China's Biotech Sector Takes on Big Pharma
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On February 12, 2025, a significant ruling was made by the federal court in Delaware, marking Amgen as a new defendant in the ongoing patent enforcement case involving the Chinese biotechnology firm, Harpoon TherapeuticsThis development is a notable escalation in the battle for intellectual property rights, illustrating a shift in dynamics that has often seen domestic firms on the defensive against aggressive multinational corporations.
The origins of this legal confrontation trace back to 2021, when Harpoon Therapeutics launched a lawsuit against Teneobio, claiming infringement on its patentsHowever, in July of that year, Teneobio was acquired by Amgen for a staggering $2.5 billion, primarily to bolster its capabilities in developing dual-antibody therapeutic platformsSubsequently, Harpoon Therapeutics aimed to include Amgen in the lawsuit as it sought to strengthen its legal position.
Known for its litigation prowess, Amgen appeared undaunted by this endeavor and proposed what might be described as a strategic maneuver to shift representation, seeking to replace Harpoon’s attorneys with its ownAmgen also made a bid to preclude any legal actions or compensation claims from Harpoon against itself or its subsidiariesHowever, this request was not granted by the court, which reaffirmed the integrity of the original legal claims.
Historically, many pharmaceutical companies in China have found themselves in a defensive posture concerning patent enforcement, frequently becoming targets of multinational corporations that are eager to protect their interestsThe emergence of a Chinese biotech firm like Harpoon actively pursuing patent claims against a global giant like Amgen is a relatively rare and groundbreaking occurrence in this landscape.
This case remains unresolved, capturing the attention of the domestic innovation-driven pharmaceutical sectorOver the coming years, it is inevitable that patent disputes between local Chinese firms and their multinational counterparts will become increasingly common
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The landscape is poised for change and adaptation, necessitating that Chinese biotechs evolve rapidly to keep pace with the shifting tides of global competition.
The battle surrounding the dual-antibody platform is particularly intenseAn industry saying goes: "Monoclonal antibodies look to the target, while dual antibodies rely on the platform." For Harpoon Therapeutics, its dual-antibody platform is more than just a competitive edge; it is a hallmark of its innovation and strategic directionAfter its establishment in 2016, Harpoon achieved a significant milestone by acquiring the Dutch company, Harbour Antibodies, which provided them with access to the Harbour Mice platform, a transgenic mouse technology capable of producing fully human antibodies.
During the acquisition process, Harbour Antibodies reportedly informed Harpoon about Teneobio's UniRat platform, which appeared to be modeled after the Harbour Mice technologyIn unfortunate circumstances, attempts were made by Harpoon to discuss potential infringement issues with Teneobio in 2017, but these overtures were met with resistance, prompting the eventual litigation.
In July 2021, following Teneobio's acquisition by Amgen, Harpoon Therapeutics initiated its patent infringement lawsuit against Teneobio, marking the formal beginning of this particular conflictThe Harbour Mice platform stands out as the world's first genetically engineered mouse platform capable of generating fully human heavy-chain antibodies, designed to yield new-generation antibodies that are only half the size of traditional Immunoglobulin G (IgG) antibodiesSeveral of Harpoon's products, such as PD-L1/CD40 and B7H4/CD3 dual antibodies, are based on this innovative platform.
In addition to its focus on innovative drug development, Harpoon has effectively utilized its platform to establish a contract research organization (CRO) known as Nona Bio, further expanding its revenue streamsPrestigious clients, including Pfizer, AstraZeneca, Modena, and BeiGene, have turned to Harpoon for their expertise and advanced capabilities in biopharmaceutical research.
To maintain profitability, Harpoon has successfully balanced its innovative drug development with its CRO services
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The significance of the technologies at stake in this legal dispute is immense, as the potential acquisition of similar platforms by Amgen could pose a serious challenge to Harpoon's market position.
While Teneobio may not have a dedicated legal team, being backed by Amgen provides it with a substantial level of security in these legal battlesAmgen, with its extensive experience in patent litigation, attempted to position itself advantageously in court by claiming a conflict of interest due to shared legal representation and sought to limit Harpoon's ability to pursue any legal actions against Amgen and its subsidiariesUltimately, the court dismissed Amgen's demands, and after more than four years of drawn-out legal proceedings, the case continues without a final resolution.
For Harpoon Therapeutics, taking proactive steps to include Amgen as a defendant may tilt the scales in its favorIn the event of a victory, the potential for substantial financial compensation looms largeEven in the case of a loss, the costs might be manageable, primarily limited to litigation expenses, keeping the overall impact relatively low.
This active defense on the part of Harpoon Therapeutics serves as a commendable example for the emerging Chinese innovation-driven pharmaceutical sectorHistorically, the response of Chinese innovators has often been reactive—waiting until competitors launched lawsuits before engaging in a legal battle of their ownHowever, as more and more Chinese innovative drugs enter the global market, the necessity for a proactive, aggressive approach to patent protection becomes increasingly apparent.
DrYi-Ping Rong, the chief scientist at Harpoon, previously highlighted the crucial need for Chinese biotechs to prioritize patent protection efforts, remarking that current considerations within domestic firms are insufficientAs these companies expand into international markets, especially in commercialization phases, they may face severe challenges from the robust international intellectual property enforcement landscape.
Globally, patent litigation has become an all-too-common strategy among pharmaceutical companies, utilized not solely for financial gain but as a means to suppress competition and solidify market positions
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