In Patent Clash Over Injectable Keytruda, Merck and Halozyme Dig In for a Fight
In a significant development in the pharmaceutical industry, Merck & Co. and Halozyme Therapeutics are embroiled in a fierce patent dispute concerning an under-the-skin version of Merck’s blockbuster cancer drug Keytruda. The legal skirmish underscores the high stakes involved in drug formulation and the competitive landscape of cancer treatments.
The Core of the Dispute
At the heart of the conflict is Halozyme’s accusation that Merck’s newly formulated injectable Keytruda infringes upon its patented technology. This technology utilizes a protein known as human hyaluronidase, which is integral for enabling the subcutaneous delivery of various medications. During the recent TD Cowen 45th Annual Healthcare Conference, Halozyme’s CEO Helen Torley expressed a firm resolve to either negotiate a licensing arrangement with Merck or, if necessary, pursue legal action to protect their patents.
Merck, on its part, has filed petitions with the U.S. Patent and Trademark Office (USPTO) seeking to invalidate seven of Halozyme’s patents related to this technology. This indicates a strategic move by Merck, as they aim to assert their legal standpoint and defend their market strategies for Keytruda.
Strategic Importance of Subcutaneous Keytruda
Merck’s initiative to develop a subcutaneous formulation of Keytruda is not merely an extension of its product line; it is a crucial strategy aimed at expanding patient access and safeguarding revenue. The original intravenous version of Keytruda is set to lose patent protection by 2028, making the introduction of a new formulation a pressing concern for Merck’s leadership.
Rob Davis, the CEO of Merck, emphasized the company’s plans to launch the new formulation in 2025, which aligns with the ongoing clinical testing phases. Preliminary data revealed that the subcutaneous version of Keytruda performed comparably to its intravenous counterpart, thus indicating its potential effectiveness in treating non-small cell lung cancer.
Market Dynamics and Future Projections
The market for subcutaneous Keytruda is projected to be significant, especially among patients dealing with early-stage cancers. Merck estimates that nearly 50% of Keytruda patients will utilize the subcutaneous formulation by 2028. This potential demand is driving Merck’s focus on rapid development and market entry.
To facilitate the creation of this new product, Merck has entered into a licensing agreement with Alteogen for a variant of hyaluronidase known as ALT-B4. Notably, the sequence of ALT-B4 remains undisclosed in any of Halozyme’s patents, indicating a potential gap in Halozyme’s protective claims.
Halozyme’s Position and Technological Expertise
Halozyme has positioned itself as a leader in hyaluronidase technology with the introduction of its Mdase group of modified human hyaluronidases. This innovation is aimed at expanding partnerships with companies that couldn’t previously leverage Halozyme’s established Enhanze platform due to existing exclusive licensing arrangements. The Mdase portfolio boasts approximately 100 patents, with protections extending into 2032 in Europe and 2034 in the United States, providing Halozyme with a solid legal foundation.
Torley highlighted Halozyme’s extensive experience and patent portfolio as critical factors that enhance the company’s position in the ongoing dispute. She confidently stated that the company’s historical investment in innovation places them in a robust position for any potential legal battles.
Next Steps in the Legal Battle
According to Halozyme’s general counsel Mark Snyder, there is optimism on their side regarding the outcome of Merck’s patent challenge. He stated that the company believes the patents in question are not susceptible to the challenges Merck has raised. With the USPTO expected to make a decision on whether to review these patents by June, both companies are preparing for a protracted legal confrontation or potential negotiations.
If efforts for a licensing arrangement come to a standstill, Halozyme is prepared to initiate an injunction lawsuit aimed at preventing Merck from launching the subcutaneous version of Keytruda, underscoring the seriousness of the matter.
Conclusion
The ongoing patent clash between Merck and Halozyme highlights the intricate dynamics of the pharmaceutical industry, where innovation meets litigation. With billions of dollars at stake in the cancer treatment market, the resolution of this dispute will not only affect both companies but also shape the future landscape for cancer therapies. As both parties dig in for the fight, stakeholders in the healthcare sector are watching closely to see how this battle unfolds, marking another chapter in the complex interplay of drug development, patents, and competition.