March 22, 2007

Intellectual Property in the Modern Age

Posted by Eric at 1:33 pm | Category: Literature, Pharmaceuticals, Politics, Science

I recently read an interesting PLoS Biology article that covers the issues underlying intellectual property law as it would apply to synthetic biology, or the creation of new organisms and biological building blocks. It tries to address the balance between incentivizing products (such as drugs) by allowing for profit-making and some privatization and the need for openness and freedom to allow research and new innovation to happen.

Over the years, there have been lots of problems with the U.S. Patent system as it tries to keep up with the changing world. In this day and age, a lot of inventions are about ideas, information, and ways to organize such information. Software, algorithms, processes. The patent system wasn’t really designed to handle that kind of innovation, but rather the tangible kind, with physical products that would result.

Now, we have kind of a mess on our hands, and that’s starting to creep into biology. Can we patent the products of human genes? Is it legitimate to patent all diagnostics related to a particular gene? Derek Lowe often talks about patent issues with regards to the biotech and pharmaceutical industries, including the legitimacy of patenting recombinant genes as new chemical entities, and the finer distinctions in filing patents on genes and uses of genes.

For more on patenting genes and uses of genes, see this article from the Council for Responsible Genetics. One of the arguments against being able to patent the uses of genes is that it halts medicine via overly broad patents. Sure, using certain gene sequences to predict disease in a strict algorithm is patentable (and should be encouraged, to induce people to look for new, innovative ways of linking basic biology to medicine), but is using any natural gene for any diagnostic or research whatsoever patentable? That’s what Ariad did with NFkB, a gene that’s implicated in all sorts of biology. If the patent were actually enforced, research and drug development in immunology, inflammation, pain treatment, and so many other things would probably be crippled for the next 10 years. There needs to be some sort of balance, but where that should be struck is a hard question.

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2 Responses to “Intellectual Property in the Modern Age”

  1. rosko Says:
    March 24th, 2007 at 5:18 am

    I also fear the possibility of a patent thicket growing in engineered biological components.

    The courts seem to be willing to uphold patents for outrageously broad and simple things when it regards anything to do with medical diagnostics and treatment, as evidenced by the recent Metabolite Labs vs. LabCorp case. The patent in question here was on the act of concluding that a vitamin deficiency is present if the blood concentration of homocysteine is found to be elevated by a test (ANY test, not just the proprietary one of the patent holder, for which patentability is quite uncontroversial). In effect, the correlation between two biochemical variables was held to be patentable. The worst part was that the patent was interpreted by the court as prohibiting anyone to THINK about the fact that homocysteine levels and vitamin deficiency were correlated.

    Unfortunately, the Supreme Court declined to rule on the case, meaning that for the time being the decision of the lower courts to uphold the patent will stand.

  2. Eric Says:
    March 24th, 2007 at 10:29 pm

    Right now, I do tend to think that the main problems that you and I are talking about with the patent system is caused not only by a broken and underfunded patent office, but that at almost every level, patents are regulated by people who aren’t educated in science and technology. The patent office has most of its work done by BAs who don’t necessarily have the education to understand some of the issues involved. The court system has judges who’s last encounter with learning science may have been high school decades ago. Legislators also tend not to have a strong education in medicine or science. The system can be patched a bit by having scientific or technology advisors, but still, at some point, experts have to step in. I think some sort of patent reform in that respect would help resolve a lot of these problems.

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