This article argues that divisional patent applications and litigation are strategically employed in the pharmaceutical sector to delay generic and biosimilar market entry. These practices are given a legitimate basis in the European Patent Convention and the Patents Act 1977, but recent UK case law shows that their misuse results in deliberate obfuscation of existing safeguards. Nonetheless, patent law should not be passive. The reintroduction of the divisional filing time limit coupled with shorter compliance periods would offer practical administrative steps for shortening the time frame within which divisionals can be filed. Moreover, further clarity surrounding the implementation of the double patenting prohibition would reduce the number of substantially similar divisional patents that are successfully obtained. This article also discusses Arrow declarations at length, before concluding with a brief analysis of the suitability of the abuse of process doctrine for dealing with divisional misuse.
{"title":"The devil is in the divisional: an analysis of divisional patents, deadlines, declarations and suggestions for future practice","authors":"Mieke Filler","doi":"10.1093/jiplp/jpae046","DOIUrl":"https://doi.org/10.1093/jiplp/jpae046","url":null,"abstract":"\u0000 This article argues that divisional patent applications and litigation are strategically employed in the pharmaceutical sector to delay generic and biosimilar market entry. These practices are given a legitimate basis in the European Patent Convention and the Patents Act 1977, but recent UK case law shows that their misuse results in deliberate obfuscation of existing safeguards. Nonetheless, patent law should not be passive. The reintroduction of the divisional filing time limit coupled with shorter compliance periods would offer practical administrative steps for shortening the time frame within which divisionals can be filed. Moreover, further clarity surrounding the implementation of the double patenting prohibition would reduce the number of substantially similar divisional patents that are successfully obtained. This article also discusses Arrow declarations at length, before concluding with a brief analysis of the suitability of the abuse of process doctrine for dealing with divisional misuse.","PeriodicalId":508706,"journal":{"name":"Journal of Intellectual Property Law and Practice","volume":"13 6","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-06-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141336107","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Twenty years since Professor Cornish asked whether IP is ‘omnipresent, distracting, irrelevant?’, this article revisits that question following recent times of instability, which have compounded the polycrisis the world is facing, whilst the 2030 deadline to achieve the UN Sustainable Development Goals looms closer and closer. This contribution argues that IP plays a critical role as one of multiple regulatory systems seeking solutions in the highly dynamic and insecure contexts of the climate emergency, uneven global development and pandemics, requiring timely and comprehensive normative development. However, over the last two decades there has been a glacial pace towards setting appropriate IP norms and states, policymakers and legislatures have to move beyond merely settling for a ‘more of the same’ approach. The ongoing World Health Organization’s Pandemic Accord negotiations present an opportunity to confirm IP’s relevance to combatting the polycrisis by setting effective norms and a technology transfer mechanism. It is concluded that missing this opportunity would render debates about IP no more than a deadly distraction.
{"title":"Intellectual property norms in the polycrisis—(still) omnipresent, distracting, irrelevant?","authors":"Caroline B. Ncube","doi":"10.1093/jiplp/jpae054","DOIUrl":"https://doi.org/10.1093/jiplp/jpae054","url":null,"abstract":"\u0000 Twenty years since Professor Cornish asked whether IP is ‘omnipresent, distracting, irrelevant?’, this article revisits that question following recent times of instability, which have compounded the polycrisis the world is facing, whilst the 2030 deadline to achieve the UN Sustainable Development Goals looms closer and closer. This contribution argues that IP plays a critical role as one of multiple regulatory systems seeking solutions in the highly dynamic and insecure contexts of the climate emergency, uneven global development and pandemics, requiring timely and comprehensive normative development. However, over the last two decades there has been a glacial pace towards setting appropriate IP norms and states, policymakers and legislatures have to move beyond merely settling for a ‘more of the same’ approach. The ongoing World Health Organization’s Pandemic Accord negotiations present an opportunity to confirm IP’s relevance to combatting the polycrisis by setting effective norms and a technology transfer mechanism. It is concluded that missing this opportunity would render debates about IP no more than a deadly distraction.","PeriodicalId":508706,"journal":{"name":"Journal of Intellectual Property Law and Practice","volume":"6 6","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-06-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141337228","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Preventive patent enforcement by artificial intelligence","authors":"Thomas Heinz Meitinger","doi":"10.1093/jiplp/jpae055","DOIUrl":"https://doi.org/10.1093/jiplp/jpae055","url":null,"abstract":"","PeriodicalId":508706,"journal":{"name":"Journal of Intellectual Property Law and Practice","volume":"6 3","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-06-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141341705","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
This two-part article analyzes and discusses the legal requirements of, as well as the opportunities and risks associated with the SPC Manufacturing and Stockpiling Waiver as introduced by EU Regulation 2019/933. The introduction of the SPC Manufacturing/Stockpiling Waiver on July 1, 2019 opened up opportunities for generics and biosimilars companies established in the EU to manufacture and stockpile medicinal products before expiry of the respective SPC, either for export to third countries or for timely Day-1 market entry in the EU. But unlike, for example, the bolar exemption, application of the SPC Waiver is dependent upon compliance with specific notification, due diligence and labeling obligations. Although introduced more than four years ago, there is still considerable legal uncertainty surrounding the application of the SPC Waiver, something recent court decisions in Germany and The Netherlands have exacerbated rather than clarified. In this first part, the policy background of the Regulation is explained and the territorial and temporal scope of the SPC Waiver is examined. In the second part of the article, to be published in the next edition of the Journal of Intellectual Property Law and Practice Vol.(…) Issue (…) I will take a close look at the material scope and core components of the waiver, particularly as it relates to privileged acts and the conditions under which the waiver is applicable
{"title":"SPC manufacturing and stockpiling waiver—part 1","authors":"Marco Stief","doi":"10.1093/jiplp/jpae052","DOIUrl":"https://doi.org/10.1093/jiplp/jpae052","url":null,"abstract":"\u0000 This two-part article analyzes and discusses the legal requirements of, as well as the opportunities and risks associated with the SPC Manufacturing and Stockpiling Waiver as introduced by EU Regulation 2019/933. The introduction of the SPC Manufacturing/Stockpiling Waiver on July 1, 2019 opened up opportunities for generics and biosimilars companies established in the EU to manufacture and stockpile medicinal products before expiry of the respective SPC, either for export to third countries or for timely Day-1 market entry in the EU. But unlike, for example, the bolar exemption, application of the SPC Waiver is dependent upon compliance with specific notification, due diligence and labeling obligations. Although introduced more than four years ago, there is still considerable legal uncertainty surrounding the application of the SPC Waiver, something recent court decisions in Germany and The Netherlands have exacerbated rather than clarified. In this first part, the policy background of the Regulation is explained and the territorial and temporal scope of the SPC Waiver is examined. In the second part of the article, to be published in the next edition of the Journal of Intellectual Property Law and Practice Vol.(…) Issue (…) I will take a close look at the material scope and core components of the waiver, particularly as it relates to privileged acts and the conditions under which the waiver is applicable","PeriodicalId":508706,"journal":{"name":"Journal of Intellectual Property Law and Practice","volume":"33 3","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-06-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141342886","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
The so-called separation principle, according to which claims for infringement and the validity of a patent are assigned to different specialized courts, is a peculiarity of the German patent system, albeit not unique to it. Much more widespread across Europe is the so-called principle of unity, which provides infringement and validity to be decided jointly at the same court. The drafters of the Agreement on a Unified Patent Court (UPCA), however, did not favour one principle over the other, and thus did not opt for a bifurcated or a non-bifurcated system; rather they decided in favour of a hybrid system. Against this background, at the Unified Patent Court (UPC), the interplay of infringement and validity is rather complex. What this looks like exactly is the focus of this article, which also keeps an eye on the legal situation in Germany.
{"title":"Separated, united or a bit of both? Infringement and validity at the Unified Patent Court","authors":"Nora Kessler, Christoph Palzer","doi":"10.1093/jiplp/jpae050","DOIUrl":"https://doi.org/10.1093/jiplp/jpae050","url":null,"abstract":"\u0000 The so-called separation principle, according to which claims for infringement and the validity of a patent are assigned to different specialized courts, is a peculiarity of the German patent system, albeit not unique to it. Much more widespread across Europe is the so-called principle of unity, which provides infringement and validity to be decided jointly at the same court. The drafters of the Agreement on a Unified Patent Court (UPCA), however, did not favour one principle over the other, and thus did not opt for a bifurcated or a non-bifurcated system; rather they decided in favour of a hybrid system. Against this background, at the Unified Patent Court (UPC), the interplay of infringement and validity is rather complex. What this looks like exactly is the focus of this article, which also keeps an eye on the legal situation in Germany.","PeriodicalId":508706,"journal":{"name":"Journal of Intellectual Property Law and Practice","volume":"17 18","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-06-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141340836","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Standing up for geographical indications in Africa","authors":"Nora Ho Tu Nam","doi":"10.1093/jiplp/jpae056","DOIUrl":"https://doi.org/10.1093/jiplp/jpae056","url":null,"abstract":"","PeriodicalId":508706,"journal":{"name":"Journal of Intellectual Property Law and Practice","volume":"29 3","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-06-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141342575","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"To be or not to be (the copyright holder)","authors":"Cédric Manara","doi":"10.1093/jiplp/jpae047","DOIUrl":"https://doi.org/10.1093/jiplp/jpae047","url":null,"abstract":"","PeriodicalId":508706,"journal":{"name":"Journal of Intellectual Property Law and Practice","volume":"4 4","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-05-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141098704","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Should the EU unify copyright laws?","authors":"Eleonora Rosati","doi":"10.1093/jiplp/jpae053","DOIUrl":"https://doi.org/10.1093/jiplp/jpae053","url":null,"abstract":"","PeriodicalId":508706,"journal":{"name":"Journal of Intellectual Property Law and Practice","volume":"68 20","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-05-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141101502","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Starting from 2020, the Chinese courts have actively participated in the jurisdictional battles for the standard essential patent (SEP) disputes, a pivotal development marked by the Supreme People’s Court’s inaugural SEP-related anti-suit injunction (ASI) in Huawei v Conversant. Subsequently, lower courts in China have emulated this approach by issuing ASIs targeting SEPs in the domain of information and communication technology. The present study highlights the features of the Chinese ‘act preservation measures’ by comparing them with the typical ASIs originally developed in the common law jurisdictions. This comparison reveals significant divergence in the factors considered by Chinese courts issuing ASIs, particularly in the context of cross-border patent litigation. The study aims at elucidating potential defenses that the respondents in SEP litigation may employ to contest the issuance of ASIs in Chinese judicial proceedings, with particular attention accorded to the principles of comity and public interest. The article concludes that the invocation of international comity and public interest in SEP litigation will encounter a formalistic assessment by the Chinese judiciary due to potential conflicts with statutory provisions and the lack of a more context-specific analysis. As a result, in the absence of supra-national mechanisms that would address the problem of parallel litigation, there appears to be little room for judicial self-restraint.
自 2020 年起，中国法院开始积极参与标准必要专利（SEP）纠纷的管辖权争夺战，最高人民法院在华为诉 Conversant 案中首次发布了与 SEP 相关的反诉禁令（ASI），标志着这一关键发展。随后，中国的下级法院也纷纷效仿这一做法，针对信息和通信技术领域的 SEP 发布反诉禁令。本研究通过将中国的 "行为保全措施 "与普通法司法管辖区最初制定的典型 ASI 进行比较，突出了这些措施的特点。这种比较揭示了中国法院在签发专利申请保全措施时所考虑的因素存在重大差异，尤其是在跨国专利诉讼中。本研究旨在阐明 SEP 诉讼中的被申请人可能采用的抗辩理由，以便在中国的司法程序中对 ASI 的签发提出异议，并特别关注礼让和公共利益原则。文章的结论是，由于与法律规定的潜在冲突以及缺乏更具体的背景分析，在 SEP 诉讼中援引国际礼让和公共利益将遭遇中国司法机构的形式主义评估。因此，在缺乏解决平行诉讼问题的超国家机制的情况下，司法自我约束的空间似乎很小。
{"title":"The anti-suit injunctions in patent litigation in China: what role for judicial self-restraint?","authors":"Alexandr Svetlicinii, Fali Xie","doi":"10.1093/jiplp/jpae049","DOIUrl":"https://doi.org/10.1093/jiplp/jpae049","url":null,"abstract":"\u0000 Starting from 2020, the Chinese courts have actively participated in the jurisdictional battles for the standard essential patent (SEP) disputes, a pivotal development marked by the Supreme People’s Court’s inaugural SEP-related anti-suit injunction (ASI) in Huawei v Conversant. Subsequently, lower courts in China have emulated this approach by issuing ASIs targeting SEPs in the domain of information and communication technology. The present study highlights the features of the Chinese ‘act preservation measures’ by comparing them with the typical ASIs originally developed in the common law jurisdictions. This comparison reveals significant divergence in the factors considered by Chinese courts issuing ASIs, particularly in the context of cross-border patent litigation. The study aims at elucidating potential defenses that the respondents in SEP litigation may employ to contest the issuance of ASIs in Chinese judicial proceedings, with particular attention accorded to the principles of comity and public interest. The article concludes that the invocation of international comity and public interest in SEP litigation will encounter a formalistic assessment by the Chinese judiciary due to potential conflicts with statutory provisions and the lack of a more context-specific analysis. As a result, in the absence of supra-national mechanisms that would address the problem of parallel litigation, there appears to be little room for judicial self-restraint.","PeriodicalId":508706,"journal":{"name":"Journal of Intellectual Property Law and Practice","volume":"5 8","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-05-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141100404","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"‘Designating’ the future of geographical indications","authors":"Bernardo Calabrese","doi":"10.1093/jiplp/jpae048","DOIUrl":"https://doi.org/10.1093/jiplp/jpae048","url":null,"abstract":"","PeriodicalId":508706,"journal":{"name":"Journal of Intellectual Property Law and Practice","volume":"49 20","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-05-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141122230","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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