For decades the U.S. Patent Office has been issuing patents for naturally occurring genes. This affects you directly whether you know it or not. Because a company legal "owns" a gene sequence, they control who is able to test or research that gene. In the case of genetic testing, labs are limited on what genes they can offer tests for because of gene patents, which limits the choices they can offer patients. Labs that are allowed to test a patented gene pay royalties to the companies that own the genes which drives up the cost of the genetic test. Many labs, like ones I have worked in, just chose not to offer the test at all.
In the case of some genes like the breast cancer genes BRCA I and BRCA II, one company, Myriad, owns the gene and only Myriad offers the test for variations that signal a high risk of breast or ovarian cancer. This means that if a patient wants a second test run by another company to confirm the test result and test interpretation before they have radical surgery, they are out of luck. In addition, many women who fear that they are at risk simply cannot afford the $3000 test that could give them the information to save their life. And because of gene patents, they cannot go anywhere else.
To put a human face on gene patents, I once got a call from a frantic father whose daughter was diagnosed with Long QT, a rare and serious genetic heart condition. He and his wife were faced with putting their 4 year-old little girl on serious medication and fitting her with a pace maker because of the genetic testing results showed she had a rare genetic mutation for Long QT. Something about the lab that gave them their results did not sit right with them. Before initiating the invasive procedures on their daughter, they wanted a second opinion. The could not get one without traveling overseas because only one lab in the United States owned the patent for the gene and only they offered the test.
Last year the ACLU stepped up and did the right thing and sued Myriad Genetic and the U.S. Patent office over Myriad's patent on the BRCA I and II genes. The initial ruling was that DNA isolated from its natural environment cannot be patented. Judge Sweet wrote:
DNA represents the physical embodiment of biological information, distinct in its essential characteristics from any other chemical found in nature. It is concluded that DNA’s existence in an ‘isolated’ form alters neither this fundamental quality as it exists in the body nor the information it encodes.
The U.S. Department of Justice agreed:
"...the unique chain of chemical base pairs that induces a human cell to express a BRCA protein is not a ‘human-made invention.’ Nor is the fact that particular natural mutations in that unique chain increase a woman’s chance of contracting breast or ovarian cancer. Indeed, the relationship between a naturally occurring nucleotide sequence and the molecule it expresses in a human cell – that is, the relationship between genotype and phenotype – is simply a law of nature. The chemical structure of native human genes is a product of nature, and it is no less a product of nature when that structure is ‘isolated’ from its natural environment than are cotton fibers that have been separated from cotton seeds.”
Of course Myriad appealed the ruling. Last week the appellate court ruled for Myriad and stated that genes CAN be patented because isolated DNA is fundamentally different than DNA in the body. From the New York Times:
“The claims cover molecules that are markedly different — have a distinctive chemical identity and nature — from molecules that exist in nature,” Judge Alan D. Lourie wrote for the court.
I find this ruling to be ridiculous and this is why. I have personally isolated DNA from thousands of patients for genetic testing. I find the ruling that all that DNA I isolated is so fundamentally different that it is eligible for a patent laughable. Is the DNA I isolated still have all of the proteins that surround it naturally? No. It is in the same shape that it was when it was in a white blood cell? No. Is it still in a continuous piece? No. Is it still a naturally occurring molecule that has information about the organism from which it was isolated? Absolutely!!!
When I isolated DNA, I did not create or reorder that DNA. It still has information encoded by and about the person from which it came. The proof is that after I isolate it, I put the patient's name on it, not mine. If the DNA was so fundamentally altered by the isolation process that it was no longer the naturally occurring DNA from the patient, then why would I test it? If isolating it changed it so much then it wouldn't tell me anything about the organism that it came from.
I recently put together a puzzle with my daughter. The puzzle was made from a beautiful photo of a hot air balloon rally over a reflective body of water. The person who took that photo owns that photo. This ruling is like saying that if I removed one piece from that puzzle then I could patent just that piece. The piece looks different without what naturally surrounds it but it still holds all the same information it did when it was in the puzzle. Did I fundamentally change the information on the puzzle piece when I removed it? Of course not!
This ruling allows what I believe to be an unethical practice continue: the systematic claim of ownership to naturally occurring DNA. This ruling basically says that you own your DNA while it is in your body, but if someone extracts it and identifies the purpose of it, they can own it. This naturally reduces the human body to pieces that can be bought and sold.
It is not easy find official Church teaching on gene patents, but I did find this quote from John Paul II in an address to the Pontifical Academy of Sciences that addresses the issue:
On this subject, we rejoice that numerous researchers have refused to allow discoveries made about the genome to be patented. Since the human body is not an object that can be disposed of at will, the results of research should be made available to the whole scientific community and cannot be the property of a small group.
