The U.S. Patent Trial and Appeal Board (PTAB) has ruled one of the core patents of global subcutaneous injection (SC) platform corporations Halozyme invalid.
It is the first final decision to come out of the post grant review (PGR) filed by Merck (MSD). The industry says the tide has turned in favor of Halozyme's competitor Alteogen and MSD.
On the 13th, according to the industry, the PTAB issued a final ruling on Halozyme's U.S. Patent No. 11,952,600 that "claims 1–4 and 8–21 are unpatentable."
Post grant review (PGR) is a system in the United States that reexamines patent validity for a set period immediately after registration. In its decision, the PTAB said, "Based on the evidence submitted by petitioner MSD, it has been shown that the claims at issue fail to meet patentability requirements."
This decision is the first final conclusion among multiple PGRs related to the MDASE patents that MSD filed against Halozyme.
The patent at issue concerns Halozyme's drug-delivery platform technology, "MDASE." It uses a hyaluronidase enzyme to enable existing intravenous (IV) medicines to be administered in subcutaneous (SC) form.
Because the technology can shorten dosing time and reduce the burden of hospital stays, global pharmaceutical corporations with blockbuster IV oncology drugs have flocked to it.
MSD has obtained approval in the United States and Europe and is selling the Keytruda SC formulation, "Keytruda Qurexx," which applies Alteogen's SC platform ALT-B4.
In response, Halozyme filed a lawsuit in U.S. federal court in New Jersey, alleging infringement of its patents. However, the court determined that a validity assessment should come first and has paused the litigation until the PTAB's PGR results are issued.
The industry expects the decision to have a significant impact on the trajectory of future patent litigation. With Halozyme's core patents shaken, MSD and Alteogen could see their defensive arguments strengthened.
Jeon Tae-yeon, CEO of Alteogen, said, "With Halozyme's MDASE patent invalidated, we have been able to greatly reduce the legal risks related to Keytruda Qurexx," and added, "We expect similar determinations in other ongoing PGRs."
He went on, "Global partners, including MSD, are taking this result positively," and said, "We plan to accelerate discussions on additional partnerships for ALT-B4 based on this."
Keytruda Qurexx recently received a permanent J-code in the United States. As a result, with in-hospital dosing and insurance billing streamlined, observers expect the shift from IV to SC formulations to speed up. Alteogen is set to receive up to $1 billion in sales milestones tied to Keytruda Qurexx revenue, along with separate royalties (license fees).
The ruling documents also note that, beyond this patent, several other Halozyme MDASE patents are undergoing PGR. The industry believes the remaining PGR outcomes could reshape competition in the global SC platform market.
Meanwhile, during the PGR proceedings, Halozyme voluntarily canceled rights to claims 5–7 of U.S. Patent No. 11,952,600. The PTAB then ruled in this final decision that all remaining claims are also unpatentable.