Key issues of legal regulation of the supplementary protection of inventions in the field of pharmacy in the national legislation of Ukraine

Keywords: supplementary protection certificate, basic patent, procedure for obtainingsupplementary protection certificate Key issues of legal regulation of the supplementary protection of inventionsin the field of pharmacy in the national legislation of UkraineThe article is devoted to the study of key issues of legal regulation of supplementaryprotection of inventions after the adoption of the Law of Ukraine «On Amendmentsto Certain Legislative Acts of Ukraine on Patent Legislation Reform» in the absenceof bylaws to regulate the procedure for issuing supplementary protection certificates.The study also highlights the main shortcomings and gaps in the regulation ofcertain issues of application of supplementary protection certificates in the currentLaw of Ukraine «On protection of rights to inventions and utility models.»The author in details analyses European Union approaches to definition of thesubject matter of the supplementary protection, providing criteria which are recommendedto use in order to decide whether the product is covered by the basicpatent in force. Also, the paper is focusing on the issues related to verification ofdata and materials provided together with the application for a certificate — suchas whether the requirement that the medicinal product must be submitted formarketing authorization in Ukraine no later than during one year after it’s first marketing authorization in the world, whether the authorization provided is thefirst authorization in Ukraine, etc.Another problem which is highlighted in the study is the application of the rule tosubmit the petition for obtaining supplementary protection to those patents and marketingauthorizations which were issued before the amendments to the Law came inforce, as this question remained unresolved due to the lack of transitional provisionsin the Law. Also author points out the necessity to align the provisions of the Article271 of the Law of Ukraine «On Protection of Rights to Inventions and Utility Models»regarding the definition of the subject matter of supplementary protection in accordancewith patent legislation by excluding application of the medicinal product fromthe list as it is not patentable according to Ukrainian law. In addition, the author emphasizedthe urge to adopt relevant bylaws (procedure) regulating the issue of certificatesof supplementary protection.

Ensuring the confidentiality of patient information obtained during a clinical trial of a medicinal product

Keywords: clinical trial, confidential information, personal data, patient Clinical trials are conductedin accordance with legal norms, subject to human rights and in accordance with internationalethical principles. Each clinical trial for the patient (subject) begins on a voluntarybasis and with acquaintance of the patient (subject) about the features of the study, itspurpose and purpose, explanation of possible risks, in addition, the patient is informedabout innovative drugs and access to free treatment during research. The patient participatesin the study of the drug of his own volition, signing a voluntary informed consent.It is important to ensure that the rights of the patient (subject) in the clinical trial of themedicinal product to privacy and the protection of personal data, which is confidential informationabout the person who is the subject of the study, are respected. During clinicaltrials, researchers and all persons involved in the research process should treat responsiblythe person participating in the study of the medicinal product as the object of study,namely with respect for the human right to privacy and its secrecy. Individuals and legalentities should be able to protect information legally under their control from disclosure,acquisition or use by others without their consent in a manner contrary to fair commercialpractice, if such information is confidential in the sense that it is as a whole or in theexact configuration and combination of its components, commonly known or available topersons in the circles normally involved with the information in question. It is importantto note that any information that becomes known about the patient (subject) during theclinical trial of the drug should be carefully protected by the party conducting the study.Therefore, it is important to note that the right of a patient not to disclose confidentialinformation about him is guaranteed by the Constitution of Ukraine. The right to medicalsecrecy is enshrined in the Law of Ukraine "Fundamentals of Health Legislation". Incases where the rights of the patient (subject) have been violated, the legislator providesfor criminal liability for intentional disclosure of medical secrets to a person who becameknown in connection with the performance of professional or official duties, if such an actcaused serious consequences and for illegal collection, storage, use, destruction, disseminationof confidential information about a person or illegal change of such informationcomes criminal liability.

Orphan Medicinal Products for the Treatment of Pancreatic Cancer: Lessons Learned From Two Decades of Orphan Designation

Pancreatic cancer has a dismal prognosis and only a few treatment options are available. In the European Union, pancreatic cancer classifies as a rare disease, allowing drug developers to apply for orphan medicinal product (OMP) designation. The aim of this study was to provide more detail on OMPs for pancreatic cancer. All applications for OMP designation submitted to the EMA between 2000 and 2019 were identified. For each medicinal product that received an OMP designation, the mode of drug action, use of protocol assistance, and current life cycle status was determined. Fifty-two medicinal products received an OMP designation. At the time of submission, eighteen OMPs were at the non-clinical and 34 OMPs were at the clinical stage of development. At least fourteen kinds of mode of action were explored in the condition. For eighteen out of 52 OMPs protocol assistance was sought. At the time of data analysis, one OMP received marketing authorisation and 24 OMPs were ongoing in development. Many medicinal products for pancreatic cancer received an OMP designation and the majority of these products was already in the clinical stage of development. Nonetheless, the success rate of OMPs for pancreatic cancer that reach the market is low, and increasing this rate is something to aspire. Fortunately, development is still ongoing for a part of the OMPs, and a few developers are planning to submit a marketing authorisation application in the near future. This however does not guarantee success, as pancreatic cancer remains a difficult disease to treat. Developers are advised to make optimal use of incentives such as protocol assistance, establishing (early) dialogue between regulators and drug developers and to agree on important topics such as clinical trial design.

Orphan Medicine Incentives: How to Address the Unmet Needs of Rare Disease Patients by Optimizing the European Orphan Medicinal Product Landscape Guiding Principles and Policy Proposals by the European Expert Group for Orphan Drug Incentives (OD Expert Group)

Today policy makers face the challenge to devise a policy framework that improves orphan medicinal product (OMP) development by creating incentives to deliver treatments where there are none and to authorize innovative and transformative treatments where treatments already exist. The European Expert Group on Orphan Drug Incentives (hereafter, OD Expert Group) came together in 2020 to develop policy proposals to facilitate EU policy makers to meet this challenge. The group brings together representatives of the broad rare disease community, including researchers, academia, patient representatives, members of the investor community, rare disease companies and trade associations. The group’s work builds on the recognition that only an ambitious policy agenda developed in a multi-stakeholder setting can bring about the quantum leap needed to address unmet needs of rare disease patients today. Along the OMP development path, the OD Expert Group has identified four main needs that a policy revision should address: 1) Need to improve the R&D ecosystem for basic research and company take-up of development. 2) Need to improve the system of financial incentives and rewards. 3) Need to improve the flexibility, predictability and speed of the regulatory pathway. 4) Need to improve the coherence and predictability of demand and pricing for OMPs. This article presents the results of the OD Expert Group work as a set of guiding principles that the revision of the policy framework should follow and a set of 14 policy proposals that address the main needs of OMP development in Europe today.

Extension of Indication for Authorised Oncology Products in the European Union: A Joint Effort of Multiple Stakeholders

After marketing authorisation, the development of a medicinal product often continues with studies investigating new therapeutic indications. Positive results can potentially lead to changes to the terms of the marketing authorisation, such as an extension of therapeutic indication(s). These studies can be initiated and sponsored by the marketing authorisation holder (MAH) or by others. When results from an investigator-initiated trial suggest that an authorised medicinal product is safe and effective for a new therapeutic indication, physicians may want to treat their patients with this medicinal product. In such a situation, it is desirable to extend the therapeutic indication(s) via the regulatory approval process, as this can facilitate patient access within the European Union. There may however be challenges when the MAH did not conduct the study and might not have access to the data. In this perspective, we focus on the possibilities to extend the therapeutic indication(s) of an already authorised medicinal product based on results from investigator-initiated trials. We address: (1) the advantages of an extension of indication; (2) the regulatory requirements for a variation application; (3) investigator-initiated trials as a basis for regulatory approval; (4) the role of the MAH in extending the indication. With this article, we want to emphasize the importance of a collaborative approach and dialogue between stakeholders with the aim to facilitate access to effective medicinal products.

Safety and tolerability of a single infusion of autologous ex vivo expanded regulatory T cells in adults with ulcerative colitis (ER-TREG 01): protocol of a phase 1, open-label, fast-track dose-escalation clinical trial

IntroductionAccumulating evidence suggests that the adoptive transfer of ex vivo expanded regulatory T cells (Treg) may overcome colitogenic immune responses in patients with inflammatory bowel diseases. The objective of the ER-TREG 01 trial is to assess safety and tolerability of a single infusion of autologous ex vivo expanded Treg in adults with ulcerative colitis.Methods and analysisThe study is designed as a single-arm, fast-track dose-escalation trial. The study will include 10 patients with ulcerative colitis. The study intervention consists of (1) a baseline visit; (2) a second visit that includes a leukapheresis to generate the investigational medicinal product, (3) a third visit to infuse the investigational medicinal product and (4) five subsequent follow-up visits within the next 26 weeks to assess safety and tolerability. Patients will intravenously receive a single dose of 0.5×106, 1×106, 2×106, 5×106 or 10×106 autologous Treg/kg body weight. The primary objective is to define the maximum tolerable dose of a single infusion of autologous ex vivo expanded Treg. Secondary objectives include the evaluation of safety of one single infusion of autologous ex vivo expanded Treg, efficacy assessment and accompanying immunomonitoring to measure Treg function in the peripheral blood and intestinal mucosa.Ethics and disseminationThe study protocol was approved by the Ethics Committee of the Friedrich-Alexander University Erlangen-Nürnberg, Erlangen, Germany (number 417_19 Az). In addition, the study was approved by the Paul-Ehrlich Institute, Federal Institute for Vaccines and Biomedicines, Langen, Germany (number 3652/01). The study is funded by the German Research Foundation (DFG, KFO 257 project 08 and SFB/TransRegio 241 project C04). The trial will be conducted in compliance with this study protocol, the Declaration of Helsinki, Good Clinical Practice and Good Manufacturing Practice. The results will be published in peer-reviewed scientific journals and disseminated in scientific conferences and media.Trial registration numberNCT04691232.

The use of biopreparations in the therapy of mastitis in cows

With the aim of improving productive potential of black pied cattle, preventing and treating clinical mastitis we used biopreparations developed by scientists of the Federal State Budgetary Establishment of Higher Education ‘Chuvash State Agrarian University’: Prevention-N-E and Prevention-N-B-S, as well as Mastinol, homeopathic medicinal product for treatment of mastitis. It follows from the results of our studies that the biological preparations used in the experiments did not influence the physiological condition of animals but activated cell factors of non-specific organism protection. The most obvious effect was demonstrated by Prevention-N-B-S, rather than Prevention-N-E, however this difference was insignificant (P>0.05). Prevention of mastitis in cows with Prevention-N-B-S biopreparation turned out to be more effective than with Prevention-N-E and Mastinol. Recovery of one cow of the 1st experimental group treated by Prevention-N-E took place in 4±0.08 days, which is 7±52 less than in the 3rd experimental group, where Mastinol was used. Atrophy of an udder lobe was observed in one cow in the 3rd experimental group. As a result, the issue of pathogenetic therapy of mastitis in cows is still relevant and we plan to solve it with the use of immunostimulants.

Product, Medicinal Product, Basic Patent: The Relationship of Concepts in Regulation 469/2009 Overlooked by the CJEU

The CJEU Santen judgment defined the concept of a product for the purposes of Regulation 469/2009 on the supplementary protection certificate for medicinal products (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 (Codified version), [2009] OJ L152/1, as last amended by Regulation (EU) 2019/933 of 20 May 2019, [2019] OJ L153/1). Leaving aside the practical implications of this judgment in terms of the possibility of obtaining a supplementary protection certificate for a product protected by a patent for a second or further medical application (“application patent”), it is worth considering the reasoning the Court relies on to arrive at the thesis it formulates. While the Court’s response and the resulting impact will be treated differently depending on whether the actual extension of patent protection in the pharmaceutical industry is assessed as appropriate and desirable or whether the justification for said protection is questioned, the manner in which the provisions of Regulation 469/2009 are proposed to be interpreted raises doubts as to whether the final outcome of the interpretation is correct.

Pharmaceutical Law and Patent Law

The patent law and pharma laws and regulations need to be coordinated. The interpretative proposal of the author is that a patent claim aiming at protecting the invention as a medicinal product must necessarily be expressed using the appropriate terms provided for by the laws and regulations concerning the industrial medicinal product, such as “medicinal product” and “active substance”; otherwise the patent may not be considered as covering a “medicinal product” or an “active substance”. Moreover, as a consequence, the presentation of a product in a patent claim as a medicinal product or an active substance implies that the enforceability of such claim is conditioned upon the demonstration of the efficacy and safety of the product through the preparation and approval by the competent authorities of a dossier of pharmacological and clinical trials. The legal system taken into consideration by the author is the European one, but the interpretative proposal is, mutatis mutandis, applicable to other systems of law.