Posts Tagged: "TRIPS Agreement"

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.

Following four letters sent by Senator Thom Tillis (R-NC) to United State Trade Representative (USTR) Katherine Tai regarding the proposed waiver of intellectual property rights under the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement, Tai on November 8 replied to a July 14  letter sent by Tillis and Senator Tom Cotton (R-AR). That letter referred Tai and Commerce Secretary Gina Raimondo to a May 19 letter in which Tillis, Cotton and 14 other senators requested responses to 10 questions on the proposal to waive IP rights for COVID-19 related technology. The May 19 letter had requested Tai and Raimondo’s responses by July 19, 2021.

The implications of the announcement that the Biden Administration will support efforts to waive intellectual property protection for COVID-19 vaccines and therapies is still sinking in. The Wall Street Journal wrote two editorials in three days, the second more blistering than the first. “Biden’s Vaccine IP Debacle” begins: “… [T]his may be the single worst presidential economic decision since Nixon’s wage-and-price controls.” Not to second guess the paper, but President Nixon’s decision only harmed our economy—this one threatens both our economy and our health far into the future.

Over the course of four months, close to 850 million doses of COVID-19 vaccines have been administered in over 100 countries. To the extent the unprecedented pace of research, development and manufacturing to combat the ongoing pandemic is a success, it has many fathers. But it would not have been possible without the participation of the U.S. biopharmaceutical industry and its collaboration with global partners. To ensure that developed and developing countries around the globe maintain and expand access to safe and effective COVID-19 vaccines, therapeutics and diagnostics, it is critical that the U.S. government support ongoing industry collaboration and oppose well-intentioned but counterproductive efforts to waive intellectual property (IP) rights.

Intellectual property protection has played an important role in this pandemic. As some have pointed out, without legal protection for innovative ideas, there may not have been such a rapid response to the pandemic – both in terms of testing/ treatment and, most recently, vaccines. Companies like Moderna, in conjunction with research and funding from the National Institutes of Health (NIH), have spent a decade developing key technology that enabled quicker vaccine development than ever before. Without some intellectual property protections in place that provide strong financial incentives to invest in new ideas, innovation like this may never have come to light. Nevertheless, India and South Africa initiated a proposal in October that is gaining traction among like-minded World Trade Organization (WTO) members. This proposal would temporarily suspend certain provisions of the Agreement on Trade-Related Aspects of Intellectual Property (TRIPS Agreement) for products related to COVID-19, including vaccines. What began with a handful of nations has now reached a majority, with 57 national sponsors of the proposal, and over 60 WTO members who are in support.

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).

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.