Posts Tagged: "IP waiver"

A number of lower-income countries (LMICs) on Tuesday, December 6, proposed new text to the World Trade Organization (WTO) urging them to adopt it and proceed with an extension of the waiver of IP rights for COVID-19-related technologies under the Agreement on Trade-Related Aspects of IP Rights (TRIPS). The text was sent following the United States’ announcement on the same day that it supports a delay of the deadline to decide whether to extend the waiver to diagnostics and therapeutics pending an International Trade Commission investigation that the Office of the United States Trade Representative (USTR) has ordered.

The Office of the United States Trade Representative (USTR) this morning announced support for delaying the deadline to decide whether to extend a waiver of intellectual property rights under the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) to diagnostics and therapeutics. The USTR also said it has asked the United States International Trade Commission (USITC) “to launch an investigation into COVID-19 diagnostics and therapeutics and provide information on market dynamics to help inform the discussion around supply and demand, price points, the relationship between testing and treating, and production and access.”

On November 10, a group of Democratic members of congress sent a letter to United States Trade Representative Katherine Tai expressing concerns about extending a waiver of intellectual property rights under the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement to therapeutics and diagnostics for the treatment of COVID-19. The letter comes as talks are heating up at the World Trade Organization (WTO) about such an extension, with the technical deadline for a decision being December 19. The letter poses seven questions for Tai to consider and respond to as she formulates the U.S. position on waiver extension, including whether the current waiver of IP rights for vaccine-related technology has been effective, how “diagnostics” and “therapeutics” will be defined, and that she provide a list of countries that have expressed interest in gaining access to American IP for COVID-related diagnostics and therapeutics.

In the wake of the development of COVID-19 vaccines, the Biden-Harris Administration has suggested major shifts in U.S. policy concerning patent protection. In May of this year, Ambassador Katherine Tai, the U.S. Trade Representative (USTR) announced the Administration’s support for waiving intellectual property protections for COVID-19 vaccines. Most recently, the National Institutes of Health (NIH) Director Dr. Francis Collins accused Moderna of excluding three NIH scientists as co-inventors of a key patent for the COVID-19 vaccine. This article explores an alternative possibility of the Administration exercising certain rights in the COVID-19 vaccine invention under the 1980 Bayh-Dole Act—one day after the bill’s co-sponsor, Senator Bob Dole, passed away—and whether such an exercise of rights is in line with past precedent or would be a violent disruption to the status quo.  

Experts agree: The COVID-19 vaccines are one of humanity’s greatest achievements. The previous record for vaccine delivery was almost five years; today’s innovators delivered the COVID-19 vaccines in less than one. The achievement is a testament to the dedication of those innovators, as well as the strength of the policy framework that supports their work. Unfortunately, some people want to destroy that framework. Some nations are promoting a dangerous proposal, supported by the administration, to waive intellectual property (IP) protections – such as patents and trade secrets – for COVID-19 vaccines. At the end of November, at a World Trade Organization (WTO) ministerial meeting, they’ll present this proposal as the best way to defeat the pandemic. But what they won’t mention is that their approach will actually threaten ongoing vaccine production, hurt our successful health care innovators, patient safety, economic competitiveness, American leadership, and the discovery pipeline in the process. 

One-hundred-twenty-four professors and academics from around the world have penned an open letter supporting India and South Africa’s proposed waiver of certain provisions of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement), which they claim will help to combat the COVID-19 pandemic. According to a press release about the letter, the United Kingdom, Ireland, Australia, Brazil, Japan, Norway, Switzerland and the EU continue to oppose the waiver proposal. The United States expressed its support for waiver in May. Over the last several weeks, Europe has doubled down on its opposition to the proposal in ongoing talks.

Waiving intellectual property (IP) protections for COVID-19 vaccines will hinder rather than further three meritorious objectives of the current U.S. Presidential Administration: ending the pandemic as soon as possible, leveling the IP playing field with China, and pursuing a worker-centric trade policy. Ensuring equitable, widespread, and successful distribution of vaccines across the globe to meet the challenges of COVID-19, ending the erosion of U.S. IP at the hands of China, and putting Americans back to work are goals that most of us in the U.S. share. An examination of the facts, however, demonstrates that waiving IP rights in the name of COVID-19 relief undermines each of these three U.S. government goals.

On June 4, the European Commission submitted to the World Trade Organization (WTO) its proposal for improving access to COVID-19 vaccines and treatments in countries suffering from vaccine shortages. The plan was submitted as an alternative to other proposals that would eliminate international patent rights for COVID-19 vaccines and treatments under the premise that such action would improve vaccine access in poorer countries. While the EU alternative contemplates the possible use of compulsory licensing, it addresses supply chain issues that will help to inoculate the entire globe against COVID-19 much more quickly than any patent waiver could ever hope to accomplish.

Intellectual property (IP) made modern vaccines possible. It took billions of dollars in private and public investments in research and development to be able to create, in record time, multiple viable vaccines to fight the COVID-19 pandemic. The entire world should be celebrating the innovators that continue to push forward with new solutions to problems we will face in the future. This pandemic will end, but there will be another. We should be eternally grateful to have companies like Pfizer, Moderna and Johnson & Johnson that have the capability to create and manufacture vaccines at large scale…. It has been over four months since President Biden’s inauguration. As of yet there has not been a nomination for the Under Secretary of Commerce for Intellectual Property and Director of the U.S. Patent and Trademark Office (USPTO). In addition to running the USPTO, the Director is responsible for advising the President on intellectual property issues. I believe that President Biden would have benefitted from an experienced voice knowledgeable about the dangers of supporting the erosion of property rights during the discussions on whether to support India and South Africa’s proposal to the World Trade Organization to waive IP protections under the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS).

While the discussions around waiving intellectual property (IP) rights set forth in the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) are currently (and somewhat amorphously) limited to COVID-19 related drug and medical products, it is probably shortsighted to ignore the implications for other technologies critical to sustaining our environment and advancing a more healthful world. In fact, if we want to ensure continued investment in these technologies, we should be very concerned about the message conveyed by the international political tide: if you overcome a challenging scientific problem and your solution has the potential to save lives, be prepared to be subjected to intense political pressure and to potentially hand over your technology without compensation and regardless of the consequences.

The implications of the announcement that the Biden Administration will support efforts to waive intellectual property protection for COVID-19 vaccines and therapies is still sinking in. The Wall Street Journal wrote two editorials in three days, the second more blistering than the first. “Biden’s Vaccine IP Debacle” begins: “… [T]his may be the single worst presidential economic decision since Nixon’s wage-and-price controls.” Not to second guess the paper, but President Nixon’s decision only harmed our economy—this one threatens both our economy and our health far into the future.

The petition by South Africa and India at the World Trade Organization (WTO) to waive most of the protections in the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement was all but dead. It failed in October, December, January, March, and May. Then, after the Biden Administration expressed in the most neutral terms is was “considering” and “discussing” the proposal, U.S. Trade Representative Katherine Tai yesterday announced U.S. support for text-based negotiations that “will take some time.” IP rights are not the barrier to rapid production of vaccines advocates think they are, the waiver would cause more harm than possible good. The WTO would do much better to discuss removing obstacles to the trade of COVID-19 related items than removing intellectual property rights. There are 191 trade restriction measures on COVID-19 related supplies.