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MYRIAD AFTER MYRIAD: THE PROPRIETARY DATA DILEMMA
John M Conley1, Robert Cook-Deegan2, Gabriel Lázaro-Muñoz3
1William Rand Kenan, Jr. Professor at the University of North Carolina School of Law and an investigator in the Center for Genomics and Society at the University of North Carolina School of Medicine. A.B., Harvard; J.D., Ph.D., Duke.
Myriad Genetics is shifting from patent reliance to using its proprietary genetic mutation database. This strategy, while legal, may hinder medical research and health policy objectives.
Area of Science:
- Genetics
- Biotechnology
- Medical Law
Background:
- Myriad Genetics previously held a monopoly on BRCA gene testing.
- Supreme Court rulings and patent expirations are reducing Myriad's patent-based market control.
Purpose of the Study:
- To review Myriad Genetics' current patent portfolio.
- To describe Myriad's litigation strategies against competitors.
- To analyze Myriad's proprietary database strategy and its implications for medical research and health policy.
Main Methods:
- Patent portfolio analysis.
- Review of ongoing litigation.
- Analysis of proprietary database strategy and its potential impact.
Main Results:
- Myriad Genetics faces reduced patent protection but is pursuing litigation.
- Myriad is increasingly relying on its extensive, proprietary genetic mutation database.
- This database provides a unique interpretive advantage, especially for variants of unknown significance.
Conclusions:
- Myriad's database strategy is legally viable but potentially detrimental to medical research and health policy.
- The medical and research communities face challenges in countering this strategy.
- Potential strategies for the research and healthcare communities to address this issue are identified.
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