Covid-19 and the Role of Intellectual Property - Position Statement of the Max Planck Institute for Innovation and Competition of 7 May 2021

In this Statement, the authors take a position on the waiver of intellectual property (IP) protection currently being considered by the members of the World Trade Organisation. The waiver was initiated by India and South Africa as a measure to enable rapid access to affordable medical products that are necessary to combat Covid-19. The initiative gained momentum after the US decided to support it. The authors do not consider this path to be expedient. The Statement presents factual and legal arguments why a comprehensive waiver of IP protection is unlikely to be a necessary and suitable measure towards the pursued objective. Overall, it argues that IP rights may so far have played an enabling and facilitating rather than hindering role in overcoming Covid-19. The global community might not be better off if IP rights are waived, neither during nor after the pandemic. There are more efficient and direct ways to supply developing countries with vaccines quickly – if the industrialised countries are willing to do their share

Position Statement of 5 July 2022 on the Decision of the WTO Ministerial Conference on the TRIPS Agreement adopted on 17 June 2022

On 17 June 2022, after nearly one and a half years of intense debate concerning the proposal to waive IP protection in view of the COVID-19 pandemic, the Ministerial Conference of the World Trade Organization adopted a decision on the TRIPS Agreement. It has not waived any intellectual property rights as such but instead mainly clarified the application of the existing TRIPS flexibilities, in particular, regarding compulsory licensing of patents. The Position Statement shows that the Ministerial Decision makes no substantive difference in the existing international legal framework, except for lifting the limitation on the exportation of vaccines manufactured in accordance with the Decision. To the extent that the Decision can make the application of TRIPS flexibilities more expedient, it is to be welcomed. At the same time, it is argued that such facilitating effect should not be limited to, or justified by, the exceptional circumstances of the COVID-19 pandemic. More critically, it should not be restricted to COVID-19 vaccines, of which there is currently no shortage – rather, the same level of TRIPS flexibilities should apply to all medicinal products needed to overcome the COVID-19 pandemic

Variable host-pathogen compatibility in Mycobacterium tuberculosis.

Mycobacterium tuberculosis remains a major cause of morbidity and mortality worldwide. Studies have reported human pathogens to have geographically structured population genetics, some of which have been linked to ancient human migrations. However, no study has addressed the potential evolutionary consequences of such longstanding human–pathogen associations. Here, we demonstrate that the global population structure of M. tuberculosis is defined by six phylogeographical lineages, each associated with specific, sympatric human populations. In an urban cosmopolitan environment, mycobacterial lineages were much more likely to spread in sympatric than in allopatric patient populations. Tuberculosis cases that did occur in allopatric hosts disproportionately involved high-risk individuals with impaired host resistance. These observations suggest that mycobacterial lineages are adapted to particular human populations. If confirmed, our findings have important implications for tuberculosis control and vaccine development

Pelvic radiography in ATLS algorithms: A diminishing role?

This is an Open Access article distributed under the terms of the Creative Commons Attribution Licens

Genetic Diversity of PCR-Positive, Culture-Negative and Culture-Positive Mycobacterium ulcerans Isolated from Buruli Ulcer Patients in Ghana.

Culture of Mycobacterium ulcerans from Buruli ulcer patients has very low sensitivity. Thus confirmation of M. ulcerans infection is primarily based on PCR directed against IS2404. In this study we compare the genotypes obtained by variable number of tandem repeat analysis of DNA from IS2404-PCR positive cultures with that obtained from IS2404 positive, culture-negative tissue. A significantly greater genetic heterogeneity was found among culture-negative samples compared with that found in cultured strains but a single genotype is over-represented in both sample sets. This study provides evidence that both the focal location of bacteria in a lesion as well as differences in the ability to culture a particular genotype may underlie the low sensitivity of culture. Though preliminary, data from this work also suggests that mycobacteria previously associated with fish disease (M. pseudoshottsii) may be pathogenic for humans

Position Paper on the Envisaged Reform of the German Patent Act

Das Max-Planck-Institut für Innovation und Wettbewerb nimmt hiermit zum Diskussionsentwurf eines Zweiten Gesetzes zur Vereinfachung und Modernisierung des Patentrechts Stellung, der vom Bundesministerium der Justiz und für Verbraucherschutz im Januar 2020 vorgelegt wurde. Das Institut begrüßt die Initiative des Ministeriums, empfiehlt im Hinblick auf die Beschränkung des patentrechtlichen Unterlassungsanspruchs und die Stärkung des Schutzes von Geschäftsgeheimnissen in Patentstreitsachen jedoch gewisse Präzisierungen. Mit Blick auf die Beschränkung des Unterlassungsanspruchs nach Maßgabe des Grundsatzes der Verhältnismäßigkeit wird vorgeschlagen, die Verhältnismäßigkeitsprüfung nicht auf einen Anwendungsfall der Gebote von Treu und Glauben zu reduzieren, sondern im Sinne der ratio legis des Patentrechts zu verstehen; insoweit als Maßnahme zur Verhinderung dysfunktionaler Effekte des Ausschließlichkeitsrecht bzw. des damit verbundenen Unterlassungsanspruchs. Zur Veranschaulichung des Ansatzes wird auf die Fallgruppen der komplexen Produkte, der Patentverwerter und der standardessenziellen Patente Bezug genommen, ohne sie jedoch im Detail durchzuprüfen. Mit Blick auf die im Rahmen der Verhältnismäßigkeitsprüfung vorzunehmende Interessenabwägung wird darauf hingewiesen, dass die Interessen des Patentinhabers gegenüber jenen des Verletzers keinen grundsätzlichen Vorrang genießen. Darüber hinaus sind bei der Abwägung nicht nur die Interessen der Streitparteien, sondern auch jene Dritter, insbesondere das öffentliche Interesse, zu berücksichtigen. Mit Blick auf den Schutz von Geschäftsgeheimnissen in Patentstreitsachen verweist die Stellungnahme auf Unzulänglichkeiten des Verfahrens in Geschäftsgeheimnisstreitsachen, die durch die angedachte Anwendung der entsprechenden Vorschriften auf das Patentstreitverfahren übertragen werden. Hingewiesen wird auch auf eine mögliche Regelungslücke in Bezug auf das "Düsseldorfer Verfahren", die von Patentinhabern für sog. "fishing expeditions" ausgenutzt werden könnte

Towards a Sustainable Governance of Information Systems: Devising a Maturity Assessment Tool of Eco-Responsibility Inspired by the Balanced Scorecard

Part 3: Section 2: Sustainable and Responsible InnovationInternational audienceThe assessment of the maturity of Information System (IS) regarding its contribution to corporate social responsibility policy is considered as a stake for organizations. However, few research efforts have been dedicated to this evaluation and even less to the elaboration of a management tool. This paper adopts an engineering perspective to develop a performance assessment approach in this field. Theoretically, this communication (1) mobilizes the methodology of engineering research to build a measurement system of the IS maturity in relation to the economic, social and environmental performance, (2) extends the researches about the sustainable balanced scorecard (SBSC) to the field of IS governance. Practically, this study provides organizations with a global approach to this complex phenomenon as well as a guide to assess it. The originality of this research lies in the application of the conceptual framework of the SBSC to a new research domain

Adrenal, thyroid and gonadal axes are affected at high altitude

Humans cannot live at very high altitude for reasons, which are not completely understood. Since these reasons are not restricted to cardiorespiratory changes alone, changes in the endocrine system might also be involved. Therefore, hormonal changes during prolonged hypobaric hypoxia were comprehensively assessed to determine effects of altitude and hypoxia on stress, thyroid and gonadal hypothalamus–pituitary hormone axes. Twenty-one male and 19 female participants were examined repetitively during a high-altitude expedition. Cortisol, prolactin, thyroid-stimulating hormone (TSH), fT4 and fT3 and in males follicle-stimulating hormone (FSH), luteinizing hormone (LH) and total testosterone were analysed as well as parameters of hypoxemia, such as SaO2 and paO2 at 550 m (baseline) (n = 40), during ascent at 4844 m (n = 38), 6022 m (n = 31) and 7050 m (n = 13), at 4844 m (n = 29) after acclimatization and after the expedition (n = 38). Correlation analysis of hormone concentrations with oxygen parameters and with altitude revealed statistical association in most cases only with altitude. Adrenal, thyroid and gonadal axes were affected by increasing altitude. Adrenal axis and prolactin were first supressed at 4844 m and then activated with increasing altitude; thyroid and gonadal axes were directly activated or suppressed respectively with increasing altitude. Acclimatisation at 4844 m led to normalization of adrenal and gonadal but not of thyroid axes. In conclusion, acclimatization partly leads to a normalization of the adrenal, thyroid and gonadal axes at around 5000 m. However, at higher altitude, endocrine dysregulation is pronounced and might contribute to the physical degradation found at high altitude

Diffusion of e-health innovations in 'post-conflict' settings: a qualitative study on the personal experiences of health workers.

BACKGROUND: Technological innovations have the potential to strengthen human resources for health and improve access and quality of care in challenging 'post-conflict' contexts. However, analyses on the adoption of technology for health (that is, 'e-health') and whether and how e-health can strengthen a health workforce in these settings have been limited so far. This study explores the personal experiences of health workers using e-health innovations in selected post-conflict situations. METHODS: This study had a cross-sectional qualitative design. Telephone interviews were conducted with 12 health workers, from a variety of cadres and stages in their careers, from four post-conflict settings (Liberia, West Bank and Gaza, Sierra Leone and Somaliland) in 2012. Everett Roger's diffusion of innovation-decision model (that is, knowledge, persuasion, decision, implementation, contemplation) guided the thematic analysis. RESULTS: All health workers interviewed held positive perceptions of e-health, related to their beliefs that e-health can help them to access information and communicate with other health workers. However, understanding of the scope of e-health was generally limited, and often based on innovations that health workers have been introduced through by their international partners. Health workers reported a range of engagement with e-health innovations, mostly for communication (for example, email) and educational purposes (for example, online learning platforms). Poor, unreliable and unaffordable Internet was a commonly mentioned barrier to e-health use. Scaling-up existing e-health partnerships and innovations were suggested starting points to increase e-health innovation dissemination. CONCLUSIONS: Results from this study showed ICT based e-health innovations can relieve information and communication needs of health workers in post-conflict settings. However, more efforts and investments, preferably driven by healthcare workers within the post-conflict context, are needed to make e-health more widespread and sustainable. Increased awareness is necessary among health professionals, even among current e-health users, and physical and financial access barriers need to be addressed. Future e-health initiatives are likely to increase their impact if based on perceived health information needs of intended users