Question: (Closed) Can A Biomarker Be Exclusively Licensed?
gravatar for Casbon
9.3 years ago by
Casbon3.2k wrote:

I read a press release from IntraGen which announces (emphasis mine)

IntegraGen, a French biotechnology company dedicated to gene discovery and the development of molecular diagnostic products and services, announced today that it has entered into an exclusive licensing agreement with The Johns Hopkins University and Massachusetts General Hospital to commercialize genetic tests that identify children at risk for autism which include a mutation to the Jumonji, AT Rich Interactive Domain 2 (JARID2) gene. Researchers at The Johns Hopkins University School of Medicine, Massachusetts General Hospital and IntegraGen have demonstrated that a specific mutation to this gene, known as a single-nucleotide polymorphism (SNP), is found in individuals with autism. IntegraGen has recently reported that the risk of autism is increased in children who have older siblings diagnosed with autism when this mutation of the JARID2 gene is found in combination with autism-related point mutations (SNPs) on other genes.

I found a publication from John Hopkins in Nature that shows rs7766973 is associated with Autism.

Now, the recent Myriad decision upheld the notion that the isolation of the gene is patentable, but that the information about which mutations are correlated with phenotypes is not patentable.

So is this just marketing speak for the idea that the particular test embodiement (i.e. gene isolation) is exclusively licensed, whilst anyone is free to perform this test if the data arises from, for example, whole genome sequencing?

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ADD COMMENTlink modified 9.3 years ago by Michael Dondrup48k • written 9.3 years ago by Casbon3.2k

I worked at Integragen for 7 seven years. I've forwarded your question to the director of sales.

ADD REPLYlink written 9.3 years ago by Pierre Lindenbaum131k

(later)... he's currently on vacation.

ADD REPLYlink written 9.3 years ago by Pierre Lindenbaum131k

Thanks, Pierre!

ADD REPLYlink written 9.3 years ago by Casbon3.2k

Thanks Pierre, I suppose it is August in France ;)

ADD REPLYlink written 9.3 years ago by Casbon3.2k

Btw, I just noticed this might be off-topic. What does legaleese have to do with bioinformatics?

ADD REPLYlink written 9.3 years ago by Michael Dondrup48k

@Michael. Agreed. I have labeled this question and closed it as off-topic since it is not a bioinformatics question.

ADD REPLYlink written 9.3 years ago by Casey Bergman18k

Casey, I think you're wrong. The legal protection of SNPs is clearly hugely important for for bioinformatics, which four upvotes clearly agree. I think I'm leaving and not coming back after this and your RTFM nonsense as well. Goodbye, Biostar!

ADD REPLYlink written 9.3 years ago by Casbon3.2k

@Casbon. I'm happy to re-open this question if there is support from others in the community, but as it currently reads, the question does not directly address a bioinformatics issue and is therefore off-topic, as correctly noted by Michael. I'm puzzled by your RTFM comment -- following the code of practice of e.g. the Ubuntu forum ( I never use RTFM since I think it is an insulting acronym. Neverthless, I hope that we do see you back on BioStar since your contributions are valued here!

ADD REPLYlink written 9.3 years ago by Casey Bergman18k

@Casbon, I hope to see you again after a 'cool-down' xD. I noticed that this is off-topic while trying to write an answer. Why? because I know bioinformatics but I am not a lawyer, and I simply guess most people reading this forum aren't. That means in this case most answers would be just guessing and oppinion, and a patent lawyer might be reluctant to answer this given the mere complexity of the problem. Not only that this is (borderline?) off-topic, any answer from a non-expert could cause trouble for anyone taking such answer seriously.

ADD REPLYlink written 9.2 years ago by Michael Dondrup48k
gravatar for Istvan Albert
9.3 years ago by
Istvan Albert ♦♦ 85k
University Park, USA
Istvan Albert ♦♦ 85k wrote:

IMHO any such genetic testing methodology has to be practical, efficient, reproducible, commercially feasible etc. Each of these requirements may include a series of patentable concepts and approaches. I read the announcement above as licensing the "know how" rather than patenting the information itself. I could be wrong.

ADD COMMENTlink written 9.3 years ago by Istvan Albert ♦♦ 85k
gravatar for Michael Dondrup
9.3 years ago by
Bergen, Norway
Michael Dondrup48k wrote:

Answering in the sense of your headline: "Can a biomarker be exclusively licensed?" Afaik (please ask your favorite patent lawyer...) Yes! Given, holding a valid patent (irrespective of the content), the patent holder is free to license it to whomever he/she pleases, to a single licensee, many, or to none at all.

Maybe then the question arises, can there exist valid patents on biomarkers? That may depend a bit on the patent laws of the country. Again afaik, for both US and (upcoming?) EU patents, not the invidual SNP can be patented but an application based on the biomarker (rsXYZ), e.g. not in the sense that you may no longer mention the SNP or write an article about the association with a disease; but to patent the invention to develop a clinical test for autism based on the SNP rs7766973. If the patent holder doesn't want or cannot develop that test, then the license to do so could be given/sold to another institution. I think that is what happened here. For obtaining US patents (again afaik), some quality criteria a mentioned by Istvan may be required.

ADD COMMENTlink written 9.3 years ago by Michael Dondrup48k

legal notice: Ignore this post xD

ADD REPLYlink written 9.2 years ago by Michael Dondrup48k
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