scholarly journals Rethinking the Role of Clinical Trial Data in International Intellectual Property Law: The Case for a Public Goods Approach

2009 ◽  
Author(s):  
Jerome H. Reichman
Keyword(s):  
Clinical Trial ◽  
Intellectual Property ◽  
Public Goods ◽  
Clinical Trial Data ◽  
Trial Data ◽  
Property Law ◽  
Intellectual Property Law

From Market Access to Cumulative Innovation

2017 ◽  
Author(s):  
Adrian Kuenzler
Keyword(s):  
Intellectual Property ◽  
Market Access ◽  
Step Test ◽  
Property Law ◽  
Intellectual Property Law ◽  
Rights Protection ◽  
Intellectual Property Rights Protection ◽  
Property Rights Protection ◽  
Production Output

This chapter argues for a reinvigorated role of the market access doctrine and references a number of important antitrust and intellectual property law decisions in which courts have given priority to market access. It finds a novel function for market access to play within antitrust and intellectual property law liability: courts that grant plaintiffs access to a defendant’s production output should refer to a three-step test under which they inquire (1) whether the inventor, through first-mover advantages, has reaped a sufficient reward such that contractual or intellectual property rights protection would no longer be required to facilitate innovation, (2) whether competitors were able to challenge the proprietary platform’s position in the market without the possibility of granting access, and (3) whether competitors seeking to benefit from market access will make use of it to facilitate the introduction of new goods rather than merely to copy the initial invention.

Role of Radiation Therapy and Fluoropyrimidines in the Treatment of Gastrointestinal Malignancies

1996 ◽  
Vol 3 (4) ◽  
pp. 319-328
Author(s):  
William W. Wong ◽  
Steven E. Schild ◽  
James A. Martenson
Keyword(s):  
Clinical Trial ◽  
Clinical Trial Data ◽  
Trial Data ◽  
Combined Chemotherapy ◽  
Gastrointestinal Malignancies ◽  
Treatment Regimens ◽  
Improved Outcomes ◽  
Clinical Benefits ◽  
Positive Results

Background The use of combined chemotherapy and radiation for gastrointestinal malignancies has several theoretical advantages, and clinical trials to determine the type and extent of clinical benefits have been performed. Methods The basic science and clinical trial data evaluating such combinations are reviewed, with an emphasis on the interactions between fluoropyrimidines and radiation. Results Improved outcomes from chemoradiotherapy have been demonstrated in patients with selected stages of anal, esophageal, rectal, and pancreatic cancer. Conclusion Despite these positive results, further work is needed to demonstrate even more effective and less toxic treatment regimens.

Emerging Role of Interleukins for the Assessment and Treatment of Liver Diseases

2021 ◽  
Vol 21 ◽  
Author(s):  
Aaliya L. Ali ◽  
Namrata P. Nailwal ◽  
Gaurav M. Doshi
Keyword(s):  
Hepatocellular Carcinoma ◽  
Clinical Trial ◽  
Liver Disease ◽  
Alcoholic Liver Disease ◽  
Liver Diseases ◽  
Clinical Trial Data ◽  
Trial Data ◽  
Alcoholic Fatty Liver ◽  
Assessment And Treatment

Background: The most common liver diseases are fibrosis, alcoholic liver disease, non-alcoholic fatty disease, viral hepatitis, and hepatocellular carcinoma. These liver diseases account for approximately 2 million deaths per year worldwide, with cirrhosis accounting for 2.1% of the worldwide burden. The most widely used liver function tests for diagnosis are alanine transaminase, aspartate transaminase, serum proteins, serum albumin, and serum globulins, whereas antivirals and corticosteroids have been proven to be useful for the treatment of liver diseases. A major disadvantage of these diagnostic measures is the lack of specificity to a particular tissue or cell type, as these enzymes are common to one or more tissues. The major adverse effect of current treatment methods is drug resistance. To overcome these issues, interleukins have been investigated. The balance of these interleukins determines the outcome of an immune response. Interleukins are considered interesting therapeutic targets for the treatment of liver diseases. In this review, we summarize the current state of knowledge regarding interleukins in the diagnosis, treatment, and pathogenesis of different acute and chronic liver diseases. Objective: To understand the role of interleukins in the assessment and treatment of different types of liver diseases. Methods: A literature search was conducted using PubMed, Science Direct, and NCBI with the following keywords: Interleukins, Acute Liver Failure, Alcoholic Liver Disease, Non-Alcoholic Fatty Liver Disease, Liver Fibrosis, Hepatocellular Carcinoma, Inflammation, Liver injury, Hepatoprotective effect. Clinical trial data on these interleukins have been searched on Clinicaltrials.gov. Results: Existing literature and preclinical and clinical trial data demonstrate that interleukins play a crucial role in the pathogenesis of liver diseases. Conclusion: Our findings indicate that IL-1, IL-6, IL-10, IL-17, IL-22, IL-35, and IL-37 are involved in the progression and control of various liver conditions via the regulation of cell signaling pathways. However, further investigation on the involvement of these interleukins is necessary for their use as a targeted therapy in liver diseases.

The impact of immunotherapy education on GI cancers.

2021 ◽  
Vol 39 (3_suppl) ◽  
pp. 479-479
Author(s):  
Kinjal Parikh ◽  
Katie Lucero ◽  
Charlotte Warren ◽  
Emily Sherene Van Laar ◽  
Patrick Kugel ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Checkpoint Inhibitors ◽  
Statistical Significance ◽  
Clinical Trial Data ◽  
Trial Data ◽  
Educational Activities ◽  
Cancer Subtypes ◽  
Gi Cancers ◽  
The Impact

479 Background: Gastrointestinal (GI) cancers are a heterogeneous group of cancers with varying underlying pathophysiology and distinct treatment paradigms. Immunotherapy (IO) is unique in each of the subtypes and biomarkers utility varies. With the expansion of IO in each cancer subtypes, education remains essential to optimize patient outcomes through integration of the latest evidence-based data at point of care. Through the partnership between Medscape Oncology and the Society for Immunotherapy of Cancer, 2 educational activities were designed to increase the knowledge and competence of oncologists surrounding the role of IO in patients with advanced GI cancers. Methods: The 2 educational activities included a text based online activity with 3 chapters focused on gastroesophageal cancers, colorectal cancers, and hepatocellular carcinoma (HCC) and a 30-minute online, video discussion with 3 faculty and synchronized slides on HCC. Educational effectiveness was assessed with repeated paired pre/post assessment where learners served as their own controls. A chi-square test was used to identify statistical significance in proportion of correct responses. The first activity launched 11/27/2019 and the second activity launched on 5/8/20. Data were collected and reported through 8/25/2020. Results: A total of 8433 learners, including 1543 oncologists, participated from 11/2019 through 8/2020. Participation in education resulted in significant relative improvements among oncologist learners on IO in GI cancers in (n = 641): 110%: role or eligibility of immune checkpoint inhibitors (ICIs) (p < .001) 38%: clinical trial data of ICIs (p < .001) Subsequent education on unresectable HCC demonstrated a significant relative improvement in both knowledge and competence for oncologist learners (n = 902): 19%: regarding clinical trial data in unresectable HCC (p = .073) 19%; competence identifying role of ICIs in unresectable HCC (p < .05) 59%: competence managing irAEs in unresectable HCC (p < .001). Conclusions: These 2 online CME-certified educational activities resulted in statistically significant gains in oncologist knowledge surrounding the use of IO in advanced GI cancers Follow-up education on HCC demonstrated the value and benefit of multi-modal and sequential activities on improving competence among oncologists caring for patients with unresectable HCC There remains a need for continuous education as more oncologists utilize IO in their practice while the understanding and availability of clinical data continues to expand and evolve in the varying GI cancer subtypes. More than 50% of learners continued to demonstrate a need in understanding the clinical trial data or role of IO in metastatic GI cancers with more than 40% of the learners demonstrating continued need on clinical trial data or role of IO in HCC specifically.

scholarly journals Data Exclusivities in the Age of Big Data, Biologics, and Plurilaterals

2019 ◽  
Vol 6 (4) ◽  
pp. 22-33
Author(s):  
Peter K. Yu
Keyword(s):  
Clinical Trial ◽  
Big Data ◽  
Intellectual Property ◽  
Clinical Trial Data ◽  
Trade Agreements ◽  
The United States ◽  
Trial Data ◽  
Marketing Approval ◽  
Clinical Practices ◽  
Pharmaceutical Industries

The past decade has seen many new developments impacting the intellectual property system. The introduction of big data analytics has transformed the fields of biotechnology and bioinformatics while ushering in major advances in drug development, clinical practices, and medical financing. The arrival of biologics and personalized medicines has also revolutionized the healthcare and pharmaceutical industries. In addition, the emergence of bilateral, regional, and plurilateral trade agreements have raised serious, and at times difficult, questions concerning the evolution of domestic and international intellectual property standards. One topic linking all three developments together concerns the establishment of international standards to protect clinical trial data that have been submitted to regulatory authorities for the marketing approval of pharmaceutical products. During the negotiations for the Trans-Pacific Partnership (TPP), for example, the protection of clinical trial data submitted for the marketing approval of biologics was highly contentious. Although the United States’ withdrawal in January 2017 has since placed the TPP Agreement and its data exclusivity provisions for pharmaceuticals and biologics on life support, the debate on the protection of clinical trial data will continue and will emerge in future bilateral, regional, and plurilateral trade negotiations, including the renegotiations on the North American Free Trade Agreement (NAFTA). Part I of this Article reviews the protection of clinical trial data under Article 39.3 of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) of the World Trade Organization (WTO). Even though the provision covers both pharmaceutical and agricultural chemical products, this Article focuses only on the former. Part II examines the additional protection clinical trial data have received through TRIPS-plus bilateral, regional, and plurilateral trade agreements. Part III outlines five specific recommendations to help advance the debate on such protection in the age of big data, biologics, and plurilateral trade agreements.

scholarly journals Which Kraft of Statutory Interpretation? A Supreme Court of Canada Trilogy on Intellectual Property Law

2008 ◽  
Vol 46 (1) ◽  
pp. 1 ◽  
Author(s):  
Cameron J. Hutchison
Keyword(s):  
Intellectual Property ◽  
Supreme Court ◽  
Judicial Discretion ◽  
Property Law ◽  
Supreme Court Of Canada ◽  
Statutory Interpretation ◽  
Intellectual Property Law ◽  
Law Making

The techniques used by courts to interpret statutes can be characterized as inconsistent, and at times, excessive. Current methodologies of statutory interpretation often reflect deeply normative views about the appropriate institutional role of the legislative and judicial branches of law-making, but this characterization of the debate is misleading. Rather, the problem lies with properly discerning legislative meaning and intent in full awareness of the limitations and possibilities of statutes as communicative devices. The author suggests a new methodology of statutory interpretation, whereby courts analogize the facts before them with certain paradigm cases. This methodology serves to constrain judicial discretion and enables courts to fill gaps in legislation in connection with novel cases.

WIPO's International Registration of Trademarks: An International Administrative Act Subject to Examination by the Designated Contracting Parties

2008 ◽  
Vol 9 (11) ◽  
pp. 1597-1624 ◽  
Author(s):  
Karen Kaiser
Keyword(s):  
Developing Countries ◽  
Intellectual Property ◽  
International Institutions ◽  
World Intellectual Property Organization ◽  
Property Law ◽  
Industrial Property ◽  
Intergovernmental Organization ◽  
Intellectual Property Law ◽  
The World

Although the World Intellectual Property Organization (WIPO) is a technical intergovernmental organization with a limited mandate, it has been entrusted with a panoply of tasks. These include, inter alia, the international harmonization of intellectual property law, the administration of fee-based global intellectual property protection services, and the delivery of dispute resolution services to individuals. While the central role of WIPO in the continuous development of substantive intellectual property law has been questioned by developing countries, the administrative activities of WIPO have remained largely unscathed by critique and, therefore, have not attracted much attention. They revolve around the international filing, registration or recognition of industrial property rights, such as patents, industrial designs and trademarks, and provide an interesting perspective on the law of international institutions.

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