“Like air and water, DNA should not be patentable,” blared the March headline in a major Canadian newspaper.  The article underneath this headline detailed an out-of-court settlement after the Children’s Hospital of Eastern Ontario (CHEO) brought a lawsuit against a company which marketed and sold a diagnostic genetic test for a serious heart condition called Long QT syndrome. CHEO launched the lawsuit against Transgenomic Inc. to invalidate the company’s patents, which covered isolated genes involved in Long QT syndrome and diagnostic tests for assessing the risk for the condition in individuals.  The settlement agreement allows public sector hospitals and laboratories the right to test for Long QT syndrome using Transgenomics’ inventions. CHEO, and the author of the aforementioned article, hailed the settlement agreement, which will potentially save governments millions of dollars in the future if doctors do not have to pay for patented diagnostic tests. In view of this settlement, the author further warned that biotech companies would not be able to profiteer from gene patents, as though companies involved in such research are somehow unethical for patenting their inventions. Similar to the headline, the author concluded that “some things should not be patentable — not water, not air and not human DNA.” While catchy, the headline and conclusion of the article belies an understanding of the patent system and its role in fostering innovation.

Companies that develop and patent diagnostic genetic tests expend significant resources to find genetic markers and correlate those markers to a disease or condition. Such research may result in new diagnostic tests, allowing doctors to provide an early diagnosis of a condition, thereby improving the possibility of successful treatment. While gene sequences are often patented, it is only isolated and purified DNA segments that are patentable. The DNA within a person’s cells and tissues is never patented. Accordingly, there is no threat to the sanctity of the patient and their own DNA is never compromised as a result of the gene patents. Moreover, the true value of the patents resides in the diagnostic tests, where purified and isolated DNA is analyzed for certain disease markers. 

Let me provide a corollary for the chemical world. It would be an understatement to say that certain parts of the world are in dire need of fresh water. While the world is surrounded by water, unfortunately most of it is saline and unfit for human consumption or irrigation. It’s no surprise then that there is a significant amount of innovation in water technology. After years of research, what if an inventor developed a process for the desalination of water that was simple and not energy-intensive? Ultimately, the product of such a process is water. There’s not a patent lawyer I know who would argue that water is, or should be, patentable. However, would we be so cavalier to say that the inventor is attempting to profit from his or her invention and that it shouldn’t be patentable because like air, water shouldn’t be patentable?  The chemicals are different but the principles are the same.

While the CHEO settlement may be viewed by some as a win, such a perspective could be short-sighted. Of course, patients potentially suffering from Long QT syndrome no longer have to worry whether the government will cover the expense of the patented test; no doubt, that’s a good thing. However, the invalidation of such patents is a disincentive for researchers to investigate genetic markers for other diseases, which could be a significant detriment to society as a whole. It’s easy to demonize companies in the medical field for profiting from sickness. In the abstract, many people probably cheer CHEO’s win for reducing overall medical costs. The longer-term consequences, however, could result in fewer diagnostic tests brought to market. Clearly the Long QT diagnostic test has real value for patients suffering from the disorder; why else would CHEO seek to gain access to the test through the courts? While this could be seen as an easy victory for access to new and innovative diagnostic tests, companies may then decide not to market and sell other tests here in Canada. Such an outcome would be unfortunate and would have serious consequences on the health of Canadians.  

Mike Fenwick is a patent lawyer with Bereskin and Parr LLP in Toronto and holds a master’s degree in organic chemistry.