Patents and Innovation: Friends or Foes?

Lévèque, François; Ménière, Yann

doi:10.2139/ssrn.958830

Cited by 14 publications

(5 citation statements)

References 108 publications

(139 reference statements)

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“…Throughout the course of patent law history, and especially in modern times, inventors are seeking to protect their intellectual property from illegal competition as a means to increase profitability for a limited time 217 . However, the question of whether patents accelerate or restrict innovation has not been brought up for discussion 218 . A different, yet no less controversial, debate arises during global emergencies (such as wars or pandemics) over patent waiver.…”

Section: Bottom-up Preparation Methodsmentioning

confidence: 99%

Nanodelivery of nucleic acids

2022

Nat Rev Methods Primers

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Gene therapy uses nucleic acids as functional molecules to activate biological treatment for a wide range of diseases, such as cancer 1,2 , cystic fibrosis 3 , heart disease 4 , diabetes 5 , haemophilia and HIV/AIDS 6 . Nucleic acids have been attracting increasing attention owing to the global effort in the human genome elucidation together with recent discoveries such as RNA interference (RNAi) and CRISPR-based genome editing [7][8][9] . Gene therapy uses genetic material to alter the expression of a target gene or to modify the biological properties of living cells for therapeutic needs. In recent years, multiple gene therapy products have been approved by the regulatory agencies for various applications 10 . Perhaps the most relevant example is the authorization of mRNA vaccines to fight the COVID-19 outbreak 11 .Gene therapy can be divided into three main avenues, as detailed in Fig. 1. First is editing mutated genes using CRISPR-Cas technology to cause gain or loss of function 12,13 . Second, upregulating gene expression can be achieved through the insertion of a functional gene copy to be expressed by using molecules such as DNA plasmid (pDNA), minicircle DNA (mcDNA), synthetic mRNA, circular RNA and self-amplifying RNA (saRNA) [14][15][16] . Last is downregulating gene expression using molecules such as small interfering RNA (siRNA), antisense oligonucleotides (ASOs), short hairpin RNA (shRNA) and microRNA (miRNA) 17,18 .Nucleic acids have promising advantages compared with conventional drugs 19 . Unlike the latter, the mechanism of action and high specificity of nucleic acids present a possible therapy route for viral infections, various cancers and undruggable genetic disorders with unmet clinical need. Moreover, theoretically, a single treatment of the genetic payload can achieve a durable and even curative effect 20 . However, delivering nucleic acids to reach their active site inside the cell is challenging owing to their low in vivo stability and rapid host clearance outside cells. Additionally, nucleic acids are poorly permeable through the cellular membrane owing to their negative charge, high molecular weight and hydrophilicity 21 . Nonetheless, few delivery challenges differ between DNA and RNA. For example, the payload and carrier toxicity are of greater concern when delivering RNA molecules usually associated with short-term activity and low retention inside the cell, hence requiring more frequent administration 22 . Alternatively, DNA activity inside the nucleus adds complexity related to low nuclear transport, thus leading to distinguishing design concepts regarding the delivery system compared with RNA molecules 23 . Together with specific challenges relevant to the delivered molecule, the fundamental challenge is to develop tailored systems that can facilitate nucleic acid uptake into target cells. The carrier itself needs to overcome extracellular and intracellular barriers, provide protection from nuclease activity in the bloodstream, enhance and assist with cellular uptake, and promote ...

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Section: Bottom-up Preparation Methodsmentioning

confidence: 99%

Nanodelivery of nucleic acids

2022

Nat Rev Methods Primers

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“…An overview of general law and economics literature on the patent bargain offers neutral to negative support for such a claim. 179 The patent bargain, which provides the utilitarian justification of patent rights, namely that a private monopoly right is justified for the public good, requires calculation of values that are difficult to quantify. 180 Landes and Posner, in their economic analysis of IP law, remark: '[W]hether the benefits exceed the costs is impossible to answer with confidence on the basis of present knowledge.'…”

Section: Analysing the Argument That The Trips Waiver Will Weaken Innovation Incentivesmentioning

confidence: 99%

The TRIPS Intellectual Property Waiver Proposal: Creating the Right Incentives in Patent Law and Politics to end the COVID-19 Pandemic

et al. 2021

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The structure of global intellectual property law as incorporated in the World Trade Organization (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) is implicated in the current lack of COVID-19 vaccines, medical equipment, medicines and diagnostics needed to combat the pandemic. In this paper, we elucidate the legal issues surrounding the 'TRIPS waiver' proposal initially put forward by India and South Africa in October 2020, which, as of June 2021, is supported by more than 60 states. We analyse the different intellectual property rights relevant to the proposal -focusing primarily on patent rights and trade secrets -which are most relevant to the present COVID-19 vaccine context. We explain why the existing TRIPS flexibilities around compulsory licensing are incapable of addressing the present pandemic context adequately, in terms of both procedure and legal substance. Given the ongoing absence of sufficient engagement by the pharmaceutical industry with proposed global mechanisms to share intellectual property rights, data and know-how to address the pandemic, we argue that both incentives and mandatory mechanisms are needed.We make two arguments to this effect: first, the TRIPS waiver is a necessary and proportionate legal measure for clearing intellectual property (IP) barriers in a direct, consistent and efficient fashion, enabling the freedom to operate for more companies to produce COVID-19 vaccines and other health technologies without the fear of infringing another party's IP rights and the attendant threat of litigation; and second, the TRIPS waiver acts as an important political, moral and economic lever towards encouraging solutions aimed at global equitable access to vaccines, which is in the wider interest of the global public. The TRIPS waiver is an essential legal instrument in this context for enabling a radical increase in manufacturing capacity, and hence supply, of COVID-19 vaccines, creating a pathway to achieve global equitable production and access.

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“…Analysts are therefore quick to point out that the market advantage of patent exclusivity spurs pharmaceutical companies to invest further in other research ventures (Grabowski, , p. 849; Levin, Klevorick, Richard, Nelson, & Winter, , p. 783) . By conferring a temporal “exclusive market position,” (Leveque & Ménière, , p. 10) inventors and investors can recover spending costs and also benefit through profits from sales which provide the capital to reinvest in other medicinal R&D undertakings (PhRMA, 2015, pp. 26–29).…”

Section: Part Ii: Patents the Trips Agreement And Access To Essentimentioning

confidence: 99%

“…Third, having invested financially and undertaken the risk associated with the development and research of a new drug, a patent secures the inventor's interest against imitation and commercial appropriation of inventive results, because new drugs can quickly be reverse engineered and reproduced in bulk (Leveque & Ménière, , p. 21; Scherer, , p. 8). This argument leads commentators to point out that a patent is significant to pharmaceutical firms because it is an effective tool to ward off and control competition (Bessen & Meurer, , p. 10; Shadlen et al, , p. 2) .…”

Section: Part Ii: Patents the Trips Agreement And Access To Essentimentioning

confidence: 99%

A re‐evaluation of the framework for the protection of patents, women’s health in Nigeria and the issue of accessing pharmaceutical innovation in Africa: Designing strategies for medicines

Mike

2019

World Intellectual Property

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The objective of this study is to make a case for Nigerian women to have access essential medicines in light of patent protection of pharmaceuticals. Consequently, this study argues for an improvement of women's access to medicines within the context of patent law and rights, the available flexibilities in the international IP regime of the Trade Related Aspect of Intellectual Property Rights (TRIPS) Agreement and Nigeria's national patent system. Towards this goal, the article makes the point that patent law and its exclusive rights, both the TRIPS Agreement and national law of Nigeria, do not exist in a social welfare vacuum. The legal text of patent law, which confers rights on inventors when enforced, translates to many other things outside the sphere of property rights; indeed, it can be a matter of life and death. It is argued in this regard that patent right could, in effect, interfere with access to medicines and therefore, the right to health and prospects for human development. This study adopts a doctrinal methodology to examine, analyse, and evaluate the issues that have arisen in the context of patent protection of pharmaceuticals and its effect on access medicines. It concludes that while the hindrances to accessibility of essential drugs in Nigeria are multifaceted and demand a multidimensional approach for a lasting solution, the TRIPS flexibilities are significant means for addressing the challenges of affordable access to important health treatments within the context of patent law. However, it is emphasised that utilising the flexibilities will require that Nigeria's patent system is strategically designed to take full advantage of the available exceptions, safeguards, and options.

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Patents and Innovation: Friends or Foes?

Cited by 14 publications

References 108 publications

Nanodelivery of nucleic acids

Nanodelivery of nucleic acids

The TRIPS Intellectual Property Waiver Proposal: Creating the Right Incentives in Patent Law and Politics to end the COVID-19 Pandemic

A re‐evaluation of the framework for the protection of patents, women’s health in Nigeria and the issue of accessing pharmaceutical innovation in Africa: Designing strategies for medicines

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