Posts Tagged: "TRIPS Agreement"

Nearly 50 former government officials and other well-known figures in the IP space signed onto a letter today penned by the Council for Innovation Promotion (C4IP) urging President Biden to oppose the World Trade Organization’s (WTO’s) proposed extension of the COVID-19 IP waiver to therapeutics and diagnostics. The WTO announced a deal on waiver of IP rights for COVID-19 vaccine technologies under the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) in June 2022. The final text made almost no one happy and was much narrower than the original proposal by South Africa and India. The waiver is limited to “patented subject matter required for the production and supply of COVID-19 vaccines” only.

The U.S. International Trade Commission (ITC) released a sprawling report on Tuesday analyzing market dynamics surrounding the question of whether to extend the waiver of IP rights for COVID-19 technologies under the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) to diagnostics and therapeutics. The report stopped short of making any recommendations, but ultimately did not find any definitive evidence that IP rights present a barrier to access in the context of COVID diagnostics and therapeutics. However, it largely amounts to a reiteration of talking points on both sides and seemingly does little to further the debate.

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.

The International Trade Commission (ITC) conducted an all-day hearing today featuring a range of stakeholders with interests in the World Trade Organization’s (WTO) pending decision on extending what has come to be known as the TRIPS [Agreement on Trade-Related Aspects of Intellectual Property Rights] waiver from strictly COVID-19 vaccine technologies to COVID-19 related therapeutics and diagnostics. The initial agreement on waiver came in June of last year and left most of those at the table unhappy. The decision presently applies only to “ingredients and processes necessary for the manufacture of the COVID-19 vaccine” and contemplates extending that to therapeutics and diagnostics no later than six months after the date of the decision, which would have been December 17, 2022. However, that was delayed in December amid concerns there wasn’t enough information to make an informed decision on extension.

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.

A terrible idea – wayward and ill-conceived, criticized by all economic, political and geopolitical fronts – has come to fruition. The World Trade Organization’s (WTO) TRIPs waiver on patents related to COVID-19 vaccines will disincentivize the entire industry from investing in vaccine production. To understand what happens next, let’s understand history first.

Following a week of round-the-clock deliberations, the World Trade Organization (WTO) this morning announced a deal on waiver of IP rights for COVID-19 vaccine technologies under the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). The final text has made almost no one happy and largely mirrors the draft text going into negotiations, with a few key changes. With respect to open questions in the draft text, the final agreement indicates that all developing country WTO Members will be considered eligible to take advantage of the waiver, but that those with “existing capacity to manufacture COVID-19 vaccines are encouraged to make a binding commitment not to avail themselves of this Decision.” This language is primarily targeted at China, which has publicly stated that it would not use the waiver provision but had objected to language based on percentage of global vaccine exports that would have categorically excluded it. The draft text had encouraged members with vaccine export capabilities to opt out rather than to make a binding commitment.

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.”

Senate Finance Committee Chair Ron Wyden (D-OR), Ranking Member Mike Crapo (R-ID) and Senators Bob Menendez (D-N.J.), Charles Grassley (R-IA), Catherine Cortez Masto (D-NV) and Ben Sasse (R-NE) sent a letter today to U.S. Trade Representative (USTR) Katherine Tai asking that she “dramatically improve” transparency in the negotiations surrounding waiver of intellectual property rights under the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). The letter noted that details of the draft text of a waiver agreement were announced in March, before Congress had been briefed or shown the text. Most recently, a new draft was shared with all World Trade Organization (WTO) Member States that has caused controversy on all sides of the issue.

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.

From the “one hand doesn’t know what the other hand is doing” category, believe it or not, the Food and Drug Administration (FDA) is effectively refusing to release documents it possesses relating to the approval of the Pfizer-BioNTech COVID-19 vaccine. More precisely, Public Health and Medical Professionals for Transparency (PHMPT), a group of doctors and scientists, submitted a Freedom of Information Act (FOIA) request for documents relating to the approval of the Pfizer COVID-19 vaccine. After the FDA denied a request by the PHMPT to expedite release of the documents, a lawsuit was filed. In response to that lawsuit, the FDA proposed to release 500 pages per month, which would allow the agency time to redact material as necessary. Given that there are 329,000 pages responsive to the PHMPT request, at the proposed FDA rate of 500 pages per month it would take 55 years for the FDA to fully release the Pfizer COVID-19 vaccine documents.