World Intellectual Property Rights Day is an excellent time to celebrate human achievement and the significance of intellectual property (IP) rights.

The theme for the 2022 celebration, which is on April 26, is “IP and Youth:  Innovating for a Better Future.”  Young people will get a chance to better understand how they can become part of the innovation economy, as well as the importance of protecting IP rights. 

The Constitution provides protection for only one form of property.  Article I, Section 8, Clause 8 of the Constitution states, “To promote the progress of science and useful arts, by securing for limited times to authors and inventors the exclusive right to their respective writings and discoveries.” 

Intellectual property rights were essential to the development of safe and effective COVID-19 vaccines, which have saved and will continue to save millions of lives. Future cures for not only the next pandemic, but also every type of disease, rely on IP and attempts to undermine IP rights jeopardize future research and development.  Without those rights, researchers and scientists like Drew Weissman and Katalin Karikó would not have had the ability in the mid-1980s to build on discoveries from the 1960s to develop the mRNA technology that was used to rapidly produce safe and effective COVID-19 vaccines. 

Despite the proven importance of IP rights, there are significant threats coming from both overseas and in the United States.  The World Trade Organization’s (WTO) proposed language for the Trade-Related Aspects of Intellectual Property Rights (TRIPS) waiver regarding COVID-19 vaccines would threaten intellectual property and the development of future vaccines. 

As Citizens Against Government Waste has previously noted, the waiver will make it more difficult to make vaccines available; give China, Russia, and other competitors access to valuable technology; appease members of Congress like Sen. Bernie Sanders (I-Vt.) and Rep. Alexandria Ocasio-Cortez (D-N.Y.) by undercutting IP and leading to a government takeover of first the biopharmaceutical and then other industries; and, undermine decades of global IP leadership by the U.S.

The waiver was first proposed in October 2020, when two of the worst countries in the world in protecting IP rights, India and South Africa, asked the WTO to allow other countries to obtain for free and without any compensation to the holder of the IP rights, the technology used to produce vaccines, medicines, diagnostics, or any medical technology during the COVID-19 pandemic.  Their request stated, “Given this present context of global emergency, it is important for WTO Members to work together to ensure that intellectual property rights such as patents, industrial designs, copyright and protection of undisclosed information do not create barriers to the timely access to affordable medical products including vaccines and medicines or to scaling-up of research, development, manufacturing and supply of medical products essential to combat COVID-19.”  Despite the latest effort to reach a “compromise,” nothing short of a complete rejection of any waiver should be acceptable to the United States.    

Another attack on IP could come from the federal government. The Bayh-Dole Act, signed into law in 1980, was passed to solve a patent and manufacturing problem when at the time, only 5 percent of government-funded technology was brought to market, resulting in a waste of federal research dollars.  One of the many results of Bayh-Dole was a significant increase in biopharmaceutical research and development.  For example, in 2019, the pharmaceutical industry spent $83 billion on research and development, and between 2010 and 2019 the number of new drugs approved for sale increased by 60 percent.  

The Bayh-Dole act provides for the patent of a government-funded invention to be awarded to the inventor. However, the law permits march-in rights of any of these patents to be applied to other applications under certain circumstances for health and safety needs if the current patent holder has yet to take action after a specific time frame.  Despite the large private sector investment in pharmaceutical research and development, some government officials are attempting to misuse march-in rights beyond the original intended use of the law, using the COVID-19 pandemic as an excuse to take this unprecedented action.

On August 4, 2020, California Attorney General Xavier Becerra and Louisiana Attorney General Jeff Landry, along with 32 other attorneys general, authored a letter to Department of Health and Human Services Secretary Alex Azar, National Institutes of Health Director Dr. Francis S. Collins, and Federal Drug Administration Commissioner Steven Hahn, asking them use march-in rights under the Bayh-Dole Act to increase the supply of remdesivir, a treatment for COVID-19 made by Gilead.  The AGs claimed that Gilead had received millions of dollars in federal funding for the drug, but was putting profit before production, unable to provide a sufficient supply, and failing to achieve a reasonable price or meet the health and safety needs of the public.  They wrote that if the federal government would not use its march-in rights, the states should be given the authority to do so.  CAGW strongly urged against the use of this power to take control of the production and distribution of remdesivir or any other drug.  Misusing march-in rights could dissuade future innovation and result in fewer cures.

Infringing on the IP rights that are essential for the research and development of treatments and cures for diseases will have a significant impact on everyone’s lives.  The United States should create an environment where healthcare discoveries are pursued without fear that intellectual property will be taken or redistributed by a government entity.  It is imperative to protect future innovation so that the next pandemic can also be responded to quickly and many other diseases can be treated and cured.