Harbour BioMed Secures Patent Validity and Advances Legal Battle Against Biocytogen in China
On June 5, 2025, the China National Intellectual Property Administration (CNIPA) confirmed the validity of Harbour BioMed’s patent concerning its innovative binding molecule technology. This patent, particularly focused on the production of fully human heavy-chain-only antibodies (HCAbs) using transgenic animals, emerged as a contentious point after Biocytogen Pharmaceuticals initiated an invalidation request against it. Harbour BioMed, a prominent player in global biopharmaceuticals, specializes in the research and development of novel antibody therapeutics aimed at tackling critical issues in immunology and oncology. The decision by CNIPA is crucial as it strengthens Harbour BioMed's intellectual property foundation, vital for their research and development investments.
This patent dispute is not just a legal formality; it has significant implications for the commercial viability of both companies. In September 2024, Harbour BioMed filed a lawsuit in the Shanghai Intellectual Property Court against Biocytogen, asserting that their RenNano platform infringes on Harbour's HCAb patent. In response, Biocytogen challenged the jurisdiction of the court, initiating a series of legal maneuvers that included an appeal to the Supreme People's Court in March 2025. However, the court dismissed the appeal, affirming the jurisdiction of the Shanghai Intellectual Property Court to proceed with the infringement case.
Dr. Jingsong Wang, the Founder, Chairman, and CEO of Harbour BioMed, expressed great satisfaction with the CNIPA's ruling, highlighting its significance in safeguarding the company's pioneering innovations and the essence of its intellectual property. He stated that this decision not only protects their existing patents but also fortifies their ongoing investments into the development of new therapeutics made possible through their proprietary Harbour Mice® platform and associated technologies.
Harbour BioMed has made strides in creating a comprehensive patent portfolio across key global markets, which is essential for securing their position in the competitive biopharmaceutical landscape. The company's proprietary antibody technology, notably the Harbour Mice® platform, produces HCAbs and monoclonal antibodies in both the traditional two heavy and two light chain format, as well as the innovative heavy chain-only format. This versatility facilitates the development of advanced therapeutic options that are proving to be pivotal in modern medical treatments.
Moreover, Harbour BioMed is advancing the field with its HCAb-based technologies like the HBICE® bispecific antibody technology, designed to enhance tumor-killing effects beyond the capabilities afforded by conventional combination therapies. The development of biologics targeting immunological and inflammatory diseases, through their HBICATM technology, positions Harbour BioMed as a leader in innovative biopharmaceutical solutions.
With the latest legal victory, Harbour BioMed is poised to continue its trajectory by leveraging its patented HCAb technology. It aims to foster extensive collaborations with global partners, focusing on the accelerated delivery of transformative therapies to patients worldwide. The implications of this legal confirmation extend beyond the present, potentially setting a precedent for future patent disputes within the biopharmaceutical industry in China and beyond. Not only does it affirm Harbour BioMed's innovative strengths, but it also showcases the dynamic nature of patent protection in facilitating groundbreaking advancements in healthcare.
This ruling underpins Harbour BioMed’s commitment to navigating the complex landscape of biopharmaceutical development while remaining steadfast in its mission to improve patient lives through cutting-edge therapeutic solutions. As the company progresses with its development pipeline, it reinforces the importance of robust intellectual property rights in fostering innovation and supporting the growth of the biopharmaceutical sector.
This patent dispute is not just a legal formality; it has significant implications for the commercial viability of both companies. In September 2024, Harbour BioMed filed a lawsuit in the Shanghai Intellectual Property Court against Biocytogen, asserting that their RenNano platform infringes on Harbour's HCAb patent. In response, Biocytogen challenged the jurisdiction of the court, initiating a series of legal maneuvers that included an appeal to the Supreme People's Court in March 2025. However, the court dismissed the appeal, affirming the jurisdiction of the Shanghai Intellectual Property Court to proceed with the infringement case.
Dr. Jingsong Wang, the Founder, Chairman, and CEO of Harbour BioMed, expressed great satisfaction with the CNIPA's ruling, highlighting its significance in safeguarding the company's pioneering innovations and the essence of its intellectual property. He stated that this decision not only protects their existing patents but also fortifies their ongoing investments into the development of new therapeutics made possible through their proprietary Harbour Mice® platform and associated technologies.
Harbour BioMed has made strides in creating a comprehensive patent portfolio across key global markets, which is essential for securing their position in the competitive biopharmaceutical landscape. The company's proprietary antibody technology, notably the Harbour Mice® platform, produces HCAbs and monoclonal antibodies in both the traditional two heavy and two light chain format, as well as the innovative heavy chain-only format. This versatility facilitates the development of advanced therapeutic options that are proving to be pivotal in modern medical treatments.
Moreover, Harbour BioMed is advancing the field with its HCAb-based technologies like the HBICE® bispecific antibody technology, designed to enhance tumor-killing effects beyond the capabilities afforded by conventional combination therapies. The development of biologics targeting immunological and inflammatory diseases, through their HBICATM technology, positions Harbour BioMed as a leader in innovative biopharmaceutical solutions.
With the latest legal victory, Harbour BioMed is poised to continue its trajectory by leveraging its patented HCAb technology. It aims to foster extensive collaborations with global partners, focusing on the accelerated delivery of transformative therapies to patients worldwide. The implications of this legal confirmation extend beyond the present, potentially setting a precedent for future patent disputes within the biopharmaceutical industry in China and beyond. Not only does it affirm Harbour BioMed's innovative strengths, but it also showcases the dynamic nature of patent protection in facilitating groundbreaking advancements in healthcare.
This ruling underpins Harbour BioMed’s commitment to navigating the complex landscape of biopharmaceutical development while remaining steadfast in its mission to improve patient lives through cutting-edge therapeutic solutions. As the company progresses with its development pipeline, it reinforces the importance of robust intellectual property rights in fostering innovation and supporting the growth of the biopharmaceutical sector.
Topics Health）
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