Do companies have the right to own your genes?

Angelina Jolie recently revealed her decision to have a double mastectomy to reduce her chances of dying from cancer at a young age - like her mother did.

She knew she was at risk of getting breast cancer because of a genetic screening test that could tell her that she had inherited her mother’s faulty gene - BRCA1 - that increases her risk of getting breast cancer. By having a double mastectomy, her chances of getting cancer drop drastically.

Screening tests are becoming an important way to test for faulty genes that put you at risk of cancer or other diseases that you can inherit from your parents. But, these tests can be extremely expensive and are not routinely available in clinics - you need to see a specialist to organise the tests for you.

The BRCA1 screening tests costs up to $3000 dollars in the US - in South Africa it is covered by medical aid, depending on whether you meet certain criteria.

There are several reasons why these tests are so expensive - they are often tricky to do, needing very sophisticated equipment and trained staff to operate, requiring them to be run in a specially designed lab. Researchers are trying to develop cheaper tests, ideally that can be run right away at a clinic by a nurse or doctor with the patient.

Research into developing tests and figuring out how diseases work so that we can develop more effective drugs is a slow and very expensive business. Companies invest millions of dollars to develop a new drug or diagnostic test that may or may not be successful. They hope to make up their losses from sales when the drug is on the market. But they face the risk of a competitor beating them to it and offering a better, cheaper drug before they get theirs to market, losing their profit margin.

Companies use patents to protect their investments. Patents give owners exclusive rights to their patent products - either new gadgets, a design or invention. In biology, patents are being given for genes and organisms and even cells grown from human tissue. Companies apply for patents for a gene they are using to develop a drug or test and, when successful, on the test itself. This buys them time to develop and market the test before anyone else, making sure they get returns on their investment. Without this protection, some say companies don’t have the incentive to invest in expensive research to develop new tests and drugs.

Patenting of biological samples, especially human ones, is hotly debated. Is it right that a company or even an individual can own a patent on genes? Each one of us carries two copies of those genes in our bodies? How can someone else own them? What right does a doctor, scientist or research company have to dictate what they do with your tissues?

Also, the patenting of genes can be abused. Myriad Genetics, who owns several patents for the BRCA1 and 2 genes and for the diagnostic tests used to find those faulty genes, has been accused of monopolising the industry - stopping other researchers from studying this form of cancer. Because they own the patent, they can send cease-and-desist letters, threaten to sue or force other companies to pay heavy licensing fees to use similar products. They also charge exorbitant prices for the BRCA1 diagnostics test, making it accessible only to the privileged.

They have been taken to court over this issue. Recently, the US Supreme Court ruled against them being able to patent natural genes - the ones each one of us has. This overturns years of patents that researches have filed for human genes that they discovered. An important distinction in this ruling is that only natural genes are restricted from being patented. If a gene is changed or even made synthetically, it can be patented. Myriad genetics still holds the patent on the genetic test for BRCA1, but its monopoly over who can use the gene has been weakened.

The Supreme Court ruling now gives other researchers a chance to study the BRCA1 and 2 genes without being chased down by Myriad Genetics. It is thought that this will drive down costs for genetics tests and hopefully provide and opportunity to develop affordable tests for those that need it.