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U.S. PTAB judges 2 additional Halozyme PH20 patents invalid. Korea IR Council predicts operating profit of KRW 247.4 billion, an increase of 131.4% this year
Merck (MSD) is expanding its lead in the U.S. patent battle surrounding 'Keytruda SC', to which Alteogen (196170)'s subcutaneous injection (SC) formulation conversion technology has been applied. As the U.S. Patent and Trial Board (PTAB) ruled two additional patents related to Halozyme's PH20 invalid, patentability was denied in 11 out of 14 post-registration reexamination (PGR) cases filed by MSD. As the commercialization of Keytruda SC progresses, it is predicted that Alteogen's operating profit this year will more than double compared to the previous year.
#### Two additional PH20 patents invalidated… Attention to the remaining 3 judges
According to PTAB data under the U.S. Patent and Trademark Office on the 16th, a final written decision was made on the 15th (local time) that all claims subject to trial are not patentable in the PGR2025-00024 and PGR2025-00030 cases filed by MSD against Halozyme.
The subject of this decision is U.S. Patent Nos. 12,060,590 and 12,054,758. Both patents relate to variants of hyaluronidase PH20, which are used to convert pharmaceuticals into subcutaneous injection formulations.
The 590 patent is centered on the mutation of amino acid 307 of the PH20 protein, and the 758 patent is centered on the mutation of amino acid 317. Both patents include variants with at least 91% similarity to the existing PH20 sequence in their claims.
MSD has argued that Halozyme attempted to patent not only specific amino acid mutations but also a wide range of PH20 variants, but failed to sufficiently explain or provide a basis for implementation. In the related PGR conducted previously, the written requirements and implementability requirements were the main issues.
PTAB previously denied the patentability of the claims subject to trial in nine related patents of Halozyme. With the addition of these two cases, the number of PGRs judged invalid increased to 11. The final decisions on the remaining three cases are also scheduled by November.
In Europe, conflicting judgments were also issued. Recently, a Dutch court issued a preliminary injunction restricting local sales of Keytruda SC based on Halozyme's European patent. MSD plans to continue taking legal action against the ruling. In the UK, there are mixed judgments across countries, including the cancellation process for related patents, which is attracting attention to the development of future patent disputes.
#### Expansion of Keytruda SC commercialization… Operating profit expected to be 247.4 billion won
As the patent dispute continues, the commercialization of Keytruda SC is leading to growth in Alteogen's performance. MSD has commercialized Keytruda Qlex, which uses Alteogen's subcutaneous injection formulation conversion platform 'ALT-B4', and is expecting additional milestones and royalty income as sales expand.
In the 'Alteogen: Short injections, long growth' report published on the 16th, the Korea IR Council's Corporate Research Center predicted Alteogen's sales this year to be 419.4 billion won and operating profit to be 247.4 billion won. This is an increase of 94.3% and 131.4%, respectively, compared to the previous year, and the expected operating profit ratio is 59.0%.
Kim Seung-jun, a researcher at the Corporate Research Center of the Korea IR Council, explained, "We have expanded our partner base through technology transfers with global big pharma companies such as MSD, AstraZeneca, and Daiichi Sankyo, and have proven the business feasibility of the platform with the approval and commercialization of Keytruda Curex."
Alteogen's revenue sources are also expanding from existing down payments and development/licensing milestones to sales milestones and royalties linked to actual product sales. In the second half of the year, additional sales milestones for Keytruda Curex are expected to drive performance growth. Despite the increase in research and development costs, it is expected that the effect of improving profitability will increase as technology fee sales, which have a limited additional cost burden, increase.
The application field of ALT-B4 is also expanding from cancer immunotherapy to antibody drug conjugate (ADC). Adoption of Gemperli's platform and clinical development of Enhertu's SC formulation are in progress, and the multiple product contracts signed with Biogen and Novartis are also expected to contribute to diversifying revenue sources.
Researcher Kim said, "As the clinical performance of follow-up products and new contracts accumulate, the mid- to long-term profit-generating power of the platform beyond a single product is expected to materialize."
