For the half-year to 31 December 2014, the IPKat's regular team is supplemented by contributions from guest bloggers Rebecca Gulbul, Lucas Michels and Marie-Andrée Weiss.

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Thursday, 13 June 2013

News Flasche: Myriad ruling now out

The IPKat is grateful to his friend Dr Wolfgang Flasche (immatics biotechnologies GmbH) for news that the US Supreme Court has now give its keenly-awaited ruling in Association for Molecular Pathology et al v Myriad Genetics Inc et al (which you can read in full here). The bottom line is that DNA is held not patentable in the US.

Comment to follow when this or another Kat has the chance to read the judgment.

Footnote: the IPKat's scholarly friend Dave Berry has just posted this short note on the decision for the PatLit weblog, here.

10 comments:

Michael Factor said...

Interestingly, although arguably ultra vires, under Israel Patent Office circular MN 64, gene sequences per se. are patentable in Israel.

Michael Factor said...

Interestingly, under Israel Patent Office Circular MN 64, gene sequences are patentable in Israel.

Anonymous said...

Wondering whether the outcome will apply to genes isolated from plants? Would anybody please comment on that. Thank you.

I think that the caselaw is limited to genes isolated from humans only.

Rahul B said...

Not read the judgment yet. But consider this line from syllabus of the opinion-- "Its (cDNA's) creation results in an exons-only molecule, which is not naturally occurring."
---
I think isolated gene too consists exon only molecule. At least, that is what I would do for isolating gene with large introns. General route to isolation of gene is to isolate mRNAs and then using reverse transcriptase to create an exon-only isolated gene for example, mostly done in isolating gene for Insulin - with introns no gene is useful - that is where the isolated gene differs from the same gene in humans. Whether doing so is obvious or not is another question to answer.

Almost 4 years since I left academic research. I will like to know more from the professors and scientists who read this blog.

Anonymous said...

Case law most definitely applies to plants.

The issue decided in the immediate case was human DNA. However, the rationale used was product of nature.

Any product of nature then in a different case with different facts would use the rationale of the case.

That is how law is applied.

Tim Roberts said...

Yes, it must apply to all genes. But only for sequences that already exist in nature. Fairly clear (I would say) that you can claim sequences that don't (or aren't known to) exist in Nature. Quaere, how broadly? For example, can you claim a natural sequence under the control of an(y) exogenous promoter?

Anonymous said...

Thank you, Anonymous @ Friday, 14 June 2013 11:44:00 BST
and Tim for the quick clarification.

Mark Richardson said...

We've got a detailed look at this decision up on IPcopy - http://ipcopy.wordpress.com/2013/06/14/us-supreme-court-rules-that-human-genes-cannot-be-patented-a-look-at-the-myriad-case/

Rahul B said...

I believe that US Supreme Court has done a blunder in their opinion. They have contradicted themselves and have wrongly upheld that human genes are not patent-eligible. By wrongly I mean, their reasoning wasn't sound.

The court has upheld that cDNA is patentable because it is exons only molecules, which signifies human intervention. Now consider the claims of the US5,747,282, one of the patents challenged in the suit. The first two claim reads as:

1. An isolated DNA coding for a BRCA1 polypeptide, said polypeptide having the amino acid sequence set forth in SEQ ID NO:2.

2. The isolated DNA of claim 1, wherein said DNA has the nucleotide sequence set forth in SEQ ID NO:1.

The isolated DNA claim is based on the polypeptide sequence of BRCA1 polypeptide. The polypeptide sequence is 1863 AA sequence. Obviously, it contains no "introns", since they are already cleaved off by RNA splicing. And then the second claim is drawn to Sequence ID No 1. - which has nucleotides that correspond to the amino acids in the BRCA1 polypeptide sequence.

Now consider, the following link :

(http://asia.ensembl.org/Homo_sapiens/Location/View?db=core;g=ENSG00000012048;r=17:41196312-41322290)

The gene sequence of BRCA1 is between 41,196,312 bp-41,322,290 bp (both included) on chromosome 17. Around 125978 while the sequence ID no 1 has only about 6000 bp.

Claim 3 and claim 4 further assert that it may have regulatory sequences, which again are exon only. And claim 14 and claim 15 also support my earlier comment that first polypeptide was obtained and then the DNA sequence was deduced, instead of going by cell lysis, extractions, RNAase digestion etc.

So it can be safely concluded that sequence ID no 2 has no introns and it is all exon molecule.

Now, if SCOTUS can say cDNA as patent eligible, what made them bar sequence ID no 1 from patent eligibility? The opinion seems to have turned blind eye to this logical fallacy and inconsistency. All in all a very very poor opinion by the SCOTUS.

Anonymous said...

Rahul B - you are vastly overreaching and missing the meaning of what they said and the fact that there is no blanket protection for cDNA items. They used the example of short chain cDNA which would be products of nature. If you want to nit pick and point out something else is a product of nature, well good for you, just move that over to the non-eligible side of the ledger.

Think more of the logic (which you are not) and less of the science (which you are) and remember the context: none of these Justices are scientists, and the focus of what they are saying should not be nitpicked to examples.

The point of the decision is clear: you cannot have a patent on something that can be directly found in nature.

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