Halozyme Secures Key Patent Injunction in German Market

Halozyme Therapeutics US40637H1095

A significant legal victory in Germany has reinforced Halozyme Therapeutics' competitive standing within the lucrative subcutaneous drug delivery sector. The biopharmaceutical company recently prevailed in a critical patent dispute against global healthcare giant Merck & Co., known as MSD outside the United States.

On December 4, 2025, the Munich I Regional Court issued a preliminary injunction in Halozyme's favor. The ruling immediately prohibits Merck from marketing and selling its subcutaneous formulation of Keytruda within Germany. This decision underscores the enforceability of Halozyme's European patent protecting its proprietary ENHANZE® drug-delivery technology. The court found sufficient evidence that Merck's product, which utilizes a competing enzyme technology from Alteogen, infringes upon Halozyme's intellectual property.

This legal action grants Halozyme temporary market exclusivity against a major rival in Europe's largest pharmaceutical market. Although Merck has announced its intention to appeal, the injunction remains enforceable during the process. Analysts note this outcome also strengthens Halozyme's legal posture in ongoing patent litigations in other jurisdictions, including the United States.

Strong Financial Performance Provides Foundation

The favorable legal development is complemented by robust quarterly financial results, released on November 3, 2025. Halozyme reported substantial growth for the third quarter.

• Total revenue increased by 22% year-over-year to $354.3 million.
• Royalty revenue hit a record $236 million, representing a 52% annual gain.
• Non-GAAP earnings per share (EPS) came in at $1.72.

The surge in royalty payments is primarily fueled by the continued commercial success of partner products utilizing ENHANZE®, including DARZALEX® SC from Johnson & Johnson and Roche's Phesgo®. Based on this performance, management raised its full-year 2025 revenue guidance to a range of $1.30 billion to $1.375 billion.

Forward-Looking Strategic Position

Market attention now shifts to the progression of Merck's appeal in the German courts. A final ruling upholding the injunction would solidify Halozyme's competitive protections and could serve as a foundation for potential global settlement discussions. The combination of a growing, recurring royalty stream and reinforced patent defense is viewed as creating a durable platform for the company's continued strategic advancement.