Protection Certificates Research Articles

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

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.

Brexit – The Consequences for Pharmaceutical Patents and Supplementary Protection Certificates

Now that the UK has left the EU, and the transition period following this departure is over, we have a clearer view on the implications of Brexit on intellectual property rights and the consequences for UK based pharmaceutical companies.  Although little has changed for UK applicants wishing to obtain a European patent via the European Patent Office, the UK’s withdrawal from the Unified Patent Court and Unitary Patent is a huge blow to the realisation of the long awaited Unitary Patent system.  Meanwhile, breaking away from the EU has also had effects on how UK pharmaceutical companies can apply for supplementary protection certificates (SPCs), with further intricacies due to the Northern Ireland Protocol.  The introduction of a new manufacturing waiver for medicinal products protected by SPCs in the UK and EU will allow pharmaceutical companies more leeway with regards to stockpiling and export provisions. Perhaps most interesting of all is how UK and EU laws will diverge over the following years, now that the UK is no longer under the jurisdiction of the Court of Justice of the European Union.

Przywilej produkcyjny (SPC MW) i jego wpływ na interes społeczny w zakresie zdrowia publicznego

The length of innovative medicinal product protection time is related to the economic interest of the pharmaceutical companies and the interest in public health. To perform the tasks of patent protection of medicinal products, bearing in mind the interest in the field of public health, its maximum length must be determined by law. Due to the applicable law, the actual term of protection of innovative medicinal products is extended to the benefit of producers of innovative drugs. Regulation (EU) 2019/933 of the European Parliament and of the council of 20 May 2019 amending Regulation (EC) No 469/2009 concerning the supplementary protection certificate for medicinal products introduces a legal instrument, supplementary protection certificate manufacturing waiver (SPC MW), implementing the limits of the maximum duration of legal protection granted based on the supplementary protection certificate (SPC). According to estimated data, SPC MW may bring savings of the European public health sector in the amount of EUR 3.1 billion and savings of the National Health Fund in the amount of PLN 500 million annually. However, a final assessment of the economic and social impact on public health will only be possible after the entry into force of the new legal instrument.

Risk-Oriented Approach to Industrial Control over Occupational Health & Safety at the Main Gas Pipeline Construction Stage

In the paper, industrial health protection and labor safety inspection certificates have been analyzed. The categories of violations have been composed by the frequency of their occurrence. Based on the General Contractor’s risk assessment method, the severity of potential consequences has been determined and transformed into the ranks. Based on the results obtained, the final rank has been determined for each violation category. It has been proposed to supplement the General Contractor’s Questionnaire with a ranking criterion that will ensure a flexible industrial control system and rational planning of the company’s administrative and material resources.

Knowledge and Perception Assessment of Pharmacy Technicians on Biosimilars at the University Hospital Center -Tlemcen

Biosimilars are similar products, but not identical, to a reference biological drug already approved by the authorities, whose protection certificate has expired. Biosimilars have recently been introduced at Tlemcen University Hospital Center (TUHC). Pharmacy technicians are essential health actors for good distribution and use of biodrugs in particular biosimilars within the TUHC. For this, we have done a study to assess the knowledge of pharmacy technicians on biosimilars as well as their opinion on their efficacy-safety profiles. The data collection was carried out by the distribution of a questionnaire with 12 questions (Figure 1). We have analyzed the questionnaires of the 10 pharmacy technicians who agreed to join our study. More than half of pharmacy technicians could not correctly define a biosimilar. In addition, according to the answers provided, the stages of development and approval of biosimilars are not well known. Continuous training on the topic of biosimilars is necessary in order to raise awareness in this category of the importance of rigorous monitoring of these treatments within the TUHC. Regarding the accessory goal of the questionnaire attributed to pharmacy technicians, to provide their opinions on the efficacy and safety of biosimilars according to their daily professional experience, a large part of pharmacy technicians has expressed a satisfaction with the efficiency and safety of these drugs. However, since a certain category of pharmacy technicians affirms to witness suspicion of side effects of biosimilar treatment without informing the Central Pharmacy, it is imperative to raise awareness of the need to declare them to regional and national pharmacovigilance centers.

Knowledge and Perception Assessment of Pharmacy Technicians on Biosimilars at the University Hospital Center-Tlemcen

Biosimilars are similar products, but not identical, to a reference biological drug already approved by the authorities, whose protection certificate has expired. Biosimilars have recently been introduced at Tlemcen University Hospital Center (TUHC). Pharmacy technicians are essential health actors for good distribution and use of bio-drugs in particular biosimilars within the TUHC. For this, we have done a study to assess the knowledge of pharmacy technicians on biosimilars as well as their opinion on their efficacy-safety profiles. The data collection was carried out by the distribution of a questionnaire with 12 questions. We have analyzed the questionnaires of the 10 pharmacy technicians who agreed to join our study. More than half of pharmacy technicians could not correctly define a biosimilar. In addition, according to the answers provided, the stages of develo in order to raise aw pment and approval of biosimilars are not well known. Continuous training on the topic of biosimilars is necessary areness in this category of the importance of rigorous monitoring of these treatments within the TUHC. Regarding the accessory goal of the questionnaire attributed to pharmacy technicians, to provide their opinions on the efficacy and safety of biosimilars according to their daily professional experience, a large part of pharmacy technicians has expressed a satisfaction with the efficiency and safety of these drugs. However, since a certain category of pharmacy technicians affirms to witness suspicion of side effects of biosimilar treatment without informing the Central Pharmacy, it is imperative to raise awareness of the need to declare them to regional and national pharmacovigilance centers.

Blockchain Based Architecture for Certificate Authentication

Certificate Verification is the process of verifying a certificate issued by an institution and verifying that it is genuine and authentic Certificate issuing authorities appear to have compromised for student data protection certificates. Data is being disposed of and dishonest peoples can use this for their advantage. In preparation for solving this problem of forge certificates, the digital certificates are based on the BlockChain term. It is one of the recent technology which is able to be affected for data security. To verify the fidelity of those data, we relate a blockchain hash affirmative method. This prominence of blockchain helps to stricken the thing of the fake certificates. Authors have used two platforms of blockchain ehtereum and bitcoin for certificate verification. But those two platforms are permission-less blockchain where anyone can join the network. For making it more secured we can use the Hyper-Ledger platform which is more secured and only the present participants can join the network. This application demonstrates that blockchain-based hash validity has been developed to identify baleful and temporary changes in data. The technique that is discussed is that the main data is stored severally from the blockchain, then it allows a sense accessory and a hash of those data that presented to the blockchain, The original information is going to be verified against the hash in the block-chain at any moment.

Sertifikat o dodatnoj zaštiti - nedavne odluke suda pravde Evropske Unije

In recent years, public health systems in high-income countries have been heavily exposed to pressures due to high drug prices. High drug prices are affected by market monopolies that pharmaceutical companies have thanks to patents, i.e. the exclusive rights granted to them for drugs. An additional factor affecting high drug prices is the extended forms of intellectual property protection, including the extension of the exclusivity period after the expiration of a patent for medical devices. The supplementary protection certificate as a form of a supplementary protection for pharmaceutical products in the European Union is regulated by the Regulation 469/2009. This form of protection is also known in the national patent regulations. Since the entry into force of the Regulation 469/2009, there has been debated the question of whether the supplementary protection certificate should be available for new therapeutic uses of previously approved active ingredients. In addition, the subject of interpretation was also the Article 3(a) of the Regulation 469/2009 requiring that the "product" (i.e. the active ingredient or combination of active ingredients) being the subject matter of the SPC application, should be "protected by the basic patent". The author analyzes several important decisions of the EU Court of Justice, with an emphasis put on the recent verdicts in both the "Santen" and "Royality Pharma" cases. In the grounds of these cases, there have widely been discussed the issue concerning the encouragements given to pharmaceutical companies being involved into medical researches in order to stimulate their investment into innovation treatments.

Interpretation of ‘Product’ Under Arts. 1(b) and 3(d) of the SPC Regulation

Interpretation of ‘Product’ Under Arts. 1(b) and 3(d) of the SPC Regulation

Distinctness, uniformity and stability and GT biplot tests for the selection of snap bean lines

ABSTRACT The lack of records about snap bean cultivars is one of the obstacles that has led to a yield gap and low prominence of the crop. This work aimed at indicating snap bean lines obtained by the Breeding Program of the Universidade Estadual do Norte Fluminense (UENF) to assess their performance and to apply for a certificate of plant variety protection. The study was managed using a randomized block design with three replicates in a greenhouse at the Research Support Unit of the UENF. Nine candidate lines were compared to the commercial cultivar “Topseed Blue Line” in accordance with 56 descriptors set by the National Plant Variety Rights. All lines presented themselves as homogeneous. The L31 line provided a total of 30 different descriptors of the commercial cultivar. For the quantitative data added to the Distinctness, Uniformity and Stability, (DUS) tests, the analysis of variance was performed and the GT biplot generated by the R software. Variability was noticed among the genotypes for all assessed traits, excepting days until germination and seed thickness. The lines that showed the best mean performance were L6, L7, L10, L11, and L13. Among those, the L6 and L11 lines provided higher stability.

Dell Education Services Topic-Based Learning: Using Topic-Based Learning (TBL) to Improve the Learning Experience for our Data Protection Certification eLearning Course

<p class="0BodyText">Traditional learning is often delivered as larger courses, requiring more development time, and containing substantial amounts of information. Often, that information is not relevant to the learner and, structured in poor sequence, isn't needed until later in the training (if it is even needed at all). Topic based learning, also often referred to as task-based learning, differs from traditional learning because it focuses on what the learner needs to do, versus what they should know. TBL focuses on providing need to know information, closer to the time of need.</p><p class="0BodyText">This case study shows how using Topic Based Learning, or TBL, improved the learning experience for our Data Protection Certification eLearning course. We’ll also show how it saved not only time for the learners but also time and resources for the Dell Technologies Education Services Department.</p>

Scope of Protection of Supplementary Protection Certificates

Scope of Protection of Supplementary Protection Certificates

Molecular characterization of some Egyptian sorghum bicolor genotypes using ISSR markers

Sorghum is the second African most important cereal, it's well adapted to tropical and sub-tropical areas, It enters in the industry of flour, fuel, source of fiber, the manufacture of fermentation and beer, extracting some chemical compounds like dextrin, windbreakers, building fences and fresh fodder crops especially in summer. Microsatellites or Inter Simple Sequence Repeats (ISSRs) are becoming the markers of choice in many plant breeding programs because they are transferable, multiallelic co-dominant, PCR-based, easily reproducible, randomly and widely distributed along the genome. Twenty Egyptian sorghum (Sorghum bicolor (L.) Monech) genotypes were assessed for DNA polymorphism using 10 ISSR primers. All tested ISSR primers yielded amplified products and generated 152 alleles (average of 15.2 alleles/marker). Out of the 10 used ISSR primers, eight primers obtained 24 unique markers among the 20 studied sorghum genotypes. However, molecular characterization revealed polymorphism percentage of a 100% for ISSR markers, including a high level of polymorphism among the studied sorghum genotypes. On the other hand, cluster analysis using UPGMA method classified the 20 sorghum genotypes into two groups using ISSR markers. The cluster analysis showed a high genetic variation among the studied sorghum genotypes and the diversity of these genotypes was in an agreement with their source pedigree. The results of principle coordinate analysis (PCoA) were closely in line with those of the cluster analysis. These results could be used by breeders to develop protocols for sorghum improvement. From the commercial point of view, molecular fingerprinting is a useful tool for several applications, including its use in breeding programs, in determining relatedness of genotypes and for pedigree verification. Molecular fingerprints are useful for varietal protection to prove ownership or derivation of plant lines as well as to prove violations and breaching of patent and plant variety protection certificates or the misappropriation of trade secrets.

ISO/IEC 27701: Threats and Opportunities for GDPR Certification

The paper assesses the possible consequences for Article 42/43 certification of the recently published ISO/IEC 27701:2019 standard. The new ISO standard establishes a management system that aims to manage ‘the processes for protecting the capture, accountability, availability, integrity, and confidentiality of personal data.’ The conformity with the standard’s requirements is certifiable by the private certification bodies interested in providing this service to businesses. The paper shows that ISO/IEC 27701:2019 based certification possesses many assets to dominate the market of data protection certification and, thus, compete with the approach supported by the European supervisory authorities on data protection. ISO based certification offers many operational advantages to businesses which are looking for a workable solution to streamline information security and data protection in their organization. In the meantime, the EU supervisory authorities are still wandering on the right option to approve certification schemes under Article 42/43 regime. A strong uptake of ISO/IEC 27701:2019 based certification alongside Article 42/43 certification could confuse the general public and eventually threaten Article 42/43 implementation. But it could also offer an opportunity to the European supervisory authorities to spread data protection principles beyond EU borders and clarify the relationships they intend to establish between Article 42/43 certification and ISO standards based one.

Quantitative and qualitative analysis of head and body impacts in American 7v7 non-tackle football

ObjectivesNon-tackle American football is growing in popularity, and it has been proposed as a safer alternative for young athletes interested in American football. Little is known about the nature of...

Diversity and heterotic patterns in North American proprietary dent maize germplasm

AbstractPublicly available maize (Zea mays L.) inbred lines with expired Plant Variety Protection certificates (ex‐PVP) constitute the elite germplasm used in hybrids grown by North American farmers during the past half century. A set of 329 ex‐PVP inbreds and eight public reference inbreds was evaluated for genetic diversity using molecular marker and pedigree‐based relationships. The majority of inbreds originated from Dekalb Genetics Corporation, Holden's Foundation Seed, Pioneer Hi‐Bred International, and Syngenta via Novartis and Northrup King. Flowering ranged from 968–1806 growing degree days to anthesis, supporting that these inbreds represent adaptation across the range of North American production environments. Admixture analysis supported eight subgroups (B14, B37, B73, Oh43, Iodent, Iodent‐Lancaster, Lancaster, and Flint), reflecting heterotic patterns and company of origin. Five diallel‐cross experiments identified primary yield heterotic patterns within early‐, intermediate‐, and late‐maturity groups. Parental pedigree information was compiled for 2392 Plant Variety Protection and/or utility patented inbreds through 2017, allowing for multigenerational analysis of progenitors and the eight heterotic subgroups across current proprietary breeding programs. Key progenitors were identified for recently merged companies, Bayer Crop Science and Corteva Agriscience. The results of this study strengthen the value of the ex‐PVP inbreds as a source of elite and relevant germplasm for breeders and researchers to exploit. This study provides information that will be logistically useful to researchers who use ex‐PVP inbreds and adds to our understanding of heterotic grouping within North American proprietary germplasm.

ISO/IEC 27701 Standard: Threats and Opportunities for GDPR Certification

The paper assesses the possible consequences for Article 42/43 certification of the publication of the ISO/IEC 27701:2019 standard. This new ISO standard establishes a management system that aims to manage ‘the processes for protecting the capture, accountability, availability, integrity, and confidentiality of personal data.’ The conformity with the standard’s requirements is certifiable by the private conformity assessment bodies interested in providing this service to businesses. The paper shows that ISO/IEC 27701:2019 based certification has many assets to dominate the market of data protection certification. It offers operational advantages to businesses that are looking for a readymade solution to streamline information security and data protection. A strong uptake of ISO/IEC 27701:2019 based certification could threaten Article 42/43 certification by creating two competing approaches of data protection compliance. But it could also offer the opportunity to improve the general level of data protection and encourage the European supervisory authorities to clarify the relationships they intend to establish with ISO privacy standards.

Lies don't travel far: Article 3(c) of the SPC Regulation from a German perspective

Germany, Higher Regional Court of Düsseldorf, I-2 U 63/18, 15 March 2019 According to the Court of Justice of the European Union, Article 3(c) of the SPC Regulation precludes the holder of a patent on the basis of which a first SPC has been granted for an active ingredient thereby claimed from obtaining a second SPC for a combination if that active ingredient constitutes the sole ‘subject-matter of the invention’ (Case C-577/13) and the other active substance is not protected as such by the patent (Case C-443/12). However, this case law has raised questions that remain unanswered. In a recent decision, the Higher Regional Court of Düsseldorf sought to address the problem of how the ‘subject-matter of the invention’ is determined in case the patent is objectively incorrect. Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate (SPC) for medicinal products is a European piece of legislation in the larger context of patent term extensions. However, it is not a patent per se whose term is open for extension but rather a ‘part’ of it. This ‘part’ must be protected by the patent (Article 3(a) of Regulation No 469/2009) and relate to a ‘product’, which is defined in Article 1(b) of Regulation No 469/2009 as an active ingredient or combination of active ingredients of a medicinal product. However, the Court of Justice of the European Union (CJEU) does not seem to apply this definition in a strict or literal sense. Judge Meier-Beck of the German Federal Court of Justice (Bundesgerichtshof), writing extra-judicially (Meier-Beck, GRUR Int 2018, 657, 661), has suggested that the term ‘product’ is subject to a ‘valuation … under SPC law’. Therefore, if an active ingredient and a combination of that active ingredient and another substance have the same ‘value’ for the invention covered by the basic patent, Article 3(c) of Regulation No 469/2009 precludes the grant of a second SPC whenever one of them (either the active ingredient or the combination) has already been the subject of a first SPC. Now, the Higher Regional Court of Düsseldorf has put flesh on this suggestion to give a better understanding of how to tackle Article 3(c) of Regulation No 469/2009.

Understanding the Balancing Act Behind the Legitimate Interest of the Controller Ground: A Pragmatic Approach

The General Data Protection Regulation provides new tools and concepts such as Data Protection Impact Assessments, accountability and certification, but to a large extent retains the rationale of the Data Protection Directive for a principles-driven legislation. One of the cornerstones of both the reformed and new EU data protection legislation is the grounds for lawful processing. Much debate has taken place over consent and the conditions for a meaningful informed choice of the data subject, while other grounds have not been at the spotlight of academia and practitioners. The legitimate interest of the controller has been one of the least discussed legal grounds for lawful processing, with a few exceptions, mainly the opinion of the Article 29 Data Protection Working Party, despite its significance as equally binding ground for processing. This contribution analyses the concept of legitimate interest of the controller of art. 6 (f) GDPR in relation to art. 7 (f) of the Data Protection Directive 95/46/EC and the interpretations of the concept by the Court of Justice of the EU and the Article 29 Data Protection Working Party.

The export and stockpiling waivers: new exceptions for supplementary protection certificates

Supplementary protection certificates (SPCs) play a central function in the balance between innovation and competition in the European pharmaceutical sector. SPCs have a crucial importance for the pharmaceutical industry, since 86 per cent of the new drug products introduced in the European Union (EU) have an SPC in at least one country, and on average an SPC in 18–19 countries.1 For 49 per cent of medicines, SPCs and regulatory data protection are the last exclusivity to expire, while patents account for the other 51 per cent.2 SPCs redress the loss of exclusivity that patent holders experience as a result of the pharmaceutical development and marketing authorization processes.3 Once the patent term expires, an SPC grants temporary exclusivity for a maximum period of 5 years, or 15 years from the marketing of the active ingredient. The rationale is that, without SPCs, the period that elapses between the filing of a patent and the market authorization would be insufficient to recover the investment sunk into pharmaceutical research and development.4 Moreover, SPCs are also intended to incentivize research in new active ingredients and, by doing so, strengthen the innovative industry.5