Posts Tagged: "World Trade Organization"

What does the invasion of Ukraine have to do with COVID-19? Would you believe intellectual property is the link? Stay with me on this; it’s an interesting story. Recently, it was confirmed that the Main Intelligence Department of the Ministry of Defense of Ukraine – apparently with some help from volunteer hackers – managed to breach the network of Russia’s most guarded nuclear power facility and make off with extremely valuable trade secrets. The Beloyarsk Nuclear Power Plant contains the world’s only two operational “fast breeder” reactors. More than 20 countries, including the U.S., Japan and France, have been working for decades on this technology, which is supposed to be able to extract close to 100% of the energy from uranium, compared to about 1% for light water reactors. In other words, this is a process that can produce large amounts of energy while completely consuming the fuel and creating virtually no nuclear waste. Whoever is able to commercialize it will make a fortune. So far, no one has come close to the Russians.

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.

Reports overnight indicated that the European Union, United States, India and South Africa have reached a compromise on language for a waiver of intellectual property rights related to COVID-19 vaccine technology under the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement. The compromise is not final and still must get official approval from all 164 World Trade Organization (WTO) member countries. The latest text is limited to “patented subject matter required for the production and supply of COVID-19 vaccines” only; the previous proposal was much broader. “Patented subject matter” is defined as including “ingredients and processes necessary for the manufacture of the COVID-19 vaccines.”

The World Trade Organization (WTO) was scheduled in December to hold its 12th Ministerial Conference (MC12) in Geneva, bringing together officials from 164 countries to negotiate the future of global trade. Concerns over the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) were expected to feature in discussions, however, in-person deliberations have been tabled until at least March as a result of growing health concerns related to the Omicron COVID-19 variant. In the meantime, it is important leaders consider how TRIPS can be strengthened and refined as needed. TRIPS plays a crucial role in driving global innovation, but ambiguities surrounding the agreement’s dispute settlement mechanism have led some to conclude that it is vulnerable to abuse by countries seeking to advance their national interests.

A webinar hosted on Tuesday, January 12, by The Federalist Society’s Regulatory Transparency Project featured former U.S. Patent and Trademark Office (USPTO) Directors Andrei Iancu and David Kappos, as well as Duke University Professor of Law and former USPTO Administrator of the Office of External Affairs Arti Rai, discussing the proposal to the World Trade Organization (WTO) to waive IP rights under the Trade-Related aspects of Intellectual Property Rights (TRIPS) Agreement for certain COVID-19 technologies. While all three panelists agreed that the IP waiver discussion has become a distraction that will not solve the fundamental problems, Iancu and Kappos were especially passionate that the precedent set by the U.S. government’s decision to back the proposal could do very real harm, rather than good.

Yesterday, Senator Thom Tillis (R-NC), the Ranking Member on the Senate IP Subcommittee, wrote to Ambassador Katherine Tai, the United States Trade Representative who is responsible for negotiating an IP Waiver to the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement with the World Trade Organization (WTO). This TRIPS IP Waiver is generated by proposals submitted by South Africa and India and seeks the waiver patent and trade secret protections relating to COVID-19 innovations. This is the fifth such letter Tillis has sent Tai. As noted by Senator Tillis and many commentators, including here on IPWatchdog, the proposed TRIPS IP Waiver is nothing more than an attempt to steal intellectual property rights covering important innovations that took nearly a generation to bring to fruition. And now we have definitive proof.

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.

On Monday of IPWatchdog LIVE in Dallas, a panel on “The TRIPS IP Waiver: Separating Fact & Fiction” was moderated by president and CEO of the PCT learning center and founding partner of Berenato & White, John White, and featured IP leaders Andrei Iancu, Patrick Kilbride, and Chris Israel. The Trade Related Aspects of Intellectual Property (TRIPS) agreement is an international agreement among members of the World Trade Organization (WTO), which sets minimum standards in the international rules governing intellectual property. In 2020, India and South Africa proposed a TRIPS Agreement waiver proposal that would temporarily waive intellectual property rights protections for technologies needed to prevent, contain, or treat COVID-19, including vaccines and vaccine-related products. The proposal has been hotly contested globally, but the Biden Administration said in May of this year that the United States would back it.

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.

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 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

Bloomberg first reported today that U.S. Trade Representative Katherine Tai said that the United States will back a proposal by India and South Africa last year to waive intellectual property protections under the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement. The proposal calls for the suspension of international protections for patents, copyrights, industrial designs, trade secrets and proprietary materials, “in relation to the prevention, containment, or treatment of COVID-19 until widespread vaccination is in place globally and the majority of the world’s population has developed immunity.” Tai reportedly said “We are for the waiver at the WTO, we are for what the proponents of the waiver are trying to accomplish, which is better access, more manufacturing capability, more shots in arms.”