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Here we'll explore the nexus of legal rulings, Capitol Hill policy-making, technical standards development, and technological innovation that creates -- and will recreate -- the networked world as we know it. Among the topics we'll touch on: intellectual property conflicts, technical architecture and innovation, the evolution of copyright, private vs. public interests in Net policy-making, lobbying and the law, and more.

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In the Pipeline: Don't miss Derek Lowe's excellent commentary on drug discovery and the pharma industry in general at In the Pipeline

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April 5, 2010

Should Genes Be Patentable?

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Posted by Alan Wexelblat

In response to my posting a couple weeks back on more IP that kills, a reader suggested I cover the recent decision invalidating a patent on two genes linked to breast cancer.

I was undecided then and I remain undecided. The situation gets unpleasantly complex. First off, there's a question as to whether one ought to allow patenting of so-called natural sequences (genes, typically) or other things that come about without deliberate action or intervention. I'm not a patent lawyer, but even here I'm of two minds. I'd like to think that for-profit enterprises ought not to be rewarded simply for being first to file a sequence isolated from a creature or compound that has existed for hundreds of years - what's the invention here anyway?

But there are situations where the sequence is unknown and most essentially the relationship of the sequence to causation and effect in the macroscopic world is unknown. The science of discovering that is largely driven by profit motives - you find things like mutations or genetic markers in order to develop diagnostic tests or curative agents. Unless we give sufficient protection to the people and companies engaged in this research they may not be motivated to invest the millions the research requires. So what's the alternative to permitting patents on (gene) sequences?

Second, is there a threshold case here? Breast cancer is unpleasant at best and if untreated can lead to other cancers, major side effects, and even death. That said, a predictive genetic test for it is definitely a First World concern. The predictive test may be better than other methods, but does it pass the threshold that I feel anti-retroviral medicines for AIDS pass? I'm not sure.

Third, the ethical consequences of patents on genes are poorly understood (at best). We really don't know what it's going to mean for society to give monopoly powers over creatures and bits of our own bodies to commercial entities. The fact that this case has arisen over a situation as personal and deeply affecting as breast cancer is probably not a coincidence.

Finally, is the practice of gene isolation an important and necessary part of the process? Is that sufficient to create a patentable product or is it, as the NY Times story notes, merely a "lawyer's trick." The root problem here is that the patent system is increasingly divorced from our growing understanding of science (h/t to Greg Aharonian of PATNEWS who has been hammering on this issue for years). If patent examiners could be properly trained in the science of the area in which they're issuing patents, and if the patent law supported clear statements of the scientific principles underlying patents, then we'd be in a better position to judge this - or at least a competent scientist would be.

As with most of these big thoughts I have far more questions than answers. I do expect this case to be appealed and probably overturned on appeal, but that won't make the fundamental issues go away.

Comments (2) + TrackBacks (0) | Category: Big Thoughts


COMMENTS

1. Outtascope on April 19, 2010 3:44 PM writes...

Would you be willing to pay 10 cents a step as you walk? Would this seem reasonable or just? Would such a fee work to extend the art or science? If Newton had patented gravity, then that is exactly what would have happened. Newton did not invent gravity any more than any scientist invented the gene that causes breast cancer. Gravity predates Newton in as much as cancer predates Myriad Genetics.

If Newton, however, had invented a device for measuring gravity that was novel and non-obvious and had not been invented before, then I think he would be entitled to patent said invention.

If a pharmaceutical company invents a process for detecting the breast cancer gene that is novel, non-obvious and had not been invented before, then I think they too would be entitled to a patent on that invention.

Imagine where we would be today if all mathematical and physical facts were patented at the time of their discovery. Einstein would never have given us relativity because the encumbrances of engaging in his research and thought would have been far too costly.

You can no more patent a discovered, pre-existing gene, then you could patent water, or the sub-atomic structure of gold.

I can't believe that so many believe that discovery and invention are the same thing. Inventions utilize discoveries (of facts). Facts themselves must never be patentable.

Should the first scientist who determined the physics of respiration have been allowed to tax the breathing? Should a pharmaceutical company be allowed to force a woman with breast cancer to pay royalties? I understand that this was not the intent, but if a gene is patentable then ANY implementation must be licensable.

Taken to its logical extreme, these pharmaceutical companies are merely reverse engineering an invention of prior art by some poor woman many millennia ago. One that clearly is in the public domain by now.

Permalink to Comment

2. Outtascope on April 19, 2010 3:56 PM writes...

Let me just follow that up with the following point: If I understand the case correctly Myriad was claiming implicit patent protections on their test kit (and all test kits) by way of the fact that the genes it looked for were patented.

To me this is the smoking gun, in that the test was clearly not patentable in its own right or surely Myriad would have patented it. This perfectly illustrates the problem with allowing patents on facts. Had they won this point, then you would have to allow that all research on these genes would be subject to Myriad royalties.

It seem that it is not possible for one to be more in conflict with the intent of our patent system than this.

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