Setback for MSD as German court blocks Keytruda SC launch

A court in Munich has granted a preliminary injunction that will prevent MSD from distributing the subcutaneous version of its cancer immunotherapy Keytruda in the German market.

The verdict is the latest twist in patent litigation between MSD and Halozyme, in which the latter is claiming that Keytruda SC (pembrolizumab and berahyaluronidase alfa) – which was approved in the EU last month – infringes its intellectual property.

The suit focuses on berahyaluronidase alfa component – developed by Alteogen – that makes it possible to deliver larger volumes of drug material and improve dispersion and absorption through the skin. Halozyme claims that it falls under the scope of a European patent (No. 2 797 622) that it holds on its MDASE platform, which uses modified human hyaluronidases for drug delivery.

MSD, meanwhile, is trying to have Halozyme's patents struck down, arguing they are too broad. The two companies are also suing each other over subcutaneous Keytruda in the US, where the product was recently approved as Keytruda Qlex.

The new version still needs to be administered by a healthcare professional, but requires just a couple of minutes to deliver, rather than a 30-minute intravenous infusion, and reduces the 'chair and treatment' time for patients by around half, according to MSD, which is known as Merck & Co in the US and Canada.

German patients will still have access to the original infusion version of Keytruda, but as of now they will no longer be able to access Keytruda SC in Germany.

"Although the preliminary injunction decision is appealable, Halozyme believes the order will withstand attack if appealed," said the company in a statement, whilst also noting that proceedings against its patent – initiated by MSD in August – remain pending before the German Federal Patent Court.

Keytruda SC has been approved for use in most of the solid tumour indications already granted for intravenous Keytruda, which is MSD's biggest-selling drug with sales of $23 billion in the first nine months of the year.

The original formulation will start to lose patent protection from 2028 onwards, however, so – in addition to becoming a more convenient option for patients – Keytruda SC could help extend the patent-protected life for the franchise after biosimilar versions of the IV form reach the market.

"We are very pleased that a German court has issued a preliminary injunction for MSD's patent infringement," said Mark Snyder, Halozyme's chief legal officer (CLO), in a statement.

"Halozyme is doing everything possible to vigorously defend and enforce the MDASE patents, and we are confident we will prevail at trial."

MSD has not yet issued a statement on its intentions after the injunction, but is expected to appeal.

Rival cancer immunotherapies, including Bristol-Myers Squibb's Opdivo (nivolumab) and Roche's Tecentriq (atezolizumab), have also been approved in subcutaneous versions that use Halozyme technology.

Image by Gerd Altmann from Pixabay