Posts Tagged: "TRIPS"

The U.S. Chamber of Commerce yesterday published a letter it sent to members of congress expressing strong support for both the “No Free TRIPS Act” and the “Protecting American Innovation Act.” According to the letter, if enacted, these bills “would prohibit the Administration from negotiating or concluding any modifications to the World Trade Organization (WTO) Trade-Related Aspects of Intellectual Property (TRIPS) agreement, without the explicit authorization of Congress.” The Chamber is concerned about the potential impact of the proposed waiver of patent rights for COVID-19 vaccine technology. The letter comes after the European Union, United States, India and South Africa reached a compromise on language for waiver terms last month.

Senators Thom Tillis (R-NC), Tom Cotton (R-AR) and Marsha Blackburn (R-TN) sent a letter yesterday to Secretary of Commerce Gina Raimondo expressing their “grave concerns” with the compromise language agreed on recently in the ongoing talks to waive intellectual property rights for COVID-related technology under the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement. On March 15, the European Union, United States, India and South Africa announced the compromise language. The text is not final and still must get official approval from all 164 World Trade Organization (WTO) member countries.

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. 

Former U.S. Patent and Trademark Office (USPTO) Directors Andrei Iancu and David Kappos, and former Secretary of Commerce Gary Locke, today released a White Paper calling the Biden Administration’s decision to support a waiver of intellectual property protections for COVID-19-related technologies under the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) “strategic folly.” The report was produced by the Center for Strategic and International Studies (CSIS). In the paper, titled “The Shot Heard around the World”, the three officials, two of whom served under the Obama Administration, explained that the United States must indeed ramp up its efforts to improve vaccine diplomacy and to distribute more vaccines globally, but that “[w]aiving IP protections would not lead to the manufacture of a single additional dose of a vaccine.” Instead, they proposed a number of alternative solutions to solve the “real problems.”

Last week, at a meeting of the Council for Trade-Related Aspects of Intellectual Property Rights (TRIPS), World Trade Organization (WTO) members had an opportunity to engage in small group and bilateral meetings to discuss the proposals by South Africa and India to waive patent and trade secret protections relative to COVID-19 innovations, as well as the proposal from the European Union regarding the use of current TRIPS compulsory licensing provisions during a pandemic. Some delegations believed the discussions were encouraging, while others expressed more skepticism, pointing out that a deal will not be achieved “unless delegations are able to make some real compromises.” See Members pursue convergence for IP COVID-19 response.

Scientists, engineers, and everyday people have developed solutions for testing, preventing, and treating the COVID-19 disease. Ordinarily, we wouldn’t think twice about granting patents on these inventions. But, today, when COVID-19 is spreading all over the world and killing millions of people, some world leaders are questioning whether we should be granting the exclusionary rights of patent protection on inventions that help respond to the pandemic. Included in that group is the Biden-Harris Administration, which, in May, announced their support of an “IP waiver” on COVID 19 vaccines. 

In the early days of the vaccination efforts, Americans were anxiously online trying to register for a COVID-19 vaccination appointment. Reports of success at 1:30 am and 2:30 am made the rounds as new appointments dropped onto websites. Also common were stories of vaccine elitism and discussions of which vaccine is “the best.”  News reports continue to show a steady uptick in the percentage of vaccinated Americans. Elsewhere in the world though, the story is very different, and a darker picture is emerging. In Africa, many countries have vaccinated less than 2% of their population. While vaccine distribution is difficult in many regions of the developing world, this is a hurdle that medical assistance groups, such as Doctors Without Borders, are accustomed to handling. The challenges are known. What is most difficult in combating COVID-19 is obtaining the vaccines in the first place. Some argue that IP rights are the key problem and should be waived, while others claim they are the only solution and that waiver would be catastrophic. This article suggests a third option, somewhere between voluntary vaccine donation and a full waiver of IP rights, that may offer a way forward.

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.

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.

President Biden recently announced his support for easing patent rules surrounding COVID-19 vaccines and other COVID-related intellectual property in the wake of growing crises in India and South Africa. Despite President Biden’s public support, easing the international patent rules requires a unanimous decision on the part of the World Trade Organization (WTO), which is still uncertain. However, with the United States’ announcement, the European Union (EU) will also reportedly consider the issue. Predictably, major pharmaceutical companies, including the three pharmaceutical manufacturers with vaccines approved for use in the United States — Pfizer, Moderna, and Johnson & Johnson —have lobbied against easing patent rules. But, given the uniquely global reach of the pandemic and the practical barriers to the production and distribution of vaccines on a global scale, it would be a mistake not to provide patent infringement waivers. What is the need? What is the legal issue? And will it make a difference?

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.  

I happened to be listening to NPR yesterday morning, and caught an interview on BBC Newshour between the BBC’s Razia Iqbal and a representative of the African Union, Dr. Ayoade Olatunbosun-Alakija, who is also co-chair of the African Union COVID-19 Africa Vaccine Delivery Alliance. The discussion was somewhat unique in that the BBC host was at several points defending patent rights and pushing her guest to explain precisely how patents are the problem with respect to the undeniable crisis of insufficient vaccine access in the world’s poorest countries. An excerpted and slightly edited transcript of the interview follows