scholarly journals Changing paradigm of supplementary protection of inventions in the national legislation of Ukraine

2021 ◽  
pp. 54-61
Author(s):  
Anastasiia Homeniuk
Keyword(s):  
Patent Application ◽  
Patent Law ◽  
General Idea ◽  
Access To Treatment ◽  
National Legislation ◽  
Ukrainian Patent ◽  
Patent Term ◽  
Basic Patent ◽  
Definition Of

Key words: patent term extension, supplementary protection, supplementary protectioncertificate, drug patents, patent legislation reform The article is mainly aimed at distinguishingtwo mechanism: patent term extension which used to be applied inUkraine before the patent reform, and supplementary protection certificates whichwere introduced to national legislation in 2020.Patent term extension in the way it was provided in the Ukrainian Patent Law is arather simple mechanism that didn’t require much regulations. It used to provide additionalperiod of patent monopolies which was equal to the period which elapsed betweenthe date on which the patent application was filed and the date of the marketingauthorisation, not more than 5 years. Since there were no limitation on the type ofpatent (basic patent) or requirement of the first marketing authorization, this regimeprovided an opportunity to extend not only basic patent term, but also all secondarypatents related to one drug. This created a situation when duration of patent monopolyfor one drug exceeded 35 years.Provided that national pharmaceutical industry is oriented on manufacturing ofgeneric drugs, supplementary protection certificates are more appropriate forUkraine. Firstly, this is due to the limitation of effective patent life to 15 years whichis more feasible considering the national context. Another positive thing about SPCsis some uncertainty in relation to definition of the subject matter and scope of SPCprotection. That means that the country can have some freedom in determining theways of its interpretation. However, it should be noted that such indeterminacy is agrey zone. Thus, it is necessary to consider how the country can benefit from the supplementaryprotection regimen. Since the pharmaceutical sphere is very sensitive,the SPC issues have direct effect on public health and access to treatment. So, the articlejustifies the general idea that implementation of new legislation provisions shallbe aligned with both ensuring pharmaceutical innovations and guaranteeing that thepublic health needs are still a priority. Therefore, considering the long-term negativeeffect of the patent term extension regimen, the new SPC approach should be as balancedas possible.

scholarly journals THE EVERGREENING STUDY OF UKRAINIAN PHARMACEUTICAL MARKET

2021 ◽  
Author(s):  
Оксана Кашинцева ◽  
Mykyta Trokhymenko
Keyword(s):  
Patent Application ◽  
Pharmaceutical Products ◽  
Patent Law ◽  
Pharmaceutical Market ◽  
Law Reform ◽  
The Novel ◽  
Access To Treatment ◽  
Ukrainian Patent ◽  
Close Cooperation ◽  
The Subject

The article presents the results of the research on the part of «evergreening patents» in the pharmaceutical market of Ukraine focusing on the daft laws registered in the Ukrainian Parliament (Verkhovna Rada) of Ukraine. The authors analyse the criteria of patent abuse as obstacles to access to treatment, and analyse the novel initiatives aimed at overcoming such abuse. In particular, it concerns thepatentability's criteria of inventions on pharmaceutical products, the possibility to oppose the applications on inventions by a person whose rights or interests are violated by a patent application and prohibition of patenting substances as the utility models.At the level of the national legislation patent reform was initiated by the Parliament of Ukraine on the first reading by the draft Law of Ukraine «On Amendments to Certain Legislative Acts of Ukraine (on Patent Law Reform)» as of October 10, 2019.For the national experts, drafting the mentioned Law, the necessity to provide evergreening research in the field of health care was obvious from the 2014. In 2014 year, the National Academy of Law Sciences of Ukraine in close cooperation with NGO 100 % of Life started the global research — Harmonization of Human Rights and Intellectual Property Rights in the Field of Medicine and Pharmacy. We have to stress that only the evergreening patent research in the pharmaceutical market of Ukraine took near three years. The Research reflects that the gaps of the Ukrainian patent system which causes the possibility to grant evergreening patents have the straight impact on access to vital treatment. The methodology of the research is based on the Guidelines on Examination of the Patent Application in the field of Medicine and Pharmaceuticals based on the recommendations of the WHO and Guidelines for the Examination of Patent Applications Relating to Pharmaceuticals of the UNDP.Thus, the subject of the research is 132 patents covering vital medicines in the field of HIV, hepatitis C, tuberculosis, oncology, rheumatoid arthritis and others. The basis for the research is the followings: the patented single-source medicines, the part of which in the centralized procurements exceeded $ 100,000 in 2017 and the medicines that part of which in hospital and pharmacy procurements exceeded 50 million hryvnia (UAH) in 2017. The research also includes the patented medicines which are or which were not available because of the patent status.

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

2021 ◽  
pp. 111-119
Author(s):  
Anastasiia Homeniuk
Keyword(s):  
Medicinal Product ◽  
Legal Regulation ◽  
National Legislation ◽  
Basic Patent ◽  
Utility Models ◽  
Key Issues ◽  
The Subject ◽  
The Law ◽  
One Year ◽  
Definition Of

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.

Sandoz & Hexal v Searle & Janssen Sciences Ireland: What is the formula for patent term extensions?

2017 ◽  
Vol 13 (4) ◽  
pp. 219-221
Author(s):  
Chris Hayes
Keyword(s):  
European Union ◽  
Pharmaceutical Product ◽  
The European Union ◽  
High Court ◽  
Court Of Justice ◽  
Patent Term ◽  
Basic Patent ◽  
Commercially Important ◽  
Definition Of ◽  
The Uk

In Sandoz Ltd & Hexal AG v G.D. Searle LLC & Janssen Sciences Ireland UC [2017] EWHC 987 (Pat), the UK High Court held that an active ingredient in a pharmaceutical product that was claimed only by reference to a Markush formula and not expressly referred to in the patent was “protected” by a basic patent for the purposes of obtaining a patent term extension under the European Union Supplementary Protection Certificate Regulations. This decision will be welcomed by practitioners in adding some clarity to the interpretation of previous decisions of the Court of Justice of the European Union relating to the definition of what is protected by a basic patent in this extremely commercially important and fast-moving area of jurisprudence. The implication of this decision is discussed further in this report.

Central Otago - Built on gold, growing on grass.

2014 ◽  
Vol 76 ◽  
pp. 15-23
Author(s):  
Barrie J. Wills
Keyword(s):  
Economic Growth ◽  
Land Use ◽  
National Economy ◽  
Local Community ◽  
Central Government ◽  
Future Generations ◽  
Economic Potential ◽  
District Council ◽  
Definition Of

A warm welcome to our "World of Difference" to all delegates attending this conference - we hope your stay is enjoyable and that you will leave Central Otago with an enhanced appreciation of the diversity of land use and the resilient and growing economic potential that this region has to offer. Without regional wellbeing the national economy will struggle to grow, something Central Government finally seems to be realising, and the Central Otago District Council Long Term Plan 2012-2022 (LTP) signals the importance of establishing a productive economy for the local community which will aid in the economic growth of the district and seeks to create a thriving economy that will be attractive to business and residents alike. Two key principles that underpin the LTP are sustainability and affordability, with the definition of sustainability being "… development that meets the needs of the present without compromising the ability of future generations to meet their own needs."

Populism and Liberal Democracy

2019 ◽  
Author(s):  
Takis S. Pappas
Keyword(s):  
United States ◽  
Liberal Democracy ◽  
The United States ◽  
Comprehensive Theory ◽  
The People ◽  
Original Definition ◽  
Key Issues ◽  
Great Relevance ◽  
Definition Of

Based on an original definition of modern populism as “democratic illiberalism” and many years of meticulous research, Takis Pappas marshals extraordinary empirical evidence from Argentina, Greece, Peru, Italy, Venezuela, Ecuador, Hungary, the United States, Spain, and Brazil to develop a comprehensive theory about populism. He addresses all key issues in the debate about populism and answers significant questions of great relevance for today’s liberal democracy, including: • What is modern populism and how can it be differentiated from comparable phenomena like nativism and autocracy? • Where in Latin America has populism become most successful? Where in Europe did it emerge first? Why did its rise to power in the United States come so late? • Is Trump a populist and, if so, could he be compared best with Venezuela’s Chávez, France’s Le Pens, or Turkey’s Erdoğan? • Why has populism thrived in post-authoritarian Greece but not in Spain? And why in Argentina and not in Brazil? • Can populism ever succeed without a charismatic leader? If not, what does leadership tell us about how to challenge populism? • Who are “the people” who vote for populist parties, how are these “made” into a group, and what is in their minds? • Is there a “populist blueprint” that all populists use when in power? And what are the long-term consequences of populist rule? • What does the expansion, and possibly solidification, of populism mean for the very nature and future of contemporary democracy? Populism and Liberal Democracy will change the ways the reader understands populism and imagines the prospects of liberal democracy.

scholarly journals “I’ve Heard of It, Yes, but I Can’t Remember What Exactly It Was”—A Qualitative Study on Awareness, Knowledge, and Use of the UV Index

2021 ◽  
Vol 18 (4) ◽  
pp. 1615
Author(s):  
Katharina Diehl ◽  
Tatiana Görig ◽  
Charlotte Jansen ◽  
Maike Carola Hruby ◽  
Annette B. Pfahlberg ◽  
...  
Keyword(s):  
Qualitative Study ◽  
Qualitative Content Analysis ◽  
Sun Protection ◽  
Structured Interviews ◽  
Protection Factor ◽  
Protection Measures ◽  
Uv Index ◽  
Correct Definition ◽  
Definition Of

Pharmacists and pharmaceutical technicians play an important role in counselling customers regarding sunscreen use and sun protection measures. A potentially helpful tool that can be used during counselling is the ultraviolet index (UVI), which informs individuals when and what sun protection measures are needed at a specific place and time. Our aim in this qualitative study was to explore awareness, knowledge, and use of the UVI during counselling in pharmacies. We used semi-structured interviews with pharmacists and pharmaceutical technicians (n = 20) to answer our research questions. Interviews were audiotaped, transcribed verbatim, and analyzed using qualitative content analysis. During the interviews pharmacists and pharmaceutical technicians revealed a lot of uncertainty and lack of knowledge regarding the UVI. Eight professionals were able to give a correct definition of UVI. Amongst others, the UVI was confused with sun protection factor. Overall, the UVI was hardly used during the counselling of customers. The UVI was developed to provide guidance when which type of sun protection is required to avoid detrimental effects of ultraviolet radiation. For effective implementation, both the general population and health professionals (e.g., pharmacists) have to increase their knowledge about the UVI. This would strengthen its use during professional counselling in pharmacies and may help to reduce the incidence of skin cancer over the long term.

scholarly journals It Is Not Just Mortality: A Call From Chile for Comprehensive COVID-19 Policy Responses Among Older People

2020 ◽  
Author(s):  
Pablo Villalobos Dintrans ◽  
Jorge Browne ◽  
Ignacio Madero-Cabib
Keyword(s):  
Older People ◽  
National Level ◽  
Health Issues ◽  
Negative Consequences ◽  
Access To Health Services ◽  
Term Care ◽  
Policy Responses ◽  
Level Data ◽  
Definition Of

Abstract Objective Provide a synthesis of the COVID-19 policies targeting older people in Chile, stressing their short- and long-term challenges. Method Critical analysis of the current legal and policy measures, based on national-level data and international experiences. Results Although several policies have been enacted to protect older people from COVID-19, these measures could have important unintended negative consequences in this group’s mental and physical health, as well as financial aspects. Discussion A wider perspective is needed to include a broader definition of health—considering financial scarcity, access to health services, mental health issues, and long-term care—in the policy responses to COVID-19 targeted to older people in Chile.

scholarly journals When does proton pump inhibitor treatment become long term? A scoping review

2021 ◽  
Vol 8 (1) ◽  
pp. e000563
Author(s):  
Peter Fentz Haastrup ◽  
Dorte Ejg Jarbøl ◽  
Wade Thompson ◽  
Jane Møller Hansen ◽  
Jens Søndergaard ◽  
...  
Keyword(s):  
Proton Pump Inhibitor ◽  
Proton Pump ◽  
Cochrane Library ◽  
Clinical Context ◽  
Eligibility Criteria ◽  
Proton Pump Inhibitor Treatment ◽  
Common Definition ◽  
Definition Of ◽  
Inhibitor Treatment

ObjectiveProton pump inhibitor (PPI) use has risen substantially, primarily driven by ongoing use over months to years. However, there is no consensus on how to define long-term PPI use. Our objectives were to review and compare definitions of long-term PPI use in existing literature and describe the rationale for each definition. Moreover, we aimed to suggest generally applicable definitions for research and clinical use.DesignThe databases PubMed and Cochrane Library were searched for publications concerning long-term use of PPIs and ClinicalTrials.gov was searched for registered studies. Two reviewers independently screened the titles, abstracts, and full texts in two series and subsequently extracted data.ResultsA total of 742 studies were identified, and 59 met the eligibility criteria. In addition, two ongoing studies were identified. The definition of long-term PPI use varied from >2 weeks to >7 years. The most common definition was ≥1 year or ≥6 months. A total of 12/61 (20%) of the studies rationalised their definition.ConclusionThe definitions of long-term PPI treatment varied substantially between studies and were seldom rationalised.In a clinical context, use of PPI for more than 8 weeks could be a reasonable definition of long-term use in patients with reflux symptoms and more than 4 weeks in patients with dyspepsia or peptic ulcer. For research purposes, 6 months could be a possible definition in pharmacoepidemiological studies, whereas studies of adverse effects may require a tailored definition depending on the necessary exposure time. We recommend to always rationalise the choice of definition.

scholarly journals The evolving definition of salivary gland stem cells

2021 ◽  
Vol 6 (1) ◽  
Author(s):  
Cecilia Rocchi ◽  
Lara Barazzuol ◽  
Rob P. Coppes
Keyword(s):  
Stem Cells ◽  
Salivary Gland ◽  
Adult Stem Cell ◽  
Cell Types ◽  
Research Field ◽  
New Therapeutic Approaches ◽  
Recent Developments ◽  
Radiation Induced ◽  
Definition Of

AbstractDysfunction of the salivary gland and irreversible hyposalivation are the main side effects of radiotherapy treatment for head and neck cancer leading to a drastic decrease of the quality of life of the patients. Approaches aimed at regenerating damaged salivary glands have been proposed as means to provide long-term restoration of tissue function in the affected patients. In studies to elucidate salivary gland regenerative mechanisms, more and more evidence suggests that salivary gland stem/progenitor cell behavior, like many other adult tissues, does not follow that of the hard-wired professional stem cells of the hematopoietic system. In this review, we provide evidence showing that several cell types within the salivary gland epithelium can serve as stem/progenitor-like cells. While these cell populations seem to function mostly as lineage-restricted progenitors during homeostasis, we indicate that upon damage specific plasticity mechanisms might be activated to take part in regeneration of the tissue. In light of these insights, we provide an overview of how recent developments in the adult stem cell research field are changing our thinking of the definition of salivary gland stem cells and their potential plasticity upon damage. These new perspectives may have important implications on the development of new therapeutic approaches to rescue radiation-induced hyposalivation.

Adapting game’s evaluation metrics to virtual reality serious games and its validation on “Hellblade: Senu’s Sacrifice” (Preprint)

2021 ◽  
Author(s):  
Kim Martinez ◽  
Maria Isabel Menéndez-Menéndez ◽  
David Checa ◽  
Andres Bustillo
Keyword(s):  
Virtual Reality ◽  
Video Game ◽  
Game Design ◽  
Serious Games ◽  
Research Field ◽  
Raising Awareness ◽  
Quantitative Rating ◽  
Study Case ◽  
Definition Of

BACKGROUND The design of Virtual Reality Serious Games (VR-SG) is a subject still developing. One of its open developments is the definition of metrics to evaluate the fun and learning result. In this way, weaknesses and strengths in the design of serious games can be found for future works in this research field. OBJECTIVE This paper aims to create a metric that can be used to rate the gameplay of VR-SG. This metric’s novelty allows to evaluate the different fun and learning features and give them a quantitative rating. A study case shows the capability of implementing this evaluation to identify strengths and weaknesses of VR-SGs. METHODS The new VR-SG metric is developed on the basis of the Mechanics, Dynamics and Aesthetic (MDA) framework but including User Experience (UX) elements and adapting them to VR-SG. This metric includes 1) UX aspects: VR-headsets, training tutorials and interactive adaptions to avoid VR inconveniences; and 2) MDA aspects: exclusive VR audiovisual elements and its aesthetics interactions. RESULTS The selected indie serious game is Hellblade, developed to raise awareness about the difficulties of people suffering from psychosis with two versions: one for 2D-screens and the other for VR devices. The comparison of metric´s scores for both versions shows: 1) some VR dynamics increase the gameplay impact and therefore, the educational capacity; and 2) flaws in game design where the scores drop down. Some of these flaws are: reduced number of levels, missions and items, lack of a tutorial to enhance usability and lack of strategies and rewards in the long-term to increase motivation. CONCLUSIONS This metric allows to identify the elements of the gameplay and UX that are necessary to learn in VR experiences. The study case shows this research is useful to evaluate the educational utility of VR-SG. Further works will analyze VR applications to synthetize every game element influencing its intrinsic sensations. CLINICALTRIAL The trials have not been registered, as testing for this metric has not involved people with mental conditions or addressed other medical applications. Hellblade is a commercial video game that anyone can purchase and play. The trials have been carried out to obtain results on the gaming experience of different people in relation to the educational purpose of raising awareness of psychosis.

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