Posts Tagged: "COVID-19"

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 March 22, the U.S. Chamber of Commerce’s Global Innovation Policy Center (GIPC) sent a letter addressed to Senators Bernie Sanders (I-VT) and Bill Cassidy (R-LA), respectively the Chair and Ranking Member of the U.S. Senate Committee on Health, Education, Labor, and Pensions, regarding a Health Committee hearing held that same day on the pricing of Moderna’s COVID-19 vaccine. The GIPC’s letter sought to push back on false narratives regarding the role of public funding in private pharmaceutical research & development (R&D,) and also doubled down on the Center’s criticisms of drug pricing controls in the recently enacted Inflation Reduction Act.

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.

Substantial patent litigation activity occurred in the mRNA space in 2022, involving nearly all of the major mRNA and lipid nanoparticle (LNP) pioneers. Since this is the most significant happening in this space with respect to IP in 2022, this post will provide an overview of that activity as well as a summary exposure analysis.

A group of more than 160 charities, non-governmental organizations (NGOs), advocacy organizations, and others sent a letter today under the banner of the People’s Vaccine Alliance to World Trade Organization (WTO) Director-General Dr. Ngozi Okonjo-Iweala imploring the WTO not to accept the proposed delay of a decision to extend waiver of IP rights under the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) to therapeutics and diagnostics. The Office of the United States Trade Representative (USTR) on December 6 announced support for delaying the deadline on an extension decision.

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.”

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.

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.

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, a coalition of over 100 organizations, issued a statement this week alleging that the pharmaceutical industry is attempting to tighten its control of the world’s pandemic response plans. In the statement, the organization argues that “enshrining pharmaceutical companies’ demands in a pandemic treaty or other pandemic preparedness plans would normalize global inequalities and tie the hands of governments in future health crises.” The Alliance released the statement in response to the International Federation of Pharmaceutical Manufacturers & Associations’ (IFPMA) July statement titled the Berlin Declaration – Biopharmaceutical Industry Vision for Equitable Access in Pandemics during the World Health Summit, where stakeholders from politics, science, the private sector, and civil society gathered in Berlin from October 16-18.

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.