Did Our Founding Fathers Get It Right?

Andrew L. Pecora, MD

Editor-in-Chief of Oncology & Biotech News

Chief Innovations Officer, Professor, and Vice President of Cancer Services John Theurer Cancer Center at Hackensack University Medical Center

President, Regional Cancer Care Associates, LLC

One can never go wrong by starting a piece of writing and quoting Albert Einstein, who said, “Politics are for the present but equations are for eternity.” Recently, the US Supreme Court made a unanimous ruling that would appear to violate Professor Einstein’s sentiments. When the Founding Fathers of our nation were constructing our system of government, it is hard to believe that even they could have conceived of the far-reaching consequences of how we as a people would collectively make decisions regarding science that have a profound societal impact.

In ruling that genes and, even more striking, the information genes convey through transcription, cannot be patented, the court has had an immediate ripple effect in biotechnology, the diagnostic industry, and the practice of medicine. Myriad Genetics had received patents that predicated an increase in the incidence of breast and other cancers (BRCA 1 and 2). These patents were subsequently challenged and overturned by the Supreme Court.

The court’s decision was written by Justice Clarence Thomas, who summarized the view of the court, noting that Myriad, while finding something useful, did not invent anything, and the step of separating the genes from other genetic material in a cell does not constitute an invention. The court decided that the key distinction between what is patentable and what is not resides between natural and synthetic genetic code. According to some, in receiving patents for BRCA 1 and 2 in 1990, Myriad had cornered the market on these important tests, resulting in excessive cost for the studies that limited access.

Others went further, noting that the removal of the fear of patent infringement would result in more research and better predictive markers for disease. Several genetic counselors noted that the price for BRCA 1 and 2 dropped significantly after the ruling, thus increasing access. Myriad executives noted that many of their other patents were upheld and restated their commitment to finding new assays to enhance predictive medicine.

As we move from using chemistry and physics to making synthetic medicines, and turn to biology to make natural therapies including cells, one must wonder how this decision will play out. Will a company be able to patent a cell or a new organ made from cells? If this is in doubt, will people invest the time and money to do so? Imagine if the byproducts of natural products like proteins are deemed not patentable. Will the same be true for gene therapies or inhibitory RNA therapies at some point? Is this a slippery slope or did our justices get it right?

It would seem that the impact of transforming the human experience using natural products like cells would be similar to an Einstein equation and last for eternity. For now, there does appear to have been an immediate societal benefit from the decision, but as for eternity...only time will tell.