[E-Daily Reporter Kim Jinsoo ] “Based on the patents currently disclosed, it is difficult to conclude that Samsung Bioepis has secured a new substance to replace ALT-B4. Therefore, I do not believe this will have a direct impact on the ALT-B4 business.”

Jeon Tae-yeon, CEO of Alteogen, stated in an interview with E-Daily on the 14th, “It appears that there are differences in the subject matter and scope of protection between ALT-B4 and Samsung Bioepis’s patent.” He added, “ALT-B4 (berahyaluronidase alfa) is a novel recombinant human hyaluronidase distinct from existing PH20-based hyaluronidases, and it was developed based on a proprietary substance.”

Although it was recently reported that Samsung Bioepis had successfully developed subcutaneous (SC) formulation technology, it has been confirmed that this pertains to purification and manufacturing processes rather than a new SC platform or a new substance. In particular, while concerns were raised that this might affect Alteogen’s business prospects, it has become apparent that there is actually no significant impact. The prevailing view is that Samsung Bioepis’s SC-related patented technology is unlikely to replace Alteogen’s ALT-B4.

Former CEO Jeon stated, “Based on the currently disclosed patents, the subject matter of protection and the scope of rights are distinct. We understand Samsung Bioepis’s technology to be a process technology aimed at improving the instability factors in the existing hyaluronidase production process. As it is a patent for purification and manufacturing processes—not for a new substance—it differs in nature from patents that protect the new hyaluronidase substance itself.”

According to CEO Jeon, the international patents (PCT) disclosed by Samsung Bioepis can be broadly categorized into two types. One is a purification technology that removes cleaved hyaluronidase generated during the manufacturing process, and the other is a manufacturing process that filters out impurities. The core of both patents is the protection of manufacturing and purification processes designed to enhance purity, enzymatic activity, and productivity.

In particular, regarding the fact that some claims were not examined in the international search report, he explained, “The international search authority determined that it was difficult to make a sufficient judgment based solely on the description in the specification, so it did not complete the examination.”

In fact, according to Palm Daily’s findings, during the international search phase, none of the claims subject to substantive examination in either patent were found to possess inventive step. For the first patent, the novelty of the key claim was negated by a prior patent held by Huons Lab, and the MMC claim was deemed derivable when combined with an Alteogen patent. Regarding the second patent, the examiners determined that caprylic acid precipitation and deep filtration had been disclosed in a 2012 U.S. patent. The claim for a substance containing less than 100 ppm of HCP was even found to lack novelty.

ALT-B4 is a novel recombinant human hyaluronidase that differs from existing PH20-based enzymes. Alteogen has built a layered portfolio of composition, use, and manufacturing patents centered around its substance patent, and the term of its U.S. substance patent extends until 2043.

He went on to express confidence that there was no issue, citing the fact that Alteogen recently secured recognition of the originality of its technology for modifying subcutaneous (SC) formulations based on recombinant human hyaluronidase (PH20) in a patent dispute with Halozyme.

Last May, the U.S. Patent Trial and Appeal Board (PTAB) dismissed Halozime’s request to initiate a patent invalidation proceeding (IPR) against Alteogen’s patent for the manufacturing method of recombinant hyaluronidase.

CEO Jeon stated, “Our U.S. process patent is robustly defended against invalidity claims from competitors,” adding, “We were able to collaborate with numerous global pharmaceutical companies because our technology has been thoroughly validated by our partners.”

In fact, ALT-B4 has been licensed to companies such as Sanofi, MSD, AstraZeneca, GSK, Biogen, and Daiichi Sankyo, and is currently being sold under U.S. Food and Drug Administration (FDA) approval after being incorporated into Keytruda, the world’s top-selling cancer drug. Development is currently underway to apply the technology to partner products other than Keytruda, including Enhertu and Zemperi.

CEO Jeon stated, “We are currently in discussions with several global pharmaceutical companies regarding future contracts,” adding, “This year, we expect to achieve our best-ever business results.” He continued, “To strengthen our intellectual property rights, we are actively filing numerous patent applications to widen the gap with potential competitors.”