The continuing saga of patents and non‐invasive prenatal testing

Autor: Hawkins, Naomi, Nicol, Dianne, Chandrasekharan, Subhashini, Cook‐Deegan, Robert
Jazyk: angličtina
Rok vydání: 2019
Předmět:
Zdroj: Prenatal Diagnosis
ISSN: 1097-0223
0197-3851
Popis: Objective This paper examines the Intellectual Property (IP) landscape for non‐invasive prenatal testing (NIPT) in three key regions: the United States; Europe, with particular focus on the United Kingdom; and Australia. Method We explore the patent law issues against the commercial and healthcare environment in these regions and consider the implications for development and implementation of NIPT. Results There are many patents held by many parties internationally, with litigation over these patents ongoing in many countries. Importantly, there are significant international differences in patent law, with patents invalidated in the USA that remain valid in Europe. Despite the many patents and ongoing litigation, there are multiple providers of testing internationally, and patents do not appear to be preventing patient access to testing for those who can pay out of pocket. Conclusion The patent situation in NIPT remains in a state of flux, with uncertainty about how patent rights will be conferred in different jurisdictions, and how patents might affect clinical access. However, patents are unlikely to result in a monopoly for a single provider, with several providers and testing technologies, including both public and private sector entities, likely to remain engaged in delivery of NIPT. However, the effects on access in public healthcare systems are more complex and need to be monitored.
What's already known about this topic? Non‐invasive prenatal testing (NIPT) is a rapidly growing field of testing, with significant commercial involvement and a number of relevant patents.The patents in this field have caused concern about implications for access to testing.Recent court decisions and company acquisitions have settled some of these patent disputes and abated some of the concerns about access to testing in the United States, but significant controversy continues in the rest of the world. What does this study add? This study sets out the current law, including recent cases relevant to NIPT, and considers the implications of this law against the commercial environment in the United States, Europe, and Australia, for the future development and delivery of NIPT internationally.
Databáze: OpenAIRE
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