The Significance of Provisional Patent Applications in Protecting Early-Stage Inventions : A Legal and Empirical Analysis

IIC - International Review of Intellectual Property and Competition Law 2024, t. 55, s. 1381-1413.

Współautorstwo: Martinez, Catalina; Belowska, Joanna

This article critically examines the role of Provisional Patent Applications (PPAs) as strategic tools within the intellectual property framework, particularly highlighting their significance in safeguarding early-stage inventions. By allowing inventors to secure a priority date while still developing their inventions, PPAs provide a time frame when additional funding can be sought and further development can be pursued without losing the claim to the original invention date. This is especially important in industries like information and communication technology and the life sciences, where development timelines are lengthy and investment-intensive. PPAs serve not only as a cost-effective initial step in patent filing but also as a protective mechanism against premature disclosure, safeguarding the novelty of the invention. PPAs do not undergo formal examination and do not result in a granted patent unless followed by a standard patent application. However, they establish a legal placeholder that can be crucial for securing further patent rights. This study explores the legal framework of PPAs across various jurisdictions. The analysis also delves into the specific benefits and strategic considerations associated with drafting and filing PPAs, including their role in facilitating additional research and refinement of the invention. In addition, it presents novel empirical evidence on the growth of PPAs in the United States and their use as priorities in regular USPTO and EPO patent applications. Despite their advantages, PPAs come with limitations, such as the limited time available to convert them into standard patent applications (typically one year) to benefit from their priority date and the precise requirements for subsequent standard patent applications, which this article addresses. Through a detailed exploration of both the theoretical framework and practical applications of PPAs, the article contributes to a deeper understanding of their role in broader patent strategies, advocating for their careful and informed use in the innovation process.

To Have Your Cake and Eat It Too : Sufficient Disclosure of Inventions in the Light of the Polish Supreme Administrative Court’s Judgment of 24 April 2022, II GSK 1724/18

International Review of Intellectual Property and Competition Law 2023, nr 54, s. 1105-1115.

The subject matter of this opinion is the Polish Supreme Administrative Court’s judgment on the invalidity of a patent concerning a calcium-magnesium fertiliser due to its insufficient disclosure. This paper presents the course of the invalidation proceedings before the Polish Patent Office and administrative courts against the background of the Polish Industrial Property Law and the Polish Patent Office’s Guidelines concerning sufficient disclosure of inventions. It also briefly refers to the EPC and EPO practice on the standards of sufficient disclosure, including the recent EPO decision G2/21. Finally, it offers approving comments on the judgment itself, notices the practical impossibility of remedying the failure to disclose enough and mentions current systemic challenges to the requirement of sufficient disclosure as a fundamental rule of patent systems.

The EU regulatory data protection in the agrochemical industry : Towards a data sharing model in favour of sustainable market play and a sustainable environment

Journal of World Intellectual Property 2023, t. 26, nr 3, s. 458-476.

Współautorstwo: Lenarczyk, Gabriela

Regulatory data protection is mandated in the Agreement on the Trade Related Aspects of Intellectual Property Rights (TRIPS Agreement) for two kinds of goods: medicinal products and plant protection products (PPP). In the European Union (EU), the level of their protection has been set far beyond the minimum TRIPS standards and the adopted model of protection has been, for the most part, based on temporary exclusivity. Innovative plant protection products benefit from data exclusivity combined with a compulsory data sharing regime. Data exclusivity refers to products being authorised for the first time for the market of the EU on the grounds of a complete authorisation procedure, based on submission of a full data dossier. Within the period of exclusivity, these data may not be referred to in the authorisation procedure of a generic product—an equivalent to the reference one. In this way, data exclusivity creates a period of factual monopoly for the innovative products and constitutes a sui generis intellectual property right. This paper presents the regime of regulatory data protection in the European Union law as an instrument of legal protection for innovative products in the agrochemical industry. It first analyzes the purpose and functions of regulatory data protection in EU law and in the TRIPS Agreement. Then, the rules of protection by means of data exclusivity and compulsory data sharing are examined. This allows for further considerations on the role of regulatory data protection and compulsory sharing of data in the overall legal protection for innovative products in the agrochemical industry. In view of the above, this chapter discusses both the instruments of protection for PPP regulatory data and poses several questions concerning their rules, practical meaning and possible future modifications. In particular, it is considered whether data exclusivity is the optimal regime of protection for registration data and recommend that a data sharing approach could be used instead of the data exclusivity rule, as is the case with compulsory vertebrate data sharing, to the benefit of the industry and public interest. This chapter allows for evaluation and assessment of the economic and social value of data exclusivity in said areas for fostering primary and secondary innovation, while acknowledging other vital interests such as protection of public interest and safeguarding competition in the relevant markets. Finally, this chapter maps challenges of the current model of protection and indicates areas for further consideration in both creating a coherent and balanced framework of PPP data protection and the possible extrapolation of the data sharing rules to systems of data protection for other life science products.

Clinical Trial Data Transparency in the EU : Is the New Clinical Trials Regulation a Game-Changer?

International Review of Intellectual Property and Competition Law 2023, t. 54, nr 5, s. 732-763.

Współautorstwo: Lenarczyk, Gabriela

The benefits of access to clinical trial data are related to their inestimable value from the perspective of clinical trial participants, society as a whole, public health systems and scientific progress. In light of the development of innovative data analysis technologies, access to raw clinical trial data opens up an ever-widening array of possibilities: it can profoundly facilitate machine data analysis for, inter alia, hypothesis generation, risk modelling, counterfactual simulation and – finally – drug repurposing and development. The enactment of the new Clinical Trials Regulation (EU) No. 536/2014 (CTR) and introduction of the Clinical Trials Information System (CTIS) were heralded as ensuring a level of transparency in clinical trials that is sufficient to contribute to protecting public health and fostering the innovation capacity of European medical research, while recognizing the legitimate economic interests of sponsors. This paper presents the hitherto binding rules for the disclosure of clinical trial data and, against this background, their new framework, introduced by the CTR. In addition to assessing whether the CTR’s objectives are fulfilled, this paper examines whether the latest changes impact the hitherto existing rules on protection of regulatory data via regulatory exclusivities. Finally, it points out concerns regarding whether data gathered in the CTIS can be efficiently used by innovative data analysis technologies for further processing for both commercial and non-commercial purposes.

The CJEU abolishes Neurim and SPCs for new therapeutic indications

Journal of Intellectual Property Law & Practice 2021, t. 16, nr 2, s. 94-97.

Judgment of the Court of Justice of the European Union (Grand Chamber) in Case C-673/18 Santen SAS v. Directeur général de l’Institut national de la propriété industrielle, 9 July 2020. In Santen v INPI, the Grand Chamber of the Court of Justice of the European Union ruled that supplementary protection certificates must not be granted for further therapeutical indications of known medicines, adjudicating that the SPC system is aimed at promoting new active substances. Supplementary protection certificates (SPC), governed by Regulation 469/2009 (Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products OJ L 152, 16.6.2009; SPC Regulation), are legal instruments extending patent protection for innovative medicinal products. Any medicinal product in the EU needs a marketing authorization (MA), which is based on lengthy tests and trials carried out during the period of patent protection and thus consuming several years of it. The period of the so-called effective patent protection, starting at the moment of obtaining a MA for the final product, is deemed too short to cover the investment put into the research at hand and to incentivize further pharmaceutical innovation in the EU. Thus, the general function of an SPC is to enable the holder of a patent for a medicinal product to enjoy a maximum 15 years of overall basic and supplementary patent exclusivity, counting from the day of obtaining the relevant MA. Certificates are granted for a period not exceeding five years, and the protection granted is strictly confined to the product which obtained authorization.

IP and Access to COVID-19-relevant Medicines : in Search of an Optimal Legal Framework

Zeszyty Naukowe Uniwersytetu Jagiellońskiego. Prace z Prawa Własności Intelektualnej 2020, nr 4, s. 141-163.

Współautorstwo: Lenarczyk, Gabriela

In light of the global nature of the pandemic, and its severe social and economic consequences, it is crucial to create a well-weighted legal framework regulating access to COVID-19 medicines. This article presents and assesses the possible legal instruments suitable for such a framework, as well as depicts up-to-date developments in both domestic legal orders and at the international level. We analyse public law regulations allowing access to IP protected goods under exceptional circumstances: compulsory licenses for domestic use and for export, government use, and missing waivers of data exclusivity, and identify legal and non-legal problems concerning compulsory access instruments. We then discuss models of sharing access to intellectual property through private ordering - namely, patent pools and patent pledges - and their role in facilitating management of IP rights over health innovation. The article concludes with postulates for a proper IP law response to the current pandemic situation.

Ochrona roślin w prawie własności przemysłowej - porównanie modelu ochrony patentowej i ochrony wyłącznym prawem hodowcy. Europ.Prz.Sądowy 2015 nr 1 s. 26-37, Sum.

Europejski Przegląd Sądowy

Współautorstwo: Felchner, Krzysztof

Ochrona roślin w prawie własności przemysłowej - porównanie modelu ochrony patentowej i ochrony wyłącznym prawem hodowcy. Europ.Prz.Sądowy 2015 nr 1 s. 26-37, Sum.

Ochrona patentowa produktów leczniczych a rynek leków w Polsce. Rzecznik Patentowy 2012 nr 1/4 s. 7-24.

Rzecznik Patentowy. Kwartalnik samorządu rzeczników patentowych

Ochrona patentowa produktów leczniczych a rynek leków w Polsce. Rzecznik Patentowy 2012 nr 1/4 s. 7-24.

Poufność danych farmaceutycznych w procedurze dopuszczania leku do obrotu (tajemnica farmaceutyczna). Monitor Prawniczy 2014 nr 14 s. 772-776, Sum.

Monitor Prawniczy

Poufność danych farmaceutycznych w procedurze dopuszczania leku do obrotu (tajemnica farmaceutyczna). Monitor Prawniczy 2014 nr 14 s. 772-776, Sum.

Wyłączenie patentowania metod leczniczych, chirurgicznych i diagnostycznych w Konwencji o udzielaniu patentów europejskich. Zesz.Nauk.UJ Pr.Wynal. 2010 nr 1(107) s. 80-97, Sum.

Zeszyty Naukowe Uniwerysytetu Jagielońskiego Prace z Wynalazczości i Ochrony Własności Intelektualnej

Wyłączenie patentowania metod leczniczych, chirurgicznych i diagnostycznych w Konwencji o udzielaniu patentów europejskich. Zesz.Nauk.UJ Pr.Wynal. 2010 nr 1(107) s. 80-97, Sum.