Posts Tagged: "COVID-19"

I happened to be listening to NPR yesterday morning, and caught an interview on BBC Newshour between the BBC’s Razia Iqbal and a representative of the African Union, Dr. Ayoade Olatunbosun-Alakija, who is also co-chair of the African Union COVID-19 Africa Vaccine Delivery Alliance. The discussion was somewhat unique in that the BBC host was at several points defending patent rights and pushing her guest to explain precisely how patents are the problem with respect to the undeniable crisis of insufficient vaccine access in the world’s poorest countries. An excerpted and slightly edited transcript of the interview follows

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.”

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.

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.

Never more than in this past year has reflection and introspection been important to cope with the isolation and stress brought by a raging pandemic. As I look back at World IP Day last year, I immediately recognize how much we have learned and evolved since the beginning of this aggressive and deadly disease. In little more than a year, the outlook is significantly more positive: vaccines are being rolled out in vast quantities, their effect in curbing infections and deaths starts to be recognized, the economy is showing signs of recovery, schools are reopening and there is finally more optimism.

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.

The Philippines has so far relied on donations and direct purchase to obtain vaccines to address the pandemic. As of March 2021, the Philippines received 2 million Sinovac doses from China and about half a million doses of AstraZeneca vaccines from the COVAX facility. However, these doses could only vaccinate 1% of the country’s more than 110 million people. Concerns regarding access to COVID-19 vaccines are also looming in other developing and least developed countries. It is reported that due to a supposed vaccine hoarding by wealthy countries, low-income countries have minute chances of getting their populations vaccinated against COVID-19 in the coming year. On the contrary, wealthier nations have already been able to secure nearly three times the doses needed to vaccinate their entire populations. As the United Nations Secretary General lamented back in February, progress in COVID-19 vaccinations has been “wildly uneven and unfair.”

Shortly after we posted about Moderna, Inc.’s October 2020 pledge not to enforce its COVID-19-related patents during the pandemic, the United States Food & Drug Administration (FDA) granted emergency regulatory approval for two COVID-19 vaccines produced by Moderna and BioNTech (with Pfizer), making these groups the first to ever enter the commercial market with mRNA-based therapies. This little-known and never-before-approved mRNA technology has since been widely administered and represents a primary weapon being used to defeat the pandemic. While this effort carries on, market players are confident that COVID-19 is but one of many indications that the mRNA technology platform might be utilized for, and that approval of the mRNA vaccines could open the door for the approval of other mRNA-based medicines, creating a wide range of new markets. With the anticipated increase in market activity and competition, we will provide an overview of the mRNA IP and competitive landscape in a series of three posts in the context of certain key players’ patent positions, drug pipelines, strategic relationships, and other attributes. These posts are based on publicly available information, are non-exhaustive, and do not identify all market players or potential market players in this space.

The U.S. Chamber of Commerce’s Global Innovation Policy Center (GIPC) held a webinar on Tuesday, April 6, as part of its Innovation Ecosystem series, titled “Worth Protecting,” which included Steve Francis, Assistant Director, HSI Global Trade Investigations Division Director, National IPR Coordination Center, as one of the panelists. Francis explained that public-private partnerships have been key to combating the spike in illicit activity that has occurred during the COVID-19 pandemic. 85%-90% of illicit activity on seizures over the last five years has originated from Hong Kong and China, said Francis.

The COVID-19 pandemic has caused a dramatic shift in how IP professionals manage their patent and trademark portfolios. Fortunately, many IP law firms and corporate IP departments have survived and managed well in this new environment. They are even showing great optimism as the industry trends toward greater consolidation and tighter global integration. Nonetheless, major concerns remain, challenging both IP owners and their advisers to find more effective ways to solve their portfolio management challenges while focusing on the long-term strategic value of IP.

Though it is not over, it seems that the end of the Covid-19 pandemic may be in sight. A select group of countries has managed to bring vaccines to the market in record time. Take the United States, for example. At the time of this writing, three U.S. companies have managed to produce vaccines that received approval from the U.S. Food and Drug Administration (FDA). The intellectual property that underlies these products quite literally has life-saving potential. This achievement no doubt represents a significant feat in human ingenuity, but it also presents a ripe issue in the intellectual property space — namely, compulsory licensing and intellectual property (IP) waivers. Some feel that the cost of sharing this information represents a bold degradation of the intellectual property system. In developing countries, however, the lack of vaccine availability is proving particularly difficult to manage.

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.

One would think it was ripped from today’s headlines: a deadly respiratory disease sweeps across the world—killing one person every 22 seconds. But this disease is not COVID-19. The threat is tuberculosis (or TB), which has flourished for centuries thanks to the ability of the bacteria that cause the disease (Mycobacterium tuberculosis) to quickly spread from person to person through the air that we breathe. Even though treatments exist, TB can easily become a chronic or fatal condition if left unchecked. According to the World Health Organization (WHO), in 2019, 10 million people became ill with TB, and 1.4 million people lost their lives to the disease—a serious, even silent pandemic that is deadlier than HIV.

After a year of cancellations and postponements, awards season is here. The competition for the best in film, TV, and music is fierce: There are underdogs, there are crowd favorites, there are snubs, and there are critics’ darlings, but this year, the hero of the hardware isn’t one single piece. It’s the creative industry itself. The creative industry has overcome every obstacle – from shutdowns and funding squeezes to changing production regulations and new social norms – to keep us connected, protected, and informed throughout the pandemic.