Chong Kun Dang Joins the SC Conversion Race... IP Competition Heats Up
Chong Kun Dang Patent Faces Similarity Concerns with Prior Art
Overlap Found in Amino Acid Sequences with ALT-B4
Celltrion and Samsung Bioepis Accelerate SC Development Efforts
Securing IP Emerges as Key Variable in the SC Market
The competition over subcutaneous injection (SC) formulation-switching technology among South Korea’s pharmaceutical and biotech industry is growing increasingly fierce. Alteogen, a leading player, has demonstrated the potential of this technology by concluding a series of major technology licensing deals in the global market. As latecomers are entering the market one after another, the competition over intellectual property (IP) rights with existing technologies is intensifying as well.
According to the industry on September 15, it has been confirmed that the SC formulation-switching technology, for which Chong Kun Dang submitted an international patent application (PCT) in February, was not recognized for novelty and inventiveness for some of its claims because they are similar to prior patents for Alteogen's SC conversion platform 'ALT-B4.' This is because part of the amino acid sequence of the human hyaluronidase PH20 variant developed by Chong Kun Dang had already been disclosed in prior patents related to Alteogen’s PH20 variants. This opinion was compiled by the Korean Intellectual Property Office, acting as the PCT International Searching Authority (ISA).
The written opinion of the ISA is a preliminary and non-binding view on whether the internationally filed invention has novelty and inventiveness compared to existing prior art. National patent offices then use this document as reference material when examining registration at the domestic stage. A Chong Kun Dang representative stated, “This does not mean the domestic patent application itself was rejected. We will respond in various ways, such as by amending the claims.”
Industry observers attribute South Korean pharmaceutical and biotech companies’ race to secure SC formulation-switching technology to a combination of Alteogen’s series of licensing successes and the coming ‘patent cliff’ for blockbuster drugs. With the expiration of key patents for major medications such as Merck (MSD)’s immuno-oncology therapy Keytruda approaching, global big pharma are focusing on converting existing intravenous (IV) products to more convenient SC formulations. When blockbuster patents expire and biosimilars enter the market, original drugs experience sharp declines in revenue and market share. In response, pharmaceutical firms are adopting the strategy of extending product lifecycles by differentiating their assets through SC formulations.
Anticipating such demand, Alteogen has bolstered its presence this year by signing four contracts with global pharmaceutical companies alone. South Korean challengers are also entering the fray. Celltrion is developing an SC formulation of its breast cancer treatment Herzuma using its own hyaluronidase technology, while Samsung Bioepis is working to secure its proprietary PH20-based SC formulation-switching technology. Huons Lab is also developing its own recombinant human hyaluronidase-based platform called HyDIFFUZE.
With the SC switching technology race heating up, industry forecasts suggest that, moving forward, the main challenge will not just be the superiority of each company’s hyaluronidase technology, but also the ability to efficiently navigate around existing patents of early movers and secure independent intellectual property. As the commercial value of SC conversion technology increases, the capacity to develop distinctive IP that does not overlap with existing patents will likely be a key determinant of business success.
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One industry insider said, “The ultimate purpose of SC conversion technology is either to outlicense it to global pharmaceutical companies or apply it to one’s own products for commercialization. Simply having a high-performing enzyme is not enough to ensure competitiveness. From a big pharma standpoint, the risk of patent disputes after adopting such technology must be considered. Therefore, how clearly a company secures its own independent patent domain will also affect its negotiating power in technology transfer deals.”
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