医疗技术公司还必须警惕要求在提交申请时专利转让必须具有与委托书相同的签名的要求。在美国，不像在日本，中国和韩国那样由单个“公司代表”代表公司签署所有转让和委托书的做法在美国并不普遍。可能经常使用公司印章。实际上，鉴于快速发展的医疗技术初创企业通常会在公司领导层中产生高营业额，因此医疗技术公司将需要格外小心，并在可能的情况下努力保持正式文件的签署一致性。在美国，不像在日本，中国和韩国那样由单个“公司代表”代表公司签署所有转让和委托书的做法在美国并不普遍。可能经常使用公司印章。实际上，鉴于快速发展的医疗技术初创企业通常会在公司领导层中产生高营业额，因此医疗技术公司将需要格外小心，并在可能的情况下努力保持正式文件的签署一致性。在美国，不像在日本，中国和韩国那样由单个“公司代表”代表公司签署所有转让和委托书的做法在美国并不普遍。可能经常使用公司印章。实际上，鉴于快速发展的医疗技术初创企业通常会在公司领导层中产生高营业额，因此医疗技术公司将需要格外小心，并在可能的情况下努力保持正式文件的签署一致性。根据中国专利法，如果专利申请的权利要求不针对单个可专利或技术概念，则专利审查员应以缺乏“统一性”为由拒绝该权利要求。根据经修订的指南，对于第一个分案申请，审查员依职权发出进一步分案通知书，或者审查员以公职不统一为由驳回该要求（统称为统一驳回），只有 在第一分案申请获得统一驳回的情况下，申请人才可以申请第二分案申请（或第一个部门申请的父申请）仍处于待处理状态。否则，将不允许第二分案申请。这与先前的指导原则有所不同，该指导原则允许在第一项分案申请获得统一驳回后提交第二项分项申请，只要专利家族中存在相关的待决申请（与第一项分案申请共同存在）不需要）。一些从业人员认为，先前的指导意见允许提出无限的进一步分案申请。修订后的指南消除了这一可察觉的漏洞，现在要求医疗技术申请人更加谨慎地制定和实施策略，以在其专利组合中寻求分案申请。如果技术（1）与政府倡导的行业有关，则修订指南现在使医疗技术申请人可以要求优先检查。（2）对国家或公共利益有重大影响；（三）有一定的市场需求。通常，涉及绿色技术，电动汽车，新一代信息技术和生物医学技术的应用可能属于此范围。但是，随着健康和医疗问题对中国政府的重要性日益提高，医疗技术公司可能会从获得优先检查的新机会中受益。通常，允许进入优先检查队列的申请应期望在几个月内开始检查，而不是当前的一到两年延迟期。在修订指南之前，只能与专利审查员进行电话沟通，以讨论意义不大且不太可能引起误解的形式缺陷。现在，经修订的指南使审查员和申请人可以通过电话讨论实质性问题，包括他们对所要求保护的发明和相关现有技术参考文献的理解。这一变化使医疗技术公司可以宝贵地接触中国专利审查员，并在保护关键技术方面促进了更好的倡导。经修订的指南删除了在开始审查员面试时先前必需的某些标准。例如，申请人现在可以在审查员发出申请中的第一项办公室行动之前发起审查员面试（1）；（2）在首次发出诉讼之时或审查员提出面试之时。因此，根据经修订的指南，专利申请人或审查员可以在实质审查过程中的任何时间要求或提供采访。这一重大变化使医疗技术公司可以更轻松地访问中国专利审查员，并有可能改善审查过程中的沟通和效率。专利审查员在证明所要求保护的特征是“本领域中的众所周知的知识”时增加了举证责任经修订的指南会增加专利审查员在以任何方式基于“本领域众所周知的知识”发出的驳回时的举证责任。现在，审查员需要提供支持其依赖于此类“知识”的证据，同时还要如果没有提供证据或证据不足，则很容易受到申请人的质疑。即使没有申请人的反对，经修订的指南仍要求审查员如果将发明的关键技术特征确定为“本领域众所周知的知识”，则应在审查意见书中提供相关证据。这一重要的证据要求将肯定会对医疗技术申请人有所帮助，因为此类技术通常需要特定的，细微的科学或生物学知识，而非申请人可能不会对此加以理解或简化。中国商标，商业秘密和不正当竞争法的更新除了对专利审查标准进行的这些更改之外，医疗技术公司还应该意识到中国商标，商业秘密和不正当竞争法的其他变化。的确，随着国内对公平市场的日益增长的需求和国际贸易压力，中国已经对有关商标，商业秘密和其他不正当竞争的知识产权法进行了重要修订。在保护非专利中国知识产权时，以下选择要点对于医疗技术公司必须要意识到的重要。修订后的中国商标法也于2019年11月1日生效。新商标法将使那些向其他提出“仿冒”商标申请但不真正希望在商业中使用商标的人作为目标的医疗技术公司受益。根据该修正案，对商标申请的这种“恶意”现在构成了所有审查，异议和无效程序的实际依据。该修正案还要求商标代理机构，如果他们知道或有理由知道该申请是出于恶意提出的，则拒绝该申请；否则，商标代理机构可能要承担行政甚至刑事责任。商标法的修正案还将法定损害赔偿的上限从原来的人民币300万元（约合426,000美元）提高到了人民币500万元（约合710,000美元）。由于法定赔偿金在中国的民事商标诉讼中得到了广泛应用，因此，现在预计品牌所有者将更加积极地保护自己的品牌。此外，该修正案将惩罚性损害赔偿金从法定公式确定的损害赔偿金的三倍提高（即通过以下三种方法之一确定）：（1）商标所有者的实际损失；（2）收益；或（3）基础商标许可费的合理倍数，如果方法（1）或（2）都不起作用的话）最多为损害赔偿金的五倍。但是，鉴于过去很少判处惩罚性赔偿（惩罚性赔偿只能在发现恶意侵权或其他严重情况下才能判给），中国也做出了其他修正和司法解释，以使惩罚性赔偿的认定更加明确和有效。。在寻求损害赔偿裁决时，Medtech品牌所有者肯定会从这些附加限制和更清晰的内容中受益。中国还于2019年4月修订了《反不正当竞争法》，以加强对商业秘密的保护。与商标法的修订类似，商业秘密法的修订将法定损害赔偿的上限提高到了人民币500万元（约合71万美元），并规定了高达法定公式计算的损害赔偿金五倍的惩罚性损害赔偿。和以前一样，只有在发现恶意侵权或其他严重情况时才能给予惩罚性赔偿。2019年的《反不正当竞争法》还规定了确立侵犯商业秘密的举证责任。为了证明盗用商业秘密，原告必须证明：（1）原告拥有有效的商业秘密；（2）被告获取，披露，使用或许可的信息与商业秘密相同或基本相同；（3）被告使用不正当手段获取，披露，使用或许可商业秘密。根据新法律，负担转移到被告身上，以表明被告使用的是另一种手段，而不是商业秘密。举证责任的这种变化将使医疗技术公司能够在诉讼中更加密切地保护自己的商业秘密，同时使被告更难以操纵其以其他方式有效的商业秘密主张的方式。这些变化表明，中国致力于发展和改善对医疗技术公司的IP保护。由于这些变化已成为投资组合战略的考虑因素，因此医疗技术公司可以提高在中国市场内外实现目标的效率。End-
|
