![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](https://image.slidesharecdn.com/brcabrac12clutteredscotus-131009110039-phpapp01/85/Brca-brac-1-2-cluttered-scotus-1-320.jpg)
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Brca brac 1 & 2 cluttered scotus
- 1. 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
- 2. Gikii September 2013 Ray Corrigan, Open 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.”
- 3. Gikii September 2013 Ray Corrigan, Open University 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."
- 4. Gikii September 2013 Ray Corrigan, Open University Celebrations all round AMP: We won! Myriad Genetics: We won!
- 5. Gikii September 2013 Ray Corrigan, Open University Scotus reasoning Unanimous but confused
- 6. Gikii September 2013 Ray Corrigan, Open University Source: National Human Genome Research Institute via http://upload.wikimedia.org/wikipedia/commons/0/07/Gene.png
- 7. Gikii September 2013 Ray Corrigan, Open University “A naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated”
- 8. Gikii September 2013 Ray Corrigan, Open University Information patents Not Chemistry patents pp14 - 15
- 9. Gikii September 2013 Ray Corrigan, Open University A bit of chemistry…
- 10. Gikii September 2013 Ray Corrigan, Open University 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
- 11. Gikii September 2013 Ray Corrigan, Open University No functional information distinction between and
- 12. Gikii September 2013 Ray Corrigan, Open University Information patents Not Chemistry patents
- 13. Gikii September 2013 Ray Corrigan, Open University 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
- 14. Gikii September 2013 Ray Corrigan, Open University 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
- 15. Gikii September 2013 Ray Corrigan, Open University "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
- 16. Gikii September 2013 Ray Corrigan, Open University
- 17. Gikii September 2013 Ray Corrigan, Open University 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
- 18. Gikii September 2013 Ray Corrigan, Open University Yet Myriad gets to control the recipes
- 19. Gikii September 2013 Ray Corrigan, Open University 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
- 20. Gikii September 2013 Ray Corrigan, Open University 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.
- 21. Gikii September 2013 Ray Corrigan, Open University 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?
- 22. Gikii September 2013 Ray Corrigan, Open University 2. How do we begin to inject a modicum of scientific & technical literacy into the courts & legislatures?
Notas del editor
- BRCA1 Breast cancer susceptibility gene 1 is found on chromosome 17 BRCA2 Breast cancer susceptibility gene 1 is found on chromosome 13
- Myriad Genetics, as is clear from the statement about the case on their website, see the decision largely as a victory in two respects - Firstly although the Court struck down the company's claimed ownership of the naturally occurring DNA segments that are the BRCA1 and BRCA1 genes, they upheld Myriad's patent claims relating to complementary DNA, cDNA. (Note cDNA is called complementary DNA by experts, not 'composite' DNA, the term used by Justice Thomas in the decision). So Myriad has the exclusive right to synthetically create BRCA1&2 cDNA. Secondly, though the case was not reviewing Myriad's method patents – patents relating to the way the company does genetic testing, biotech research and other processes – the company are interpreting some of the remarks of Justice Thomas in Part III of the ruling as re-inforcing all of their method patent claims. The Association for Moleular Pathology seems equally pleased: "The decision helps to lay the foundation for continued research and application of diagnosis and treatment of diseases at the molecular level. "AMP applauds the U.S. Supreme Court on their ground breaking, unanimous decision. There is no question that this is a critical and right decision for the future of medicine and science. Biomedical researchers, clinicians, and most importantly patients will see great benefit from this development," said Jennifer L. Hunt, MD, MEd, AMP President."
- The fact that the Court has decided that a naturally occurring DNA segment is not patentable is clear. The attempted logic they use to get from there to the patentability of cDNA is flawed.
- Justice Thomas goes to great pains to emphasise that the Myriad patents under review are information patents not chemistry patents (see p14): ...extensive effort alone is insufficient to satisfy the demands of §101. Nor are Myriad’s claims saved by the fact that isolating DNA from the human genome severs chemical bonds and thereby creates a nonnaturally occurring molecule. Myriad’s claims are simply not expressed in terms of chemical composition, nor do they rely in any way on the chemical changes that result from the isolation of a particular section of DNA. Instead, the claims understandably focus on the genetic information encoded in the BRCA1 andBRCA2 genes" Merely doing chemistry and breaking a chunk of gene out of a DNA chain is not enough to grab ownership of that gene. That makes sense. We shouldn't be allowed to cut up products of nature and say we now own the offcuts.
- If you really want to understand this stuff it’s hard to beat an in depth study of Molecular Biology of the Cell 5 th ed (2008) by Bruce Alberts , Alexander Johnson , Julian Lewis, Martin Raff, Keith Roberts & Peter Walter
- DNA chains have useful functional sequences of crossbars called exons and less useful sequences called introns. On the route from DNA - to RNA where the DNA unwinds into single strands from the original double helix to the removal of the useless introns to mRNA where the exons spliced back together in their original sequence then on to the production amino acids and proteins in cells the naturally occurring information content of the DNA does not change . So breaking down BRCA1&2 genes, stripping out the introns and putting the genes back together as cDNA without the introns does not change the information content of the genes . So if the DNA is not patentable the equivalent cDNA cannot be patentable, from an information perspective.
- Let's put it another way. The collections of genes inside living cells are a bit like the cells' recipe books. When a cell needs to do something like manufacture a protein it consults the gene recipe book and follows the instructions there. BRCA1&2 DNA and cDNA have the same information content, in the same order, the same recipes. The BRCA1&2 cDNA recipe book might be shorter and neater, stripped of the waste intron pages, but it contains the same instructions, methods, recipes.
- Master slide corner image courtesy of the Human Genome Research Institute http://www.genome.gov/glossary/resources/dna_deoxyribonucleic_acid.ppt
- Courts, legislatures and commerce are mucking about with the building blocks of life.
- If courts & legislatures are doling out real estate in the information that constitutes the building blocks of life, they really should understand what it is they are giving away.