Category: Intellectual Property

Bill of Health - Globe and vaccine, covid vaccine

COVID-19 Showcased Failed Global Cooperation

The Petrie-Flom Center Staff Leave a comment

By Kayum Ahmed, Julia Bleckner, and Kyle Knight

In mid-May, the World Health Organization officially declared  the “emergency” phase of the COVID-19 pandemic over. However, the deep wounds of the pandemic remain, compelling  those concerned about this pandemic and  future health emergencies to account for catastrophic failures by those in power. These reflections suggest that the public health crisis could have been addressed differently, both reducing COVID-19’s unprecedented magnitude of illness and death, and preserving human dignity.

The COVID-19 pandemic isn’t over, and the end of this pandemic’s emergency phase certainly doesn’t mean we accept the widely abysmal response as the model for the world’s reaction to the next one. Public health emergencies aren’t entirely preventable. We live in a complex world where health is increasingly affected by a changing climate, extraordinary levels of pollution, and inadequate preventive and responsive health services. Emergencies will happen. But when they do, responses that uphold human rights need to be the norm.

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five multi ethnic business people negotiating in modern boardroom.

A Pseudo-Nonprofit Model for Psychedelic Clinical Trial Funding

Vincent Joralemon Leave a comment

By Vincent Joralemon

A $70 million deal struck between a venture capital firm and a prominent psychedelic advocacy organization suggests that funding for psychedelic research may increasingly rely on nonprofit and commercial partnerships.

As the commercial appeal of these substances grows, this might serve as a promising model to channel the resources of for-profit entities toward this field. This funding can support clinical trials, FDA approval, and ultimately insurance coverage for these promising (but resource-intensive) therapies.

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Risograph clenched, raised fists with speech bubble and geometric shapes, trendy riso graph design.

Introduction to the Symposium: From Principles to Practice: Human Rights and Public Health Emergencies

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By Roojin Habibi, Timothy Fish Hodgson, and Alicia Ely Yamin

Today, as the world transitions from living in the grips of a novel coronavirus to living with an entrenched, widespread infectious disease known as COVID-19, global appreciation for the human rights implications of public health crises are once again rapidly fading from view.

Against the backdrop of this burgeoning collective amnesia, a project to articulate the human rights norms relevant to public health emergencies led to the development of the 2023 Principles and Guidelines on Human Rights and Public Health Emergencies (the Principles).

This symposium gathers reflections from leading scholars, activists, jurists, and others from around the world with respect to the recently issued Principles.

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Hundred dollar bills rolled up in a pill bottle

Reasonable Pricing Clauses: A First Step Toward Ensuring Taxpayers a Fair Return on their Public R&D Investment

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By Nikhil Chaudhry and Reshma Ramachandran

Earlier this month, the Department of Health and Human Services announced that it had successfully included a reasonable pricing provision in a $326M investment contract with Regeneron for development of a next generation monoclonal antibody therapy for COVID-19. This was the first time the Biden Administration had included such a provision as part of its research funding agreements with the private sector, demonstrating that it is indeed possible for the federal government to negotiate deals with pharmaceutical companies that ensure that products developed with public dollars are priced comparably to the global market.

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View of runners crossing Verrazano Bridge at the start of NY City Marathon

What the New York City Marathon Can Teach Us About Equitable Access to Vaccines

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By Ana Santos Rutschman

What can the New York City Marathon experience teach those reflecting on ways to increase equity in the transnational allocation of scarce vaccine doses?

Quite a lot, it turns out. I explore this analogy in a recently published article in the Journal of Law, Medicine and Ethics (JLME), Increasing Equity in the Transnational Allocation of Vaccines Against Emerging Pathogens: A Multi-Modal Approach.

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Blood glucose monitor and insulin.

Monthly Round-Up of What to Read on Pharma Law and Policy

Ameet Sarpatwari Leave a comment

By Ameet Sarpatwari, Alexander Egilman, and Aaron S. Kesselheim

Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) review the peer-reviewed medical literature to identify interesting empirical studies, policy analyses, and editorials on health law and policy issues.

Below are the citations for papers identified from the month of June. The selections feature topics ranging from a review of modifications to blood glucose monitoring systems and related patent protections, an examination of insulin price changes from 2012-2019, and a discussion of why a proposed federal bill that would ban government health care programs from using the quality-adjusted life-year is misguided. A full posting of abstracts/summaries of these articles may be found on our website.

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EU flags in front of European Commission in Brussels.

European Union Debates Further Patent Protections

Sarah Gabriele Leave a comment

By Sarah Gabriele

In line with the European Union’s efforts to strengthen the single market and as part of the Single Market Strategy presented by the European Commission in 2015, the European Commission has presented a proposed regulation regarding the Unitary Supplementary Protection Certificate (“USPC”). The proposed regulation will extend patent protections across the Union, creating a stronger right for brand-name pharmaceutical companies. However, the proposed regulation, in line with the most recent case law of the European Court of Justice, further strengthens the limit for pharmaceutical companies to obtain only one certificate per product per patent holder.

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Vaccine and syringe in front of EU flag.

The European Commission’s New Compulsory Licensing Proposal: A Step Forward?

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By Sarah Gabriele

On April 27, 2023, the European Commission proposed new legislation that would allow companies to make drugs without the patent holder’s consent in emergency situations. The proposed legislation constitutes a step forward in the European Union’s effort to harmonize patent law in the Union, after the establishment of Unitary Patents and the European Patent Court.

In its proposal, the EU Commission acknowledges that intellectual property rights, and, in particular, patent rights play an important role in access to medicine, especially during public health crises. The COVID-19 crisis demonstrated how the need for protecting and incentivizing innovation clashed with the need to make products widely available. To solve this tension, the Commission recognizes that patent law already offers a solution: compulsory licensing.

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Narcan Naloxone nasal spray opioid drug overdose prevention medication.

Public Health Product Hops

The Petrie-Flom Center Staff 1 Comment

By Michael S. Sinha, Edna Besic, and Melissa Mann

Members of Congress have been focused on drug pricing for the last several years, culminating recently in new drug pricing provisions within the Inflation Reduction Act of 2022. One reason for our drug pricing problem is that we allow manufacturers to charge whatever the market will bear for a new therapeutic. However, as we have also seen, manufacturers often engage in anticompetitive “games” aimed at extending market exclusivity and forestalling generic competition. One of these games is product hopping.

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