Don’t Jeopardize U.S. Pharmaceutical Innovation When We Need It Most

Amid today’s coronavirus pandemic, there’s an astonishing – and potentially encouraging – number to consider. 

The United States, with only 4% of the world’s population and 24% of the global economy, accounts for an outsized two-thirds of all new pharmaceuticals introduced worldwide. 

That disproportionate share of life-saving and life-improving pharmaceutical innovation didn’t occur by accident or coincidence.  Rather, it’s the direct result of policy choices that we’ve made, and it’s important to consider as the world desperately seeks new drugs to mitigate or defeat coronavirus. 

And what most distinguishes the United States in the realm of pharmaceutical development?   A comparatively market-based approach, and a legacy of protecting pharmaceutical patent rights over the years and decades like no other nation in the world. 

The United States has throughout its history maintained the world’s strongest intellectual property protections, including patent rights, which our Founding Fathers explicitly protected in Article I of the Constitution, even before adding the Bill of Rights.  As a direct result, no nation in history rivals our legacy of innovation, including pharmaceutical innovation.   

Those same principles that made America the world’s leader in pharmaceutical innovation are the same ones that will help incentivize ways to address coronavirus. 

Unfortunately, some in Congress mindlessly seek to undermine those principles amid their political jockeying. 

Specifically, as the House of Representatives considers the “No BAN Act,” which would limit presidential authority to restrict alien entry into the United States in situations like the current coronavirus pandemic, some Members seek to include legislative language weakening pharmaceutical patent protections. 

Those proposals reflect misguided provisions introduced in recent months by the Senate Finance Committee regarding allegedly anticompetitive conduct involving patentable improvements to approved pharmaceuticals, falsely labeled “patent-thicketing” or “product-hopping.”  Such proposals would only undermine pharmaceutical advancements by subjecting future improvements to drugs already approved by the Food and Drug Administration (FDA) to new Federal Trade Commission (FTC) scrutiny.  They would even impose a presumption of illegality under the FTC Act that would become the innovators’ burden to rebut, thereby chilling improvements to existing therapeutic options for medical patients. 

A House Judiciary Committee proposal actually offers a far better option to the counterproductive Senate Finance Committee provisions. 

In contrast to the misguided Senate Finance Committee proposals, the House Judiciary Committee’s alternative language adheres more closely to established antitrust law;  it contemplates a more reasonable enforcement timeline so that innovators don’t operate under an excessively lengthy liability window;   it rightly ensures safe harbor provisions for accurate product descriptions;  and it specifies that only improvements to existing pharmaceuticals – as opposed to novel drugs composed of differing ingredients – are subject to the provisions. 

The Senate Finance Committee proposals would introduce potentially crippling new burdens upon America’s pharmaceutical innovators by weakening the patent protections that have made us by far the world’s leading producer of new life-saving and life-improving drugs.  Current laws allow patent rights for new and useful improvements to existing drugs, which rewards the multiple years of risk-taking and experimentation necessary to invest in research and development.  New medicines and improvements can require ten or more years to perfect, and of all innovations that reach the clinical trial stage, only 10% or fewer ultimately secure FDA approval. 

Obviously, that sort of risk and investment can only be sustained by greater certainty and reliability upon regulatory incentives that the Senate Finance Committee alternative would undermine. 

While some dangerously dismiss improvements to existing pharmaceuticals as “patent-hopping” or “patent-thicketing,” those improvements open the door for reduced side effects, lower dosage requirements, improved potency, extended effectiveness duration and alternative uses. 

Advancements of that sort are particularly important as it relates to mutating viruses, changing world conditions and other evolving circumstances.  Weakening existing pharmaceutical patent protections would dangerously undermine the incentive to pursue such improvements. 

We simply cannot risk that legacy, or American consumers’ access to the world’s most innovative pharmaceutical market, by discouraging innovation and weakening pharmaceutical patent protections. 

Congress must therefore reject any provisions in H.R. 2214 that would weaken existing pharmaceutical patent protections on which American consumers and innovators depend.  Particularly in a moment like this, there’s far too much at stake.