As the use of genetic resources for innovation becomes more prevalent, the wider field of engineering biology offers a way to tackle societal pressures – such as the development of fossil fuel replacements, new vaccines and alternative proteins – while also driving economic growth. These international opportunities are consequently driving a significant increase in the focus globally on the interplay between the use of genetic resources, intellectual property (IP) and equitable benefits sharing.
随着利用遗传资源进行创新的情况日益普遍，工程生物学这一更广泛的领域提供了一种应对社会压力的途径，比如开发化石燃料替代品、新型疫苗以及替代蛋白质等，同时还能推动经济增长。因此，这些国际机遇正促使全球对遗传资源的利用、知识产权以及公平的惠益分享之间的相互关系给予更多的关注。
1.全球监管重点
A new World Intellectual Property Organisation (WIPO) treaty on IP, genetic resources and associated traditional knowledge has recently been adopted, which, when in force, will establish a new international disclosure requirement for patent applicants whose inventions are based on genetic resources or associated traditional knowledge. This would be a separate requirement to those in the Nagoya Protocol.
世界知识产权组织（WIPO）最近通过了一项关于知识产权、遗传资源及相关传统知识的新条约。该条约一旦生效，将针对那些发明基于遗传资源或相关传统知识的专利申请人设立一项新的国际披露要求。这将是与《名古屋议定书》中的要求相互独立的一项规定。
In addition, there has also been the adoption of a decision under the United Nation's Convention on Biology Diversity (CBD) that paves the way for benefits sharing, albeit voluntarily at this stage, from the use of digital sequence information (DSI) of genetic resources.
此外，根据《联合国生物多样性公约》（CBD）通过了一项决定，该决定为从遗传资源的数字序列信息（DSI）的使用中进行惠益分享铺平了道路，尽管在现阶段这是自愿性质的。
Although both the agreed treaty and the decision are watered down versions of the proposals originally made and are said to lack "teeth", they do signal a greater global focus on the issues surrounding the use of genetic resources.
尽管这份已达成共识的条约以及那项决定都是最初所提提案的弱化版本，且据说缺乏“执行力”，但它们确实表明全球对围绕遗传资源利用的相关问题给予了更多的关注。
Both the treaty and the decision will have to be implemented nationally to take effect. In the UK, the Regulatory Horizons Council has recently called on the government to ensure that implementation reflects the needs of the engineering biology sector and has maximum impact without hindering science, research and innovation. Businesses involved in this sector should follow carefully how these developments unfold.
该条约和决定都必须在国家层面予以实施才能生效。在英国，监管地平线委员会最近呼吁政府确保实施过程能反映工程生物学领域的需求，并且在不妨碍科学、研究和创新的前提下发挥最大作用。涉足该领域的企业应当密切关注这些进展的发展态势。
2.新的披露要求
Under the WIPO treaty, there are new disclosure requirements when a patent application is based on either genetic resources or traditional knowledge associated with genetic resources. Patent applicants in contracting states will be required to disclose either the country of origin of the genetic resources or the indigenous people – or local community – of the traditional knowledge. If these are unknown, the applicant must provide the source of the information or make a declaration that the source is unknown.
根据WIPO的条约，当专利申请基于遗传资源或与遗传资源相关的传统知识时，有了新的披露要求。缔约国的专利申请人将被要求披露遗传资源的原产国，或者相关传统知识所属的原住民群体或当地社区。如果这些信息未知，申请人必须提供相关信息的来源，或者声明来源未知。
In the treaty, the definition of genetic resources is consistent with the approach taken in the CBD and, therefore, relates to material from plants, animals, microbes or other origins that is of actual or potential value – crucially, it does not include human genetic resources. Traditional knowledge is not defined in the treaty.
在该条约中，遗传资源的定义与《联合国生物多样性公约》（CBD）所采用的方式一致。因此，它指的是来自植物、动物、微生物或其他来源的具有实际或潜在价值的物质——关键的是，它不包括人类遗传资源。该条约中并未对传统知识作出定义。
The disclosure requirement applies where the genetic resources were or the traditional knowledge was necessary for the claimed invention – and the claimed invention depends on the specific properties of the genetic resources and traditional knowledge.
当遗传资源或相关传统知识对于所主张的发明而言是必要的，并且所主张的发明依赖于遗传资源和传统知识的特定属性时，披露要求即适用。
This disclosure requirement would be separate to and go further than the requirements of the Nagoya Protocol, which deals with access and benefits sharing relating to the use of genetic resources. Under the Nagoya Protocol, patent applicants (and other users of genetic resources and associated traditional knowledge) must make a due diligence declaration, stating that they have complied with any requirements in the country of origin to obtain prior informed consent or enter into mutually agreed terms.
这一披露要求将独立于《名古屋议定书》的要求，且比其更进一步。《名古屋议定书》处理的是与遗传资源利用相关的获取和惠益分享问题。根据《名古屋议定书》，专利申请人（以及遗传资源和相关传统知识的其他使用者）必须作出尽职调查声明，表明他们已遵守遗传资源原产国的任何要求，以获得事先知情同意或达成双方商定的条款。
For businesses or institutions that are already complying with the Nagoya Protocol, this information could be reused to meet the WIPO treaty obligations.
对于那些已经遵守《名古屋议定书》的企业或机构而言，这些信息可以再次利用，以履行WIPO条约所规定的义务。
However, the Regulatory Horizons Council has recently reported that the implementation of the Nagoya Protocol in the UK has been "heavy handed" and had a chilling effect on research falling within its scope. If the UK were to adopt the WIPO treaty, it would need to ensure that a similar approach to implementation is avoided.
然而，监管地平线委员会最近报告称，《名古屋议定书》在英国的实施方式“过于严厉”，对属于其适用范围内的研究产生了寒蝉效应。如果英国要采纳WIPO的这项条约，就需要确保避免采取类似的实施方式。
3.适用性和执行力有限
Despite this additional requirement on patent applicants, patent offices would have no obligation to verify any disclosures made. However, they would be expected to provide guidance on how to meet the disclosure requirement. Additionally, the treaty is non-retroactive, so would only apply to patents filed after it enters into force in contracting states.
尽管对专利申请人有这项额外要求，但专利局没有义务核实所做的任何披露内容。不过，专利局应就如何满足披露要求提供指导。此外，该条约不具有追溯力，因此仅适用于在其在缔约国生效后提交的专利申请。
The sanctions for failing to make a disclosure in the treaty have been watered down from earlier proposals. There are no consequences for the validity of a patent if there has been a failure to disclose the origin of the genetic resources or the traditional knowledge. Applicants must also be given opportunities to rectify failures to disclose or incorrect disclosures.
该条约中对于未进行披露行为的制裁措施相较于早期提案已有所弱化。如果未披露遗传资源或传统知识的来源，对于专利的有效性不会产生任何影响。申请人也必须被给予机会，以纠正未披露或披露错误的情况。
However, provision is made for possible post-grant sanctions or remedies where there has been "fraudulent intent in regard to the disclosure requirement". The nature of any sanctions or remedies would be for each contracting member state but it does mean that revocation could be possible (if fraudulent intent can be shown).
然而，对于在“披露要求方面存在欺诈意图”的情况，条约规定了可能在专利授予后实施的制裁或补救措施。任何制裁或补救措施的具体形式将由各缔约成员国自行决定，但这确实意味着（如果能证明存在欺诈意图）专利有可能被撤销。
The treaty will only enter into force three months after it has been ratified by 15 states–currently, Malawi is the only state to have ratified. None of the UK, the US or the EU and its member states are among the 38 signatories to the treaty (which indicates an intention to ratify). However, the US Patent and Trademark Office is currently seeking public comments on whether Washington should sign and implement the treaty. As the consultation was published just before the change of administration, it remains to be seen whether it is a priority for the new incumbents.
该条约只有在15个国家批准后的三个月才能生效——目前，马拉维是唯一已批准该条约的国家。英国、美国、欧盟及其成员国都不在该条约的38个签署国（签署表示有意批准）之列。然而，美国专利商标局目前正在就华盛顿方面是否应该签署并实施该条约征求公众意见。由于这项意见征询是在政府换届前夕发布的，对于新上任的官员们来说，这是否会成为一个优先事项还有待观察。
4.数字序列信息
Agreement was also reached at the end of last year on a mechanism for sharing benefits from genetic DSI under the CBD. This decision established a voluntary fund–called the Cali Fund–in order to promote access and benefit-sharing in the use of genetic resources.
去年年底，各方还就《联合国生物多样性公约》框架下遗传数字序列信息的惠益分享机制达成了协议。该决定设立了一项名为“卡利基金”的自愿基金，旨在促进遗传资源利用方面的获取和惠益分享。
Businesses benefiting from DSI from nature can contribute to the fund, which will be used to support further use of DSI, and the conservation and sustainable use of nature. A significant proportion of the fund will go to indigenous peoples and local communities. Although this paves the way for a compulsory access and benefits-sharing regime for genetic DSI akin to the Nagoya Protocol (which covers tangible genetic materials rather than digital genetic data), at this stage, contributions to the Cali Fund are entirely voluntary. Proposals to make contributions compulsory were abandoned during the negotiation process.
从自然界的数字序列信息中获益的企业可以向该基金捐款。该基金将用于支持数字序列信息的进一步利用，以及对自然的保护和可持续利用。该基金的很大一部分将流向原住民群体和当地社区。尽管这为建立一个类似于《名古屋议定书》（其涵盖的是有形的遗传物质，而非数字遗传数据）的、针对遗传数字序列信息的强制性获取与惠益分享制度铺平了道路，但在现阶段，向“卡利基金”捐款完全是自愿的。在谈判过程中，有关强制捐款的提议已被放弃。
As this decision has been reached under the CBD framework, it will be applicable to the UK and the EU, both of which will have to develop legislation to implement the mechanism. However, the US is not a signatory to the CBD and therefore it is not applicable there.
由于这项决定是在《联合国生物多样性公约》框架下达成的，它将适用于英国和欧盟，这两者都必须制定相关立法来落实这一机制。然而，美国并非《联合国生物多样性公约》的签署国，因此该决定在美国不适用。
In the UK, the government has said that it will work with industry to develop a voluntary mechanism and the Regulatory Horizons Council has suggested working with the government to ensure implementation supports its proposed changes to the regulatory landscape for the engineering biology sector. The timeframe for implementation is not yet clear.
在英国，政府表示将与业界合作制定一项自愿机制，而监管地平线委员会则建议与政府合作，以确保相关实施工作能够支持其对工程生物学领域监管格局所提出的变革。目前，该机制的实施时间框架尚不明确。
5.结论
Although these developments add nothing mandatory to the current framework, either in the UK or elsewhere, they highlight the increased global focus on the use of genetic resources and genetic DSI in the innovation process, and IP rights and benefits associated with that innovation.
尽管这些进展无论是在英国还是其他地方，都没有为当前的框架增添任何强制性的内容，但它们凸显了全球对在创新过程中使用遗传资源和遗传数字序列信息，以及与该创新相关的知识产权和惠益给予了更多的关注。
It is a particular focus of debate in the UK, with calls on the government to "turbocharge" the engineering biology sector, a sector for which access to and use of genetic resources and genetic DSI is crucial. It is likely that the regulation of this sector, including the implementation of the Nagoya Protocol, whether to implement the WIPO treaty and the implementation of the benefits sharing mechanism for DSI, will receive government attention at some point. Development of the sector could be crucial to the current government's pro-innovation agenda and pro-growth ambitions; however, it remains to be seen how quickly these issues will be addressed.
这在英国是一个备受争议的焦点问题。人们呼吁政府大力推动工程生物学领域的发展，而对于这个领域而言，获取和利用遗传资源以及遗传数字序列信息至关重要。对该领域的监管，包括《名古屋议定书》的实施、是否要实施WIPO的相关条约，以及遗传数字序列信息惠益分享机制的落实，很可能在某个时候会得到政府的关注。该领域的发展对于当前政府支持创新的议程以及促进经济增长的目标可能至关重要；然而，这些问题能以多快的速度得到解决还有待观察。