Our current leaders seem determined to rip down one of the most well-established and successful tenets of our nation's legal system: intellectual property
IP rights -- which include patents -- ensure that only inventors can profit from their creations for a set period of time. Any truly novel product or technology can be patented, but these protections are especially relevant in medicine, because they encourage the development of new treatments and cures.
Abraham Lincoln -- the only U.S. president to ever hold a patent -- said, "the patent system adds the fuel of interest to the fire of genius."
Recognizing the potential power of IP rights, the Founding Fathers authorized Congress to create a patent system to "promote the progress of science and useful arts." But for all their foresight, if the Framers of the Constitution came back today, they might be stunned to see just how well their system has worked: IP-intensive industries now contribute more than $7.5 trillion to annual U.S. gross domestic product.
And yet, today's politicians think they know better. In recent years, they've championed multiple proposals that, if successful, would punch gaping holes in our intellectual property
Exhibit A: During the pandemic, the Biden administration supported an international proposal to waive intellectual property
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Proponents of the waiver argued that patents were to blame for early problems with vaccine access, though there were no facts to support this view. As quickly became clear, the world's vaccine-access issues were due to logistical barriers like poor transportation, storage problems, and an insufficient supply of trained medical staff. By 2021, there was a global glut of Covid shots, with millions of doses going unused. But the World Trade Organization adopted the waiver anyway, which it couldn't have done without U.S. backing.
Far from causing shortages, patents are the very reason that companies were able to develop Covid treatments and vaccines in record time -- and, indeed, the reason any new medicine gets invented.
Drug development is a risky and expensive process. The average cost to create and launch a single new medicine is over $2 billion, and just 12% of drug candidates that enter clinical trials earn FDA approval.
Companies and their investors are willing to take a gamble on research projects despite these sobering odds because they know that their IP rights are secure. If a drug is one of the few that prove successful, a company can recoup its outlay and earn a return -- thanks to holding the key patents. This system keeps billions of dollars flowing into drug research every year.
Now, a new campaign to undermine IP rights is underway. Today, the Biden administration is going after a landmark law known as the Bayh-Dole Act.
Passed in 1980, Bayh-Dole allowed universities to retain patent rights on breakthroughs that received federal funding. Previously, such patents reverted to the government, which did nothing to develop them further. The new law encouraged universities to license their patents to companies that could turn them into real-world products. Today, thousands of consumer goods and hundreds of drugs trace their roots back to Bayh-Dole. They include treatments for sickle cell disease, prostate cancer, and leukemia.
Some Democrats have asserted that Bayh-Dole empowers Washington bureaucrats to "march in" and strip companies' of their patent rights on such products if they disagree with the price -- even after the companies have invested decades of research and billions of dollars. The law doesn't say anything like that. Yet the White House is close to implementing such a plan.
Using Bayh-Dole for this purpose will send a chilling message to inventors: the U.S. government no longer believes in rewarding innovation.
Those are just a couple of recent anti-IP efforts, but there are more. Lawmakers have pushed the administration to reduce the number of drug patents companies can file, and pressured the U.S. Patent and Trademark Office to reject certain patent applications even before they've been made. In a letter to Health and Human Services Secretary Xavier Becerra, Sen. Elizabeth Warren and colleagues exhorted the government to simply appropriate drug patents from rights holders and license them to other companies -- a wild misinterpretation of Section 1498 of the U.S. Code.
If we continue down our current path, patients will pay the price, and the United States will say goodbye to its position as one of the world's most innovative nations.
Peter J. Pitts, a former FDA associate commissioner, is president of the Center for Medicine in the Public Interest.
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