Posts Tagged: "WTO"

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.

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.

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.”

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.

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.”

Intellectual property (IP) made modern vaccines possible. It took billions of dollars in private and public investments in research and development to be able to create, in record time, multiple viable vaccines to fight the COVID-19 pandemic. The entire world should be celebrating the innovators that continue to push forward with new solutions to problems we will face in the future. This pandemic will end, but there will be another. We should be eternally grateful to have companies like Pfizer, Moderna and Johnson & Johnson that have the capability to create and manufacture vaccines at large scale…. It has been over four months since President Biden’s inauguration. As of yet there has not been a nomination for the Under Secretary of Commerce for Intellectual Property and Director of the U.S. Patent and Trademark Office (USPTO). In addition to running the USPTO, the Director is responsible for advising the President on intellectual property issues. I believe that President Biden would have benefitted from an experienced voice knowledgeable about the dangers of supporting the erosion of property rights during the discussions on whether to support India and South Africa’s proposal to the World Trade Organization to waive IP protections under the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS).

The horrific second wave of COVID-19 in India has compelled the government to introduce an expedited vaccination drive from May 1, 2021, where all citizens above the age of 18 (and not just priority groups) will be eligible to register. The program also came with the promise of an introduction to several new vaccines in the market. A majority of the states also decided to roll out the vaccine for free. Unfortunately, reports that stock had run out followed shortly in several states. States like Maharashtra and Delhi had to keep the drive on hold. Bengaluru also faced supply problems ahead of the drive. A popular proposition is that patent restrictions and exclusivity of “know-how” are a barrier to adequate production of vaccines.

India and South Africa recently urged the World Trade Organization to suspend intellectual property protections for COVID-19 vaccines and treatments. The claim is that this would allow developing countries to manufacture “cheap” COVID-19 therapeutics and vaccines, hastening the end to the pandemic—at least, that’s what proponents claim. They’re wrong. Dangerously wrong. Gutting IP protections won’t make COVID-19 medications more readily available but it will set a terrible precedent that will chill future medical innovation.

The biggest vaccination effort in the history of medicine is underway to eradicate the global pandemic, with several strong prospects appearing poised for regulatory approval. As of December 2020, data from the World Health Organization showed over 50 vaccine candidates in clinical research, and 163 more in the preclinical stage. The wait could soon be over. Two separate vaccines – one from Pfizer and BioNTech and one from Moderna – are pending emergency use authorization from the U.S. Food and Drug Administration. The former is already being administered for the first time outside of clinical trials following its approval by the UK government. That’s why recent calls to strip away intellectual property protections are so dangerous. Specifically, some nations have asked the World Trade Organization (WTO) to waive intellectual property protections related to COVID-19 – including not only vaccines, treatments, diagnostics, and medical technologies, but all forms of IP – until the majority of the world’s population has developed immunity. They argue that the current global intellectual property system is a barrier to accessing said COVID-19 vaccines, treatments, diagnostics, and medical technologies.

In withdrawing the 2013 statement, the new 2019 guidance by the DOJ, NIST and the USPTO states the obvious, i.e. that there is no difference in the law between F/RAND assured standard essential patents and all other patents. While some would have perhaps liked to break the unitarity approach of the patent system so as to weaken remedies against the infringement of essential patents, a legal system that would apply a different standard to standard essential patents as opposed to other patents would violate U.S. trade obligations.

On the morning of Thursday, July 19th, the House Permanent Select Committee on Intelligence held a hearing titled China’s Threat to American Government and Private Sector Research and Innovation Leadership. The day’s hearing was dedicated to discuss strategies, both legal and illicit, which are employed by the Chinese government and designed to gain a competitive advantage over the United States.

Among the many bureaucratic changes that resulted from the amendments to the Chinese Constitution included the integration of trademark responsibilities with the other intellectual property activities of the State Intellectual Property Office (SIPO). Such responsibilities, including the management of trademark applications, grants and administrative adjudications, were formerly the province of China’s State Administration for Industry and Commerce (SAIC), which has been disbanded. The newly reorganized SIPO will also handle applications and grants for geographical indications of product origin.

A group of 16 leaders from politically conservative institutions sent a letter addressed to President Donald Trump lauding the Trump Administration’s decision last summer to initiate an investigation into Chinese trade practices regarding intellectual property. The investigation, authorized under Section 301 of the Trade Act of 1974, was aimed at identifying instances where U.S. technologies have been forcibly transferred to Chinese entities as a cost of entering the Chinese domestic market as a foreign entity… The recent letter to President Trump from conservative leaders is the latest indication that right-leaning institutions and think tanks have been more engaged with the debate surrounding the current U.S. intellectual property system.

This latest victory for a foreign plaintiff asserting intellectual property claims is proof of yet another step down the road leading to a reformed, intellectual property friendly China, with China cracking down on infringers — as promised by Chinese President Xi Jinping… The Chinese IP court in Beijing reportedly ordered three domestic shoemakers to pay a total of 10 million yuan ($1.5 million USD) to New Balance for infringing upon the slanted ‘N’ logo utilized by New Balance on its branded shoes. That’s not a huge damages award in the grand scheme of trademark damages ordered around the world but reports indicate that the damages in this cases were the most ever handed out by a Chinese court to a foreign plaintiff for trademark infringement allegations.