ACLU fights gene patents

The ACLU is seeking to have patents on genetic tests overturned on constitutional grounds, arguing that genes are not inventions, and that patents on them do not advance science because the companies that win them are capricious and greedy and deny legitimate researchers access to the patented arts.

On May 12, 2009, the ACLU and the Public Patent Foundation at Benjamin N. Cardozo School of Law (PUBPAT) filed a lawsuit charging that patents on two human genes associated with breast and ovarian cancer are unconstitutional and invalid. The lawsuit was filed on behalf of four scientific organizations representing more than 150,000 geneticists, pathologists, and laboratory professionals, as well as individual researchers, breast cancer and women's health groups, genetic counselors and individual women. Individuals with certain mutations along these two genes, known as BRCA1 and BRCA2, are at a significantly higher risk for developing hereditary breast and ovarian cancers...

"Scientific research and testing have been delayed, limited or even shut down as a result of gene patents, stifling the development of new diagnostics and treatments," said Tania Simoncelli, ACLU science advisor. "The government should be encouraging scientific innovation, not hindering it."

"Patenting human genes is counter to common sense, patent law and the Constitution," said Daniel B. Ravicher, Executive Director of PUBPAT and co-counsel in the lawsuit. "Genes are identified, not invented, and patenting genetic sequences is like patenting blood, air or e=mc2."

ACLU Challenges Patents on Breast Cancer Genes (Thanks to everyone who suggested this!)

• [Anonymous]

  I think the ACLU will be successful with this suit, based on precedent–they have a valid point that if the basis of the patent is nothing more than having identified the genes, this is not a patentable invention. If they have some unique way of testing for the genes, such as using telepathic martian slugs, then they could patent a specific type of test based on the slugs, but it is contrary to the spirit of science to prevent competitors from trying to make a test for BRCA1 or BRCA2 based on the idea that they “own” that sequence for 17 years.

  However, single gene or single protein biomarkers are on the way out. Aside from a very few successes, such as BRCA or PSA, the industry has been pretty unsuccessful at identifying individual biomarkers that accurately and specifically identify people with disease. (That is, without a lot of false positives and false negatives.) The wave of the future is the multiprotein test, and these should have better IP protection, too, because selecting a panel of say, eight biomarkers to test involves a lot more inventiveness than just grabbing a single gene out of a database, and leaves plenty of room for your competitors to try their own mix and see if it’s better. (Gene tests are actually not useful to tell you if you have a disease, only if you have risk of getting the disease later, and it’s very hard to make decisions based on risk. Much better to try to cheaply and accurately identify who has a disease in the earliest stages with a proteomic or metabolomic test.)

  Catherine Shaffer

• [Lester]

  Royalties? Is that why I need to pay your mom so much every time I mix my genes with hers?

• [Anonymous]

  Dear Sir or Madame,
  We are writing to inform you that Myriad Genetics has been recently awarded the patent for the genetic code of the human eye. Please contact us to schedule a payment plan for past and future use of your eyeball(s). If you do not contact us within 30 days we will assume you wish to forfeit their use in respect to our patents. As such, we will have no choice but to recall any and all eyeballs in your use.

  If you wish to request a warranty repair of any defective eyeball products, please be aware before contacting us that there is a limited 30 day warranty starting on the installation date of the said defective eyeball.

  Thank you for your time.

  Be seeing you,
  Myriad Genetics

• [Kieran O’Neill]

  Hmmm – I completely agree with what seems to be the core tenet of this case – that human (and other naturally-occurring genes should not be patented). (Or, in this case, the association between a point mutation and a particular phenotype, which is knowledge, not invention.)

  However, one has to be careful about saying that no genes are patentable – there are certainly synthetic genes which carry out functions beyond those occurring in nature (as well as synthetic combinations of genes, such as plasmid vectors, which I believe do constitute “inventions”.)

  But yes, this trend of patenting discoveries in the U.S. is really, really silly and counterproductive.

• [Anonymous]

  Tania Simoncelli, is a foolish sort. One cannot patent something that was not invented no matter how much money will be generated for the few. If the scientific community will not do the research without monetary reward then they are not actual scientists at all!

• [Michiel]

  I think it needs a “bro”.

• [Zombie]

  What a dark and frightening prospect…. I hope that the ACLU wins this. Why do so many consider making and keeping money as the be all, end all of life’s purpose – even if it be at the sake of their own humanity?

• [Anonymous]

  Point worth making on this: IIRC, the BRCA1/2 patents include the sequence itself, not just a specific means of identifying it. So for example, your body contains 2 copies each of BRCA1 and 2. You may have normal copies, or you may have mutant copies that predispose you to cancer. Odds are you don’t know. Here’s the kicker – Myriad Genetics owns that piece of information about you. It is not legal for you to pay someone to tell you that information (about your own body) without permission from Myriad – no matter how they do it (and Myriad has actually said they won’t license it period, so you have to go through them). If a time-travelling Captain Kirk shows up with a tricorder that hasn’t even been invented yet, and tells you, he has violated Myriad’s patent – because that piece of data about your genome does not belong to you, it belongs to Myriad Genetics.

• [Brainspore]

  We must all owe James Watson and Francis Crick a hell of a lot in royalties.

• [Anonymous]

  It’ll be funny if the courts decide that my genes constitute prior art.

• [Anonymous]

  Be aware that almost 20% of the human genome is already patented, not just BRCA1 and 2. This is bad for medical diagnoses, gene therapies and research that will provide new ways of improving medial treatment through genetics! Write your legislators and take a stand against gene patenting.

  ~Annika (cell biology PhD student)