The Supreme Court of the US (SCOTUS) has agreed to hear a patent dispute between Amarin and Hikma that could have implications for the legality of 'skinny labels,' which can help generic drugmakers bypass intellectual property protections.
The highest court has said it will consider an appeal by UK-headquartered Hikma of an earlier ruling that allowed Amarin to proceed with a lawsuit seeking to block the use of a generic of its Vascepa (icosapent ethyl) product, with a truncated set of indications on its label.
Vascepa – a formulation of omega-3 fatty acids used to reduce blood triglyceride levels in patients with severe hypertriglyceridaemia – is Amarin's only product and accounts for the bulk of its revenues, which were around $215 million last year, in sales and royalties.
It was first launched in 2012 in the US for the hypertriglyceridaemia indication, with a follow-up approval in 2019 for the reduction of cardiovascular risk, in combination with statin drugs, in high-risk patients with elevated triglycerides and established cardiovascular disease or diabetes.
Hikma's generic reached the market in 2020 after a US court invalidated several of Amarin's patents on the product. It launched with a label covering the severe hypertriglyceridaemia indication, omitting the cardiovascular risk reduction claim, which remains protected by method-of-use patents.
This skinny label approach has been a source of considerable contention in the pharmaceutical industry in recent years, including in a recent lawsuit between GSK and Teva over the cardiovascular drug Coreg (carvedilol).
In 2023, SCOTUS refused to hear that lawsuit, despite a request from the US Solicitor General, leading to speculation that it could signal the end of the cherry-picking label strategy by generic drugmakers.
Brandname drug manufacturers claim that skinny labels allow generic manufacturers to bring products to market that are then used off-label – and sometimes promoted – for patent-protected indications.
US-Irish drugmaker Amarin sued Hikma in 2020, claiming that the company was encouraging doctors to prescribe its generic version of Vascepa in patent-infringing ways, without specifying that it is approved only for severe hypertriglyceridaemia. That case was dismissed by a district court in 2022, but revived after an appeal.
Hikma wants SCOTUS to look into its claims that Amarin is simply using the suit to block legitimate generic competition for its product.
"As a practical matter, any branded pharmaceutical company can now point to some public statement by the generic-drug manufacturer to justify a post-launch suit alleging induced infringement, even when the generic product is labelled only for unpatented uses," it said in a statement.
The skinny label pathway was introduced by the Hatch-Waxman Act many years ago to stop developers of brand-name drugs from 'evergreening' patent protection by sequentially adding new indications to the label.
The Trump administration – as part of its efforts to drive down medicine prices in the US – is supporting Hikma's case.
https://pharmaphorum.com/news/skinny-generic-vascepa-label-case-reaches-us-supreme-court
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