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Single-cell Gene Expression Profiling Using FACS and qPCR with Internal Standards

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Published on: February 25, 2017

International Divergence in Gene Patenting.

Dianne Nicol¹, Rochelle C Dreyfuss², E Richard Gold³

¹Centre for Law and Genetics, Faculty of Law, University of Tasmania, Hobart, Tasmania 7001, Australia;

Annual Review of Genomics and Human Genetics

|February 21, 2019

Summary

International patent law is diverging on gene patent eligibility, particularly concerning BRCA gene sequences. This divergence may significantly impact industry and consumer access to genetic diagnostics.

Keywords:

Myriad diagnostics genetics international divergence patentable subject matter patents

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Area of Science:

Intellectual Property Law
Biotechnology Law
Genomic Medicine

Background:

International patent law has historically faced challenges in defining patent eligibility for isolated and synthetic DNA sequences.
Key legal decisions, especially in the United States and Australia concerning BRCA gene sequences, have created a divergence in patent eligibility criteria.
This review traces the evolution of gene patenting practices across five major jurisdictions since the 1980s.

Observation:

A notable divergence in international patent law concerning gene sequences and related subject matter has emerged.
This divergence is largely driven by landmark court decisions in the US and Australia regarding the patentability of BRCA gene sequences.
Patent offices, legal systems, and policymakers globally have grappled with establishing clear boundaries for gene-related patent claims.

Findings:

Early gene patenting approaches showed similarities across jurisdictions, making the recent divergence a significant development.
The current legal landscape reflects a complex interplay of judicial decisions and policy responses to gene patenting.
Mapping historical gene patenting events reveals the trajectory leading to the present international legal divergence.

Implications:

The long-term consequences of this legal divergence remain uncertain due to a lack of empirical data.
Potential impacts include significant effects on the biotechnology industry within affected regions.
Consumer access to genetic diagnostic tools and services may be substantially influenced by these evolving patent laws.