Posts Tagged: "TRIPS IP waiver"

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 Senate Judiciary Committee’s Subcommittee on Intellectual Property held a hearing today featuring a panel of patent-savvy witnesses to underscore the crucial role intellectual property plays in the U.S. economy and to define the biggest threats to IP rights, both foreign and domestic. The conclusion of most panelists as to what one step is most important in reestablishing the United States as an IP powerhouse was that we need to clean up our own IP system at home in order to even begin addressing threats from foreign competitors like China.

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.

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.

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.

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 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.”

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.

Last year at this time we thought we had been through the worst of it and, with the new vaccines arriving, that life would return to normal in 2021. Hahaha, how naïve we were! But take heart; some things hold steady through the storm, such as the popular sport of trade secret litigation. Unlike most patent and copyright cases, every dispute is guaranteed to unfold as a morality play—a story of good guys and bad guys. Let’s now look back on the year when remote work dug in to become a permanent fixture, and remind ourselves of the broad sweep of trade secret law by looking at some of the more instructive and interesting opinions issued by the courts – and one inexplicable decision by our government.

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.

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.

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.