Myriad BRCA breast cancer patent: upheld on appeal.

This decision came down from the federal court of appeals last week, and appears to have largely tracked expectations in terms of Myriad's patent being upheld.


For a very nice, short, non-technical summary of the narrow grounds of the case, see Derek Lowe's always interesting and informative blog, In the Pipeline. (Is he moonlighting as a patent lawyer on the side?)

As for the long term implications of the decision for the personalized medicine industry, see this helpful analysis from the Genomics Law Report:

Looking ahead, it appears increasingly unlikely that Myriad's denouement, when it finally arrives in 2013 or 2014, will produce a significant effect one way or the other on either Myriad or the personalized medicine industry. We think this is likely to be true regardless of the litigation's substantive outcome.

For Myriad, win or lose in court, its challenged patents will expire by the end of 2015. But the company's additional patents (the litigation involves only a small minority of Myriad's overall BRCA portfolio), its decades of experience as the sole provider of clinical BRCA diagnostic testing and its proprietary database of BRCA mutation information should allow Myriad to comfortably maintain its advantage in the marketplace against would-be direct competitors of clinical BRCA diagnostic testing.

More broadly, competition for single-gene diagnostic providers like Myriad is expected to increase thanks to a growing cohort of companies deploying next-generation sequencing platforms to develop multiplex or whole-genome diagnostic and interpretive products. The price for these broad-based products is expected to rival what Myriad and other similar companies currently charge to analyze only one or two individual genes. And the technology employed by these companies - which include Genomic Health, Foundation Medicine, GenomeQuest, Ingenuity, Personalis, Silicon Valley Biosystems and many, many others - may very well invent around any Myriad-style gene patents on isolated DNA sequences that manage to survive both legal challenge and patent expiration, although that proposition has yet to be tested in court.

So Myriad's patent will be upheld, but it's due to expire in a couple of years, and new technologies that look at multiple gene and/or gene-protein interactions will likely prove to be very powerful (and potentially superior) competitors to the incumbent's BRCA test.

Still, we haven't heard the final word from the Surpreme Court on the topic yet.

Related Entries:

keep in touch     Follow Us on Twitter  Facebook  Facebook

Our Research

Rhetoric and Reality—The Obamacare Evaluation Project: Cost
by Paul Howard, Yevgeniy Feyman, March 2013

Warning: mysql_connect(): Unknown MySQL server host '' (2) in /home/medicalp/public_html/incs/reports_home.php on line 17
Unknown MySQL server host '' (2)


American Council on Science and Health
in the Pipeline
Reason – Peter Suderman
WSJ Health Blog
The Hill’s Healthwatch
Forbes ScienceBiz
The Apothecary
Marginal Revolution
Megan McArdle
LifeSci VC
Critical Condition
In Vivo Blog
Pharma Strategy Blog
Drug Discovery Opinion