US government opposes gene patenting

November 9, 2010 • 12:14 am

by Greg Mayer

In a move that got lost in the run up to the recent US elections, the Federal government has reversed its longstanding policy that genes are patentable. Released the Friday before the elections, and covered by the New York Times the following day, with a follow up article the day before the election, the Justice Department’s brief in the case argued that gene sequences unmodified by man are products of nature, and thus ineligible to be patented; and that isolating the sequence doesn’t change its status. Here’s a summary of the argument:

The district court [which invalidated two gene patents] correctly held, however, that genomic DNA that has merely been isolated from the human body, without further alteration or manipulation, is not patent-eligible. Unlike the genetically engineered microorganism in Chakrabarty [an earlier decision, allowing the patenting of genetically modified organisms], the unique chain of chemical base pairs that induces a human cell to express a BRCA protein is not a “human-made invention.” Nor is the fact that particular natural mutations in that unique chain increase a woman’s chance of contracting breast or ovarian cancer. Indeed, the relationship between a naturally occurring nucleotide sequence and the molecule it expresses in a human cell — that is, the relationship between genotype and phenotype — is simply a law of nature. The chemical structure of  native human genes is a product of nature, and it is no less a product of nature when that structure is “isolated” from its natural environment than are cotton fibers that have been separated from cotton seeds or coal that has been extracted from the earth.

The friend of the court brief was filed in an appeal of a case brought by a group of scientific and medical societies and individuals against Myriad Genetics, which had been granted patents on two genes associated with breast and ovarian cancer. In a surprise ruling last March, US District Court Judge Robert Sweet invalidated the patents (more on the ruling here and here), and the current brief was filed in response to Myriad’s appeal of the adverse ruling. The Feds argue that some aspects of Judge Sweet’s ruling erred, but that it’s main conclusion was correct: “…products of nature do not constitute patentable subject matter absent a change that results in a fundamentally new product. … [T]he purification of native DNA does not alter its essential characteristic– its nucleotide sequence– that is defined by nature…” (pp. 107 & 132 of the ruling, full text here).

The Federal position comes as good news to the scientists and medical groups involved, and to anyone who wants the law to make  sense. The notion that a gene is a human invention, rather than a product of nature, is absurd to any biologist (unless perhaps you were granted one of these bogus patents, which may be one of those cases where, as Upton Sinclair put it, it is difficult to get a man to understand something, when his salary depends upon his not understanding it). This is one instance in which the Obama administration has followed up on his promise that “Science and the scientific process must inform and guide decisions of my Administration on a wide range of issues”.

Russell Blackford has noticed the new anti-patent brief, and also had a nice overview of some of the issues at the time of Sweet’s ruling. NPR also noticed the new brief a few days later.

16 thoughts on “US government opposes gene patenting

  1. Well about time! I could never understand how a gene which already exists in millions of copies could possibly be patentable. It’s just silly.

  2. Absolutely right – it was always a ridiculous idea from the common sense & philosophical points of view. In the EU though it is still patentable – according to an intellectual property legal firm’s website, “if you discover a new gene, but do not know the function of the gene, this would be a discovery as opposed to a patentable invention. However, if you discover that the gene is involved in the pathology of obesity, and you have data showing that modulation of the expression level of the gene can attenuate the development of obesity, then you would have an invention.”

    A question though – will it mean that biotech companies do not pursue research in certain areas because they will not have control over the results, or will it make life easier for biologists? I know a lot of universities are investing in the intellectual property of their researchers in order to create companies that can put money back into the universities.

    1. It makes it harder for people who did the gene sequencing to make money off their information. People should still pay for the work someone else did on the gene sequencing. What is important here is that if you create drugs which interact at the genetic level you don’t have to worry about someone suing you because they have the patent on an affected gene.

      What the law firm may mean is that if you have a gene sequence you can’t patent that because it will be classified as a discovery. However, if you have a new means to control the gene then you have an invention which can be patented.

      At any rate, the human genome was sequenced quite a few years ago; in the USA the patents lapse 17 years after originally approved (though the application may have been filed 5 years ago and just about to be approved) and I can’t imagine how a patent on genes can be extended except by amendment of the patent laws. Anyway, this is a great decision because it removes some impediments to research and it will hopefully also lessen the burden of the USPTO because they can now immediately reject applications for patents on genes.

  3. It’d be like the person who found the Burgess Shale patenting the Cambrian Era; it’s patently absurd! Patenting therapies BASED on these gene sequences should be OK, though.

  4. It might be useful to throw a little insiders light on this question. I was involved in a team that discovered a gene that is involved in the development one of the most common leukemias. While we didn’t try to patent the gene the issue did arise, not as a means to ringfence research on the gene or even to make money for our group but rather as a means of getting commercial involvement for the production of testing kits that would aid diagnosis.
    That said I think it is important to distinguish between the two types of patenting that people seem to be confusing here. I would class them as the commercial testing patent and the ownership patent. The commercial testing patent is usually an effort by a company to patent a genetic testing kit for a particular gene such that other companies cannot get in on the market. This is the Myriad Genetics BrCa test scenario. I would place this on the ‘slightly evil’ side of the scale as it doesnt have major effects on research and is rather limited timewise.
    I would contrast this with the ‘exceedingly evil’ position that was attempted by Craig Venter a few years back when his group tried to patent as many human genes as they could find in their human genome project(without having a clue about their function or possible uses as disease markers etc). Venters approach failed – and led to the demise of Celera (thank goodness! – if he had succeed then he would now be living in a volcanic lair, plotting a new nefarious plan while stroking his white cat and sending out invoices for the use of his intellectual property).
    I am not so worried about the Myriad approach but I guess in the age of cheap genomic sequencing it will become both an anomaly and an actual impediment to gene testing so it is probably for the best that this type of patenting goes the way of Venters approach.

    1. “I would class them as the commercial testing patent and the ownership patent.”

      There are no such things. While the original patent holders may have one intention, anyone can buy a patent and then do as they please – this has happened numerous times in history (for example, the GIF patent). A patent is a patent and the owner can charge pretty much what they want for licensing. There is a “reasonable fee” clause but lawyers rub their hands at the thought of arguing what constitutes a reasonable fee. In fact if a patent troll believes you’re not exploiting the patent as best you can, they may buy the patent off you and do just that.

  5. Does this legislation have any impact on the food guys? Like that GMO corn that’s resistant to the European corn borer? They have a patent on the organism, not the gene, right? You can’t google this stuff without getting a bunch of anti-GMO propaganda… It’s so hard to tell fact from fiction on these polemical topics.

    1. Sweet’s ruling (which might still be overturned on appeal) does not invalidate patents for modified genes or organisms, so resistant strains of corn (which are a human invention) would remain patentable under his legal analysis.


  6. “The notion that a gene is a human invention, rather than a product of nature, is absurd to any biologist …”

    Unless he’s an IDCer who believes the particular gene was created by the Designer [cough]God[cough] who assigned his rights in the gene to the biologist.

  7. Gee, that only took what – 15 years? That was my comment all along way back then – that genes are a product of nature and cannot be patented. However, the actual sequence information can be protected by copyright so you cal sell or license that information to users. The tricky bit there is that someone else can discover it independently and it’s not clear to me if you are protected by copyright when someone else does the experiments and publishes their results.

      1. I thought that would be the case – so the best that an owner of gene sequence information can do is charge for that information until someone else does the experiments and publishes.

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