Posts Tagged: "COVID IP waiver"

The United States Trade Representative (USTR) released its annual Special 301 Report on April 26, adding two countries to the “Watch List”: Bulgaria and Belarus. In total, there are now 29 countries on either the Priority Watch List or Watch List, up from 27 last year. Belarus was added because it passed a law that “legalized unlicensed use of certain copyrighted works if the right holder is from a foreign state ‘committing unfriendly actions.’” This includes the U.S. sanctions imposed on Belarus for its support of Russia’s invasion of Ukraine. “

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.

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.”

Two major trade organizations representing global vaccine manufacturers are officially backing a proposal submitted to the G20 and G7 countries in July that they claim offers practical solutions for future pandemics to avoid the inequities that have been highlighted by the COVID-19 pandemic. The Berlin Declaration was proposed in July 2022 by the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) and calls on industry to commit to “reserve an allocation of real-time production of vaccines, treatments and diagnostics for priority populations in lower income countries and take measures to make them available and affordable.”

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.

The United States National Institutes of Health (NIH) signed a deal today with the World Health Organization’s COVID-19 Technology Access Pool (C-TAP) and the Medicines Patent Pool (MPP) that allows manufacturers greater access to key COVID-19 technologies owned by NIH. The licensing agreement offers 11 technologies under transparent, global and non-exclusive licenses. They include “the stabilized spike protein used in currently available COVID-19 vaccines, research tools for vaccine, therapeutic and diagnostic development as well as early-stage vaccine candidates and diagnostics.”

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.

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.

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.”

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.