Literature DB >> 25544836

MYRIAD AFTER MYRIAD: THE PROPRIETARY DATA DILEMMA.

John M Conley1, Robert Cook-Deegan2, Gabriel Lázaro-Muñoz3.   

Abstract

Myriad Genetics' long-time monopoly on BRCA gene testing was significantly narrowed by the Supreme Court's decision in AMP v. Myriad Genetics, Inc., and will be further narrowed in the next few years as many of its still-valid patents expire. But these developments have not caused the company to acquiesce in competition. Instead, it has launched a litigation offensive against a number of actual and potential competitors, suing them for infringement of numerous unexpired patents that survived the Supreme Court case. A parallel strategy may have even greater long-term significance, however. In announcing expanded operations in Europe, Myriad has emphasized that it will rely less on patents and more on its huge proprietary database of genetic mutations and associated health outcomes-a strategy that could be used in the United States as well. Myriad has built that database over its many years as a patent-based monopolist in the BRCA testing field, and has not shared it with the medical community for more than a decade. Consequently, Myriad has a unique ability to interpret the health significance of patients' genetic mutations, particularly in the case of rare "variants of unknown significance." This article reviews the current state of Myriad's patent portfolio, describes its ongoing litigation offensive, and then analyzes its proprietary database strategy. The article argues that Myriad's strategy, while legally feasible, undercuts important values and objectives in medical research and health policy. The article identifies several ways in which the research and health care communities might fight back, but acknowledges that it will be a difficult uphill fight.

Entities:  

Year:  2014        PMID: 25544836      PMCID: PMC4275833     

Source DB:  PubMed          Journal:  N C J Law Technol        ISSN: 1542-5177


  13 in total

Review 1.  Human genotype-phenotype databases: aims, challenges and opportunities.

Authors:  Anthony J Brookes; Peter N Robinson
Journal:  Nat Rev Genet       Date:  2015-11-10       Impact factor: 53.242

2.  Are the gene-patent storm clouds dissipating? A global snapshot.

Authors:  Johnathon Liddicoat; Tess Whitton; Dianne Nicol
Journal:  Nat Biotechnol       Date:  2015-04       Impact factor: 54.908

3.  A universal genetic testing initiative for patients with high-grade, non-mucinous epithelial ovarian cancer and the implications for cancer treatment.

Authors:  Erica M Bednar; Holly D Oakley; Charlotte C Sun; Catherine C Burke; Mark F Munsell; Shannon N Westin; Karen H Lu
Journal:  Gynecol Oncol       Date:  2017-06-10       Impact factor: 5.482

4.  Brazilian legal and bioethical approach about donation for research and patents of human body parts.

Authors:  Márcia Santana Fernandes; Lúcia Silla; José Roberto Goldim; Judith Martins-Costa
Journal:  J Community Genet       Date:  2017-05-29

5.  Protecting products versus platforms.

Authors:  Jacob S Sherkow
Journal:  Nat Biotechnol       Date:  2016-05-06       Impact factor: 54.908

6.  Economic regulation of next-generation sequencing.

Authors:  Barbara J Evans
Journal:  J Law Med Ethics       Date:  2014       Impact factor: 1.718

7.  Integrating Genomics into Psychiatric Practice: Ethical and Legal Challenges for Clinicians.

Authors:  Eric T Ward; Kristin M Kostick; Gabriel Lázaro-Muñoz
Journal:  Harv Rev Psychiatry       Date:  2019 Jan/Feb       Impact factor: 3.732

8.  BRCA1/2 Variant Data-Sharing Practices.

Authors:  Juli M Bollinger; Abhi Sanka; Lena Dolman; Rachel G Liao; Robert Cook-Deegan
Journal:  J Law Med Ethics       Date:  2019-03       Impact factor: 1.718

Review 9.  "The Google of Healthcare": enabling the privatization of genetic bio/databanking.

Authors:  Kayte Spector-Bagdady
Journal:  Ann Epidemiol       Date:  2016-06-01       Impact factor: 3.797

Review 10.  Sharing data under the 21st Century Cures Act.

Authors:  Mary A Majumder; Christi J Guerrini; Juli M Bollinger; Robert Cook-Deegan; Amy L McGuire
Journal:  Genet Med       Date:  2017-05-25       Impact factor: 8.822

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