Posts Tagged: "pandemic"

The People’s Vaccine Alliance released comments this week on a draft of a pandemic accord currently being considered during the fourth meeting of the Intergovernmental Negotiating Body (INB) at the World Health Organization (WHO). The organization criticized the draft for lacking strong language that would obligate WHO member parties to share knowledge and intellectual property during a pandemic. The Zero Draft is being discussed at the INB meeting from February 27-March 3, and the organization will later decide if it will be the basis of negotiation for the pandemic prevention accord. After the fourth meeting, the INB will hold another meeting from April 3-6, and it will report on developments around the accord in May, at the 76th World Health Assembly. The People’s Vaccine Alliance saw some positives in the Zero Draft; however, the group asked for more concrete language on the issue of intellectual property rights, among other topics.

In 2020, the percentage of pending patent applications that were abandoned rose to 62% over a previous four-year drop of 49%-41%. The implication was that patent applicants were cutting back on expenses in response to the adverse economic impact of the coronavirus pandemic. At the same time, there was a 2% drop in the number of U.S. patent applications filed in 2020 and a minor drop of 0.4% in U.S. patent applications filed in 2021, according to preliminary data.

This article, originally published on 12/27/2021, was updated on 1/12/2022 and republished on 1/13/2022 to include information that was omitted in error, beginning after “Conclusions and Outlook”.

In Part I of this post, we provided an update on three lead pioneers in the mRNA IP space, Moderna, BioNTech and CureVac. In this post we profile Sanofi, Arcturus, eTheRNA and other mRNA companies and offer conclusions. Sanofi (NASDAQ: SNY), headquartered in Paris, FR, acquired mRNA pioneer Translate Bio in September 2021 for approximately $3.2 billion and mRNA startup Tidal Therapeutics in April 2021 for approximately $470 million. With its acquisition of Translate alone, Sanofi obtained an mRNA pipeline of nine candidates (two in the clinic), hundreds of patents, and undoubtedly valuable mRNA-based technical and regulatory know-how.

Former U.S. Patent and Trademark Office (USPTO) Directors Andrei Iancu and David Kappos, and former Secretary of Commerce Gary Locke, today released a White Paper calling the Biden Administration’s decision to support a waiver of intellectual property protections for COVID-19-related technologies under the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) “strategic folly.” The report was produced by the Center for Strategic and International Studies (CSIS). In the paper, titled “The Shot Heard around the World”, the three officials, two of whom served under the Obama Administration, explained that the United States must indeed ramp up its efforts to improve vaccine diplomacy and to distribute more vaccines globally, but that “[w]aiving IP protections would not lead to the manufacture of a single additional dose of a vaccine.” Instead, they proposed a number of alternative solutions to solve the “real problems.”

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.

Last week, at a meeting of the Council for Trade-Related Aspects of Intellectual Property Rights (TRIPS), World Trade Organization (WTO) members had an opportunity to engage in small group and bilateral meetings to discuss the proposals by South Africa and India to waive patent and trade secret protections relative to COVID-19 innovations, as well as the proposal from the European Union regarding the use of current TRIPS compulsory licensing provisions during a pandemic. Some delegations believed the discussions were encouraging, while others expressed more skepticism, pointing out that a deal will not be achieved “unless delegations are able to make some real compromises.” See Members pursue convergence for IP COVID-19 response.

What would you say about a technology commercialization system that kept on performing even through the worst pandemic in over a century? How about if it improved its performance over the previous year and was a critical factor in developing desperately needed therapies to protect people around the world? Would it seem reasonable that this was something that all of us should highly value and want to protect? You might think so, but some in Washington apparently don’t agree.

June marked the 40th anniversary of the first reported AIDS case. On the anniversary, UNAIDS released a strategy to end HIV/AIDS by 2030, a goal that seemed unthinkable over 40 years ago. Yet since 1981, the innovative scientific community has delivered a series of treatments that revolutionized the outlook for HIV/AIDS patients. Those early days of 1981 were not unlike what we experienced with coronavirus last spring. Hospitals began to see cases of a mysterious pneumonia with few options for how to treat it, just as physicians across the country struggled to identify effective treatments for COVID-19 patients last March. Indeed, Dr. Anthony Fauci – who dedicated 40 years of his career to combatting HIV/AIDS – recalled “the first few years were the darkest years of my medical career, because I was working countless hours taking care of desperately ill young men.”

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. 

One-hundred-twenty-four professors and academics from around the world have penned an open letter supporting India and South Africa’s proposed waiver of certain provisions of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement), which they claim will help to combat the COVID-19 pandemic. According to a press release about the letter, the United Kingdom, Ireland, Australia, Brazil, Japan, Norway, Switzerland and the EU continue to oppose the waiver proposal. The United States expressed its support for waiver in May. Over the last several weeks, Europe has doubled down on its opposition to the proposal in ongoing talks.

As we scan the press attention around medical intellectual property (IP) during these pandemic times, an impassioned debate centers on whether there should be a reprieve on patent rights for COVID-19 vaccines. This threat to longstanding agreements and investment in public/private sector partnerships undermines not only the ownership of IP but also sets a dangerous precedent in terms of downstream consequences. An additional challenge to patents owned by academic medical centers and pharmaceutical companies is posed by activist groups that are lobbying our government to exercise march-in rights to influence pricing of medicines in the United States. Working with medical research centers around Bayh-Dole Act compliance has uncovered, time after time, a more systemic risk that eats away at the health of the research portfolio and could add fuel to the fire for diluting IP protection, thereby undermining the foundation of innovation.

Bloomberg first reported today that U.S. Trade Representative Katherine Tai said that the United States will back a proposal by India and South Africa last year to waive intellectual property protections under the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement. The proposal calls for the suspension of international protections for patents, copyrights, industrial designs, trade secrets and proprietary materials, “in relation to the prevention, containment, or treatment of COVID-19 until widespread vaccination is in place globally and the majority of the world’s population has developed immunity.” Tai reportedly said “We are for the waiver at the WTO, we are for what the proponents of the waiver are trying to accomplish, which is better access, more manufacturing capability, more shots in arms.”

In Part I of this series providing a summary of the mRNA IP and competitive landscape through one year of the COVID-19 pandemic, we focused on market players BioNTech, Moderna and CureVac; in Part II, we discussed Translate BIO, Arcturus, and eTheRNA (and other startups) and provided background on activity relating to certain Arbutus lipid nanoparticle (LNP) delivery technology. Here, in our final post, we provide an analysis of the current landscape and offer conclusions.

Starting a business is steeped with uncertainty, especially during a global pandemic. Small business owners are constantly running through the scenarios: Can I make payroll? Will I recoup my investment? Can I change my community for the better? There are plenty of systems at play that tell them, “No.” It’s too difficult to get a loan; the commercial real estate market is too competitive; advertising and marketing is too expensive. Even so, there’s one system that sings a resounding, “Yes!” That’s America’s intellectual property system.