[E-Daily Reporter SONG YOUNG-DOO ] It has been confirmed that the patent technology related to a subcutaneous (SC) injection formulation filed by Samsung Bioepis was not recognized as novel or inventive during the publication stage of the Patent Cooperation Treaty (PCT) application. In particular, while concerns were raised that the news of the SC technology development might affect Alteogen Inc.’s business prospects, analysis showed that the filed technology pertains to the hyaluronidase manufacturing process (CMC) and is fundamentally unlikely to have a significant impact on Alteogen Inc.’s business prospects.

According to an E-Daily investigation on the 14th, based on international publication data from the World Intellectual Property Organization (WIPO), the International Search Report (ISR) issued by the Korean Intellectual Property Office, and the International Search Authority’s (ISA) opinion, Samsung Bioepis filed two hyaluronidase-related patent applications simultaneously on December 23 of last year.

The filed patents are: △ “METHOD FOR REMOVING TRUNCATED HYALURONIDASE” (WO2026142299) △METHOD FOR REMOVING IMPURITIES THROUGH CAPRYLIC ACID AND DEPTH FILTRATION (WO2026142300). Both patents were internationally published via WIPO on the 2nd.

These two patents are not “technologies for switching to SC administration” but rather “technologies for producing enzymes used in SC administration.” The first patent describes a technology for filtering out “defective proteins” generated during hyaluronidase production, while the second patent describes a technology for removing impurities produced alongside the enzyme during the manufacturing process. Although their approaches differ, both patents share the common goal of developing manufacturing processes to produce purer hyaluronidase.

Hyaluronidase is an enzyme that helps drugs spread effectively in the tissue beneath the skin. By utilizing this enzyme, existing intravenous (IV) therapies can be converted to subcutaneous (SC) injections; currently, Halozyme’s “ENHANZE” and Alteogen Inc.’s “ALT-B4” are considered the leading platforms in the global market.

Notably, it was found that none of these patents were deemed to possess inventive step or novelty during the international search phase. According to the international search authority’s report, for the first patent, all claims subject to substantive examination—Claims 1 through 53, 56, and 58 through 67—were found to lack inventive step. The international search authority determined that the novelty of the key claims had already been disclosed by a prior art patent held by Huons Co., Ltd.

Regarding the claims (5–7) utilizing MMC (multimode chromatography), which were presented as the core of the patent, the office denied their inventive step, stating that a person skilled in the art could readily derive them by combining the Huons Co., Ltd. patent with Alteogen Inc.’s prior art.

Similarly, for the second patent, none of the 51 claims subject to substantive examination were found to possess inventive step. The International Searching Authority determined that the purification process combining caprylic acid precipitation and deep filtration was already disclosed in a U.S. prior art patent published in 2012. Furthermore, it viewed the claims applying hyaluronidase as technology that could be easily derived by combining Halozime’s prior art patent.

Regarding the substance claim for “hyaluronidase with an HCP content of less than 100 ppm,” the office did not even recognize novelty, stating that even if the manufacturing process differed, the substance itself was indistinguishable from existing hyaluronidase.

The International Searching Authority determined that both patents merely optimized or combined existing purification technologies and, therefore, did not recognize inventive step for any of the claims subject to substantive examination. However, as this is a preliminary opinion issued during the international phase, there remains a possibility that the scope of the claims could be amended during future patent examination processes in Korea and other countries to pursue registration.

“Unable to Surpass Alteogen Inc.’s Technology… Raising Uncertainties Is an Overly Broad Interpretation”

Alteogen Inc.(196170) ’s stock price plummeted on the 14th following the disclosure of this patent technology. This was due to uncertainty raised regarding the viability of the SC platform business. However, industry observers are taking a cautious view of this possibility, based on the currently disclosed details of Samsung Bioepis’s patent and the results of the international search.

The prevailing view in the industry is that this Samsung Bioepis patent is interpreted not as technology for developing the SC platform itself, but rather as an attempt to secure manufacturing and purification technologies for in-house production of the hyaluronidase used in the platform.

An industry insider stated, “All of Samsung Bioepis’s internationally published patents are related to manufacturing processes (CMC) for producing hyaluronidase; they are not patents for a new SC platform or new substances. “They are more akin to process technologies for the stable production of hyaluronidase,” the source explained, adding, “Hyaluronidase has characteristics that compromise its stability—such as the enzyme being easily cleaved during the production process—so manufacturers have been researching various purification processes. It appears that Samsung Bioepis was also attempting to improve its production process in this context.”

In particular, he noted, “Even in international examinations, neither patent was recognized as distinct from prior art in terms of novelty and inventive step,” adding, “It would be an overinterpretation to conclude, based solely on the currently disclosed patents, that Alteogen Inc.’s platform business viability is undermined or that the competitive landscape has changed.”

Samsung Bioepis: ‘No’ to Platform Business Patent… “No Separate Commercialization Plans Either”

Samsung Bioepis also maintains that this patent is not a strategic patent for a new SC platform business, contrary to how it is being interpreted in the market.

A company official said, “This patent was filed to secure the manufacturing technology necessary for the development of biosimilars; it is not a technology currently part of the company’s official pipeline or being pursued as a separate business.” The official further explained, “Interest has grown because the patent, which was filed to secure technology needed during the development process, was published internationally.”

The company also drew a clear line regarding recent speculation about a Keytruda SC formulation or the potential expansion of its platform business. The spokesperson said, “We have not yet decided which product to apply this to, nor do we have any separate commercialization plans,” adding, “Please understand this simply as manufacturing technology secured during the development of SC biosimilars.”

However, regarding the international examination authority’s negative opinions on the novelty and inventive step of both patents, the company maintains that it is difficult to disclose specific response strategies at this time.

A Samsung Bioepis official said, “We cannot disclose our patent strategy, such as how we will handle patents in individual countries going forward,” adding, “While the disclosure of these two purification-related patents has been interpreted as implying a platform business or application to specific products, this is an overinterpretation. Internally, we view them as technology patents secured during the development process.”