Opinion: Drug patents aren’t a ‘necessary evil.’ They save lives.

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This op-ed originally appeared in the Boston Business Journal online on May 12, 2023.

Intellectual property protections for drug discoveries are considered by many to be a “necessary evil.” Yes, it is conceded, we need to give those big, bad drug companies some incentive to find cures, so let’s give them a “monopoly” on what they find—but only for a few years. But sotto voce, we really don’t want to give them this gift.

But consider the moral opposite—that drug patents are not a “necessary evil,” but one of the most important public policy innovations in all of human history, and a boon to patients awaiting cures.

During the drafting of the Constitution, there was great pressure on James Madison to avoid inserting patent protections into the document. Thomas Jefferson and others recalled the abuses of the East India Company, which retained monopolies on famous products like tea, and they lobbied Madison to avoid patent protections that could create monopolies. Madison, to his credit, demurred, and he gave Congress the power to grant patents. In one of the most important phrases ever written into a policy document, he gave Congress the right “To promote the progress of science and useful arts, by securing for limited times to authors and inventors the exclusive right to their respective writings and discoveries.”

With that phrase, America became the mother of invention.

Just a couple of weeks ago, Vertex, a Boston company, submitted to the Food and Drug Administration (FDA), an application to approve a gene therapy that could be a cure for sickle cell disease. Sickle cell disease is a blood disease which, as the CDC describes it, “the hemoglobin is abnormal, which causes the red blood cells to become hard and sticky and look like a C-shaped farm tool called a ‘sickle.’” There is basically no cure for sickle cell disease. You die.

As STAT News described it, the Vertex drug could be a “permanent correction” to the disease or, to give it a better description, a “cure.”

One can only ask: without Madison’s decision to protect patents, would Vertex have poured millions of dollars into finding a cure for sickle cell disease? Without patent protection, Vertex’s discovery could be stolen on the day it was announced. Vertex would never have done it without that Patent Clause in the Constitution. James Madison may be dead, but he is very alive in Vertex’s application to the FDA.

However, the view that patents are a “necessary evil” is the prevailing view. In the recent Inflation Reduction Act, the President imposed price controls on pharmaceutical discoveries, essentially stripping inventors of “the exclusive right to their respective…discoveries.” Spend a great deal of money to invent something, and the government can tell you how much it is worth. Is this an incentive for invention?

Policy makers need a different view on patents and intellectual property protections. And patients awaiting cures do too. Inventions only come when inventors are rewarded, not punished. Patents are not a “necessary evil.”

Boston and Cambridge host the most important biopharmaceutical cluster in the world, holding the promise of cures for diseases that have plagued humankind for thousands of years. We need to recognize that these companies, these medical schools, these foundations—none of it would exist without James Madison’s sagacity.

William S. Smith, PhD, is Senior Fellow and Director of the Life Sciences Initiative at Pioneer Institute.