Much-needed medical supplies were developed and manufactured quickly during the rapid response to the COVID-19 pandemic. Medical device manufacturers as well as new players stepped up to fill urgent demands. But how did intellectual property fare in the global manufacturing flurry?
Sharon Hwang, shareholder and executive committee member at McAndrews, Held & Malloy, answers MD+DI’s questions on the unprecedented pandemic manufacturing and on any impacts to IP rights. Hwang is a patent and technology attorney focused on helping innovative companies protect, monetize, and enforce their intellectual property.
Many medical device products were developed and launched in response to emergency needs during the COVID-19 pandemic. What was the situation for intellectual property filings?
Hwang: Generally speaking, patent application filings were down for medical devices during the first half of 2020, likely due in part to the shift to remote work and the halting of clinical trials. The temporary halting of elective surgeries also deeply affected many medical device companies and how they chose to allocate their resources.
Beginning in July 2020, the USPTO offered Prioritized Patent Examination for small and micro entities for COVID-related inventions without requiring payment of certain fees associated with prioritized examination. This resulted in 33 COVID-19-related patents being allowed or granted to such entities as of December 28, 2020, including patents on medical treatments, vaccines, diagnostic technology, ventilators, personal protective equipment, and other technology related to COVID-19.
Did you see any unexpected trends in IP in 2020?
Hwang: The pandemic forced many medical device companies to pivot to developing products in response to the pandemic. For example, on short notice, innovative companies like Stryker developed a low-cost, limited-release emergency response bed to help with the need for more hospital beds for COVID patients, worked on a solution to decontaminating N95 masks for emergency use, provided non-sterile versions of PPE for use in healthcare environments outside of the operating room, and even provided emergency relief patient covers to protect caregivers and patients. Other innovative companies and universities developed diagnostic tests and antibody tests. We even saw automotive manufacturers like Ford, General Motors, and Tesla repurposing their manufacturing facilities to help make ventilators.
The University of Illinois College of Engineering developed RapidVent technology, a device that could help the sickest patients to breathe by plugging into the oxygen source available in most hospital rooms or into a tank of oxygen, then turned around and offered free licenses to more than 60 companies and institutions around the world. Other universities, such as the University of South Florida, provided its patent-protected 3D print swab design files to licensees free of charge to allow 3D printing of nasal swabs for non-commercial purposes during the pandemic.
The Open COVID Pledge was founded by tech companies like Intel, Microsoft, HPE, Amazon, and IBM. They invited universities, companies, and other owners of IP to grant free and temporary licenses to use their patents in the fights against novel coronavirus without fear of legal ramifications. Very few medical device companies opened up their patent portfolios, although Medtronic released its ventilator design files and manufacturing guidance using a permissive license for COVID-19 use.
The USPTO also launched the Patents 4 Partnerships program in May 2020 to provide a user-friendly, searchable repository of patents and published patent applications related to the COVID-19 pandemic that are available for licensing. The repository resides on the USPTO website and provides a meeting place that enables patent owners who are willing to license their IP rights to connect with businesses that have the ability to commercialize the inventions. At last check, there were 906 COVID-19-related patents and patent applications available for licensing.
Due to the pandemic, interest and innovations in telehealth, robotics, and Internet of Medical Things have skyrocketed.
Did the pandemic reveal any issues with IP practices in the medical device supply chain?
Hwang: The global shortage of PPE and critical ICU equipment such as ventilators and respirators caused many companies to reassess their supply chains and to consider manufacturing products closer to their final markets.
Perhaps the most talked-about IP issue during the pandemic is the United States’ announcement that it would support the temporary waiver of intellectual property rights relating to COVID-19 medical products, including vaccines, therapeutics, PPE, tests, and medical devices. The U.S. has since softened its stance and now supports a waiver covering vaccine IP rights instead of the broader waiver covering medical products and technologies as originally requested by India and South Africa. Supporters of the waiver argue that such a waiver is necessary to ensure sufficient and equitable worldwide access to COVID-19 vaccines. Those who oppose the waiver argue that such a waiver will not make COVID-19 vaccines more available due to significant barriers to production given the complexity of the technology and required manufacturing facilities. Moreover, a waiver would effectively transfer U.S. innovations to China, India, Russia, and other countries. In reality, the leading U.S. vaccine developers have already licensed their technologies and/or have agreed not to enforce patent rights during the pandemic. Many fear that unilaterally waiving IP rights would discourage future investments in medical innovations.
If there were any changes in approaches to IP, are there any lasting impacts or lessons learned from these changes?
Hwang: This remains to be seen! While the collaborative efforts shown by many universities and companies have been admirable and have undoubtedly helped in curbing the COVID-19 pandemic, such collaborations may lead to disputes down the road. In particular, most collaborations are clearly directed to fighting the COVID-19 pandemic, but it is difficult to monitor whether use of a technology is being limited to fighting COVID-19. Disputes may also arise relating to ownership of rights, i.e., what did each party independently own prior to the collaboration, and who owns any improvements made? Similarly, parties who believe that they are getting a free license may find that they are using other IP that is not part of a COVID pledge.
Do you expect any post-pandemic changes?
Hwang: It is very difficult to speculate on post-pandemic changes. At the moment, the proposed COVID-19 IP waiver is dominating the news, but it remains to be seen what will happen, whether such a waiver will actually be implemented, and if so, the scope of such a waiver. What I can say is we should continue to work together to encourage innovation and the critical role that intellectual property plays in a free market economy.