Pile of colorful pills in blister packs

The Age of Orphans

Join the author today for the 2021 CeBIL Symposium. Register here!

By Sarah Rickwood

The 2020s are the age of orphan medicines.

Orphan medicines are available for a larger number of diseases and patients than ever before, a testament to the success of legislation established decades ago encouraging the development of these medicines in both the U.S. and European Union.

Orphan medicines were the majority of European Medicines Agency (EMA) approvals for the first time ever in 2016 (59%) and the majority of U.S. Food and Drug Administration (FDA) approvals for the first time ever in 2018 (58%).

Read More

person cuts salami sausage on a wooden cutting board.

Tackling Salami Slicing and Indication Stacking in Orphan Drug Innovation Incentives

Join the author on Friday, September 17, 2021 for the 2021 CeBIL Symposium. Register here!

By Sven Bostyn

The development of orphan drugs, so named for the rare diseases they treat, has been incentivized through regulation in the European Union. The primary reward is 10 years’ market protection (or exclusivity).

But are these incentive mechanisms working as they should? To date, only 131 orphan drugs have been brought to market. Findings from the European Commission’s long-awaited evaluation of the orphan drug system in Europe, 20 years after its inception, suggest there may be cause for concern.

Read More

Blister pack of pills, but instead of bills dollar bills are rolled up in the packaging

Mortal Sins of Orphan Drug Development: How to Save the Lost Souls

Join the authors on Friday, September 17, 2021 for the 2021 CeBIL Symposium. Register here!

By Jakob Wested and John Liddicoat

In a working paper from November 2020, the EU Commission finds a significant inefficiency in the EU orphan drug regulation (a pan-EU piece of legislation): that it does not contain a provision to safeguard the affordability and accessibility of orphan medicines.

The working paper then entertains the idea of inserting such a provision into the regulation. But, is the orphan drug regulation the right place for this type of law?

Diagnosing the problem behind orphan drug pricing is the key issue to address before jumping to consider ways to address excessive pricing.

Read More

Globe and vaccine.

Access-to-Medicines Activists Demand Health Justice During COVID-19 Pandemic

By Brook K. Baker 

It was apparent from the outset of the COVID-19 pandemic that a business-as-usual approach — perpetuating the biopharmaceutical industry’s intellectual property-based monopolies and allowing artificial supply scarcity and nationalistic hoarding by rich countries — would result in systemic failure and gross inequity.

The world had seen it all before, from the Big Pharma blockade of affordable antiretrovirals to treat HIV/AIDS, to the hoarding of vaccines by the global north during the H1N1 bird flu outbreak in 2009 and its stockpiling of Tamiflu.

Activists in the access-to-medicines movement quickly mobilized to combat the threat of vaccine/therapeutic apartheid.

Read More

international connections concept art.

The Prospects for an IP Waiver Under the TRIPS Agreement

By Duncan Matthews and Timo Minssen

The informal meeting of the World Trade Organization (WTO) Trade-Related Aspects of Intellectual Property Rights (TRIPS) Council today, July 6, 2021, focuses international attention once more on prospects for a waiver of the TRIPS Agreement in response to the COVID-19 pandemic.

Regardless of whether an actual TRIPS waiver ultimately comes to pass, the real significance of these efforts lies in the increased focus they have placed on the role of IP and trade secrets in improving access and affordability, and scaling-up of manufacturing and supply of vaccines and other health-related technologies. These conversations have introduced the possibility of a rethinking of the relationship between IP, innovation, conservation, and access.

Read More

Traditional countryside scene in the Netherlands with windbreak lane of poplar trees in the wind under summer sky. Ens, Flevoland Province, the Netherlands.

Q&A with Mason Marks on New Psychedelics Law and Regulation Initiative

By Chloe Reichel

On June 30th, the Petrie-Flom Center announced the launch of a three-year research initiative, the Project on Psychedelics Law and Regulation (POPLAR), which is supported by a generous grant from the Saisei Foundation.

The Project on Psychedelics Law and Regulation at the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School will advance evidence-based psychedelics law and policy.

In 2017, the FDA designated MDMA a breakthrough therapy for post-traumatic stress disorder, and in 2018 the agency recognized psilocybin as a breakthrough therapy for treatment-resistant depression. These designations indicate that psychedelics may represent substantial improvements over existing treatments for mental health conditions. Many other psychedelics, including ibogaine, ketamine, and dimethyltryptamine, are the focus of ongoing psychiatric research and commercialization efforts.

Despite the proliferation of clinical research centers and increasing private investment in psychedelic drug development, there is a relative lack of research on the ethical, legal, and social implications of psychedelics research, commerce, and therapeutics.

In the following interview, which has been edited and condensed, Senior Fellow and POPLAR Project Lead Mason Marks explains how POPLAR will fill this gap, and previews some of the initiative’s topics of inquiry.

Read More

image of the US Supreme Court

The Patent Trial and Appeal Board Again Survives Supreme Court Review

By Gregory Curfman

For the generic drug and biosimilar industries, the Supreme Court’s recent decision in United States v. Arthrex, Inc. comes as a relief.

In his opinion, Chief Justice John Roberts allowed the Patent Trial and Appeal Board (PTAB) to survive and to continue to provide an alternative route for generic drugs and biosimilars to gain early market entry.

Patients, who may rely heavily on these less costly alternatives for their prescription drugs, will also benefit significantly from the Court’s decision in this case.

Read More

Photo of person with gloved hand holding flask at lab bench.

US Support for a WTO Waiver of COVID-19 Intellectual Property – What Does it Mean?

By Jorge L. Contreras

On May 5, 2021, U.S. Trade Representative Katherine Tai announced that the U.S. would support a “waiver of IP protections on COVID-19 vaccines to help end the pandemic” currently being discussed at the World Trade Organization (WTO). This announcement, representing a reversal of longstanding U.S. policy toward intellectual property, came as a welcome surprise to much of the world, but elicited strong negative responses from the pharmaceutical industry as stock prices of leading vaccine producers sank.

In the short time since the announcement was made, there has been a fair amount of speculation, hyperbole, and misinformation on the topic. In this post, I offer an explanation of what just happened, and my guess as to what its likely effects will be, bearing in mind that the situation is fast-moving and somewhat unpredictable.

Read More

Syringe being filled from a vial. Vaccine concept illustration.

The COVID-19 Vaccine Patent Waiver: The Wrong Tool for the Right Goal

By Ana Santos Rutschman and Julia Barnes-Weise

As the toll of COVID-19 continues to increase in many countries in the Global South, there has been a renewed push to address the problem of vaccine scarcity through a waiver of patent rights. Calls for waivers have been recurring throughout the pandemic, from formal proposals introduced in 2020 by some of the larger developing economies (India and South Africa), to op-eds in mainstream media, and editorials in scientific publications, such as Nature. This push gained momentum in early May 2021, just before the meeting of the World Trade Organization’s General Council.

Waiver proposals have attracted the support of prominent names in public health. Dr. Tedros Adhanom Ghebreyesus, the Director-General of the World Health Organization, endorsed patent waivers as a tool to address the current vaccine scarcity problem in an article titled Waive Covid Vaccine Patents to Put World on “War Footing.” Others — including, most recently, Dr. Anthony Fauci — have been critical of waiver proposals.

In this piece, we explain the mechanics of patent waivers and argue that waivers alone are the wrong policy tool in the context of the COVID-19 pandemic. We agree with supporters of the waivers in their ultimate goal — that of scaling up the manufacturing of COVID-19 vaccines, and then distributing them according to more equitable models than the ones adopted thus far. However, we doubt that the particular types of goods at stake here can be easily replicated and produced in substantially larger quantities simply through a waiver of intellectual property rights.

Read More

U.S. Supreme Court

The Patent Trial and Appeal Board Returns to the Supreme Court  

By Gregory Curfman

For the second time in the span of just three years, the Patent Trial and Appeal Board (PTAB) within the U.S. Patent and Trademark Office (USPTO) is under scrutiny by the Supreme Court.

How the Supreme Court decides this latest PTAB case, United States v. Arthrex, will have important implications for patent law and for administrative law more generally.

Read More