Category: Intellectual Property

Moderna’s U.K. Vaccine Patent Pledge Cut Short by Boilerplate

Jorge Contreras Leave a comment

By Jorge L. Contreras

On July 2, 2024, the High Court of the United Kingdom issued a decision in Moderna’s mRNA vaccine patent litigation against Pfizer and BioNTech. As I previously discussed in October of 2020, Moderna pledged not to enforce its patents against makers of COVID-19 vaccines during the pandemic. Then, in 2022, Moderna sued competing vaccine makers Pfizer and BioNTech.  Pfizer/BioNTech responded that Moderna’s pledge authorized them to practice the asserted patents, at least until the end of the World Health Organization (WHO)-declared pandemic, which occurred in May 2023. Last week, however, the U.K. court found that the “forward-looking statement” boilerplate routinely appended to press releases of U.S. public companies permitted Moderna to revoke its pledge before the end of the pandemic, and that Moderna successfully did so in March 2022.

Read More

blue brain hovers over bright blue circle.

Is OI the New AI? Questions Surrounding “Brainoware”

Adithi Iyer Leave a comment

By Adithi Iyer

The idea of artificial intelligence is just seeping into our collective consciousness, but as we watch new developments in the space, the true “new kid on the block” may be a new type of infused human-technology intelligence — one derived from a blob of cells no larger than a grain of rice. These new units of computational prowess are brain organoids, grown in-lab and capable of producing very basic, but real-time, neurological activity. Brain organoids are a specific, and arguably the most interesting, subset of organoid models that are just beginning to enter legal debates.

Read More

Person examining psilocybin mushrooms in lab.

Psychedelic Inequities and Unexplored Risk: Colonization, Commercialization, and Regulation

The Petrie-Flom Center Staff

By Tegan M. Carr

As a researcher studying the psychedelic experiences of people of color in hopes of driving equitable psychedelic health care, I’m concerned about the ways in which Black, Brown, and Indigenous contributions have been excluded in the development of the psychedelic field and investigation of novel psychedelic therapies. By excluding diverse contributions to the psychedelic field, we risk establishing psychedelic practices that exacerbate racial health inequities (disparities) in which people of color experience worse health outcomes as compared to whites on a population level. These patterns are already emerging in therapeutic psychedelic outcomes.

This piece identifies three interrelated topics that warrant scrutiny as drivers of psychedelic racial health inequities: the colonization of psychedelics, psychedelic commercialization & rent-seeking, and regulatory processes.

Read More

medieval castle and moat at sunrise with mist over moat and sunlight behind castle

Beyond the Psychedelic Competitive Moat: Chasing the Patent Dragon

The Petrie-Flom Center Staff Leave a comment

By Amanda Rose Pratt and Shahin Shams

In the last five years, the granting of overly broad psychedelic patents led to the creation of the nonprofit online psychedelic prior art library Porta Sophia. As Porta Sophia-affiliated researchers with expertise in psychedelic science, patent law, archival history, and rhetoric, we have come face to face with the way psychedelic hype manifests within the world of psychedelic patent documents.

Here, we examine hype in the context of a perennial tension at the heart of patenting communication: between advertising innovation and keeping it secret. Given the fact that innovators cannot disclose their technological innovations if they hope to gain patent rights over them, and that they simultaneously need to attract investors—often on the merits of their intellectual property portfolios—what public communication strategies emerge? We look closely at the patenting strategies of the psychedelic biotech company MindMed here because their case reveals important insights about the rhetorical dynamics related to tensions around public psychedelic patent communication.

Read More

wirikuta hikuri hallucinogen mexican peyote flower.

Should Sacred Plant Medicines Have Standing? The Original Instructions and Western Jurisprudence

The Petrie-Flom Center Staff Leave a comment

By Keith Williams and Ariel Clark

The resurgence of interest in psychedelics, or sacred plant and fungal medicines and their psychoactive constituents, has been described as a kind of “renaissance” much like the European renaissance that blossomed between the 14th – 17th centuries. The comparison is apt—for, in addition to a flowering of learning and human achievement, the psychedelic renaissance, like its namesake, is only possible because of the underlying extractivist colonial logic informing activity in this domain. We are both writing as people with ancestry from Indigenous communities, and we have a profound interest in respecting, honoring, and becoming-with our more-than-human kin. A business-as-usual approach to the so-called psychedelic renaissance will only reinforce the harmful extractivism inherent in contemporary global capitalist culture and will foreclose the kind of collective healing possible with reciprocity as an orienting principle. This post offers a brief sketch of the potential for Rights of Nature legislation to safeguard these sacred medicines by recognizing them as rights holders unto themselves and by embedding into law a relational positionality of respect and responsibility with our plant and fungal kin.

Read More

scales on blue background.

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

The Petrie-Flom Center Staff Leave a comment

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

In developing the digital symposium, From Principles to Practice: Human Rights and Public Health Emergencies (which ran from October – December 2023), as editors we endeavored to get scholars, human rights advocates, judges, and policy makers to engage critically with the expert Principles and Guidelines on Human Rights and Public Health Emergencies (the PHE Principles), published by the International Commission of Jurists and the Global Health Law Consortium in May 2023. In doing so, we encouraged contributors to comment on the Principles’ potential usefulness as guidance in addressing real emergency situations, as well as any possible gaps and weaknesses.

While summarizing the entire content of the 13 blogs comprising this symposium in any depth is not possible here, this concluding post will attempt to synthesize some of the major inputs from the contributions. We also provide some of our own observations, as participants in the drafting of the Principles, with the aim of pushing the discussion prompted by the posts forward.

Read More

macro normal female mosquito isolated on green leaf.

Climate Change and Neglected Tropical Diseases: Key Takeaways from the WHO-WIPO-WTO Trilateral Symposium

Aparajita Lath Leave a comment

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.

Read More

Torso of doctor in white coat with hands displaying in between them a rendering of an antibody.

The SCOTUS Antibody Ruling Has an Uncertain Impact for Drug Makers and Patients

Timothy Bonis Leave a comment

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.

Read More

U.S. Supreme Court

Don’t Be Too Alarmed by the New SCOTUS Antibody Ruling

Timothy Bonis Leave a comment

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.

Read More

Hundred dollar bills rolled up in a pill bottle

Ketamine Is the New Viagra

Vincent Joralemon Leave a comment

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.

Read More