Addressing Exclusivity Issues: Covid-19 and Beyond

Research output: Chapter in Book/Report/Conference proceedingBook chapterResearchpeer-review

Standard

Addressing Exclusivity Issues : Covid-19 and Beyond. / Sinha, Michael S.; Bostyn, Sven; Minssen, Timo.

COVID-19 and the Law: Disruption, Impact, and Legacy (2023). ed. / I. Glenn Cohen; Abbe Gluck; Katherine Kraschel; Carmel Shachar. Cambridge University Press, 2023. p. 237 - 252.

Research output: Chapter in Book/Report/Conference proceedingBook chapterResearchpeer-review

Harvard

Sinha, MS, Bostyn, S & Minssen, T 2023, Addressing Exclusivity Issues: Covid-19 and Beyond. in IG Cohen, A Gluck, K Kraschel & C Shachar (eds), COVID-19 and the Law: Disruption, Impact, and Legacy (2023). Cambridge University Press, pp. 237 - 252. https://doi.org/10.1017/9781009265690

APA

Sinha, M. S., Bostyn, S., & Minssen, T. (2023). Addressing Exclusivity Issues: Covid-19 and Beyond. In I. G. Cohen, A. Gluck, K. Kraschel, & C. Shachar (Eds.), COVID-19 and the Law: Disruption, Impact, and Legacy (2023) (pp. 237 - 252). Cambridge University Press. https://doi.org/10.1017/9781009265690

Vancouver

Sinha MS, Bostyn S, Minssen T. Addressing Exclusivity Issues: Covid-19 and Beyond. In Cohen IG, Gluck A, Kraschel K, Shachar C, editors, COVID-19 and the Law: Disruption, Impact, and Legacy (2023). Cambridge University Press. 2023. p. 237 - 252 https://doi.org/10.1017/9781009265690

Author

Sinha, Michael S. ; Bostyn, Sven ; Minssen, Timo. / Addressing Exclusivity Issues : Covid-19 and Beyond. COVID-19 and the Law: Disruption, Impact, and Legacy (2023). editor / I. Glenn Cohen ; Abbe Gluck ; Katherine Kraschel ; Carmel Shachar. Cambridge University Press, 2023. pp. 237 - 252

Bibtex

@inbook{8c795ae57dd5473ca1ec1032ad7648f7,
title = "Addressing Exclusivity Issues: Covid-19 and Beyond",
abstract = "Almost every aspect of the COVID-19 response, from vaccines, diagnostics, and therapeutics to medical equipment, tracking systems, software, and other innovations, are or will become subject to some form of exclusive rights. Many of these involve intellectual property rights (IPRs). By offering innovators the exclusive right to exploit their innovations while recouping the costs of research, development, and other expenditures, IPRs may incentivize the development of new technologies. But IPRs may also preclude others from important research, manufacturing, and distribution. In the same vein, these exclusionary rights allow right holders to set prices in the absence of competition. Since this may limit access to innovations that are crucial for tackling pandemics, IPRs are a key factor in pandemic response and preparedness. Consequently, they have generated much controversy around the globe.Many of these debates have concentrated on traditional IPRs, particularly patent rights. Numerous existing patent claims cover new chemical or molecular entities. Patents are also filed for repurposed drugs and vaccine platforms (e.g., COVID-19 mRNA platforms), with separate patent protection for the vaccine and its elements, including viral particles, adjuvants, and vaccine boosters. Even in situations where no patent protection is available, many COVID-19 therapeutics and vaccines will also obtain regulatory, data, and market exclusivities. Consequently, the specific design and new areas of application for regulatory exclusivities have become an increasingly important issue in general innovation policy debates.This chapter addresses exclusivity issues, with a particular emphasis on regulatory exclusivities for vaccines and therapeutics. We begin with a basic overview of the current regulatory exclusivity landscape in Europe and the US, followed by a discussion of current developments in COVID-19 vaccines and therapeutics. Next, we describe the influence of these technological developments on debates surrounding regulatory exclusivities while describing their relationship to other forms of exclusivities. From these assessments, we draw some lessons for market exclusivity, innovation, and access during the COVID-19 pandemic and beyond.",
keywords = "Faculty of Law, Covid-19, Innovation policy, vaccines, EMA, FDA",
author = "Sinha, {Michael S.} and Sven Bostyn and Timo Minssen",
year = "2023",
doi = "10.1017/9781009265690",
language = "English",
pages = "237 -- 252",
editor = "Cohen, {I. Glenn } and Abbe Gluck and Katherine Kraschel and Carmel Shachar",
booktitle = "COVID-19 and the Law",
publisher = "Cambridge University Press",
address = "United Kingdom",

}

RIS

TY - CHAP

T1 - Addressing Exclusivity Issues

T2 - Covid-19 and Beyond

AU - Sinha, Michael S.

AU - Bostyn, Sven

AU - Minssen, Timo

PY - 2023

Y1 - 2023

N2 - Almost every aspect of the COVID-19 response, from vaccines, diagnostics, and therapeutics to medical equipment, tracking systems, software, and other innovations, are or will become subject to some form of exclusive rights. Many of these involve intellectual property rights (IPRs). By offering innovators the exclusive right to exploit their innovations while recouping the costs of research, development, and other expenditures, IPRs may incentivize the development of new technologies. But IPRs may also preclude others from important research, manufacturing, and distribution. In the same vein, these exclusionary rights allow right holders to set prices in the absence of competition. Since this may limit access to innovations that are crucial for tackling pandemics, IPRs are a key factor in pandemic response and preparedness. Consequently, they have generated much controversy around the globe.Many of these debates have concentrated on traditional IPRs, particularly patent rights. Numerous existing patent claims cover new chemical or molecular entities. Patents are also filed for repurposed drugs and vaccine platforms (e.g., COVID-19 mRNA platforms), with separate patent protection for the vaccine and its elements, including viral particles, adjuvants, and vaccine boosters. Even in situations where no patent protection is available, many COVID-19 therapeutics and vaccines will also obtain regulatory, data, and market exclusivities. Consequently, the specific design and new areas of application for regulatory exclusivities have become an increasingly important issue in general innovation policy debates.This chapter addresses exclusivity issues, with a particular emphasis on regulatory exclusivities for vaccines and therapeutics. We begin with a basic overview of the current regulatory exclusivity landscape in Europe and the US, followed by a discussion of current developments in COVID-19 vaccines and therapeutics. Next, we describe the influence of these technological developments on debates surrounding regulatory exclusivities while describing their relationship to other forms of exclusivities. From these assessments, we draw some lessons for market exclusivity, innovation, and access during the COVID-19 pandemic and beyond.

AB - Almost every aspect of the COVID-19 response, from vaccines, diagnostics, and therapeutics to medical equipment, tracking systems, software, and other innovations, are or will become subject to some form of exclusive rights. Many of these involve intellectual property rights (IPRs). By offering innovators the exclusive right to exploit their innovations while recouping the costs of research, development, and other expenditures, IPRs may incentivize the development of new technologies. But IPRs may also preclude others from important research, manufacturing, and distribution. In the same vein, these exclusionary rights allow right holders to set prices in the absence of competition. Since this may limit access to innovations that are crucial for tackling pandemics, IPRs are a key factor in pandemic response and preparedness. Consequently, they have generated much controversy around the globe.Many of these debates have concentrated on traditional IPRs, particularly patent rights. Numerous existing patent claims cover new chemical or molecular entities. Patents are also filed for repurposed drugs and vaccine platforms (e.g., COVID-19 mRNA platforms), with separate patent protection for the vaccine and its elements, including viral particles, adjuvants, and vaccine boosters. Even in situations where no patent protection is available, many COVID-19 therapeutics and vaccines will also obtain regulatory, data, and market exclusivities. Consequently, the specific design and new areas of application for regulatory exclusivities have become an increasingly important issue in general innovation policy debates.This chapter addresses exclusivity issues, with a particular emphasis on regulatory exclusivities for vaccines and therapeutics. We begin with a basic overview of the current regulatory exclusivity landscape in Europe and the US, followed by a discussion of current developments in COVID-19 vaccines and therapeutics. Next, we describe the influence of these technological developments on debates surrounding regulatory exclusivities while describing their relationship to other forms of exclusivities. From these assessments, we draw some lessons for market exclusivity, innovation, and access during the COVID-19 pandemic and beyond.

KW - Faculty of Law

KW - Covid-19

KW - Innovation policy

KW - vaccines

KW - EMA

KW - FDA

U2 - 10.1017/9781009265690

DO - 10.1017/9781009265690

M3 - Book chapter

SP - 237

EP - 252

BT - COVID-19 and the Law

A2 - Cohen, I. Glenn

A2 - Gluck, Abbe

A2 - Kraschel, Katherine

A2 - Shachar, Carmel

PB - Cambridge University Press

ER -

ID: 256471593