Brca brac 1 & 2 cluttered scotus

Gikii September 2013 Ray Corrigan, Open University

BRCA [Brac]1 & 2 – The cluttered reasoning of the US Supreme Court in

AMP v Myriad Genetics

Gikii VIII at the seaside

Bournemouth University


Association for Molecular Pathology v. Myriad Genetics, 569 U.S. 12-398 (2013)

http://www.supremecourt.gov/opinions/12pdf/12-398_1b7d.pdf

“A naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated, but cDNA is patent eligible because it is

not naturally occurring.”


Justice Scalia

Did not sign up to the majority description of the “fine details” of the science but concurred:

“the portion of DNA isolated from its natural state sought to be patented is identical to that portion of the DNA in its natural state; and that complementary DNA (cDNA) is a synthetic creation not normally present in nature."


Celebrations all round

AMP: We won!

Myriad Genetics: We won!


Scotus reasoning

Unanimous

but

confused


Source: National Human Genome Research Institute via http://upload.wikimedia.org/wikipedia/commons/0/07/Gene.png


“A naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated”


Information patents

Not

Chemistry patentspp14 - 15


A bit of chemistry…


Source: National Human Genome Research Institute http://www.genome.gov/Images/EdKit/bio2i_large.gif via http://commons.wikimedia.org/wiki/File:DNA_exons_introns.gif

http://www.genome.gov/Images/EdKit/bio2i_large.gif

http://commons.wikimedia.org/wiki/File:DNA_exons_introns.gif


No functional information distinction between

and


Information patents

Not

Chemistry patents


But…

“cDNA does not present the same obstacles to patentability as naturally occurring, isolated DNA segments…the lab technician unquestionably creates something new when cDNA is made. cDNA retains the naturally occurring exons of DNA, but it is distinct from the DNA from which it was derived. As a result, cDNA is not a “product of nature” and is patent eligible”

Part II C, p16, one paragraph


So…

• BRCA1 & BRCA2 genes are naturally occurring DNA segments (with naturally occurring exon recipe books)

• they are not patentable just by cutting them out of the DNA chain

• Chemistry doesn't cut it - to earn patent control • BRCA1&2 cDNA, however, (with their naturally occurring

exon recipe books with the same natural recipes) are patentable because they are different without the introns and there's more chemistry


"Myriad did not create or alter either the genetic information encoded in the BCRA1 (sic) and BCRA2 (sic) genes or the genetic structure of the DNA. It found an important and useful gene, but groundbreaking, innovative, or even brilliant discovery does not by itself

satisfy the §101 inquiry." P2, Syllabus



I don’t get it

Myriad has not created or altered the functional genetic information – the naturally occurring recipe book –

encoded in the BRCA 1 and BRCA2 cDNA


Yet Myriad gets to control the recipes


Summary

• The dispute is concerned primarily with the information contained in the genetic sequence

• Myriad cannot control the information in the naturally occurring DNA segments that are the BRCA1 & BRCA2 genes;

• these are products of nature and not patent eligible merely because they have been discovered/isolated

• Myriad can control the same information after some chemistry has tidied up the naturally occurring DNA and turned it into synthetic cDNA


In other words -

It's not about chemistry.

It's about information.

The information cannot be commercially controlled.

If you do some chemistry the same information can be commercially controlled.

QED.


2 Qs for Gikii…

1. Was this cluttered thinking by Scotus or a result driven decision based on the justices’ concerns about inhibiting the

biotech industry?


2. How do we begin to inject a modicum of scientific & technical literacy into the

courts & legislatures?

Education

Brca brac 1 & 2 cluttered scotus