Seeking Clinical Utility

Myriad Breast Cancer Gene Patent Controversy: Upcoming Genetic Alliance Webinar

Recently, we discussed the ongoing controversy over the invalidation of some of Myriad Genetics' breast cancer gene patents.  The controversy continues to rage in both traditional media and the blogosphere. 

One thing that seems quite clear is the impressive polarization of opinions supporting either side in this case, which likely will end up in the Supreme Court eventually.

For those who are still seeking to understand the perspective of one side or the other in this case, Genetic Alliance is presenting a webinar this Friday, April 30, which should be well worth your time:

Genetic Alliance Webinar

The Myriad Gene Patent Case - What Does it Mean, and Why Does it Matter?

Friday, April 30, 2010, 12:00pm - 1:30pm Eastern Time

Presenters

John Conley - Professor of Law, University of North Carolina - Chapel Hill

Joshua Sarnoff - Professor & Associate Director, Glushko-Samuelson Intellectual Property Law Clinic, Washington College of Law, American University

Hans Sauer - Associate General Counsel for Intellectual Property, BIO

Ann Waldo - Senior Counsel, Genetic Alliance

 

The webinar is free.  Click here to register for it at the Genetic Alliance website.  It should be a very interesting discussion.

 

New Hereditary Breast and Ovarian Cancer Gene: RAD51C

In a paper published online over the weekend in Nature Genetics, Alfons Meindl and colleagues demonstrated that rare monoallelic mutations in the gene RAD51C (which is also newly implicated in Fanconi anemia-like disorder when biallelic mutations are present) confer increased risk for breast and ovarian cancer.  It's too early to really know for sure, but it appears that mutations in this gene may behave somewhat similarly to those in BRCA2 (in terms of high penetrance, the Fanconi anemia pathway connection, etc.).

BayBio 2010 Conference Panel on Next Generation Sequencing - April 7, 2010

I have really enjoyed having an opportunity to help organize the upcoming BayBio 2010 conference (via the BayBio 2010 Advisory Board and the BayBio 2010 Company Presentations Advisory Board).  It will be held on Wed., April 7, 2010 in Burlingame, CA, so I'm putting one last plug in to try to reach those who might be thinking about attending.

In particular, I'm looking forward to having a chance to moderate what should be a fun (and hopefully very useful) panel in the conference's innovation track on the implications of emerging next generation sequencing technologies for the Bay Area biotech industry. 

Here's the lineup:

Moderator

• Matt Mealiffe, MD - Founder/Principal, Clinical Utility Consulting

Panelists

• Rade Drmanac, PhD - Co-Founder and Chief Scientific Officer, Complete Genomics, Inc.
• Omead Ostadan - Vice President, Marketing, Illumina, Inc.
• Eric Schadt, PhD - Chief Scientific Officer, Pacific Biosciences, Inc.
• Daixing Zhou, PhD - Director, Business Development, Life Technologies, Inc.

Hope to see you there!

Myriad Breast Cancer Gene Patents Invalidated

A New York judge invalidated several of Myriad Genetics' breast cancer gene patents this week in a widely watched summary judgment ruling(pdf).  Much has been said about the ruling, which has evoked extremely strong reactions (both positive and negative) from every single person I've discussed it with this week.  However, I want to share several items that I found (on the web, on the radio, and on TV) to be particularly illuminating. 

I've certainly been amply exposed to both perspectives in this case, having worked with many individuals belonging to organizations who are plaintiffs in the case and also having taken care of many women pursuing BRCA1 and BRCA2 testing in the clinic as a clinical cancer geneticist, in addition to having worked in the molecular diagnostics industry.  I'll have more to say on the issue, but for now, I want to share the following useful links: 

1. A PBS NewsHour segment that includes a discussion with Daniel Ravicher, who is a patent lawyer and Executive Director of the Public Patent Foundation (part of the broad coalition of plaintiffs) and Ken Chahine, who is a patent attorney, a visiting professor of law at the University of Utah, and a former biotech CEO (who submitted an amicus brief on behalf of Myriad Genetics in the case):

2. A NPR Science Friday piece has Ira Flatow interviewing Robert Cook-Deegan, MD (Director, Center for Genome Ethics,Institute for Genome Sciences and Policy, Duke University): click here to access the podcast and a transcript.

3. Dan Vorhaus, a lawyer at Robinson Bradshaw & Hinson, writing in Genomics Law Report has a series of quite useful posts with lots of analysis:

• Breaking: District Court Rules Myriad Breast Cancer Patents Invalid
• Pigs Fly: Federal Court Invalidates Myriad's Patent Claims
• More Myriad: Moving Beyond Single Gene Patents

I hope that you find these useful.  I'd love to hear what you think about the ruling in the comments!

Update

For those interested in a not so serious take on the issue, check out Stephen Colbert's clip on the Myriad Genetics' breast cancer gene patents ruling on the Colbert Report here.

Update #2 (April 26, 2010)

We have a new post mentioning an upcoming Genetic Alliance webinar on April 30 that will feature a moderated discussion involving parties supporting either side in the Myriad breast cancer gene patent controversy.  The webinar should be worth your time if you'd like to better understand the perspective of either side in this lawsuit.