Pharmaceutical Law and Patent Law

2021 ◽  
Vol 3 (2) ◽  
Author(s):  
Carlo A. Piria ◽  
Carlo A. Piria
Keyword(s):  
Clinical Trials ◽  
Medicinal Product ◽  
Legal System ◽  
Active Substance ◽  
Patent Law ◽  
Efficacy And Safety ◽  
Patent Claim ◽  
Laws And Regulations

The patent law and pharma laws and regulations need to be coordinated. The interpretative proposal of the author is that a patent claim aiming at protecting the invention as a medicinal product must necessarily be expressed using the appropriate terms provided for by the laws and regulations concerning the industrial medicinal product, such as “medicinal product” and “active substance”; otherwise the patent may not be considered as covering a “medicinal product” or an “active substance”. Moreover, as a consequence, the presentation of a product in a patent claim as a medicinal product or an active substance implies that the enforceability of such claim is conditioned upon the demonstration of the efficacy and safety of the product through the preparation and approval by the competent authorities of a dossier of pharmacological and clinical trials. The legal system taken into consideration by the author is the European one, but the interpretative proposal is, mutatis mutandis, applicable to other systems of law.

scholarly journals Divided Infringement Claims

2016 ◽  
Author(s):  
Mark Lemley
Keyword(s):  
Legal System ◽  
Patent Law ◽  
Patent Claim ◽  
The Subject ◽  
National Boundaries ◽  
Modern Technologies ◽  
Do So

Patent law is territorial. It is also designed to deal with thecircumstance of unified infringement by a single actor. But modern commerceis not limited by national boundaries or by corporate forms. Patentswritten to cover modern technologies, particularly network computingtechnologies, are attempting to bring the distributed acts of differentusers around the globe into the ambit of a territorial legal system thatlooks for a single infringer. Not surprisingly, the effort to do so hascreated significant problems for patent cases.Two of those problems are the subject of our article. They involve what wecall divided or distributed patent claims - claims that are infringed onlyby aggregating the conduct of more than one actor, or aggregating conductthat occurs in more than one country. Patent law doesn't deal well witheither class of divided patent claim. Prosecutors and litigators need to beaware of these problems in order to most effectively represent theirclients.

Clinical Efficacy and Safety: The Concept of Benefit–Risk

2021 ◽  
pp. 27-59
Keyword(s):  
Clinical Trial ◽  
Eighteenth Century ◽  
Clinical Trials ◽  
Medicinal Product ◽  
Clinical Efficacy ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Statistics And Probability ◽  
Randomised Controlled ◽  
Clinical Trial Regulation

This chapter looks at clinical efficacy and safety as different concepts that are measured and debated as distinct properties of a medicinal product. It describes clinical efficacy and safety in terms of their probabilities and magnitudes of effects and discusses how they are inevitably, inextricably intertwined through their contributions to the overall benefit–risk profile of the medicinal product. It also mentions statistics and probability techniques that were occasionally used in the eighteenth century in support of medicine and public health. The chapter refers to the Clinical Trial Regulation (Regulation (EU) No 536/2014), which harmonises the assessment and supervision processes for clinical trials throughout the EU via a Clinical Trials Information System. It considers a clinical trial as an art of scientific investigation, while double-blind randomised controlled trials are the standard for regulatory approval.

Crizotinib Versus Chemotherapy on ALK-positive NSCLC: A Systematic Review of Efficacy and Safety

2018 ◽  
Vol 19 (1) ◽  
pp. 41-49 ◽  
Author(s):  
Mingxia Wang ◽  
Guanqi Wang ◽  
Haiyan Ma ◽  
Baoen Shan
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Adverse Events ◽  
Objective Response Rate ◽  
Retrospective Studies ◽  
Response Rate ◽  
Objective Response ◽  
Treated Group ◽  
Efficacy And Safety ◽  
Alk Positive

Introduction: Crizotinib was approved to treat anaplastic lymphoma kinase (ALK)- positive non-small cell lung cancer (NSCLC) by the Food and Drug Administration in 2011.We conducted a systematic review of clinical trials and retrospective studies to compare the efficacy and safety of crizotinib with chemotherapy. </P><P> Methods: We searched electronic databases from inception to Dec. 2016. Clinical trials and retrospective studies regarding crizotinib and crizotinib versus chemotherapy in treatment of NSCLC were eligible. The primary outcomes were the objective response rate (ORR) and disease control rate (DCR). Results: Nine studies (five clinical trials and four retrospective studies) including 729 patients met the inclusion criteria. Crizotinib treatment revealed 1-year OS of 77.1% and PFS of 9.17 months. And crizotinib had a better performance than chemotherapy in ORR (OR: 4.97, 95%CI: 3.16 to 7.83, P<0.00001, I2=35%). DCR revealed superiority with crizotinib than chemotherapy (OR: 3.42, 95% CI: 2.33 to 5.01, P<0.00001, I2=0%). PR (partial response) were significant superior to that of chemotherapy through direct systematic review. No statistically significant difference in CR (complete response) was found between crizotinib-treated group and chemotherapy-treated group. Regarding SD (stable disease), chemotherapy-treated group had a better performance than crizotinib-treated group. Common adverse events associated with crizotinib were visual disorder, gastrointestinal side effects, and elevated liver aminotransferase levels, whereas common adverse events with chemotherapy were fatigue, nausea, and hematologic toxicity. This systematic review revealed improved objective response rate and increased disease control rate in crizotinib group comparing with chemotherapy group. Crizotinib treatment would be a favorable treatment option for patients with ALK-positive NSCLC. ALK inhibitors may have future potential applications in other cancers driven by ALK or c-MET gene mutations.

scholarly journals Efficacy and Safety of Intravenous rtPA in Ischemic Strokes Due to Small-Vessel Occlusion: Systematic Review and Meta-Analysis

2021 ◽  
Author(s):  
Bartosz Karaszewski ◽  
Adam Wyszomirski ◽  
Bartosz Jabłoński ◽  
David J. Werring ◽  
Dominika Tomaka
Keyword(s):  
Clinical Trials ◽  
Ischemic Stroke ◽  
Randomized Clinical Trials ◽  
Small Vessel Disease ◽  
Small Vessel ◽  
Efficacy And Safety ◽  
Eligibility Criteria ◽  
Vessel Occlusion ◽  
Excellent Outcome ◽  
Symptomatic Intracerebral Hemorrhage

AbstractIntravenous recombinant tissue plasminogen activator (iv-rtPA) has been routinely used to treat ischemic stroke for 25 years, following large clinical trials. However, there are few prospective studies on the efficacy and safety of this therapy in strokes attributed to cerebral small vessel disease (SVD). We evaluated functional outcome (modified Rankin scale, mRS) and symptomatic intracerebral hemorrhage (sICH) using all available data on the effects of iv-rtPA in SVD-related ischemic stroke (defined either using neuroimaging, clinical features, or both). Using fixed-effect and random-effects models, we calculated the pooled effect estimates with regard to excellent and favorable outcomes (mRS=0–1 and 0–2 respectively, at 3 months), and the rate of sICH. Twenty-three studies fulfilled the eligibility criteria, 11 of which were comparative, and there were only 3 randomized clinical trials. In adjusted analyses, there was an increased odds of excellent outcome (adjusted OR=1.53, 95% CI: 1.29–1.82, I2: 0%) or favorable outcome (adjusted OR=1.68, 95% CI: 1.31–2.15,I2: 0%) in patients who received iv-rtPA compared with placebo. Across the six studies which reported it, the incidence of sICH was higher in the treatment group (M-H RR = 8.83, 95% CI: 2.76–28.27). The pooled rate of sICH in patients with SVD administered iv-rtPA was only 0.72% (95% CI: 0.12%–1.64%). We conclude that when ischemic stroke attributed to SVD is considered separately, available data on the effects of iv-rtPA therapy are insufficient for the highest level of recommendation, but it seems to be safe. Although further therapeutic trials in SVD-related ischemic stroke appear to be justified, our findings should not prevent its continued use for this group of patients in clinical practice.

scholarly journals Efficacy and safety of Finasteride (5 alpha-reductase inhibitor) monotherapy in patients with benign prostatic hyperplasia: A critical review of the literature

2020 ◽  
Vol 91 (4) ◽  
pp. 205-210
Author(s):  
Gian Maria Busetto ◽  
Francesco Del Giudice ◽  
Daniele D'Agostino ◽  
Daniele Romagnoli ◽  
Andrea Minervini ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Benign Prostatic Hyperplasia ◽  
Adverse Events ◽  
Clinical Efficacy ◽  
Critical Review ◽  
Reductase Inhibitor ◽  
Prostate Volume ◽  
Prostatic Hyperplasia ◽  
Urinary Flow ◽  
Efficacy And Safety

Background: Combination therapy with 5 alpha-reductase inhibitor (5-ARI) and alpha-blocker can be considered as a gold standard intervention for medical management of lower urinary tract symptoms related to benign prostatic hyperplasia (LUTS/BPH). On the other hand, 5-ARI monotherapy and in particular Finasteride alone is currently getting focus of attention especially due to lack of systematic reviews investigating efficacy outcomes and/or adverse events associated. Objectives: Aim of the present critical review was to analyze current knowledge of clinical efficacy and incidence of adverse events associated with 5-ARI treatment for LUTS/BPH. Materials and methods: A systematic review of clinical trials of the literature of the past 20 years was performed using database from PubMed, Cochrane Collaboration and Embase. A total of 8821 patients were included in this study and inclusion criteria for studies selection were: data from randomized clinical trials (RCTs) focusing their attention on the clinical role of Finasteride monotherapy for symptomatic BPH. Parameters of research included prostate specific antigen (PSA), prostate volume (PV), International Prostate Symptom Score (IPPS), postvoid residual urine (PVR), voiding symptoms of IPSS (voiding IPSS), maximum urinary flow rate (Qmax), and adverse events (AEs). Results: Overall 12 original articles were included and critically evaluated. Sample sizes of patient actively treated with finasteride varied from 13 to 1524 cases analyzed in a single study. Follow-up after treatments ranged from 3 to 54 months. The effect of finasteride in reducing prostate volume (PV) was moderate (standardized mean difference (SMD) effect between 0.5 to 0.8 for all trials evaluable) while the effect on IPSS score and Qmax was considered significant (SMD in the 0.2 to 0.5 variation range). No severe AEs and/or psychiatric disorders were retrieved among the studies. Sexual health dysfunctions were significantly influenced by finasteride therapy when compared with placebo treated patients. Conclusions: Although significant clinical benefits of finasteride monotherapy were demonstrated, the effective size of the available reports included in the analysis is limited. Additional head-to-head studies would be needed to re-evaluate clinical efficacy and safety of 5-ARI in combination or not with alpha blockers.

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