Patenting genes: the question finally goes to the courts

Students and laypeople alike often view biotech patents with baffled disbelief. How is it possible to patent bacteria? Mice? Cell types and DNA sequences? How can someone else "own" gene sequences that all of us have carried inside our bodies since birth?

Honestly, as a biologist, the concept of patenting a gene doesn't really throw me for a loop. Think about it: although we all have genes, we can't read them unless we use a variety of lab techniques, many of them patented. In turn, reading the sequence isn't any use unless we know why we care - that this gene is relevant and can be used to test for a disease, for example. Tests can be patented. While a gene itself existed centuries ago - long before any gene patents - it couldn't be isolated, sequenced, and put into a useful context until many bright scientists and engineers generated a whole lot of good, incremental ideas.

Now, that doesn't mean that we should patent genes. But it does mean that it's not a simple question of right or wrong. Historically, the idea behind patents is to promote innovation by giving inventors the right to exclude others - temporarily - from profiting from their ideas and hard work. Temporarily. Eventually, the patents on these genes will expire and patients will be able to get generic gene tests - assuming there's a market for them, which with breast cancer seems very likely.

In the meantime, though, we have unhappy patients and unhappy researchers who don't want to - or can't - wait for a generic test. Whose rights are more important?

We may find out soon. The ACLU, breast cancer patients, and researchers are challenging a patent held by Myriad Genetics. You can read more about the suit in an excellent article for Slate by Culture Dish's Rebecca Skloot, or in John Schwartz' article for the NYT.

There's no question that patients are in need. But if the patent system is to be changed, and gene patents (and perhaps other types of biotech patents) no longer issued, what would be the basis for this revision? There are many possibilities. For example,

-genes are products of nature;

-gene patenting offends our cultural value system (ie, human beings and their biological material should not be "owned" - although patents don't exactly confer "ownership" in the usual sense);

-potential harm to patients outweighs the public benefit obtained by encouraging innovation (If the last, then how can we justify the extension of multimillion-dollar patents owned by Big Pharma on brand-name drugs? The high cost of drugs affect many more people than genetic tests do - often forcing them to choose between high out-of-pocket payments, proper medical care, or other necessities);

-gene patents stifle, rather than encourage, innovation (that seems to be the perspective of the researchers involved in the Myriad suit)

There are other possible rationales as well, of course; this list is hardly inclusive. Perhaps a combination of these and other reasons offers the best argument against gene patenting. At any rate, the debate, which straddles patent law, health policy, politics, and the culture of scientific research, is far too complex for a blog post. It needs a book. Fortunately, it turns out there is a book on the history of BRCA gene testing, Myriad Genetics, and the different strategies Myriad used in the US and Britain to corner the market on BRCA testing. Helpful, no? It's called Building Genetic Medicine: Breast Cancer, Technology, and the Comparative Politics of Health Care (Inside Technology), and it's from 2007, so although it predates the current lawsuit, it establishes the background you can't get from brief articles in the mainstream media.

Unfortunately, I haven't actually read the book yet. And since the author is my friend Shobita Parthasarathy, I am doubly embarrassed. Which is why I just bought a copy - and if you are interested in getting more deeply into the weeds on this subject, you may wish to do so too.


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no. the idea behind patents isn't "to promote creativity", is to defend intellectual property.
and generally, you can patent processes, that's legal - on this p.o.v., the processes to read a gene or to use that info for any purpose can be parented, but not the gene itself.
a gene is biological property - and that can be public or personal
it's my opinion.

Frank, the philosophy behind patents is that granting inventors a period of exclusive benefit from the product of their work stimulates innovation, thus benefiting society as a whole. If the benefit to society as a whole was not a concern, patents would arguably not need to expire, and the patent would not need to disclose the invention in detail. Further, genes - purified DNA of a specific sequence - are indeed claimable in patents. I suggest Patents for Chemicals, Pharmaceuticals, and Biotechnology by Grubb if anyone wants to get into the weeds on this, since I'm not going to do it here.

Patenting the PROCESS of extracting a specific gene sequence is one thing but exclusively saying something that exists in all life can only be used and researched through one entity alone is unethical. If another method is found to isolate the same gene and researched for different processes or even the same that should be open commons as long as different steps are used. The idea no one will do anything unless they can make a profit or recoup investment is bald greed and avarice not biomedical ethics to help heal and do no harm.

In my opinion, the best legal argument against allowing patents on genes per se--that is, an isolated DNA segment of a specified nucleotide sequence--in the absence of any novel process, device, or other entity based upon the gene is that given the current state of the biology arts, gene sequences are obvious to one of ordinary skill in those arts.

Yeah, I agree and I think they are cracking down on pure sequence claims now in new patents partly for that reason. If they'd had mol biologists making the decisions back in the day, who knows if they ever would have gone there? But there are already a lot of issued patents including DNA sequence claims out there.

My apologies in advance for a long comment. (Not a sound excuse, but I type reasonably fast...!) I'm not an expert on IP: these are my ruminations on how things ought to be, not expert advice on how they are.

My understanding is that the original idea of patents was a trade-off between exclusive rights and disclosure for the (longer term) benefit of mankind (meant to cover both sexes here...). In the past, some inventors literally took their inventions to the grave. In effect, while they were alive, they use "trade secret" as their means of protection of their invention, but were so cautious about exposing their secret to others that they left no record at all so the public at large lost out in the long term. Patents were developed as a trade-off between inventors (understandable) want to benefit from their invention during their lifetime, but to the invention recorded so that invention didn't just die when the inventors did.

Since then patents have taken on a number of other roles in a sense. Preliminary patents (not the full thing) can be used as a form of advertisement (e.g. patents are scanned by technology companies). Patents can be bought and sold in their own right. And so on.

As for patenting genes... Patents have to have an "invention" somewhere in them, an element of novelty, be non-trivial, etc.

Gene sequences themselves make no sense to patent to me, as not only are they (now) trivial, they are also simply observations of a pre-existing thing. Consider that I decide to try to patent an image of a sunset for therapeutic use as a soothing agent for clients. You can't patent a photograph of it: not only would it be considered trivial, but it'd also be considered not an invention at heart. You could try other ways of recording it, but it seems to me that no matter how complex the observation methodology, it's still just an observation. With that in mind, I get frustrated when I see people trying to argue that because the observation was non-trivial the thing deserves consideration for a patent. In my book, no, it doesn't. (Aside: You can copyright [some kinds of] recorded observations.)

I personally think that the patent offices should block patents that represent observations with no real element of invention and to me this is the nub of why gene sequence patents are a bad idea, not the "triviality" element. Observations can be repeated and are of pre-existing things.

While you could consider patenting the process of sequencing, cloning, etc., genes, as a practical matter the initial versions at least rarely are as they are usually developed in a non-commercial environment and openly published as "common knowledge for all". (i.e. are placed in the public domain.) To me, it makes far more sense to patent the equipment that carries out the process, than the process itself. This also seem fairer to me, as it allows others to carry out the process "by hand" or other means; blocking this is a form of monopoly. They can certainly offer a business model using the process they have developed, but blocking others using a process via patents seems wrong to me.

Wouldn't most processes be a better fit to either work under a trade secret approach, or under a service model? In the case of medical (in the broadest sense), the former isn't realistic.

Patenting a product (not process) that uses knowledge derived from knowing the sequence, etc., of a gene, makes more sense.

I believe that surgical procedures can't be patented. You can patent the instruments used in the procedure, but not the process itself. In a similar light, I have two minds about patents on genetic screening tests. They could patent a device that makes the tests simpler, etc., but the basic test itself is more questionable. They might patent lab kits to perform the test. Alternatively, they might set up a service-based business founded on the fact that they are the original developers of the test.

A related issue is the scope of the patent. I might be persuaded to accept the notion that someone could patent a very specific process, provided others could still develop (different) competing processes. I'd be unhappy at the notion of patenting something as general as, say, "the use of the BRCA1 gene in screening for breast cancer", as it'd be anti-competitive, blocking better (implying different) tests using the same underlying information. Broad patents always strike me as preemptive and anti-competitive.

By BioinfoTools (not verified) on 17 May 2009 #permalink

I think BioInfoTools is just expressing a philosophical position, because there are several things in the comment that do not reflect current law.

I wouldn't say TOTALLY false, CPP. At least, not since 1997. Perhaps it might be better to admit that there are some gray areas with regard to patenting of surgical procedures?

Frank - I'm with you. As long as I'm not an expert, I still feel it's simply unfair to patent genes. It's not something that a scientist created (in opposite to tools or procedure) - it's like patenting US or hair colour. Are they going to sue anybody who happens to have some specific gene or what? It's simply pointless...

Historically, the idea behind patents is to promote innovation by giving inventors the right to exclude others - temporarily - from profiting from their ideas and hard work.

It's actually worse than that--there's no need to produce a working invention any longer (there are many Internet patents written by lawyers on obvious concepts like video over networks that they couldn't and didn't implement) and patents also prevent someone who also invents the idea on his or her own from using their own idea, which has always been a common situation (Elisha Gray and Alexander Bell) but which is even more common due to the trivial nature of so many patents being granted today (IBM patented drawing a line more than one pixel side on a computer screen.)

By John Smith (not verified) on 19 May 2009 #permalink

@7: I recall being told that by a presenter at an IP meeting, I'm merely repeating it. I'm well aware of my limitations in judging the guy's comment, hence why I prefaced this with "I believe that..." Having said that, I believe there is some truth in what I wrote and it's not "totally false" (my emphasis).

More to the point, I did try to point out from the onset that my post is how I feel about the issues, not how they are practised (these are my ruminations on how things ought to be, not expert advice on how they are).

By BioinfoTools (not verified) on 19 May 2009 #permalink


Yes, patent is supposed to promote creativity. Intellectual Property is the device by which it is promoted. From the U.S. Constitution, Article 1, Section 8: "To promote the Progress of Science and useful Arts, by securing for limited Times to Authors and Inventors the exclusive Right to their respective Writings and Discoveries;" ... this give Congress the powers it used to create the Patent Act.

Myriad has patents not just on the methods, which are inventive, but also on the bare sequences of the genes, which are not the products of human invention but rather millions of years of natural evolution. They are inappropriate subject matter for patents, and the PTO has made and maintained a grave error in allowing these patents.

By the way, for some more general philosophical and legal theory behind gene patenting and its problems, my own book came out this March, and is called "Who Owns You? The Corporate Gold Rush to Patent Your Genes"…