By Aparajita Lath*
The World Health Organization (WHO), in collaboration with the World Intellectual Property Organization (WIPO) and the World Trade Organization (WTO), hosted the 10th Trilateral Symposium on Human Health and Climate Change in Geneva this November. This article reflects the significant effort made to put climate-sensitive diseases, many of which are neglected tropical diseases (NTDs), at the forefront of these talks.
How Amgen v. Sanofi will affect innovation and the pharmaceutical industry.
By Timothy Bonis
Millions of patients rely on monoclonal antibodies. The global market in 2022 was $210B with a compound annual growth rate of 11 percent. Monoclonal antibody patents are now some of the world’s most valuable intellectual property.
Monoclonal antibody patent law has been in turmoil for the past two decades. The Court of Appeals for the Federal Circuit (the “Federal Circuit”) has repeatedly raised the standards for antibody patents, forcing patentees to rethink how they protect their inventions. In April 2023, the increasingly stringent standards of the Federal Circuit were affirmed by the Supreme Court. In Amgen v. Sanofi, the justices unanimously upheld the invalidation of two antibody patents, potentially transforming patent law across biotech.
This post reviews the emerging post-Amgen literature, distilling the ruling’s likely impact on innovation and the pharmaceutical industry. A companion post addresses the ruling’s legal significance.
This post has three parts. Part I describes monoclonal antibodies and why Amgen is important. Parts II and III address innovation, first by discussing whether Amgen is reflective of modern antibody science and second by exploring how the ruling may affect the pharmaceutical industry.
Amgen v. Sanofi is an important case, but it won’t transform patent law on its own.
By Timothy Bonis
Last April, the Supreme Court ruled in Amgen v. Sanofi, a closely watched patent case where the justices upheld the invalidation of two monoclonal antibody patents for lack of enablement. The ruling has attracted significant interest for two reasons.
First, Amgen involved genus claims in biological and chemical fields, which some experts believe the Federal Circuit has made unduly hard to obtain. This viewpoint, most prominently expressed by Mark Lemley, Sean Seymore, and Dmitry Karshtedt in The Death of The Genus Claim (2021), informed much of the debate about Amgen, although it has been challenged by scholars like Christopher Holman.
Second, Amgen dealt with monoclonal antibody patents, which now represent some of the most valuable intellectual property. (The global market for monoclonals in 2022 was $210B.) Moreover, the scope of antibody patent claims has been narrowed markedly by heightened standards for enablement and written description introduced over the past two decades; antibody inventors once received broad protection through functional claims, but the Patent and Trademark Office (PTO) has raised its requirements, partially in response to repeated invalidations of antibody genus claims at the Federal Circuit (see Chiron v. Genentech, 2004, Centocor v. Abbott, 2011, and AbbVie v. Janssen, 2014).
The decision in Amgen continues the trend of narrowing antibody patents and the perceived trend of limiting genus claims. Thus, how impactful Amgen will be on its own remains uncertain. Does it add new constraints to the patentability of antibodies, small molecules, and chemicals, or does it merely recapitulate the Federal Circuit’s previous rulings? This post reviews that debate. Part I examines how scholars and attorneys have reacted to Amgen, focusing on whether they think the case will have a legal and practical impact. Part II synthesizes these perspectives, arguing that Amgen’s direct impact will be limited. A companion piece summarizing the ruling’s significance for the industry and innovation will follow.
By Anne Kjersti Befring and Cecilia Marcela Bailliet
The COVID-19 pandemic posed a grave threat to humanity and revealed the need for a new approach to improve transnational cooperation within the global health system and new perspectives on solidarity addressing the cross-border spread of infection and distribution of vaccines.
The Principles and Guidelines on Human Rights and Public Health Emergencies (“the Principles”), developed by the Global Health Law Consortium and the International Commission of Jurists, set forth a human rights-based solidarity approach that can provide a basis for implementing the obligations of States and responsibilities of Non-State actors to achieve the goal of limiting the harmful effects of serious health crises.
By Vincent Joralemon
Spravato, the first FDA-approved psychedelic therapy, just outsold Viagra. Johnson & Johnson’s ketamine-based formulation generated $183 million in Q3, surpassing Pfizer’s erectile dysfunction (ED) drug, which earned $110 million over the same period. Remarkably, a therapeutic made from ketamine, once dismissed as a “club drug” or “horse tranquilizer,” now sells more than one of the most notable 21st-century pharmaceuticals.
Yet, these two drugs have more in common than meets the eye, and the path Spravato has taken looks strangely similar to that of Viagra. By looking at the journey traversed by Viagra over the past twenty years, we can predict where Spravato (and other psychedelic therapies) are headed.
By Zione Ntaba
Malawi is not a stranger to public health crises in the last number of years, having faced a severe HIV epidemic and several cholera outbreaks continuing into 2023. Nevertheless, the onset of the COVID-19 pandemic caused a major panic in the country’s legal system and judiciary. COVID-19 brought to fruition a major ethical dilemma in ensuring the justice system’s continued functioning, while also protecting the lives of all those involved, and simultaneously ensuring the promotion and protection of human rights.
The constitutional mandate of ensuring access to justice in Malawi, a country which already struggles with effective and efficient justice delivery at the best of times, required urgent resolution, especially noting the potential of human rights violations arising from State responses to COVID-19 worldwide. Interestingly, in addition to the general need to safeguard the justice system as a whole, the pandemic itself brought before the courts issues relating to public health and human rights.
The prevailing principle in Malawi, as it is internationally, is for the judicial system to ensure that there exists an equal balance between the protection and promotion of human rights and the fair and just administration of justice. The courts in Malawi were called upon to rise above the political bureaucracy, to ensure judicial impartiality when dealing with pandemic-related issues. This was crucial in a context in which political responses to the pandemic sometimes remained unquestioned or unchallenged. However, unless these principles — of human rights and fair administration of justice — were properly upheld by the courts, sadly they may have remained in the world of the metaphysical.
It is with this context in mind that I turn to reflecting on the Principles and Guidelines on Human Rights and Public Health Emergencies (“Principles”).
By Adithi Iyer
Last month, President Biden signed an Executive Order mobilizing an all-hands-on-deck approach to the cross-sector regulation of artificial intelligence (AI). One such sector (mentioned, from my search, 33 times) is health/care. This is perhaps unsurprising— the health sector touches almost every other aspect of American life, and of course continues to intersect heavily with technological developments. AI is particularly paradigm-shifting here: the technology already advances existing capabilities in analytics, diagnostics, and treatment development exponentially. This Executive Order is, therefore, as important a development for health care practitioners and researchers as it is for legal experts. Here are some intriguing takeaways: Read More
By Nerima Were and Allan Maleche
Taking into account our experiences as human rights lawyers working in Kenya during the COVID-19 pandemic, in this article we briefly analyze the Principles and Guidelines on Human Rights and Public Health Emergencies (the Principles) and make a case for their utility in guiding State measures to prepare for, prevent, and respond to future pandemics consistently with international human rights law and standards.
By Eduardo Arenas Catalán
The Principles and Guidelines on Human Rights and Public Health Emergencies (the Principles), entail a notable attempt to consolidate lessons learned from the COVID-19 pandemic. After the largely non-solidaristic international response to COVID-19, the Principles outline the advantages and limitations of embedding human rights discourse within the global public health machinery.
One key element that will test the Principles will be their ability to influence the measures taken, including by States, in preparing for, preventing, and responding to future public health emergencies with increased solidarity. That uncertain future aside, by incorporating critical elements of solidarity, which so far have been largely absent in the human rights corpus, these Principles strengthen the protection of human rights in international law.
By Brianna da Silva Bhatia, Michele Heisler, and Christian De Vos
American health care too often fails to protect the right to health or promote health-related rights. Despite efforts to increase access to health care and to better incentivize high-quality, value-based care, the United States’ health care system remains fragmented, largely profit-based, and predominantly disease-focused rather than prevention-focused.
To design systems and policies that promote the right to health, a holistic and proactive approach is needed, one in which people, institutions, and corporations have a shared responsibility in promoting physical, mental, and social well-being. The Principles and Guidelines on Human Rights and Public Health Emergencies (the Principles), allow us to imagine a new future and help outline a path for how to get there. In this piece, we discuss how the Principles might be applied in a rights-based approach to address some of the core problems in the U.S. health care system.