Friday, August 21, 2009

A summary of the ethical argument

1.) I argue property rights over land and moveables are grounded in brute facts of possession

2.) I argue that IP rights are not grounded, and so we can generally alter them at will except where they may conflict with grounded rights

3.) I explain that patents protect expressions (manifesting a type in some way in the world of tokens) of a type, not the type itself. They are exclusionary, not possessive rights, giving the patent holder the right to exclude another from reproduction or practice of his or her type

4.) A gene is the arrangement of nucleotides that codes for a protein. Its action involves the creation of proteins by mRNA, which as it creates the proteins, reads the beginning and end of the gene, and leaves out the introns. This is the same mechanism employed by humans when we make cDNA.

5.) A patent on cDNA, I argue, is not different than the patent on the gene itself as there is nothing new about the cDNA. Nature devised long ago the methods of reading genes and making proteins. cDNA is thus not novel and not properly patentable. (ultimately, though, my commons argument trumps all of this).

6.) Newly created genes, not otherwise found in nature but assembled from intentional action by humans are properly patentable.

7.) The human genome is a constantly evolving object that involves every member of the species, and is, I argue, a commons by necessity, like outer space, the atmosphere, sunlight, and radio spectra. Discovering its nature, replicating its processes and using them to our benefit cannot ethically be done to the exclusion of others. Granting exclusionary rights to discoverers of genes that are part of that genome interferes with our common rights as beneficiaries and possessors of parts of the human genome.

8.) Myriad, for instance, when it uses its patent on the BRCA1 and 2 genes that are linked to breast cancer, prohibits meanwhile the replication by others of the genes themselves. It has sent cease and desist letters to scientists who were doing lab work on those genes. I argue that it is our right in common to explore and investigate our individual genomes, as well as the human genome, unhindered by claims of others. What Myriad "owns" is a right to stop you from doing that, and they have exercized that right to the our common detriment.

9.) Miami Children's Hospital has done the same thing with the Canavan's disease gene, and while their right is not one of standard, possessory ownership, it is the right to exclude others from doing research on that disease. This is, I claim, an unethical usurpation of the commons of DNA.

10.) My argument differs from what lawyers know as an "anti-commons" argument, which I do discuss in my book, but which my argument does not rely upon. Anti-commons are created where over-patenting has hindered research. This may well be happening, as the Murray article tends to point that way, but my argument about the commons and DNA is a totally new, totally different argument founded on my ontology of commons by necessity.

I hope this clears up my arguments a bit. In a bit, I will also point out how I believe Holman and others have distorted my discussions of the law (as I begin to discuss above in justifying my discussion of Moore based on its use by Celera's attorneys). I have also tried to point out, in relation to Holman's lengthy selection accusing me of creating "fictions," that my position on these issues is correct if you don't buy (as I don't, and argue against) the "isolation and purification" argument, which I argue is a fiction.

I find it still very strange that Holman's review cites my chapter 7 as a re-hash of the anti-commons arguments of others, when nowhere in that chapter do I ever make anything like that argument.

But I see all that discussion as a distraction, and my book spends about 10 out of its 200 pages discussing cases, none of which are determinative of the argument or conclusions.

3 comments:

Michael R. Samardzija said...

David,

I love this synapsis of your thesis.

Regarding item 8, I am unsure as to the full accuracy of that statement. First, Myriad's patents are not directed to the BRCA1 and BRCA2 genes. Instead, Myriad holds patents to mutated parts, or sequences, of the BRCA1 and BRCA2 genes and to tests to detect those genes, which indicate an elevated risk of developing breast and cervical cancer. Second, I have read reports that allege that Myriad sent cease and desist letters to hostipals or laboratories that provided this test as a paid service to patients. Please correct me if I am wrong but I have not read any reports that allege that Myriad sent cease and desist letters to scientists conducting research on BRCA1 or BRCA2.

Why is these two points important to me. The first point is important because although I share your unease with patenting the sequence of naturally occuring normal genes, this unease disappears for non-naturally occuring and disease causing genes. The second point is important as it appears to me, viewing what Myriad has done from afar, that Myriad is trying to stop others from profiting from their IP. If these institutions were performing a public service by providing these tests at cost or free, things might have been different but these institutions are attempting to hide behind the work and great financial investment of Myriad to now make money.

To receive FDA approval, Myriad had to perform numerous tests and provide lots of data to the FDA to assure the reviewers that its tests are accurate, reproducible and effective (high specificity and high sensitivity). If we as a society take the viewpoint that anything dealing with genes - other than artificially made genes - is part of the common for all to use, then how would you allow an entity that has developed a new in vitro diagnostic test to recoup its investment? Perhaps, what you are advocating in that case is some sort of regulatory exclusivity period in lieu of patent protection. But absent that option, advocating the abolishment of patent protection of genes will slow to a halt us entering into the new era of personalized medicine.

Again, thank you for taking the time to summarize the salient point you discuss in your book.

drkoepsell said...

Michael, thanks for responding here. You raise interesting questions and points. As far as I know, and the complaint in the lawsuit alleges, that researchers sent c&d letters were conducting research on BRCA1 and 2. I'll delve more into that. But I am more concerned with why you think disease causing genes are somehow immune, as they are indeed products of nature, and my argument turns on this point. Mine is not a utilitarian argument, so I don't make such exceptions. Please elaborate, if you will, on whether the exception you are drawing is not just a utilitarian argument, because if it is, it won't change my mind about the ethics of patenting disease genes.

This is what I like, good discussion about the actual ethical and ontological arguments I try to make in my book. Thanks for participating.

best,
David

Michael R. Samardzija said...

David,

I have been swamped with my day job activities and did not want to respond without giving it some thought. I will try to provide a response early next week.