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Patents are critical to the biopharmaceuticals sector—but abundant disinformation about them has led to their dangerous undervaluation by elected leaders, Dr. Daniel M. Skovronsky of Eli Lilly writes in a recent op-ed for STAT (subscription). 
 
What’s going on: The patent system, created more than 200 years ago after President George Washington urged Congress to establish it, incentivizes the often long, arduous and expensive process of bringing a drug to market, according to Skovronsky, Eli Lilly’s chief scientific officer and executive vice president of science and technology and president of Lilly Research Laboratories and Lilly Immunology. 

• For example, “[a]t Lilly, it took 35 years of research, dozens of failed clinical trials and an investment of $10 billion to bring one of the first FDA-approved disease-modifying treatments to patients with Alzheimer’s disease.”     

A powerful tool: For the past four decades, the patent system has worked the way it should, with generic manufacturers able “to develop lower-cost alternatives” to brand-name pharmaceuticals once the patents have run out.

• “Today, 90% of all prescriptions written are for generics, which have reduced patients’ costs for specific drugs by 39% to 95%. Generic competition is the most effective tool we have to drive patient affordability.”  

Misplaced blame: Critics unfairly blame patents when there are no generic competitors for a drug, giving the patent system writ large a bad name and leading lawmakers to try to weaken it.

• Naysayers “will explain that manufacturers find ways to hold on to patents to block generic entry … [but] the lack of new market entrants despite the absence of patents likely reflects the economic realities of manufacturing and distributing insulin at scale for low prices.”  

Wrongheaded approach: Because of widespread fallacies, “the current policy environment is increasingly hostile to inventors of new medicines,” writes Skovronsky. Recent problematic legislative measures include:

• Price control provisions in the Inflation Reduction Act, which “undermine incentives to pursue small molecule medicines even if science and the best opportunities for patient care might lead there”; 
• March-in rights; and
• World Trade Organization TRIPS waivers.  

What should be done: “Unfortunately, today there is a need to recommend to our elected officials a strong, predictable and robust patent system that will yield great innovations and better medicines to help people and society,” according to Skovronsky.