Posts Tagged: "COVID-19 vaccines"

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.

On October 2, the Nobel Assembly at Karolinska Institutet announced that Hungarian-American biochemist Katalin Karikó and American immunologist Drew Weissman were awarded the 2023 Nobel Prize in Physiology or Medicine for their discoveries related to modified messenger ribonucleic acid (mRNA) for use in vaccines. A critical part of the world’s response to the COVID-19 pandemic, mRNA vaccines were not an effective option until the pioneering work of these two scientists, one of whom faced considerable rejection while laying the foundation that answered one of the world’s greatest public health crises.

On March 2, U.S. District Judge Mitchell S. Goldberg of the District of Delaware received several filings related to the impact of the U.S. government’s recent statement of interest filed in a patent infringement suit against Moderna’s COVID-19 vaccine. That statement argued that Moderna should be released from infringement liability under the terms of a government contract that “authorize[d] and consent[ed] to all use and manufacture” of any U.S. patented invention. The federal government’s statement of interest, filed on February 14, contended that the use of such authorization and consent clauses should eliminate Moderna’s alleged liability under 28 U.S.C. § 1498, the statute governing remedies for patent infringements by government use. While there’s nothing surprising about the positions taken by defendant Moderna or plaintiffs Arbutus Biopharma and Genevant Sciences, the relevance of Section 1498(a) to arguments surrounding government control of drug pricing could make Judge Goldberg’s next ruling an important moment in the drug pricing debate.

With the World Trade Organization’s (WTO’s) Council for Trade-Related Aspects of Intellectual Property Rights (TRIPS) set to meet informally on Monday, September 19, to discuss extending a waiver of IP rights for COVID-19 vaccine-related technology to diagnostics and therapeutics, the U.S. Chamber of Commerce and the Chamber’s Global Innovation Policy Center (GIPC) are urging the Biden Administration to oppose such a move in favor of “real solutions.” The GIPC’s President and CEO, David Hirschmann, and the Chamber’s Executive Vice President and Head of International Affairs, Myron Brilliant, sent a letter to U.S. Secretary of Commerce Gina Raimondo on Friday expressing confusion at the administration’s seemingly contradictory stances on intellectual property rights.

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 U.S. Court of Appeals for the Federal Circuit ruled yesterday in two precedential decisions that Moderna’s challenges to decisions of the Patent Trial and Appeal Board (PTAB) in favor of Arbutus both failed. The CAFC dismissed one ruling for lack of standing and in the other said Moderna’s arguments that the PTAB erred in its finding that Arbutus’ patent was not unpatentable as obvious were unpersuasive.

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.

Dear Ambassador Tai: I write you again today for the fourth time about the Biden Administration’s waiver of international obligations under the Trade-Related Aspects of Intellectual Property Rights, or TRIPS agreement. Last week, several open-content organizations wrote to President Biden and argued that your proposed TRIPS Waiver should cover not just patents, but also copyright and other intellectual property rights. These organizations ask that you include copyright simply because it may apply to software, medicine labels, manuals, or “tools” associated with vaccines. The letter fails to address the importance of these protections to the economy, trade, and employment, the limitations placed on protections to ensure a balanced system, and how copyright protection facilitates the very innovation, creativity, and knowledge sharing that will make it possible for us to end this once in a lifetime pandemic. The inclusion of copyright is both unsubstantiated and unwarranted, and would impose devastating consequences on American creators, businesses and workers, while doing nothing to advance the objective of combatting COVID.

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. 

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.

While coronavirus spent the majority of 2020 wreaking havoc on earth, pharmaceutical companies have been busy at work trying to invent a vaccine to combat it. Several companies, such as Pfizer, Moderna and AstraZeneca, have competed neck and neck to be the first to deliver a cure to the world. Renowned pharmaceutical companies have been successful in developing the vaccine, which will be protected under the Trade-Related Aspects of Intellectual Property Rights Agreement (TRIPS).