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August 30, 2010

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With the sequencing of the human genome completed a decade ago and the genomes of hundreds of other organisms at hand, is it not rather late to get worked up about patenting genes. The vast majority of gene sequence information has been generated at public expense. It has been very difficult to argue that the discovery or elucidation of the nucleotide sequence of a gene represents an "invention." Moreover, the huge length of time it actually takes to successfully generate and test a drug from initial determination of the sequence of a gene for a drug target makes it quite impractical to go through the enormous energy and expense required to file and maintain a gene sequence patent in all of the major jurisdictions in the world.

The situation was very different 15 years ago. Private enterprise was willing to make the huge investments necessary to undertake the sequencing of genomes in exchange for some guarantee that a return on their investment might be realized. This spurned on the growth of the biotechnology industry around the turn of the last century. The problem is that once a race began between governments and industry to sequence the human genome and this information became rapidly accessible, the value of these genomics companies plummeted, and so did the industry as a whole. It has not really recovered since then.

I suspect that had governments and disease charities not devoted a major part of their biomedical research budgets to gene sequencing and distributed their funding more widely, we would be further along in our understanding of cellular biochemistry and physiology than we are today. Basic researchers would still have had access to the sequences of human genes from the industrial effort, probably with more value added. Finally, in this new decade, all of the gene sequence patents would have expired and all of this information would have been freely available for anyone to use.

When does the appeal get underway Kev? You wanna come down the CAFC for the oral arguments?

Well, 6, Myriad's brief is due October 22, so I don't see the oral hearing until some time in 2011. Decision by next summer.

The point is moot. The Myriad patents will have expired before the appeal is finished...
The first patent US5747282 has a priority date of 8/12/1994 and an issue date of 5/5/1998. Because it was filed on 6/7/1995 it expires either 20 years from priority date - 8/12/2014, or 17 years from issue date - 5/5/2015. The CAFC may make their decision in the next year, but will the Supreme Court be able to get through the case before May 5, 2015? Assuming the ACLU appeals the CAFC opinion which should give Judge Sweet a kind lesson in patentable subject matter. He doesn't even address patent claims until 1/2 way through the opinion. Of course he also spends less time on the claims than he does on the credentials of the people who admitted to clinically copying Myriads tests in their research institutions. I digres...

crp man, that is such a long time. I don't know how you lawyers put up with so much delay in the courts.

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