Skinny Labels, Second Medical Use Patents and the Nigerian Gap: What Hikma v Amarin Means for Local Practice

Every so often a patent dispute over a single drug ends up reshaping the rules for an entire industry. Back in June, the US Supreme Court delivered one of those decisions. Although the case itself is American, the question underneath it is one Nigerian pharmaceutical patent practice will eventually have to confront, and with considerably less law to work from than either the US or the UK currently has.

In Hikma Pharmaceuticals USA Inc v Amarin Pharma Inc (2026), a unanimous Court sided with the generic drugmaker. It held that Hikma’s marketing of its version of the cardiovascular drug Vascepa did not amount to induced patent infringement, even though Amarin still held patents covering the drug’s most commercially important use. For an industry that had spent the past few years bracing for the opposite outcome, the ruling was a significant relief. The UK, as it happens, has never fully settled the same question either. Nigeria, as the final part of this piece sets out, has barely begun to ask it.

The skinny label workaround

Drug patents do not only protect a chemical compound. They can also protect a specific medical use of that compound, through what is known as a method-of-use, or “second medical use,” patent. That lets a company retain exclusive rights over one application of a drug even after the underlying compound patent, and the drug’s original approved use, have expired.

Read more:

https://manifieldsolicitors.com/wp-content/uploads/2026/09/INTRODUCTION-Entrepreneurship-has-become-the-backbone-of-Nigerias-economy.-A-2023-Forbes-Africa-statistics-report-stated-that-the-number-of-startups-in-Nigeria-sur.pdf

https://www.wipo.int/wipolex/en/treaties/notifications/details/treaty_pct_169  (Accessed: 24 August 2026).

World Trade Organization (1994) Agreement on Trade-Related Aspects of Intellectual Property Rights, Art 27.3(a). Available at: https://www.wto.org/english/docs_e/legal_e/27-trips_04c_e.htm  (Accessed: 24 August 2026).

Manifield Solicitors
Manifield Solicitors
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