April 26th is World IP Day, a day to celebrate the innovation and creativity that advance our world and make our lives better. Intellectual property rights are the backbone of biopharmaceutical inventions that improve the quality and outlook of patients’ lives.
On this and all days, intellectual property must be protected, and we urge the Biden Administration to reconsider its proposed stance on the Bayh-Dole Act’s “march-in” rights. The Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights, which was published late last year by the National Institute of Standards and Technology, indicated that the Biden Administration wants to use the Bayh-Dole Act’s march-in rights to seize drug patents if the government thinks a drug’s price is too high.
Under the Bayh-Dole Act organizations that receive federal funding for research, such as universities and nonprofit organizations, can patent discoveries made using federal funds. This protection of intellectual property has allowed innovation to flourish since the act was signed into law in 1980. The act’s march-in rights allow the government to effectively “march in” on the patent and force the patent holder to allow others to use the patented information, rendering the patent basically worthless. The reasons the government would allow a march-in under are so narrow––such as an organization sitting on critical information and doing nothing with it––that it’s never actually happened. Not only have march-in rights never been invoked, they were specifically not meant to be used to control prices. Congress rejected proposed amendments for price to be a potential reason to allow a march-in in the 1990s.
Many Americans would like some relief at the cash register when it comes to prescription drugs, but not at the price of innovation––which would be the price. In a recent letter to President Biden, a bipartisan group of former senior U.S. officials, including former heads of the U.S. Patent and Trademark Office under Democratic and Republican administrations, stated:
“We believe the adoption of the Draft Framework would destabilize our nation’s entire technology transfer system which is central to U.S. innovation, and we thus implore you to withdraw the framework in its entirety…Before Bayh-Dole was enacted in 1980, the overwhelming majority of discoveries facilitated by federal funding were never turned into products that benefited the public. In fact, before 1980, fewer than 5% of federally owned patents were ever licensed for commercialization. Today, approximately 60% of technologies arising from federal funding are licensed for commercial development.”
According to the Bayh-Dole Coalition, innovations made possible by the act include Google, Allegra, nicotine patches, organ preservation solutions, advanced ultrasound imaging, HD TV, and multiple medications including those that fight, treat, or prevent childhood diseases, cancers, AIDS, pneumonia, epilepsy, Ebola, and more. Without the intellectual property protection afforded by Bayh-Dole, many of these innovations would never have seen the light of day.
If the government is allowed to decide which drugs are priced too high and effectively remove those drugs’ patents, we’ll see fewer and fewer new, life-saving drugs come onto the market.
Critically, the government’s march-in power would not be limited to pharmaceutical innovations––there are implications for all fields of innovation from agriculture to computer science to machinery.
What we do today to protect intellectual property will have a direct impact on our country’s ability to innovate tomorrow.
