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« FDA Releases "Final" Guidances for Industry regarding the Biosimilar Approval Pathway | Main | Court Report »

May 12, 2015


For those interested, the primary article (behind a paywall for probably 12-18 months) can be found here: http://www.sciencemag.org/content/347/6229/1436.long

As with many diseases, ALS seems to be associated with a variety of mutations in multiple genes. Creating reliable genetic tests for susceptibility (similar to breast cancer and cystic fibrosis) is an elusive goal here.

It will be interesting to see the role that intellectual property plays in this field. The genes are all sequenced, and after AMP v Myriad, I would guess that a company can no longer expect patent coverage of genetic testing? The actual sequencing of DNA is rapidly becoming a commodity endeavor with prices dropping. However, this really isn't the problem. It's the interpretation of the genetic data and association with existing disease (both from the scientific and the FDA regulatory perspective) that is difficult.

Agreed, Greg, but let's posit this: someone discovers that there is a test that can predict an individual will develop ALS. There first needs to be a treatment, or else the test is merely a way to prepare for the inevitable. So either the test will be bundled as IP with the drug, or there will be stand-alone IP on the test. When I say "IP" I don't necessarily mean patents; that would be the best way but if the Mayo/Myriad combination continues to be applied as some courts have, then the only economically viable way to protect the test is how Myriad is protecting its franchise at the moment - by keeping the genetic info it has amassed over the past 15 years as a trade secret.

While that will eventually fade it will prevent free dissemination of the info until someone else discovers it, which is a very inefficient process.

Thanks for the comment.

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