“Skinny labels” refer to a practice used by suppliers of generic medicinal products to carve out from the summary of product characteristics (SmPC) and other product information any medical indications, dosage regimes or patient groups that are the subject of patent protection.  It is intended to enable a generic company that has obtained authorisation for a generic version of a branded product to market that generic product for the original indication (for which patent protection has expired) without being at risk of allegations that the product is to be used to treat the indications etc. that are still covered by patents. In other words, it is a way for suppliers of generic medicinal products to avoid infringing second medical indication patents.

Skinny labels are used in a number of jurisdictions and information about the practice in Europe can be found here. In the US, the skinny label pathway is governed by the Hatch-Waxman Act. Nevertheless, the use of skinny labels is much debated, particularly whether this practice provides a suitable balance between the rights of innovators and the need for generic medicines to reach the market as soon as possible.

This issue is now set to receive the attention of the US Supreme Court, which recently has decided to review a case between Amarin Pharmaceuticals and Hikma Pharmaceuticals, a manufacturer of generic medicines.

In the on-going dispute between these parties, the Supreme Court will consider the issue of skinny labelling in the context of Hikma’s generic version of Vascepa (icosapent ethyl), which is used for treating severe hypertriglyceridemia. In particular, the court will decide whether Hikma’s marketing of its generic product induced “off-label” use in Amarin’s follow-on indication of reducing cardiovascular risk, which is still under patent protection.

Specifically the issues are: (1) Whether, when a generic drug label fully carves out a patented use, allegations that the generic drugmaker calls its product a “generic version” and cites public information about the branded drug (e.g., sales) are enough to plead induced infringement of the patented use; and (2) whether a complaint states a claim for induced infringement of a patented method if it does not allege any instruction or other statement by the defendant that encourages, or even mentions, the patented use.

Notably, it is Hikma that petitioned the Supreme Court to review the issue arguing that a finding of infringement despite the use of a skinny label “exposes every generic drugmaker marketing the ‘generic version’ of a branded drug to potentially catastrophic damages”.

The US Supreme Court does not review patent cases regularly and previous decisions have had a significant impact on patent practices. We will wait eagerly to see if this case will shift the balance for generics and innovators in this highly competitive market.