1,720,956 research outputs found
IS SUSPENSION OF ANTI-SARS-COV2 VACCINE PATENTS THE MOST APPROPRIATE AND FEASIBLE STRATEGY TO DEAL WITH THE COVID-19 PUBLIC HEALTH EMERGENCY?
No full textDuring the Covid-19 pandemic, the exhaustingly heated debate on the advisability of suspending vac-cine patents became a familiar topic not only among patent specialists but also to the general public. There were staunch defenders of patent protection and those for whom patents merely safeguard the economic interests of pharmaceutical companies and deny citizens' right to healthcare. Every generalized health emergency - whether the appearance of HIV or the current Covid-19 pandemic - triggers acrimonious debate on the need to suspend patents covering medical devices and agent necessary to fight the disease. The consensus view is that patent monopolies bar general access to therapeutic treatments. The frequently abstract, ideological and emotional tones adopted during the debate do not help objective assessment of the pros and cons of patent suspension and its feasibility.
This work aims to provide a clear, objective overview of what suspension of anti-SARS-CoV2 (COVID-19) vaccine patents would entail.
Three essential questions are considered:
First, what is the intended purpose underpinning any suspension of anti-Covid vaccine patents;
Second, what patents should be "suspended";
Third, what, if any, legal instruments exist that would enable rapid, effective patent suspension.
EMA/707383/2020 Corr.1; 19 February 2021,
https://www.ema.europa.eu/en/medicines/human/EPAR/comirnaty;
EMA/15689/2021 Corr.1; 11 March 2021,
https://www.ema.europa.eu/en/medicines/human/EPAR/spikevax;
https://worldwide.espacenet.com/
WO2021/188969-A2; WO2021/213924-Al; WO2021/213945-A1; WO2021/214204-A1; WO 2021154763 A1; WO 2021159040 A2; WO 2021159130 A2; WO 2021222304 A2: WO 2021231963 A1; US Patent 10,960,070; US16/344,774; US2021/0275664; WO2021/163365; WO2007/024708; EP2578685 B1; US8278036 B2; US8691966 B2; US8748089 B2; US8835108 B2; US9750824 B2; WO2011/071931; WO2014/160243;US11060107B2; US 9,404,127 US9,364,435; US8,058,069; US10166298-B1; US11040112-B2; EP3532103-A; US9737619-B2 (claim 1); EP3532103 (claim 6); WO2021030701; US9,404,127; US9,364,435; US8,058,069
Going Beyond Counting First Authors in Author Co-citation Analysis
Full text linkThe present study examines one of the fundamental aspects of author co-citation analysis (ACA) - the way co-citation
counts are defined. Co-citation counting provides the data on which all subsequent statistical analyses and mappings
are based, and we compare ACA results based on two different types of co-citation counting - the traditional type that
only counts the first one among a cited work's authors on the one hand and a non-traditional type that takes into
account the first 5 authors of a cited work on the other hand. Results indicate that the picture produced through this non-traditional author co-citation counting contains more coherent author groups and is therefore considerably clearer. However, this picture represents fewer specialties in the research field being studied than that produced through the traditional first-author co-citation counting when the same number of top-ranked authors is selected and analyzed. Reasons for these effects are discussed
PATENT EXTENSION FOR MEDICINAL PRODUCTS IN EUROPE: SUPPLEMENTARY PROTECTION CERTIFICATES, SPECIFIC CASE LAW AND THE EXPORT WAIVER
No full textSupplementary Protection Certificates (SPCs) are 5-year maximum extensions to a 20-year patent for medicinal and plant protection products. The SPC was instituted to offset, at least in part, the period intervening while awaiting the issuance of a Marketing Authorisation (M.A.) for the medicinal or plant-protection product, i.e., between the filing of the patent application and the granting of an M.A.
Article 3 of Regulation EC/469/2009 specifies the conditions for obtaining this I.P. tool which is based on the two legal pillars: patent law and regulatory law.
Under patent law, application for an SPC may be filed for a product that is an active ingredient or combination of active ingredients, if that product is protected by a basic patent currently in force. The product must be an embodiment of the invention protected by the basic patent and must be specifically identified in the claims of the same basic patent by way of its structural characterisation (Medeva C-322/10) or its functional characterisation (HGS vs Eli Lilly C-493/12). In the case of combinations of active ingredients, the combination must be part of the invention covered by the patent, and each of the active ingredients must be specifically identifiable in the light of the information disclosed in that patent.
Under regulatory law, the active ingredient or combination of active ingredients for which an SPC is sought must be contained in a medicinal product with an M.A. pursuant to Directive 2001/83/EC. The medicinal product must contain all the active ingredients mentioned in the SPC application, as confirmed by decisions Georgetown C-422/10, Medeva C-322/10. The medicinal product in question may, however, also comprise other active ingredients.
No product that has been granted an SPC may obtain a second SPC. However, the same patent may generate other SPCs for different products, provided that each product is protected by that same patent and is an ingredient of the Marketing-Authorised medicinal product.
In the special case of a new combination of ingredients consisting of a first active ingredient protected by a basic patent and already the subject matter of an SPC, along with a second active ingredient known in the prior art, a new SPC may be obtained only if the combination is specified in the wording of the claims of the
basic patent and is identified as an embodiment of the invention. However, if the specific combination is not an embodiment of the invention, no new SPC may be allowed (Sanofi C-443/12).
The question of SPC protection of combinations of active ingredients is the subject of open debate in Europe and important decisions of the CJEU on the issue are expected in the very near future.
SPCs may be granted only on the basis of the first M.A. for a medicinal product. A second SPC may not be granted on the basis of a new M.A. for a second therapeutic use or for a new formulation of a product that has already been granted a first M.A. (see Decision C-673/18 - Santen vs INPI and Decision C-443/17-Abraxis Biosciences vs Comptroller).
Regulation EC/469/2009 was recently amended by Regulation EU/2019/933 to include the granting a waiver within the SPC framework to allow the manufacture and storing of generic and biosimilar forms of original active ingredients, yet without affecting the finality of the protection of intellectual property rights that remain one of the cornerstones of innovation, competitiveness and growth in the internal market. (Recital no.7).
In practical terms, the waiver system allows a medicinal containing a product SPC-protected, as well as any connected act strictly necessary for the realization to be manufactured no earlier than six months prior to the expiry of the SPC for the purpose of export to third countries where there is no protection or, for the purpose of temporarily storing product in a EU member state before release onto the market that is allowed the day after SPC expiry
TRADE SECRETS, INTELLECTUAL PROPERTY AND VACCINE
No full textKnow-how is a set of intangible techniques and practices characterized by secrecy such as to provide the holder with an economic advantage. Although this definition is not sufficient to ensure patent coverage, trade secrets can nonetheless be protected under law. EU Directive 2016/943 establishes that trade secrets constitute any information that is: a) secret in the sense that “it is not, as a body or in the precise configuration and assembly of its components, generally known among or readily accessible to persons within the circles that normally deal with the kind of information in question”; b) has commercial value because it is secret; (c) has been “subject to reasonable steps under the circumstances, by the person lawfully in control of the information, to keep it secret”. The Covid-19 pandemic caused by a new coronavirus confronted the scientific community with a major challenge: developing a vaccine. An immense effort led to the development and subsequent availability of several effective vaccines and therapies, which, however, are not accessible to the entire world population, especially those in middle and low-income countries. Since research into and development of a new drug entails intangible knowledge and processes protected by trade secret regulations, one hundred international intellectual property specialists have petitioned for a temporary derogation from the TRIPs agreements protecting intellectual property. With its resolution of 10 June 2021, the European Parliament has also come out in favour of a temporary modification to the TRIPs agreements. However, the parties involved have yet to reach a consensus. This study looks at the possible ways in which the parties could achieve an agreement that would protect their rights.
- DIRECTIVE (EU) 2016/943 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 8 June 2016 on the protection of undisclosed know-how and business information (trade secrets) against their unlawful acquisition, use and disclosure (Text with EEA relevance)
- Solenne V., P&SLegal, https://www.pandslegal.it/life-science/proprieta-intellettuale-e-salute-in-emergenza/ consulted on 20/04/2022;
-Tajoli L., Ispi on line, https://www.ispionline.it/it/pubblicazione/trade-vaccini-liberi-tutti-30436 ;
consulted on 20/04/2022;
- Zanoli E., Il Sole 24 ore, https://www.ilsole24ore.com/art/vaccini-ostacoli-licenza-obbligatoria-ADoegkPB; consulted on 03/05/2022;
- Parlamento Europeo, https://www.europarl.europa.eu/doceo/document/RC-9-2021-0306_IT.html ;
consulted on 15/05/2022
Variations on the Author
Full text link“Variations on the Author” discusses two of Eduardo Coutinho’s recent films (Um Dia na Vida, from 2010, and Últimas Conversas, posthumously released in 2015) and their contribution to the general question of documentary authorship. The director’s filmography is characterized by a consistent yet self-effacing form of authorial self-inscription: Coutinho often features as an interviewer that rather than express opinions propels discourses; an interviewer that is good at listening. This mode of self-inscription characterizes him as an author who is not expressive but who is nonetheless markedly present on the screen. In Um Dia na Vida, however, Coutinho is completely absent form the image, while Últimas Conversas, on the contrary, includes a confessional prologue that moves the director from the margins to the center of his films. This article examines the ways in which these works stand out in the filmography of a director who offers new insights into the notion of cinematic authorship
Appropriate Similarity Measures for Author Cocitation Analysis
Full text linkWe provide a number of new insights into the methodological discussion about author cocitation analysis. We first argue that the use of the Pearson correlation for measuring the similarity between authors’ cocitation profiles is not very satisfactory. We then discuss what kind of similarity measures may be used as an alternative to the Pearson correlation. We consider three similarity measures in particular. One is the well-known cosine. The other two similarity measures have not been used before in the bibliometric literature. Finally, we show by means of an example that our findings have a high practical relevance.information science;Pearson correlation;cosine;similarity measure;author cocitation analysis
Dispelling the Myths Behind First-author Citation Counts
Full text linkWe conducted a full-scale evaluative citation analysis study of scholars in the XML research field to explore just how different from each other author rankings resulting from different citation counting methods actually are, and to demonstrate the capability of emerging data and tools on the Web in supporting more realistic citation counting methods. Our results contest some common arguments for the continued
use of first-author citation counts in the evaluation of scholars, such as high correlations between author rankings by first-author citation counts and other citation
counting methods, and high costs of using more realistic citation counting methods that are not well-supported by the ISI databases. It is argued that increasingly available digital full text research papers make it possible for citation analysis studies to go beyond what the ISI databases have directly supported and to employ more
sophisticated methods
koamabayili/VECTRON-author-checklist: VECTRON author checklist
No full textWe have done our best to complete the author checklist relating to the use of animals in the hut study. Note that the objective for the hut study was to evaluate the IRS treatment applications for residual efficacy against Anopheles mosquitoes, including the local An. coluzzii mosquito population. Cows were only used to attract mosquitoes into the huts and no tests were carried out directly on the cows. The author checklist is intended for use with studies where experiments are carried out on animals, which is why we have had such difficulty in completing this for the hut study, as many of the questions do not relate to how the cows were used
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