The U.S. Supreme Court’s decision on June 13 to invalidate Myriad Genetics’ patents on two genes associated with hereditary breast and ovarian cancer just might go down as THE landmark legal decision in the history of the biotechnology industry. The debate over gene patents has been going on since the origin of the bioindustry and has always been marked by contentiousness, emotion, and acrimony. And why not? The stakes are huge!
What the Court actually ruled is that naturally occurring DNA cannot be patented but synthetically produced DNA can. One lawyer I spoke to compared the ruling to King Solomon’s decision to cut the baby in half. This is to say the lawyer believes the Court’s ruling was driven by the U.S. Justice Department, which had come to the conclusion that all biotech patents were destined to be invalidated due to an ongoing and vigorous anti-patenting campaign by the ACLU and other groups opposed to patents. According to this legal expert, by at least allowing synthetically produced genetic material to be patented, the Supreme Court basically avoided throwing the baby out with the bathwater.
And while many people contend that basic research has been hampered by the restrictions laid down by those companies that owned various patents, another argument can also be made that life-saving research will now be stifled because, they maintain, the incentive for companies and investors to fund new research studies will be severely diminished. Does the ruling mean that many current patents based on naturally produced DNA will now be invalidated? If so, this will pull the technological, IP, and financial rugs out from under the feet of many life science firms. Indeed, one industry analyst I spoke to literally fears for the future of the life science industry, saying who is now going to sink big bucks into promising new biotech discoveries if there will no longer be strong patent protection for those discoveries and a significant financial return to those investors for their support?
What I am hoping for is that as things move forward some type of compromise is reached where patent-owning biotech companies and scientists working outside the industry without the benefit of patent protection realize that it is in the best interests of everyone involved, primarily patients, to work together in an equitable and fair fashion to discover, develop, and bring to market a wide range of innovative diagnostics and life-saving therapies.