What's Happening?
A Munich court has issued a preliminary injunction preventing MSD from launching the subcutaneous version of its cancer immunotherapy, Keytruda, in Germany. This decision is part of ongoing patent litigation
between MSD and Halozyme, which claims that Keytruda SC infringes on its intellectual property. The dispute centers on the berahyaluronidase alfa component, developed by Alteogen, which is used in Keytruda SC to enhance drug delivery. Halozyme asserts that this component falls under its European patent for the MDASE platform. MSD is challenging the validity of Halozyme's patents, arguing they are overly broad. The subcutaneous version of Keytruda, which was recently approved in the EU, offers a quicker administration time compared to the intravenous form. Despite the injunction, German patients can still access the original infusion version of Keytruda.
Why It's Important?
The court's decision has significant implications for MSD, known as Merck & Co in the U.S., as it seeks to extend the patent life of its best-selling drug, Keytruda, which generated $23 billion in sales in the first nine months of the year. The subcutaneous version could provide a more convenient option for patients and help maintain market share as the original formulation faces patent expiration starting in 2028. The outcome of this legal battle could influence the competitive landscape for cancer immunotherapies, as other companies like Bristol-Myers Squibb and Roche have also developed subcutaneous versions using Halozyme's technology. The case highlights the complexities of patent law in the pharmaceutical industry and the strategic importance of intellectual property in maintaining market dominance.
What's Next?
MSD is expected to appeal the preliminary injunction, and the ongoing legal proceedings in Germany and the U.S. will continue to unfold. The outcome of these cases could set precedents for future patent disputes in the pharmaceutical sector. If MSD successfully challenges Halozyme's patents, it could pave the way for the launch of Keytruda SC in Germany and potentially other markets. Conversely, if Halozyme's patents are upheld, it could strengthen its position in the market for drug delivery technologies. The resolution of this dispute will be closely watched by industry stakeholders, as it may impact the strategies of other companies developing similar technologies.
