While the 1980s is best remembered for its questionable fashion and cultural influence, two critical policies from early in the decade transformed U.S. intellectual property infrastructure and innovation. That might not sound as flashy as neon leg warmers and synth-based pop music, but most of today’s technologies and healthcare breakthroughs wouldn’t exist otherwise.
The Bayh-Dole Act (1980) and Hatch-Waxman Act (1984) led to amazing scientific breakthroughs and a regulatory system that balanced innovation, returns on investment, and long-term health and affordability benefits for patients. With this in mind, and as we approach the Hatch-Waxman law’s 40th anniversary, it should be cause for celebrating inventive progress with a promising future, but the system that’s worked for decades is now under siege.
The administration has proposed guidance on the use of so-called “march-in rights” under the Bayh-Dole Act. This would give the federal government permission to seize patents from corporations that developed a new medicine if any amount of federal funding contributed to the research and development process.
Senators Birch Bayh and Bob Dole made clear the government should not enforce “march-in rights” as a form of price controls. However, that’s precisely what the new guidance intends.
This will weaken patent protections. This will erode partnerships between private companies and universities or government researchers. This will ultimately destroy the efficient delivery of new treatments to patients in need. This “march-in rights” approach targets the biopharmaceutical landscape. It will open the door to government intervention across other innovative industries and upend all avenues of basic collaboration. A short list of Bayh-Dole-fueled inventions includes Google, scores of prescription medications, HD televisions, cancer tests, touch screen technology and Honeycrisp apples.
Does this sound like a draconian government intercession? It is — and almost all agree.
In comments the National Institute of Standards and Technology received about the plan, 222 organizations wrote in opposition, while 18 shared support. Even Francis Collins, the former head of the National Institutes of Health, which receives the largest source of direct federal research funds, thinks marching in to control prices would be an overstep. During a recent congressional hearing, Collins said the law applies only “when a drug is simply not available to the public under any circumstance.”
So far, widespread opposition and attention to the unequivocal looming damage for patients awaiting new medical treatments has not swayed the administration from radically altering the law. Is it so hard to remember Congress intended for the Bayh-Dole Act to encourage scientific and technological cohesion between universities and private sector corporations? It doesn’t need fixing.
Making changes to the related Hatch-Waxman Act would further hinder the modern-day intellectual property system that has led to booming progress in life sciences and beyond. This carefully drafted law, which created the generic drug industry, has paved the way for new, cutting-edge healthcare discoveries to become universally affordable to patients through generic versions.
The bipartisan Hatch-Waxman law has worked so well that 90 percent of prescriptions filled in this country are for affordable generics. This process has thrived for decades and continues to experience significant growth, benefiting patients.
More than any other legal or regulatory schemes, the Bayh-Dole and the Hatch Waxman Acts have empowered innovation well beyond healthcare and medicine to other sectors like automobile equipment, screening technologies, finance, food and general products that have become synonymous with daily life. In tandem, these policies promote scientific breakthroughs and affordability.
Undoing the laws that have powered these positive developments will limit patients’ access and options for medical treatment and hurt America’s economy and lifestyle. The Biden administration should listen to the collective calls for protection. The United States must remain at the forefront of collaboration and progress and not dismantle a system that has worked for decades.
