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In a recent, widely anticipated decision that pertains to rights to some of what makes us us, a federal judge ruled in favor of patients, medical societies, and researchers, who were suing Myriad and the Utah University research foundation, owners of the patent on the two genes whose mutations had been associated with increased risk for breast and ovarian cancer, BRCA1 and BRCA2. Their ownership had allowed them to retain complete rights for these widely prescribed diagnostic tests, which have remained prohibitively expensive for many patients (currently at more than $3,000).

Interestingly, in taking the decision to invalidate such patents, the Department of Justice differs in its opinion from the US Patent and Trade Marks Office (USPTO). Meanwhile the status quo will be maintained. The Biotechnology Industry Organization (BIO), the organization that lobbies for the pharma and biotech companies, has been arguing since the beginning of the case that preventing patenting of human genes will literally impede life science innovation and had stated after the court’s decision that carrying this one out would: “undermine U.S. global leadership and investment in the life sciences”. A variety of people have spoken for and against the decision. The New York Times just wrote an article citing several of them.

The US government filled a “friend of the court” (or “Amicus curiae”) opinion entitled: ”BRIEF FOR THE UNITED STATES AS AMICUS CURIAE IN SUPPORT OF NEITHER PARTY” (you can read the pdf here ). As expected with these types of opinions (see Wiki)- and indicated by its title – the intent was not to support either of the parties. The last point listed in the government’s opinion constitutes a good summary: “Isolated Genomic DNA Is Not Patent-Eligible Merely Because It Is Useful Or Requires Investment To Identify.”

As someone who has dedicated her life to improving human health: I understand the need to recognize and reward discoveries, so that they may continue to advance the available diagnostic and therapeutic interventions. At the same time, in my opinion, a balance needs to found – or maybe a line needs to be drawn. Otherwise, these innovations will remain out of the reach of many patients who need them. The exact balance may not be easy to figure out or accept by consensus.

To what point should we own things we just happened to be the first to discover/figure out? Should various entities (researchers, universities, companies) own pieces of everybody’s proteins, DNA, or maybe their constituent atoms, electrons or the even more ephemeral particles and their interactions? These are all things that make us us. Or, going in the opposite direction, should each disease/syndrome or epidemic have owners that need to be paid before we could proceed with curing them? Am I right to assume that in such case, arrangements and payments would need to be exchanged between the owner of the gene and the person who had discovered the disease, with corresponding arrangements with those who had patented the smaller molecular or atomic pieces of the puzzle? How are we ever going to navigate such complex territorial and legal claims? Maybe Google could develop maps of the human body charting out the parcels to indicate ownership? I am on the opinion that we should only own things we create ourselves. In relation to this specific discussion, I think it is appropriate to own the rights to a new method to test or to control a gene, or a newly created molecule that could be used for diagnostic or therapeutic effect.

I know patients who were unable to take advantage of the BRCA test because of its prohibitive price and who knows how many more cases we might have failed to diagnose and treat because of these legally imposed economic barriers. Can you imagine that currently the actual cost of performing such a diagnostic test is only a few dollars? Would it be possible to compromise by assessing limits on the profit margin of diagnostic tests? I feel that we need to ensure that the initial intent – or what many say is – of our efforts to improve human health is not compromised.

What is your opinion? Should those sequencing one of the genes we all share – and its mutations – gain the exclusive rights to any diagnostic or therapeutic intervention that is related to that gene? Do you know who owns YOUR genes?

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