By Diana Dobson
The federal government may soon upend Texas’ innovative ecosystem as we know it.
A proposal, currently under consideration by the National Institute for Standards and Technology (NIST), would enable federal officials to strip essential patent rights from innovative companies. This includes the multitude of Texas-based biotechs working to deliver the next wave of cutting-edge breakthroughs for cancer and other severe diseases.
As someone committed to advancing cancer research and supporting those impacted by this disease, I am deeply concerned about the repercussions of this proposal. It stands to impede the development of new oncology treatments, ultimately eroding hope for patients not only in Texas but across the nation.
Extraordinary progress has been made in the fight against cancer in recent years. Thanks to advancements in treatment, the U.S. cancer death rate declined by 32% between 1991 and 2019. The drop was even greater for patients with lung, colorectal, prostate, and breast cancer. In 1971, there were three million cancer survivors in the United States. Today, there are over 18 million.
Patients still waiting for new treatments have every reason to hope that these treatments are right around the corner. The growing integration of biotechnology with artificial intelligence and machine learning brings us closer to realizing genuine cures. We know that in the not-too-distant future, scientists will be able to analyze the distinctive characteristics of every cancer and develop tailored drugs to target each one.
Texas plays a crucial role in this life-saving research. Our state is home to more than 6,100 biotechnology and R&D companies, which collectively employ more than 105,000 people. We are number two in the country for completed clinical trials and number three for doctorates in biotech fields.
These researchers and their investors who work to make cancer cures a reality should be able to securely license and develop patented intellectual property (IP) without fear of these long-established legal rights being stripped away.
That’s where the NIST proposal comes in. It radically reinterprets a 1980 law called the Bayh-Dole Act, which established that universities engaged in federally funded research could patent their discoveries and license them to companies for further development. Before Bayh-Dole, the government retained control of university patents but very rarely commercialized them. In other words, the federal dollars that helped fund the initial research brought no benefit to the public.
By freeing up university patents for development into useful products, the new law ushered in a wave of innovation that continues to this day. Hundreds of advanced products across a broad range of sectors – including dozens of medicines and vaccines – wouldn’t exist without Bayh-Dole.
Today, that’s all at risk. The proposed NIST framework would twist the clause in the Bayh-Dole Act that established “march-in” rights, which allow the federal government to step in and relicense a company’s patents to competitors under very limited circumstances – none of which are triggered by price considerations.
The NIST proposal seeks to expand this authority to allow the government to march in any time officials deem the price of a product too high. This would violate the clear intent and spirit of the law and devastate innovative industries. Incentives for investing in medical research would disappear. Promising drug candidates in the development pipeline would be abandoned. And many of the cancer patients I work with would find themselves bereft of hope.
The declared intent behind the proposal is to lower drug prices, which is a worthy goal. But any approach that undermines innovators’ exclusive rights to market their inventions – considering the inherent risks involved in development and commercialization – is not an appropriate course of action.
Bayh-Dole has served as a cornerstone of innovation over the past four decades. We must maintain the law’s integrity and continue to support strong IP protections that foster fruitful public-private partnerships.
These priorities resonate with significant force in Texas, where public-private partnerships are deeply ingrained in the biotech landscape. The private biotech sector and leading public institutions, like the Cancer Prevention Research Institute of Texas, allocate billions of dollars towards research.
Americans are living better and longer lives thanks to medicines developed via Bayh-Dole – and we stand on the precipice of even more breakthroughs. To sustain Texas’ strides in life-saving innovation, the government must reverse course on this proposal.
Diana Dobson is Executive Director of Regarding Cancer.
