Vaccines.

COVID-19, Patents, and Trade Secrets

By David Gindler & Jasper L. Tran

Has the worldwide distribution of COVID-19 vaccines been impacted by patent rights? David Gindler, head of IP at Milbank LA, and Jasper L. Tran, senior associate at Milbank LA, argue that the story is much more complicated — making vaccines involves much more than waiving patents, they explain.

The following article, which is adapted from the authors’ conversation with Vanderbilt Law Review podcast editor Jacob Goodman on Hot Topics in Intellectual Property Law, provides an overview of the complicated intellectual property landscape associated with COVID-19 vaccines and therapeutics.

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hand opening white plastic pvc window at home.

It’s Time for the Federal Government to Get Back to Protecting the Nation Against COVID-19

By Jennifer S. Bard

Over the past two years, the Supreme Court has shown unprecedented hostility to efforts by both state and federal government to stop the spread of what every day turns out to be an even more deadly pandemic.

These decisions are devastating, and likely signal a continued attack on government authority, but they are not a reason to give up.

The federal government can still use its vast resources to slow the spread and continued mutation of the virus, by telling people what it knows of the danger, and what it knows about how to mitigate it.

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Vaccine.

The Proposed TRIPS Compromise Risks Setting Several Bad Precedents

By James Love

On March 15, 2022, STAT published text of a proposed compromise at the World Trade Organization (WTO) to temporarily relax global standards for intellectual property for COVID-19. The original proposal tabled by India and South Africa in 2020 as IP/C/W/669 would have waived 40 articles of the WTO Trade Related Agreement on Intellectual Property Rights, known as the TRIPS.

The proposed compromise would allow for “the use of patented subject matter required for the production and supply of COVID-19 vaccines without the consent of the right holder to the extent necessary to address the COVID-19 pandemic, in accordance with the provisions of Article 31 of the Agreement, as clarified and waived.” In short, the compromise only waives a single 20-word paragraph in one article: the one dealing with exports under a non-voluntary authorization.

In general, there are no legal benefits to the proposal. Countries can already export a non-predominant share of vaccine production under the TRIPS agreement, with mechanisms that are broader regarding both exports and imports, available regardless of the technology, and permanent.

This note focuses on the practical risks the proposed agreement presents as a precedent.

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Globe and vaccine.

COVID ‘Compromise’ on International IP Underscores Need for New Approach

By Cynthia M. Ho

The leaked compromise regarding a “waiver” of international intellectual property (IP) obligations under the TRIPS Agreement for World Trade Organization (WTO) members has met harsh criticism as a shadow of the original proposal to waive international obligations regarding patent, trade secret, and copyright obligations relating to any COVID vaccine, treatment, diagnostic, or personal protective equipment (PPE).

The compromise excludes diagnostics, treatments, and PPE. It only narrowly modifies compulsory licenses of patents covering COVID vaccines. Moreover, it imposes additional restrictions on use of compulsory licenses. But still, multinational pharmaceutical manufacturers have protested even these modest changes from the status quo, arguing that there is no IP problem that needs to be fixed.

Clearly there is a problem. It has taken 18 months since the original Indian and South African proposal to get to this limited compromise, while gross vaccine inequity between wealthy and poor countries continues. In addition, the leaked compromise between four WTO members is still being debated — and even if agreement can be reached, it needs agreement of over 100 other WTO members. We need a new approach.

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American Soldiers Salute. US Army.

Vaccine Mandates in the Military: Litigation Over Religious Exemptions

By Kaitlynn Milvert

In August 2021, the U.S. Department of Defense (DoD) put in place requirements for service members to receive the COVID-19 vaccine. Litigation has since ensued over the military branches’ restrictive approach to religious exemptions to vaccination.

On March 25, the U.S. Supreme Court weighed into one such case: the Court granted the government’s request for a partial stay to allow the Navy to continue to use vaccination status in making deployment and assignment decisions while the litigation proceeds.

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close up of hands signing contract.

Using Contracts to Lessen Inequities in Access to Medicines in Pandemics and Epidemics

By Sapna Kumar and Ana Santos Rutschman

Research funding contracts can help to safeguard against profound inequities in global allocation and distribution of lifesaving diagnostics, drugs, and vaccines.

During large transnational public health crises, global demand soars for diagnostics, drugs, and vaccines. Although some of these products can be developed within compressed timelines, global production capacity remains limited. Against a backdrop of product scarcity, wealthier countries can out-bid their lower-income counterparts and capture most of the supply during the early stages of pandemics and epidemics. This leaves the vulnerable low-income populations waiting months, or even years, for their turn.

This predictable, inequitable pattern can be held off before the next pandemic. At the research and development (R&D) stage, government funders can bind producers to equity goals through targeted contractual provisions, as we explain in a recently-published Nature Biotechnology article. We summarize our proposals in the following sections. Read More

Supreme Court of the United States.

The Bind We’re in — And How the Supreme Court Put Us There

By Jennifer Bard

As the COVID-19 pandemic rages into its third year of global death and destruction, the Supreme Court of the United States has effectively thwarted every measure by federal or state government to implement the public health tools that for hundreds of years have been used to stop the spread of contagious disease. They have done so by operationalizing what were previously fringe and relatively harmless academic views in ways that extend their powers beyond any previous boundaries. These include, but are not limited to, extending the protection for religious exercise past any previously imagined, and limiting Congressional authority to respond to emergencies by imposing impossible standards of specificity on its delegation of authority to the agencies which it creates, funds, and directly oversees.

In so doing, the Court has not only undermined the health of the nation, and pushed millions of people into unnecessary long-term disability, which our fragmented health care and social security system is unequipped to handle. It has also threatened our national security by infecting what is already more than half of the children in the country with a virus that has the potential to damage every organ in their bodies, from heart to brain.

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Patient receives Covid-19 vaccine.

NFIB v. OSHA and Its Contradiction with the GOP’s Disability Employment Agenda

By Doron Dorfman

The COVID-19 pandemic has highlighted the incoherence of the Republican party’s employment agenda, which, on the one hand, deifies full, in-person employment, and, on the other, makes the workplace hostile to this aim through relentless deregulation.

Throughout the pandemic, the GOP has vocally advanced the narrative that employees must physically return to the office to prevent recession.

Additionally, the conservative view frames disability law and policy in terms of its economic value: these policies are desirable insofar as they increase productivity and participation in the job market among disabled Americans.

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U.S. Supreme Court interior.

Who ‘Deserves’ Health, Who ‘Deserves’ Freedom? A Recurrent Divide in SCOTUS Vaccine Mandate Cases

By Wendy E. Parmet

In October 2020, Martin Kulldorff, Sunetra Gupta and Jay Bhattacharya issued what they called the Great Barrington Declaration (GBD). In it, they argued that “The most compassionate approach [to the pandemic] … is to allow those who are at minimal risk of death to live their lives normally to build up immunity to the virus through natural infection, while protecting those who are at highest risk. We call this Focused Protection.”

Eighteen months and over 600,000 additional deaths later, the Supreme Court embraced that view.  On January 13, in Missouri v. Biden (Missouri), the Court by a 5-4 vote refused to stay a Centers for Medicare and Medicaid (CMS) rule requiring health care workers in facilities that participate in Medicare or Medicaid to be vaccinated against COVID-19 (subject to legally-required exemptions) in order to protect patients. In contrast, in National Federation of Independent Business v. Department of Labor (NFIB), the Court by a 6-3 vote ruled that the Occupational Safety and Health Administration (OSHA) likely exceeded its statutory authority by requiring employers with over 100 employees to mandate vaccination (subject to required exemptions) or masking and testing.  The per curiam majority stated: “Although COVID-19 is a risk that occurs in many workplaces, it is not an occupational hazard in most. COVID-19 can and does spread at home, in schools, during sporting events, and everywhere else that people gather. That kind of universal risk is no different from the day-to-day dangers that all face from crime, air pollution, or any number of communicable diseases.” Concurring, Justice Gorsuch added that a broad reading of OSHA’s authority would “enable intrusions into the private lives and freedoms of Americans.”

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Professional business teleworkers connecting online and working from home for their corporate company, remote working and networks concept.

Introduction to the Symposium: Build Back Better? Health, Disability, and the Future of Work Post-COVID

By Chloe Reichel, Marissa Mery, and Michael Ashley Stein

This week marks the two-year anniversary of World Health Organization Director-General Tedros Adhanom declaring COVID-19 a pandemic.

It is at this particular moment that we, in the United States, are beginning to see the sociological construction of the end of the pandemic: metrics measuring COVID-19 transmission have been radically revised to reshape perceptions of risk; masks are, once again, being shed en masse; and remote workers are being urged back to the office. “It’s time for America to get back to work and fill our great downtowns again with people,” President Joseph Biden said during his March 1, 2022 State of the Union address.

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