Enforceable Medical Procedure Patents: To be or Not to be?

June 11, 2020  Chrystie Swiney

  • Property
  • Intellectual Property
  • Blog

The precursors to today’s intellectual property protections, and patents specifically, can be traced back to BC times. The idea that we should be able to gain exclusive property rights over our inventions, which typically require significant investments of time, resources and efforts, is not a new one.  Indeed, the US Patent Law, which is still in force, was adopted in 1790, shortly after the US Constitution was ratified.  According to Article 1, Section 8(8) of the American Constitution, which is otherwise silent on the notion of property rights, Congress is explicitly authorized “to promote the progress of science and useful arts by granting inventors the exclusive right to their discoveries for a limited time.”   

The rationale for offering patent protection is twofold: not only should inventors be rewarded for their efforts and ingenuity, but more importantly from a public policy perspective, innovation should always be encouraged.  Offering an incentive for innovation, which is precisely what the patent system permits by giving patent owners an exclusive right to their idea for a 20 year period, is an obvious way to encourage innovation, creativity, and progress.   

However, a little known exception to the patent system exists with respect to medical procedures, arguably an area where innovation is most necessary and desirable. The practice of medicine, as in all sectors, evolves and changes over time based on new research and fresh ideas. Simply comparing medicine as it exists today with medicine as it existed a century ago, quickly reminds us of why we should care about innovation in the medical field. In 1915, the average life expectancy was 47; diarrhea was a leading causes of death; penicillin and antibiotics didn’t exist, making infections the leading cause of death; and women often died during childbirth. Needless to say, we all benefit, and should only encourage, innovation in the essential, life-saving field of medicine.  

Yet, the US patent system, since 1997, has exempted medical procedures from the robust protections afforded to nearly all other types of inventions through the US patent system. According to an amendment made to the Patent Law adopted in 1997, while a patent can be obtained for an innovative new medical procedure, such a patent is largely unenforceable, leaving it with little to no substance. This exemption is puzzling given that in virtually every other domain, including with respect to frivolous inventions focused purely on entertainment, the patent system affords protection. Yet, in this one narrow area, it does not.  

The reason for this odd exemption in patent law largely stems from the apparent conflict that it presents to medical ethics. Doctors, who swear to uphold the Hippocratic Oath, are not only required to choose the best course of action available for the health of their patients, but they are also required to freely share their knowledge with each other. While this might seem like a potential obstacle to patenting medical procedures, note that fully enforceable patents are routinely given for new medicines, medical devices and tools, and virtually any other physical or pharmaceutical element that pertains to the medical profession. Medical procedures alone are exempted, leaving the argument that the patent system shouldn’t apply to the field of medicine entirely hollow.  

The patent system was designed to encourage innovation, full stop. This idea was recognized thousands of years ago and is clearly reflected in the American Constitution, which does not discriminate on the basis of what fields should or should not be encouraged to innovate.  Those arguing against the enforceability of medical procedure patents often point to the “do no harm” principle that lies at the core of the Hippocratic Oath. Unfortunately and ironically, doing exactly the opposite: causing unknown levels of harm to us all by holding innovation and progress in the field of medicine.