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Patent Filing & Litigation

The US Waived IP Protection for COVID Vaccines. Now What?

On May 5, US President Biden announced his support for a World Trade Organization (WTO) proposal waiving IP protection for COVID vaccines. The proposal, introduced last October by India and South Africa, would temporarily lift patent protection on COVID vaccines, as well as treatments for the virus. The goal of the proposal is “vaccine equity,” as described by World Health Organization (WHO) Director-General Tedros Adhanom Ghebreyesus. He notes that 80% of all COVID vaccine doses have been administered in wealthy countries, as compared to the 0.3% of doses available in low-income countries. In addition to WHO, the proposal to waive IP protection temporarily is supported by Doctors Without Borders. 

In stark contrast to this support is the Intellectual Property Owners Association’s (IPO) stance. In a statement on May 6, the organization expressed its “disappointment and concern” over the US president’s decision. The pharmaceutical industry, as well as policy and industry experts, are echoing this concern. 

Why the opposition?

The parties on each side of this continuum believe their position is the best solution to the ongoing COVID crisis. The US backed the WTO’s proposal to remove barriers to worldwide vaccine manufacturing, which would—in theory—increase supply. The proposal would also allow other biotech companies to develop and manufacture their own vaccines without worrying about infringing on large pharmaceutical companies’ IP rights. 

However, the IPO fears that “a waiver of IP rights… would have an immediate chilling effect on the research and collaborations that are needed to continue to combat COVID-19.” The organization also fears that waiving patent protections for COVID vaccines and treatments is “a dangerous precedent” for future crises. IPWatchdog contributor Joseph Allen voices similar fears in a recent article, alleging this decision “threatens both our economy and our health far into the future.”

The pharmaceutical industry itself has much more practical concerns, at least for now. Sharing the “recipe” for complex mRNA vaccines without a supply chain for raw materials and manufacturing know-how could result in drugs that are ineffective and unsafe.

What’s next?

Support from the US government does not mean any immediate changes to WTO policy. The United Kingdom and European Union are not in agreement with the WTO at this point in time. If the WTO is able to secure support from its member countries, it would begin to negotiate an IP policy that both countries and the companies within them could agree on. This threat alone could be enough to motivate public and private entities to solve the supply chain issues already impacting vaccine manufacturing. It could also encourage pharmaceutical companies to sell their vaccine doses to low-income countries at a reduced cost.