Recognizing and Protecting Medical Invention and Innovation on World IP Day

The theme for the 2024 celebration of the annual World Intellectual Property day is "IP and the SDGs: Building our common future with innovation and creativity." The theme for the April 26 event is sustainable development, which includes resilient infrastructure, sustainable industrialization, and fostering innovation. There is nothing more important to strengthening innovation than protecting and promoting intellectual property (IP) in healthcare. IP rights are essential to developing safe and effective medicines and technologies that have saved and will continue to save millions of lives around the world.

Biopharmaceutical innovation means new treatment options for patients and medical advancements. New cutting-edge biological medicines are on the rise, including vaccines, blood and blood components, allergenics, somatic cells, gene therapy, tissues, and recombinant therapeutic proteins. Some biologics also offer personalized treatment for a variety of diseases, which is especially critical for rare disease patients.

An inspiring example of these drugs is Winrevair, a breakthrough biologic used to treat pulmonary arterial hypertension (PAH), which was approved by the Food and Drug Administration (FDA) on March 26, 2024. PAH is a rare and life-threatening disease in which blood vessels in the lungs thicken and narrow, causing significant strain on the heart. Winrevair is the first drug of its kind to treat patients with PAH.

For Katrina Barry, the approval of Winrevair is more than a medical breakthrough. Katrina was first diagnosed with PAH at age 25 and told she only had two to five years left to live based on her condition. She started treatment under clinical trials for Winrevair in March 2020, during the COVID-19 pandemic. "I had to go to the hospital because I was dying if I didn't get this drug," she said, it "was the only chance I had at survival." After four years of trials, the drug she credits with keeping her alive and allowing her to resume many of the activities she enjoyed before her diagnosis is now approved by the FDA.

Katrina's story represents millions of patients who are living with a debilitating disease and awaiting life-saving treatment. Her survival can be accredited to the IP rights that protect innovation in the medical marketplace and help to create life-saving cures.

It is not only exciting to celebrate medical success stories, but also crucial to acknowledge and reject the attempts to undermine IP rights that jeopardize future research and development. Critics of intellectual property rights have misrepresented the laws that protect intellectual property in an attempt to change them.

For example, the Biden-Harris administration is pursuing a "whole-of-government approach" to review march-in rights under the Patent and Trademark Law Amendments of 1980, or the Bayh-Dole Act. The law was originally intended to encourage commercialization of university and nonprofit entities' discoveries that were funded by the federal government, which at that time were fewer than 5 percent. The Act allowed the patents to be owned by the research entities and transferred to the private sector, which would take on the risk and expense to commercialize them.

March-in rights, which would allow the government to take over the development of pharmaceuticals that received federal funding, are meant as a safeguard and only to be used if efforts are not being undertaken for government-funded research to be commercialized. This power has never been used, and if it is imposed and abused, medical innovation will be threatened as biopharmaceutical companies will be dissuaded from researching and developing future cures.

The United States is the global leader in medical innovation, and IP rights underlie all successful discoveries, including new biologics like Winrevair. Any effort to violate or undermine IP rights is destructive and unnecessary and will hinder the future research and development needed to create new cures and life-saving technologies. On World Intellectual Property Day, the benefits of IP should be recognized and applauded, not attacked.

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