Ramblings on healthcare, medical education, and life with a spinal cord injury
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Patenting Your Genes

Before I begin, a caveat: I am not a lawyer, and my comments do not reflect a foundation in scientific law.  They’re purely opinion, unless cited, and should be treated as such.

I had an interesting discussion with some friends recently over the concept of gene patents. If you hadn’t heard, U.S. District Judge Robert Sweet in NY struck down a patent that had been granted to Myriad Genetics for the BRCA1 and BRCA2 genes present in many cases of breast cancer.  (The NYTimes has also covered this quite well).  He stated that regardless of the form of DNA being used, the fundamental bit of data is still human DNA, something that occurs in nature, and something that is inherently not patentable.

This is huge.

BRCA is a prominent gene family in oncology because it was one of the first to be identified and sequenced, and we now have tests that can examine, purely based on genetics, if a person is a carrier for a mutation. From that, we can assign a probability to their likelihood of developing breast cancer. Some women go as far as to have prophylactic mastectomies based purely upon family history and the BRCA screen. I would argue that sure, patent the testing process and the algorithms behind the analysis of the results, but you can’t patent the gene itself.

Myriad argues that because of the form the DNA is in, effectively a plasmid outside a human cell, that it should be patentable.  And they have good reason to argue for patent protection: money.  Because of their patent, they are the only company marketing a test for the BRCA1/2 genes in the US.  At a cost of over $3,000 per test.  According to the NYTimes article linked above, that test is available in Canada, where the patent is not recognized, for under $1,000.  This makes the test available to far more people who might benefit from it, thus doing a far greater good.

Now, I’m not trying to argue that money and capitalism are evil.  Far from it.  Some seem to argue that they shouldn’t be able to patent the test itself. I think that’s disingenuous, because if they’re not able to assert some financial gain, what’s the point of investing R&D money?  In that case, it’s the patients who ultimately suffer. The company has spent money to develop a test that is reliable and reproducible, and they should be able to profit from it. And there is absolutely nothing wrong with companies profiting off such processes. But patenting aspects of the human genome is not the way to do it.

I think this gets even more complicated with cancer genes, because mutations are not exactly the same. The question comes down to, what exactly are they patenting if they’re trying to patent a gene? We all have copies of the BRCA gene, and most of us go through life without having any problems with them. This isn’t because our genes don’t mutate. Conversely, we all have genes mutate fairly regularly. Now, the miniscule number of mutations that occur, compared to even a tiny calculated margin of error, is really remarkably exquisite. But nonetheless, they do occur regularly. The thing is, we have mechanisms to detect and resolve mutations. But in people who have problems with mutation detection/correction, cancer can occur.

With certain cancers, these mutations tend to occur in common locations. This is often due to the affected gene’s role in mutation repair – you need a mutation in the DNA repair machinery to develop cancer, in addition to a separate mutation in a gene that affects cell growth. This is known as the two-hit hypothesis. In breast cancer, BRCA is one of the identified mutations. However, the specific mutation can vary drastically from one person to another. The mutation can occur anywhere within that gene. So what exactly are they patenting? The whole gene? If it’s a specific mutation, that’s pointless since there’s so much variability. This is what confuses me – I don’t get exactly what they’re claiming is patentable.

It sounds as though Myriad is trying to patent genes directly using a legal end-run. And saying that somebody should be able to patent the entire BRCA gene based upon certain standard elements doesn’t seem right to me. That’s akin to saying that I should be able to patent hair and then go sue anybody who tries to work as a barber.  Additionally, what if those elements are found in other locations within the genome?  This is not unlikely.  Does their patent automatically apply to those genes as well?  If not, what is the legal basis for differentiation?

Companies need to be able to assert protection of their financial investments into new technologies. They need to be able to recoup their initial investments, provide value to investors, and profit to drive growth.  But patenting elements of the human genome is not the way to do it.  We don’t patent hair, flowers or other things found in nature.  Genes are no different.

Kudos to Judge Sweet. Finally, someone who gets it.

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