[비즈한국] In an era where technology equals money, the pharmaceutical and biotech industry—noted as a future growth engine—is no exception. As fierce competition for leadership unfolds worldwide to secure new technologies, the importance of source technology patents is being emphasized. What is the patent reality facing the domestic pharmaceutical and biotech industry, and what are the tasks ahead?
ABL Bio298380, an antibody-drug conjugate (ADC) developer, recently terminated its "Nexatecan" technology licensing agreement with IntoCell. This decision was made based on concerns about patent infringement if the technology continued to be used, following reports that a Chinese biotech firm had filed for a patent on related technology prior to IntoCell. Samsung Bioepis, which had licensed IntoCell's technology even before ABL Bio, is also reportedly re-examining its patents.
In ADCs, the core technologies are the antibody, the drug (payload), and the linker connecting them; IntoCell is a biotech company specializing in the development of linkers and drugs. IntoCell has sought to reassure shareholders, stating that there are no issues with the patents for its primary technologies and that the disputed patent only relates to one out of numerous payloads. The company also stated that it is in the process of licensing the technology in question from the Chinese biotech firm. However, the controversy has not subsided, with additional allegations raised that the company may have also infringed on the patents of another domestic ADC developer, PinoBio. IntoCell's stock price has plummeted by more than 43%, falling from a closing price of 41,250 won on July 8—the day before ABL Bio terminated the contract (July 9)—to 23,500 won at the close of the 1st of this month.
As such, the value of patents in biotech companies is so significant that it is hard to measure. The number of filed or registered patents serves as a quantitative standard for evaluating a company's R&D capabilities. Especially for biotech firms that cannot show tangible results until they commercialize drugs in development or license out candidates, the quantity and quality of patents represent both corporate value and competitiveness.
Hwang Man-soon, CEO of Korea Investment Partners, a leading domestic venture capital (VC) firm in the bio sector, said, "The value of a patent is absolute for a biotech company in that holding one can allow for up to 30 years or more of monopoly rights. If a CEO doesn't properly know the claims of their company's main patents, one should not invest in that company."
Beyond ADCs, patent battles are also fierce in fields with high growth expectations, such as messenger RNA (mRNA) and gene editing.
SK Bioscience302440 won a final victory in a patent invalidation lawsuit it filed against Moderna this past April, which is expected to provide momentum for its future mRNA vaccine development. The invalidated patent, registered by Moderna in Korea as 'Modified Nucleosides, Nucleotides, and Nucleic Acids and Their Uses,' is considered one of the core technologies for developing mRNA vaccines and treatments. Global Information predicts that the mRNA vaccine and treatment market, credited with contributing to the end of the COVID-19 pandemic, will grow at an average annual rate of 16.8%, from $63.89 billion (88 trillion won) this year to $138.88 billion (192 trillion won) by 2030. Under the support of the Coalition for Epidemic Preparedness Innovations (CEPI), SK Bioscience is developing the Japanese encephalitis vaccine candidate 'GBP560' and the Lassa fever vaccine candidate 'GBP570.' GBP560 is in phase 1/2 clinical trials, while GBP570 is in the candidate selection stage.
Competition for leadership in gene editing, which is used in the development of gene therapies touted as potential cures for intractable diseases, is also heating up.
ToolGen199800, a domestic firm holding the CRISPR Cas9 gene-editing technology, is currently in a patent dispute with the Broad Institute and the CVC Group in the US. While ToolGen is considered to have an upper hand in the US and Europe, the Japanese Patent Court dismissed ToolGen's invalidation request last June and ruled in favor of the CVC Group, raising the possibility of differing results by country. Grand View Research estimates that the global gene editing market will grow at an average annual rate of 16.1%, from $11.84 billion (16 trillion won) this year to $25 billion (34 trillion won) by 2030.
CEO Hwang advised, "As the importance of patents grows, companies must go beyond relying solely on individual patent attorneys; they must secure proper patent budgets and conduct R&D through multiple cross-checks."