Myriad Genetics patent of BRCA (breast cancer) genes denied

By Grant Jacobs 30/03/2010 17


Myriad Genetics face a judicial ruling against their patent of the BRAC1 and BRAC2 genes.

Solution structure ensemble of BRCA1/BARD1 RING domain heterodimer. Brzovic, Rajagopal, Hoyt, King and Klevit Nat. Struct. Biol. 8:833 (2001) (Source: PDB.)
Solution structure ensemble of BRCA1/BARD1 RING domain heterodimer. Brzovic, Rajagopal, Hoyt, King and Klevit Nat. Struct. Biol. 8:833 (2001) (Source: PDB.)

Judge Sweet presented this as to centre around the issue,

Are isolated human genes and the comparison of their sequences patentable?

(Isolated here means ‘extracted in pure form’.)

His ruling goes on to say,

It is concluded that DNA’s existence in an “isolated” form alters neither this fundamental quality of DNA as it exists in the body nor the information it encodes. Therefore, the patents at issues directed to “isolated DNA” containing sequences found in nature are unsustainable as a matter of law and are deemed unpatentable subject matter under 35 U.S.C. §101.

The full ruling is available on-line as a PDF file. (165 pages.)

To my hurried reading, the Judge Sweet has indicated, no, isolated DNA sequences may not be patented just because have been isolated. Read widely this may have implications, not just for Myriad’s patents on the BRAC1 and BRAC2 genes, but for many other applications.

Chromosomal location of BRCA1. (Source wikipedia.)
Chromosomal location of BRCA1. (Source wikipedia.)

I haven’t time to explore this in detail unfortunately–the ruling runs to 156 pages!–so I welcome comments elaborating on my rushed presentation of this news. The ruling mentions a “partial grant”, so I would guess there’s details to be considered too. (Interested readers find Google News a useful source for further stories on this.)

Patently of gene sequences has been deplored by biologists and many others. It would be excellent to think that this might be the beginning of the end of what many see as legal nonsense. (The judicial ruling outlines how the use of ’isolated’ is used in what others perceive as a ’lawyer’s trick’ to get around ’the prohibitions on DNA patenting of the DNA in our bodies’ in the introduction.)

An interesting take on the patent posted earlier this month, points to a paper by Kepler et al who point out that read literally this patent would cover most genes, never mind just the BRCA1 gene. (The patent claims for ’at least 15 nucleotides’ of the BRCA1 gene; most genes would contain 15 nucleotides that matched.)

HT: Many people via twitter.


17 Responses to “Myriad Genetics patent of BRCA (breast cancer) genes denied”

  • Very interesting Grant – a couple of responses from scientists in Australia courtesy of our colleagues at the AusSMC:

    Dr Luigi Palombi is a patent lawyer and author of “Gene Cartels: Biotech Patents in the Age of Free Trade”. He is also an academic at the Centre for the Governance of Knowledge and Development at The Australian National University.

    “This decision is long overdue and confirms everything that I have been saying for some time. Simply isolating a gene from its natural environment or producing a purified form of a protein in an artificial environment is not enough to distinguish it from nature. You need to do a lot more for it to be patentable.

    The judge is clearly making the point that in order to satisfy the basic parameters of patentability you have to show that you have produced something that is markedly different from nature. This judgement will clearly apply beyond the facts of this case. The patent office has been granting patents of this kind since the early 1980s and this is the first time that a court has ruled on it. There will no doubt be an appeal and it may take at least 3 years for it to be resolved. But it certainly sends a message to anyone involved in this area that it is not clear cut any longer. Unless you have created something that is truly an invention, you run the risk that the patent will be invalidated.”

    ———–

    Professor Ian Olver is Chief Executive Officer of Cancer Council Australia

    “A US court ruling that patents should never have been granted for the BRCA1 and BRCA2 gene mutations linked to breast and ovarian cancer reinforces Cancer Council Australia’s call for gene patenting reform in Australia. The judge’s finding that biological materials in an isolated form are discoveries, not inventions, and therefore should not be patented clarifies the ambiguity that has clouded the gene patenting debate. Cancer Council and other non-profit healthcare and research groups have long held the view that natural biological materials should be freely available for research and non-commercial public health purposes.

    For a court in the US – where many of the world’s gene patents are held – to reach such a determination is a major breakthrough towards protecting the public interest from commercial monopolisation of genetic material. The judge thoroughly examined the facts and fundamental issues relating to the patents, producing a 156-page analysis that also ruled as invalid the patenting of tests for identifying the gene mutations. In 2008, the Australian licensee for the BRCA1 and BRCA2 patents tried to establish a commercial monopoly by demanding that public laboratories cease conducting the tests. There was nothing in the law to protect the public interest from such a monopoly.

    This development from the US should send a message to Australian policy makers that there is increasing legal recognition that gene patents are invalid. We trust the Senate committee inquiring into this issue is watching with great interest.”

  • This is excellent news! James Watson co-discoverer of DNA was opposed to such patents and when NIH overuled him he left, or was forced out, in 1992. As the judge correctly notes these are products of nature not intellectual products. Now we are in the absurd position of being able to cheaply and rapidly sequence a persons entire genome. Is every single nucleotide polymorphism found in the individual by the testing company open to being patented. It is to my mind akin to buying a microscope and then claiming a patent on whatever components of life I find there. What about, again as the judge noted, the problem with stifling scientific advance by not being able to openly study the gene in question. I would go one further and say that no DNA sequence whether created artificially or found through sequencing may be patented. Quite often these sequences end up in self replicating or potentially self replicating organisms. There is an interesting story http://healthjournalclub.blogspot.com/2010/03/astonishing-court-case-of-becky-mcclain.html of a microbiologist who is claiming she was inadvertently infected by a genetically engineered virus. The company however, is refusing to release the sequence of the virus in question. Well what if that virus or a future one turned out to be contagious? Can you even place a patent on a computer virus? How much more foolish to claim there is patent protection on a virus that might someday be able to kill you. At the very least, requests by health practitioners or public health officials should over rule patent claims, whether a sequenced part of a genome or one made from scratch. Glad to see this ruling, gene patents hinder scientific advance and were absurd and offensive from the start.

    Paul
    http://healthjournalclub.blogspot.com/

  • Peter & Paul,

    I’ve had the same views myself for ages, like most biologists I suspect. Not being a lawyer, I’ve never really understood why they were allowed the patents in the first place. My own naïve reasoning was that you should not able to patent observations, no matter how complex a procedure you use to make the observation. A DNA sequence is just an observation. (Ditto for crystal or NMR structures, like the one shown in the article, for that matter.)

  • There is an lot articles about this out there, but Genetic Future (http://scienceblogs.com/geneticfuture/2010/03/jaw-dropping_verdict_against_m.php) suggests that Genomics Law Report (http://www.genomicslawreport.com/) is one likely blog source to follow developments.

    I must find time to investigate more to write about the second part that was also invalidated according GLR (I only mention the first above) as it would have relevance for bioinformatics patents.

    For those new to the issue, this page might give you some idea of the issues for the BRCA1/2 testing:

    http://www.cancer.ca/Canada-wide/How%20you%20can%20help/Take%20action/Advocacy%20what%20were%20doing/Gene%20patenting/Breast%20cancer%20genes/Background%20on%20the%20patenting%20of%20BRCA1%20and%202%20genes.aspx?sc_lang=en

    Sorry I didn’t say it earlier, but thanks Peter & Paul for your comments.

  • Actually, I fear everyone is celebrating way too early here. This is only a decision of a lowly court in the Southern District of New York; nothing is surer than that this will be appealed to the Federal Circuit Court, which will likely reverse the decision according to patent experts in the US (see for example Denis Crouch at http://www.patentlyo.com/patent/2010/03/court-essentially-all-gene-patents-are-invalid.html). In short this is a decision on the long (and expensive) road to the Supreme Court, and only then will a decision “stick”.

    The fascinating thing that occurs to me is that, so far as my investigation can tell, there is no equivalent to the BRCA1&2 patent in place in NZ, so making it perfectly legal to perform the genetic testing here. If that is true, why hasn’t some entrepreneurial scientist established an analytical lab to perform the tests here safe from the claws of patent infringement? So far as I understand it all NZ tests are currently sent to Australia to perform. There an equivalent patent is in place, and a licensee carries out all the BRCA1&2 genetic testing for Australasia. Why hasn’t someone thought to establish a business on this side of the “Tassie” where it appears that there is no restriction on performing the test, and to attract Australian samples on the lower cost structure of needing no license?
    (Disclaimer: I am not a patent attorney, nor a lawyer of any colour. Anyone motivated to pursue this strategy should first get competent legal advice on the patent position in NZ, and the consequences of providing results to territories where patent protection exists.)

  • MainlyMe,

    Loose thoughts:

    (As seeds for discussion: I’m not trying to be definitive here!)

    – It is a first step, but you can’t get anywhere if don’t take first steps.

    – Speaking for myself only, I’d leave forecasting the future to TV psychics. Consider this ruling itself, how many people predicted the outcome? (Did you?)

    – It’s just possible Myriad may not appeal. My understanding is that like most companies they have other patents covering other aspects that aren’t affected by this ruling. (I’m scratchy on the details here and haven’t time to look them up right now, so don’t ask me for them.) Their investors might ask that they keep a lower profile, for example, or don’t want investment money tied up in expensive legal battles. Whatever happens, business-watchers will be watching with interest.

    – Leaving Myriad aside, consider other companies at an earlier stage and their investors. Regardless of whatever Myriad does, investors might be more cautious about putting money down on companies whose IP rests on natural DNA sequences for the next wee while.

  • Grant;
    I fear that you misread my position; I do not especially care how the verdict pans out, I just want everyone to understand that the current situation is equivalent to claiming the Webb Ellis Cup when 3-0 up at half-time in the quarter final!

    You ask did I predict this outcome? No. Am I surprised at it? Again, No! It’s an American court and unexpected, even inexplicable, decisions issue frequently. I’m not a gambling man; but mark my words, this WILL be appealed. As the patent blog I referenced in my prior post states, this judgement impacts every patent that claims an isolated gene, and more importantly the businesses that are built on those. Given that impact I suspect that Myriad will not need to spend a penny of their own money as those whose livelihood is threatened by this decision rally to ensure the strongest possible case is mounted in appeal. Likewise the plaintiffs have much at stake, perhaps not financially but in harder currency, principal. So this is, as definitely as anything in the future can be, headed to go all the way in appeal. It’s not yet time to dance on the grave of the US gene patent; we spectators have much entertainment ahead of us yet!

  • Hi Grant,

    I’ve gotten around to writing up my take on this here,
    http://healthjournalclub.blogspot.com/
    if perchance you find it interesting. I understand the idea that we patent protein products of genes, ie penicillin, and so it is not a stretch to say we should patent genes, but as genes are, unlike proteins, heritable traits and often, unlike proteins, in self-propagating organisms there is a distinct difference.

    Ciao,
    Paul

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