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.

Data Protection: The New IP Frontier — An Overview of Existing Laws and Regulations

2007 ◽  
Vol 5 (1) ◽  
pp. 9-25 ◽  
Author(s):  
Dolores Cullen
Keyword(s):  
Intellectual Property ◽  
Trade Agreements ◽  
Developed Countries ◽  
The United States ◽  
Marketing Approval ◽  
Least Developed Countries ◽  
Generic Competition ◽  
General Terms ◽  
Data Exclusivity ◽  
Laws And Regulations

The paper provides an overview of laws and regulations for the protection of data submitted by pharmaceutical companies for the purposes of obtaining marketing approval for a drug in Member States of the World Trade Organization, which must comply with intellectual property provisions set in the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS). Article 39.3 of the agreement requires countries to protect undisclosed test or other data against unfair commercial use but not the adoption of exclusivity periods to protect such data. In general terms, today all developed countries have implemented an array of data exclusivity provisions with specific periods of protection, whereas most developing and least developed countries have often adopted language similar to that of Article 39.3. There are exceptions to this, mainly those countries that have negotiated free trade agreements with the United States such as Chile, Morocco and Jordan, and others that have agreed to adopt periods of exclusivity under pressure from other governments and industry groups. Furthermore, trade agreements have gradually broadened the scope of the protection thus undermining generic competition and therefore consumers' access to more affordable drugs.

Toward a Jurisprudence of Drug Regulation

2014 ◽  
Vol 42 (2) ◽  
pp. 244-262 ◽  
Author(s):  
Matthew Herder
Keyword(s):  
United States ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Medical Devices ◽  
Phase 1 ◽  
Clinical Trial Data ◽  
The United States ◽  
Trial Data ◽  
Regulatory Decisions ◽  
Clinical Study Reports

Efforts to ensure greater transparency in the regulation of “drugs” (used here as a catch-all for pharmaceuticals, biologics, medical devices, and biomarker-based technologies such as genetic testing paired with a pharmaceutical or biologic) are well underway. For example, laws in the United States and Europe now require registration of most clinical trials beyond phase 1. Yet instances of avoidable harm to patients continue to arise. In response, calls for disclosure of clinical trial data in the form of “clinical study reports,” not just trial designs and basic results, are growing. In this paper, I argue that disclosure of clinical trial data is necessary but insufficient. Rather, the regulatory decisions that flow from those trial data —whether positive (i.e., product approvals) or negative (i.e., abandoned products, product refusals, and withdrawals) —should also be open to outside scrutiny provided they are final in nature.

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