Alice and ‘something more’: the drift towards European patent jurisprudence

On the face of it the doctrinal lines of disagreement around subject matter eligibility in US law and the invention requirement, as it is known in Europe, could not be further apart. The US statute is silent as to what does not constitute patentable subject matter, while the European Patent Convention takes a much more formal approach. Unpatentable subject matter is listed, categorized either as things not to be regarded as inventions under Article 52(2) ; or as exceptions to patentability under a small number of umbrella contexts. Professor Burk’s incisive analysis of the two-pronged test of subject matter eligibility in Alice and its place within recent decisions by the SC is monitory in three particular aspects of direct relevance to the many decisions of the European Patent Office (EPO) on the ‘invention’ requirement. First, the use and development of a common denominator across excluded categories. Second, the seeping of patentability criteria into eligibility. Third, the nascent focus on the language of the claims which so far the US Supreme Court has declaimed. I will address each of these points in turn, comparing the direction of legal ideas around patent eligibility in both systems of law, before drawing conclusions

Opposition to the TRIPS waiver: dispatches from the frontline

Siva Thambisetty reflects on the ongoing failure to increase countries’ access to COVID-19 vaccines, especially through the TRIPS waiver proposal put forward in October 2020. She identifies emotion, dignity, and ideology as some of the key reasons why vaccine inequity continues

It’s not just about patents on COVID vaccines: why I am not celebrating World Intellectual Property Day

On World Intellectual Property Day, 26 April, Siva Thambisetty (LSE) explains why she will not be celebrating. The controversy over suspending COVID vaccine patents is just the latest example of acute misalignment and injustices driven by current IP law. Far from being an unmistakable force for good, she argues, patents reward certain kinds of creativity over others and privilege corporate power at the expense of those who cannot afford to defend their rights and assert their contribution

Improving access to patented medicines: are human rights getting in the way?

This paper examines the value of human rights arguments in reducing the access gap to patented medicines. Great efforts continue to be poured into institutional, doctrinal and activist settings to bring human rights thinking to bear on the grant and exploitation of patents. Far from triggering meaningful intervention, however, the international human right to health functions as a placeholder, pointing to specific sites of injury or harm and diverting attention from larger ambitions of justice over current incentive structures around patented pharmaceuticals. Excessively technical, incomplete theorising and linguistically driven decision-making have purged reflexive spaces in patent law that might have accommodated purposive reasoning aligned with the protection of human rights. Reliance on the human right to health to correct the technocratic forces in patent law is doomed to fail, because doing so ignores the source of the problem. The point is not that we should not limit patent rights; it is that we cannot do so using only human rights thinking. It would be far better to uncouple human rights from patent law, so that we may systematically retool the latter to be a purposive and reflexive system of law that understands and participates in its own consequences

Vaccines and patents: how self-interest and artificial scarcity weaken human solidarity

We are living through a humanitarian crisis, yet design faults in intellectual property mechanisms and a faith-based approach to patents is steering governments into what the WHO has called ‘a catastrophic moral failing’, writes Siva Thambisetty. To explain patents and vaccines in the context of recent developments we need larger frameworks that are not contingent on the current crisis. Right now, the UK should show moral leadership in a post-Brexit world by supporting the intellectual property waiver on patents related to COVID-19 vaccines and treatments proposed by India and South Africa at the WTO

Opposition to the TRIPS waiver: dispatches from the frontline

Siva Thambisetty (LSE) reflects on the ongoing failure to increase countries’ access to COVID vaccines, especially through the TRIPS waiver proposal put forward in October 2020. She identifies emotion, dignity, and ideology as some of the key reasons why vaccine inequity continues

Lecanemab and APOE Genotyping in Clinical Practice-Navigating Uncharted Terrain

Publication of results from the phase 3 Lecanemab for People with Early Alzheimer's Disease (Clarity AD) trial, with demonstration that the drug provided a small clinical benefit and may have slowed disease progression, has brought hope to millions of patients with Alzheimer disease (AD) and their families around the world.1 The US Food and Drug Administration (FDA) recently approved lecanemab for treating patients in early stages of AD. Analyses of Clarity AD results have already spurred passionate debate about the meaningfulness of clinical benefits observed and whether, after consideration of associated risk of adverse events, the drug represents a truly effective and safe treatment

Siva Thambisetty: "The Oceans Treaty covers issues that connect us more than divide us"

The Biodiversity Beyond National Jurisdiction (BBNJ) Treaty was agreed last year to cover marine biodiversity in the so-called “high seas”. Siva Thambisetty, associate professor at LSE’s Law School, acted as advisor to the chair of the G77 and China Group in 2022 and 2023, and to the Pacific Small Island Developing States in 2019. Siva currently leads a Knowledge Exchange and Impact (KEI) funded project called the Ocean Biodiversity Collective. In this Q&A, she spoke with Helena Vieira (LSE Business Review) about next steps and the business implications of the treaty

Lecanemab trial in AD brings hope but requires greater clarity

The phase III Clarity AD clinical trial of lecanemab, an amyloid-targeting antibody, showed a small clinical beneft in people with Alzheimer disease. However, several questions remain regarding the true clinical relevance, safety and accessibility of lecanemab in this patient populatio

How can secondary dementia prevention trials of Alzheimer's disease be clinically meaningful?

After clinical trial failures in symptomatic Alzheimer's disease (AD), our field has moved to earlier intervention in cognitively normal individuals with biomarker evidence of AD. This offers potential for dementia prevention, but mainly low and variable rates of progression to AD dementia reduce the usefulness of trials' data in decision making by potential prescribers. With results from several Phase 3 secondary prevention studies anticipated within the next few years and the Food and Drug Administration's recent endorsement of amyloid beta as a surrogate outcome biomarker for AD clinical trials, it is time to question the clinical significance of changes in biomarkers, adequacy of current trial durations, and criteria for treatment success if cognitively unimpaired patients and their doctors are to meaningfully evaluate the potential value of new agents. We argue for a change of direction toward trial designs that can unambiguously inform clinical decision making about dementia risk and progression