DOJ Starts down the logical path re gene sequence patents

November 2, 2010

The DOJ just filed an amicus brief on the Myriad breast cancer gene patents.  While an amicus brief is effectively just a position paper, filed in a very specific lawsuit, I believe that the DOJ logic prevails in the long run.

There will undoubtedly be lots of teeth gnashing about this in the biotech and patent attorney communities. For instance, the director of PTO recently spoke about the issue, comparing the process of preparing the DNA to preparing silicon for semiconductors.  This comparison seems kind of silly to me:  Nobody is saying that preparation and reading technologies are invalid and I doubt that the PTO would issue a composition of matter patent on the high purity silicon – only on the process and on unexpected uses thereof.  Lets be clear: patents on algorithms for interpreting gene sequence data are not being challenged (but won’t have much value since, like with software patents, there is usually another way to get at an equivalently good solution) nor are platforms for replicating and reading DNA.  Only patenting naturally occurring sequences is at stake.

Legal issues aside, the idea of patenting naturally occurring sequences will someday be looked back upon with amusement.  In a world where sequencing is cheap, what are gene sequence patent-ers going to do to stop you from reading your data?

The arguments about the demise of biotech if these patents don’t impress me either.  As an investor, I have very little interest in companies based on biomarker technologies.  Besides believing that patents on naturally occurring gene sequences, naturally occurring protiens, etc. are going away, the fact is that there is always a better marker or set of markers around the corner.  My guess is that innovation and revenues in molecular diagnostics would grow just as quickly, if not faster, if we just junked these patents. Yea, the cost of gaining FDA approval might be harder to for companies to pony up without some IP protection but it isn’t clear that companies won’t do it.  Similarly, the argument that there is no incentive to find the sequences doesn’t have much merit – much of the knowledge is developed with NIH funding in universities, it is getting easier and cheaper in any case, and there are other incentives to develop the tests (like Pharma’s drive for companion diagnostics that reduce clinical trial cost and increase efficacy in target populations).  For a valuable test with lots of peer reviewed publications, the esoteric CLIA labs out there will offer it (in fact, that’s how Myriad grew – so no huge investment in regulatory approval was required), make money, drive the cost down, and stimulate increased innovation in sample handling, preparation, reading and analysis technologies (all of which would remain patentable).





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