Posts Tagged: "TRIPS"

The House of Representatives’ Subcommittee on Courts, Intellectual Property, and the Internet today held a hearing titled “IP and Strategic Competition with China: Part II – Prioritizing U.S. Innovation Over Assisting Foreign Adversaries,” which focused on the World Trade Organization’s (WTO’s) agreement on a waiver of IP rights for COVID-19 vaccine technologies under the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) last June. All of the panelists agreed that COVID-19 is no longer a public health emergency and that an extension of the waiver to diagnostics and therapeutics is likely unnecessary.

With the planet now awash in unused vaccines, efforts are underway to extend the TRIPS waiver to our COVID diagnostics and therapeutics (terms that are poorly defined). By the way, China is considered a “developing country” that could use the waiver. The U.S. Trade Representative asked the U.S. International Trade Commission to investigate whether or not such an extension is justified. That effort includes seeking public comments, which are due by Friday, May 5, 2023. The Bayh-Dole Coalition, which I lead, just submitted to following letter to US ITC Secretary, Lisa Barton, laying out some of the many reasons why the extension would be a colossal blunder.

The People’s Vaccine Alliance released comments this week on a draft of a pandemic accord currently being considered during the fourth meeting of the Intergovernmental Negotiating Body (INB) at the World Health Organization (WHO). The organization criticized the draft for lacking strong language that would obligate WHO member parties to share knowledge and intellectual property during a pandemic. The Zero Draft is being discussed at the INB meeting from February 27-March 3, and the organization will later decide if it will be the basis of negotiation for the pandemic prevention accord. After the fourth meeting, the INB will hold another meeting from April 3-6, and it will report on developments around the accord in May, at the 76th World Health Assembly. The People’s Vaccine Alliance saw some positives in the Zero Draft; however, the group asked for more concrete language on the issue of intellectual property rights, among other topics.

When it comes to how to best increase access to medicines in l0w and middle-income countries (LMICs), compulsory licensing gets most of the attention. Academic articles, non-governmental organization (NGO) campaigns, conferences and United Nations (UN)-endorsed technical symposia assert it is the best approach. Certain World Trade Organization (WTO) members are pushing for COVID-19 treatments and diagnostics to be included in the waiver of intellectual property rights under the Agreement on Trade-Related Aspects of IP Rights (TRIPs waiver), which revolves around compulsory licensing. Brazil has recently amended its IP laws to make compulsory licensing easier. Despite its high political profile, compulsory licensing has rarely been used (mainly by a handful African countries in the mid 2000s to address the HIV pandemic). Even then, IP-respecting treatments available from global procurement bodies have proven cheaper. No country has yet seen the need for a compulsory license for a COVID vaccine.

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.”

In a webinar hosted today by the Council for Innovation Promotion (C4IP), the organization’s founders, Andrei Iancu and David Kappos, both former Directors of the U.S. Patent and Trademark Office (USPTO), spoke with former U.S. Secretary of Commerce, Gary Locke, about the increased skepticism surrounding a plan to extend the waiver of intellectual property protections for COVID-19 vaccines under the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) to COVID-19 diagnostics and therapeutics. According to Kappos, while World Trade Organization (WTO) member countries were supposed to decide on December 17 whether to extend the waiver, “given the rising opposition and other countries starting to raise their hands” with questions, “it’s seeming likely the WTO will defer its decision until the New Year.”

Last week, the Bayh-Dole Coalition held a webinar titled “The Three-Pronged Attack on U.S. Innovation and Intellectual Property.” Before we consider each prong, it’s worthwhile reflecting on a larger point. Each would deal a body blow to American innovation just as we struggle to keep the economy on track. And each would be a self-inflicted wound that must have our foreign rivals shaking their heads at our folly.

A communication from the governments of Mexico and Switzerland to the World Trade Organization’s (WTO’s) Council for Trade-Related Aspects of Intellectual Property Rights (TRIPS) on Tuesday raised a number of questions about the prospect of extending a waiver of intellectual property (IP) rights for COVID-19 vaccine technologies to therapeutics and diagnostics. The Council met informally in September to discuss the extension, which technically has a deadline of December 19, six months after the Ministerial Conference decision finalizing a waiver on “patented subject matter required for the production and supply of COVID-19 vaccines” only. The final agreement contemplated extending the waiver to “the production and distribution of COVID-19 diagnostics and therapeutics” within six months of adoption.

With all of the problems besetting us, you might think that the last thing we need right now is another give-away of critical technologies, but that could be about to happen. Negotiations are underway in Geneva over a proposal from “developing countries” that negating patent protections for our COVID-19 vaccines wasn’t good enough. Now they want to extend that foolish concession we agreed to earlier this year to any COVID therapy. You’d think it would be well understood by now that appeasement doesn’t foster gratitude, it only encourages the other side to push for more. We’ll soon see if we roll over again or not.

The People’s Vaccine Alliance issued a statement today, one day before the World Trade Organization’s 12th Ministerial Conference is set to end, accusing the United Kingdom and Switzerland of being “major blockers of the TRIPS waiver for twenty months while millions have died without access to COVID-19 vaccines.” Anna Marriott, Policy Lead at the People’s Vaccine Alliance and Health Policy Manager at Oxfam, said the two countries “have repeatedly disrupted negotiations using the amendment process to ensure that any text is difficult to use or implement” and added: “It would be totally false for rich countries to shift the blame for the current state of TRIPS negotiations onto anybody else.”

The World Trade Organization’s (WTO’s) 12th Ministerial Conference is set to take place this week, June 12-15, at WTO headquarters in Geneva, Switzerland. As part of the four-day meeting, discussions around the latest text of the proposal to waive intellectual property (IP) rights under the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) for COVID-19 vaccine technology will take place around the clock, and it is expected that some agreement will be reached. TRIPS Council Chair, Ambassador Lansana Gberie of Sierra Leone, said on June 7 that “delegations have entered into real negotiation mode in the last 24 hours,” and that she is “feeling cautiously optimistic now that we will get this text ready for adoption by ministers in time for the coming weekend.”

As a former Chairman of the House Judiciary Committee and co-author of major patent legislation, I have a special interest in supporting and protecting U.S. intellectual property rights. So, I took note last month when the Office of the U.S. Trade Representative (USTR) released its latest Special 301 Report on Intellectual Property Protection and Enforcement.

World Trade Organization (WTO) director-general Ngozi Okonjo-Iweala yesterday sent a letter to Ambassador Lansana Gberie, Chair of the Council for Trade-Related Aspects of Intellectual Property Rights (TRIPS), explaining that an informal group of delegates from the United States, the European Union, India and South Africa have reached a draft outcome document on the proposal to waive IP rights for COVID vaccine-related patented technologies. The text largely tracks that of a draft circulated in March, but some open questions remain for the broader membership to resolve.