Everyone is familiar with the idea of patents: filing a claim for an invention which provides you with a limited amount of time to capitalise on that invention. The only problem is that the notion of “invention” becomes a little fuzzy when you are dealing with the biological world. Three years ago, the American Supreme Court ruled that the patent (held by Myriad Genetics) on two genes which are associated with breast cancer – BRCA1 and BRCA2 – was invalid. Oh, wait. It is a bit more complicated: they ruled that Myriad Genetics could not patent the “naturally” isolated DNA, but they could patent the cDNA. For those that are unfamiliar, complementary DNA (cDNA) is derived from the messenger RNA (mRNA) when a gene is transcribed; this mRNA then gets used to make the protein instructed in the DNA. So the Supreme Court basically ruled that one cannot patent a book, but you can patent a photocopy of the same book (only it now does not contain any references). How did such a bizarre ruling come about?
Scientific illiteracy certainly played a part in the ruling. However, this does not get at the heart of why Myriad Genetics filed a patent in the first place. Every human being has the genes BRCA1 and BRCA2, but in some people they have a faulty version (or allele) which means that the women who carry these faulty versions are at higher risk of developing breast and ovarian cancer. Myriad Genetics attempted to capitalise on this information by offering a test for these faulty versions, allowing women whose family have a history of breast cancer to make an informed health choice, such as a possible preventative double mastectomy. However, Myriad Genetics did not patent the test, they patented the genes themselves. Why?
Anyone with some basic training in genetics will have realised that the majority of the intellectual work was in finding the specific genes responsible for causing a disease. Afterwards, designing a test is relatively straightforward. If Myriad Genetics had only patented the test, then any competitor could easily have designed their own (slightly different) test, undermining its profitability. So they patented the genes in order to gain a monopoly on offering the test. Understandably, this made many groups upset not the least patients who would face having to fork out thousands of dollars for a potentially life-saving test.
The issue of patents in biological science has many problems and components, the most glaring one being that the majority of the intellectual work is carried out by researchers using public funds. In the past, researchers typically did not patent their work, allowing companies to replicate it and hence patent the work for themselves, effectively privatising the profits. Now, although researchers do patent their findings, they are not in a situation to capitalise on it. It is still very rare finding a researcher who can set up a successful biotechnology company.
There are many issues with patents in bioscience which go beyond simply asking what counts as an “invention”. This question does seem devastatingly simple and yet eludes a concise answer. If one were to sequence the BRCA1 gene, as Myriad Genetics did, does this count as an “invention” considering that they did not invent the sequencing machinery? After all, the faulty versions were there, waiting in the bodies of thousands of women, ready for discovery.