Personalised medicine incentives from exclusivities provided by IP and regulatory law Laura Valtere

Format:

Book

Author/Creator:

Valtere, Laura, author.

Series:

Munich studies on innovation and competition ; 2199-7470 v. 22

Munich studies on innovation and competition 2199-7470 volume 22

Language:

English

Subjects (All):

Precision medicine--Law and legislation.

Precision medicine.

Medical laws and legislation.

Physical Description:

1 online resource

Edition:

1st ed.

Place of Publication:

Cham Springer [2026]

Summary:

It is commonly held that the limited market of Personalised Medicine (PM) undermines the relevance of patent protection, given the limited returns on investment. However, contrary to initial assumptions, this study finds that PM markets are not per se unattractive financially because of their size. While each application market may be characterised by a smaller consumer base, this does not represent the entire scale of the market. The same substance may be utilised for a multitude of applications, encompassing both personalised and conventional drugs. In addition, factors such as the added value of more efficient and targeted treatments and cost reduction of clinical trials also enhance PM's appeal. Despite the absence of any substantial challenges to the patentability of PM drugs and diagnostics in Europe, the enforcement of these rights against infringement is notably challenging. The uncertain enforcement environment has been shown to encourage strategic behavior from both patent holders and generic manufacturers, potentially leading to market dysfunction. In light of the patent system's inherent limitations, the study also investigates the regulatory exclusivity framework. This study provides an unprecedented holistic examination of the incentives for PM under patent, supplementary protection certificates, and regulatory laws. The study's findings also reveal that while the EU aspires to lead globally in PM research and acknowledge its societal importance -- especially given ageing populations and mounting healthcare expenses --no specific exclusivity rights for PM have been introduced or the existing ones adapted. In order to address this gap, the author deconstructs the concept of PM from scientific, economic, and normative perspectives to identify potential subjects that could be covered by exclusivity rights. The in-depth analysis effectively demystifies the complex scientific and economic foundations of PM, rendering them accessible and comprehensible. By undertaking this analysis, the author identifies areas within PM that may benefit from the de lege lata exclusivities or from the implementation of dedicated exclusivity rights as well as the incoherences in de lege lata and its application, especially in regard to regulatory law

Contents:

Part A Background

I. Technical background

II. Economic background

III. Legal background

Part B Personalised medicine and the exclusivity rights

I. Patents for personalised medicine drugs and diagnostic tests

II. Supplementary protection certificates for personalised medicine drugs and diagnostic tests

III. Regulatory exclusivities for personalised medicine drugs and genetic diagnostic tests

Part C Conclusions and solutions

I. Patents for personalised medicine

II. Regulatory exclusivities for personalised medicine

III. General issue: market size

References

Notes:

Includes bibliographical references

Online resource; title from PDF title page (SpringerLink, viewed May 4, 2026)

Other Format:

Print version Valtere, Laura Personalised Medicine

ISBN:

9783032040602

3032040604

OCLC:

1588479467

Access Restriction:

Restricted for use by site license