Patent oppositions in Australia: The facts

Patent opposition in Australia is an administrative process within the Patent Office, whereby third parties, such as competitors, suppliers, or customers of the patentee, raise arguments and provide evidence against the validity of a patent that has been accepted, but not yet granted. As such, it can potentially play an important role in maintaining the quality of the patent register. As a number of economists and legal scholars have pointed out, it is impossible for patent offices to find all the prior art relevant to a patent, particularly where that prior art lies outside the patent literature. Competitors and other outsiders, however, are likely to have information relevant to the validity of the patent, because they are active in the technology. If these 'outsiders' can be encouraged to bring that information to the attention of the Patent Office, the examiners will be in a better position to make the right decisions about granting patents. At the same time, there are potential benefits, especially for smaller businesses, to having a low cost mechanism for challenging the validity of patent applications, particularly in an era where increasing burdens on patent offices are raising questions about the quality of the patents being granted

Exploring mentorship as a strategy to build capacity for knowledge translation research and practice: protocol for a qualitative study

Abstract Background Research funders, educators, investigators and decision makers worldwide have identified the need to improve the quality of health care by building capacity for knowledge translation (KT) research and practice. Peer-based mentorship represents a vehicle to foster KT capacity. The purpose of this exploratory study is to identify mentoring models that could be used to build KT capacity, consult with putative mentee stakeholders to understand their KT mentorship needs and preferences, and generate recommendations for the content and format of KT mentorship strategies or programs, and how they could be tested through future research. Methods A conceptual framework was derived based on mentoring goals, processes and outcomes identified in the management and social sciences literature, and our research on barriers and facilitators of academic mentorship. These concepts will inform data collection and analysis. To identify useful models by which to design, implement and evaluate KT mentorship, we will review the social sciences, management, and nursing literature from 1990 to current, browse tables of contents of relevant journals, and scan the references of all eligible studies. Eligibility screening and data extraction will be performed independently by two investigators. Semi-structured interviews will be used to collect information about KT needs, views on mentorship as a knowledge sharing strategy, preferred KT mentoring program elements, and perceived barriers from clinician health services researchers representing different disciplines. Qualitative analysis of transcripts will be performed independently by two investigators, who will meet to compare findings and resolve differences through discussion. Data will be shared and discussed with the research team, and their feedback incorporated into final reports. Discussion These findings could be used by universities, research institutes, funding agencies, and professional organizations in Canada and elsewhere to develop, implement, and evaluate mentorship for KT research and practice. This research will establish a theoretical basis upon which we and others can compare the cost-effectiveness of interventions that enhance KT mentorship. If successful, this program of research may increase knowledge about, confidence in, and greater utilization of KT processes, and the quality and quantity of KT research, perhaps ultimately leading to better implementation and adoption of recommended health care services.</p

Exploring mentorship as a strategy to build capacity for knowledge translation research and practice: protocol for a qualitative study

Abstract Background Research funders, educators, investigators and decision makers worldwide have identified the need to improve the quality of health care by building capacity for knowledge translation (KT) research and practice. Peer-based mentorship represents a vehicle to foster KT capacity. The purpose of this exploratory study is to identify mentoring models that could be used to build KT capacity, consult with putative mentee stakeholders to understand their KT mentorship needs and preferences, and generate recommendations for the content and format of KT mentorship strategies or programs, and how they could be tested through future research. Methods A conceptual framework was derived based on mentoring goals, processes and outcomes identified in the management and social sciences literature, and our research on barriers and facilitators of academic mentorship. These concepts will inform data collection and analysis. To identify useful models by which to design, implement and evaluate KT mentorship, we will review the social sciences, management, and nursing literature from 1990 to current, browse tables of contents of relevant journals, and scan the references of all eligible studies. Eligibility screening and data extraction will be performed independently by two investigators. Semi-structured interviews will be used to collect information about KT needs, views on mentorship as a knowledge sharing strategy, preferred KT mentoring program elements, and perceived barriers from clinician health services researchers representing different disciplines. Qualitative analysis of transcripts will be performed independently by two investigators, who will meet to compare findings and resolve differences through discussion. Data will be shared and discussed with the research team, and their feedback incorporated into final reports. Discussion These findings could be used by universities, research institutes, funding agencies, and professional organizations in Canada and elsewhere to develop, implement, and evaluate mentorship for KT research and practice. This research will establish a theoretical basis upon which we and others can compare the cost-effectiveness of interventions that enhance KT mentorship. If successful, this program of research may increase knowledge about, confidence in, and greater utilization of KT processes, and the quality and quantity of KT research, perhaps ultimately leading to better implementation and adoption of recommended health care services

Economic Analysis of Fluconazole versus Amphotericin B for the Treatment of Candidemia in Non-Neutropenic Patients

Fluconazole (FLU) is an alternative to amphotericin B (AMB) for the treatment of candidemia in non-neutropenic patients. This agent has similar clinical efficacy but significantly reduced adverse effects compared with AMB. Using the database from a Canadian randomised multicentre comparative trial of FLU versus AMB in the treatment of non-neutropenic patients with candidemia, an economic analysis of antifungal therapy was conducted from a Canadian hospital perspective. Patient records were examined for information containing hospital resource consumption. This included the costs for primary intravenous therapy with either AMB or FLU, laboratory tests, patient clinical monitoring and adverse effects management. The robustness of the baseline results were then tested by a comprehensive sensitivity analysis. The mean duration of therapy in the AMB and FLU arms was 17.1 and 23.7 days, respectively (pFluconazole, Amphotericin-B, Candidiasis, Cost-analysis, Pharmacoeconomics, Antifungals

Implementation Science BioMed Central Study protocol

Exploring mentorship as a strategy to build capacity for knowledge translation research and practice: protocol for a qualitative stud

Safety and immunogenicity of the quadrivalent human papillomavirus vaccine in patients with childhood systemic lupus erythematosus: a real-world interventional multi-centre study.

Objective: This study aimed to assess the safety and immunogenicity of the quadrivalent human papillomavirus (qHPV) vaccination in childhood-onset systemic lupus erythematosus (cSLE) patients. Methods: Volunteer cSLE patients aged 9–20 years and healthy controls (HC) were enrolled to receive a two- or three-dose qHPV vaccination schedule from March 2014 to March 2016. Study visits were performed before the first dose, one month after the second and third doses and one year after the first dose. In each study visit, disease activity and adverse events following vaccination were analyzed, and a serum sample was collected for testing antibody concentrations. Participant recruitment was conducted in 15 Brazilian paediatric rheumatology units. Of the 256 cSLE patients included, 210 completed the two- or three-dose schedules; 15 had previously received one dose, and 18 had received two doses of the vaccine. The analysis was based on intention-to-treat so that participants who did not complete the entire study protocol were also included. Results: No severe adverse events were related to the vaccination. Disease activity was generally low and remained stable or even improved. The HC presented 100% seropositivity to HPV16 and HPV18, whereas the two- and three-dose cSLE groups presented 93% and 83% versus 97% and 91%, respectively. One year after the first dose, seropositivity of the three-dose cSLE group was 91% to HPV16 and 84% to HPV18. Conclusions: HPV vaccination in cSLE patients is safe and immunogenic. Since the seropositivity to HPV16 and HPV18 was higher for the three-dose schedule group, this regimen should be recommended for cSLE patients

Safety and immunogenicity of the quadrivalent human papillomavirus vaccine in patients with juvenile dermatomyositis: a real-world multicentre study.

BACKGROUND: Concerns about the safety and efficacy of vaccines in patients with autoimmune diseases (AID) have led to contradictions and low vaccination coverage in this population, who are at a higher risk of infections, including by human papillomavirus (HPV). Although HPV vaccines have been recommended for immunocompromised patients, there is still a lack of data to support its use for AID patients, such as juvenile dermatomyositis (JDM) patients. The aim of this study was to assess the safety and immunogenicity of the quadrivalent HPV (qHPV) vaccine in a cohort of JDM patients. METHODS: JDM patients aged from 9 to 20 years and healthy controls (HC) were enrolled to receive a 3-dose schedule of qHPV vaccine from March/2014 to March/2016. Study visits were performed before the first dose, 1 month after the second and third doses, and 6 months after the third dose. Participants completed a diary of possible adverse events for 14 days following each dose of vaccination (AEFV). Disease activity and current therapy were analyzed at each visit for JDM patients. In addition, serum samples from all participants were collected to test antibody concentrations against HPV16 and 18 at each visit. Participant recruitment was conducted in ten Brazilian centres. From 47 eligible JDM patients and 41 HC, 42 and 35, respectively, completed the 3-dose schedule of the vaccine, given that five JDM patients and two HC had received doses prior to their inclusion in the study. RESULTS: The AEFVs presented by the participants were mild and in general did not differ between JDM and HC groups. No severe AEFVs were related to the vaccination. Disease activity was stable, or even improved during the follow-up. One month after the third dose of the vaccine the JDM group presented seropositivity of 100% for HPV16 and 97% for HPV18, similarly to the HC group, who presented 100% for both serotypes (p = 1.000). Six months after the third dose the seropositivity for the patient group was 94% for both HPV types. CONCLUSIONS: The HPV vaccination in this cohort of JDM patients was safe and immunogenic. Since the seropositivity against HPV16 and 18 was very high after the 3-dose schedule, this regimen should be recommended for JDM patients. TRIAL REGISTRATION: Brazilian Clinical Trials Registry, number: RBR-9ypbtf . Registered 20 March 2018 - Retrospectively registered