US Supreme Court Rejects Gene Patents

For 30 years, the U.S. Patent Office has been issuing patents for naturally occurring genes.  About a fourth of our genes are patented by companies who are looking to make a profit off of a molecule we naturally make in our bodies. Objects of nature are not patentable so genes should not be patentable either.  As the late Michael Crichton pointed out, issuing patents for naturally occurring genes is like issuing a patent for noses.  Such a patent would allow a company to restrict or charge royalties for any product like glasses, sinus medication or sunscreen that has anything to do with noses.I believe gene patents are not just a legal issue, but a moral issue. The patenting of genes allows what I believe to be an unethical practice: the systematic claim of ownership of the human body.  You own your DNA while it is in your body, but if someone extracts it and identifies the purpose of it, they now own it. Even though it is still your DNA from your body.  This naturally reduces the human body to pieces that can be bought and sold.  John Paul II, in an address to the Pontifical Academy of Sciences on genetic research, stated:

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.

Gene patenting affects you directly whether you know it or not.  When 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.

These patents also allow companies hold patents on genes and not do research on those genes. They can also not allow others to do research either.  And because so many diseases have a genetic component, gene patents tie the hands of researchers who want to look at genetic links to disease.  As Dr. Iris Schrijver, president of the Association for Molecular Pathology, which is against the issuing of gene patents, observed:

Because variation in gene sequences plays an important role in the development and progression of many diseases, through gene patents patent holders can essentially gain ownership of the understanding of some diseases and of certain areas of patient care itself.

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 can’t 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, so before initiating the invasive procedures on their daughter, they wanted a second opinion.  Unfortunately, they 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.

The ACLU and the Association for Molecular Pathology have sued Myriad Genetics and the U.S. Patent Office over Myriad’s patent on the BRCA I and II genes.  The initial ruling, issued by Judge Sweet, was that DNA isolated from its natural environment cannot be patented.

Of course Myriad appealed the ruling.  Then a higher court that deals with patent cases overturned Judge Sweet’s ruling saying that DNA isolated from the body to be tested was remarkably different that the DNA found in the body.  I found this decision ludicrous.  I have isolated DNA from thousands of patients and never once did I think it didn’t contain the same information as DNA inside their bodies.  If I did think that isolated DNA was so different from DNA inside the body that it was a patentable invention, I wouldn’t bother testing it.

This case then went to the Supreme Court and last month the Court rightfully overturned the stupid decision that human DNA outside the body was remarkably different than inside the body and sent the case back down to the lower court to be reconsidered.  The high Court cited a previous ruling that they made that laws of nature are unpatentable.

This is good news.  One step closer to making the patenting of our genes invalid. Now let’s hope that the lower court gets the decision right this time.

Rebecca Taylor is a clinical laboratory specialist in molecular biology, and a practicing pro-life Catholic who writes at the bioethics blog Mary Meets Dolly. She has been writing and speaking about Catholicism and biotechnology for six years and is a regular on Catholic radio.