Intellectual Property Law Commons^™

The Patent Option, Daniel J. Gervais

Daniel J Gervais

There is a shift in the shape of intellectual property (IP) tools used to strengthen and lengthen the right of pharmaceutical companies to exclude others from making and marketing their products. Patents have traditionally been the tool of choice. Over the past two decades, however, pharmaceutical companies have increased their degree of reliance on a right known as “data exclusivity.” This right, which now exists in most major jurisdictions, is the right to prevent third parties from relying on the clinical trial data submitted by another pharmaceutical company to obtain marketing approval for a bioequivalent or biosimilar product. The right …

The Patent Option, Daniel J. Gervais

Vanderbilt Law School Faculty Publications

There is a shift in the shape of intellectual property (IP) tools used to strengthen and lengthen the right of pharmaceutical companies to exclude others from making and marketing their products. Patents have traditionally been the tool of choice. Over the past two decades, however, pharmaceutical companies have increased their degree of reliance on a right known as “data exclusivity.” This right, which now exists in most major jurisdictions, is the right to prevent third parties from relying on the clinical trial data submitted by another pharmaceutical company to obtain marketing approval for a bioequivalent or biosimilar product. The right …

The Patent Option, Daniel Gervais

Daniel J Gervais

The (Re)Newed Barrier To Access To Medication: Data Exclusivity, Srividhya Ragavan

Srividhya Ragavan

This Article is set in the background of the consequences of the WTO’s prescriptions on patenting of life-saving medications which has largely contributed to the morphing of patents o n life-saving medication into a luxury. Remarkably, there has been a transformation of the role of patents in the context of pharmaceutical innovation into a strategic business tool leading to a larger interest in creation and sustenance of regulatory rights. The biggest global development in this area is an increased effort to strengthen exclusivity using regulatory protections for all chemicals, and even, biologics, involved in all stages of drug development. Consequently, …

The (Re)Newed Barrier To Access To Medication: Data Exclusivity, Srividhya Ragavan

Akron Law Review

This Article is set in the background of the consequences of the WTO’s prescriptions on patenting of life-saving medications which has largely contributed to the morphing of patents o n life-saving medication into a luxury. Remarkably, there has been a transformation of the role of patents in the context of pharmaceutical innovation into a strategic business tool leading to a larger interest in creation and sustenance of regulatory rights. The biggest global development in this area is an increased effort to strengthen exclusivity using regulatory protections for all chemicals, and even, biologics, involved in all stages of drug development. Consequently, …

The Significance Of The Data Exclusivity And Its Impact On Generic Drugs, Srividhya Ragavan

Srividhya Ragavan

The following is a law review interview with Professor Srividhya Ragavan on the issues in interpretation of data exclusivity provisions under the TRIPS Agreement, and the impact of data exclusivity on generic drugs.

The Significance Of The Data Exclusivity And Its Impact On Generic Drugs, Srividhya Ragavan

Faculty Scholarship

The following is a law review interview with Professor Srividhya Ragavan on the issues in interpretation of data exclusivity provisions under the TRIPS Agreement, and the impact of data exclusivity on generic drugs.

The Political Economy Of Data Protection, Peter K. Yu

Peter K. Yu

Information is the lifeblood of a knowledge-based economy. The control of data and the ability to translate them into meaningful information is indispensable to businesspeople, policymakers, scientists, engineers, researchers, students, and consumers. Having useful, and at times exclusive, information improves productivity, advances education and training, and helps create a more informed citizenry. In the past two decades, those who collected or obtained access to a large amount of data began to explore ways to use the collected data as an income stream. Because the then-existing laws did not offer adequate protection for that particular purpose, they actively lobbied for stronger …

Special 301 Of The Trade Act Of 1974 And Global Access To Medicine, Sean M. Flynn

Sean Flynn

Since its inception in 1988, the United States Trade Representative’s “Special 301” adjudication of foreign intellectual property law standards has been used to promote policies restricting access to affordable medications around the world. President-elect Obama released a platform promising to “break the stranglehold that a few big drug and insurance companies have on these life-saving drugs” and pledged support for “the rights of sovereign nations to access quality-assured, low-cost generic medication to meet their pressing public health needs.” The 2009 and 2010 Special 301 reports, however, indicate that the Obama Administration has not yet implemented this pledge into administration trade …

Special 301 Of The Trade Act Of 1974 And Global Access To Medicine, Sean M. Flynn

PIJIP Faculty Scholarship

Since its inception in 1988, the United States Trade Representative’s “Special 301” adjudication of foreign intellectual property law standards has been used to promote policies restricting access to affordable medications around the world. President-elect Obama released a platform promising to “break the stranglehold that a few big drug and insurance companies have on these life-saving drugs” and pledged support for “the rights of sovereign nations to access quality-assured, low-cost generic medication to meet their pressing public health needs.” The 2009 and 2010 Special 301 reports, however, indicate that the Obama Administration has not yet implemented this pledge into administration trade …

Special 301 Of The Trade Act Of 1974 And Global Access To Medicine, Sean Flynn

Articles in Law Reviews & Other Academic Journals

Since its inception in 1988, the United States Trade Representative’s “Special 301” adjudication of foreign intellectual property law standards has been used to promote policies restricting access to affordable medications around the world. President-elect Obama released a platform promising to “break the stranglehold that a few big drug and insurance companies have on these life-saving drugs” and pledged support for “the rights of sovereign nations to access quality-assured, low-cost generic medication to meet their pressing public health needs.” The 2009 and 2010 Special 301 reports, however, indicate that the Obama Administration has not yet implemented this pledge into administration trade …

The Political Economy Of Data Protection, Peter K. Yu

Chicago-Kent Law Review

Information is the lifeblood of a knowledge-based economy. The control of data and the ability to translate them into meaningful information is indispensable to businesspeople, policymakers, scientists, engineers, researchers, students, and consumers. Having useful, and at times exclusive, information improves productivity, advances education and training, and helps create a more informed citizenry. In the past two decades, those who collected or obtained access to a large amount of data began to explore ways to use the collected data as an income stream. Because the then-existing laws did not offer adequate protection for that particular purpose, they actively lobbied for stronger …