Lonza says it is “clearly disappointed” after the Intellectual Property Tribunal in Korea ruled in favor of Samsung BioLogics in invalidating a patent relating to cell line development.
Samsung BioLogics challenged fellow contract development and manufacturing organization (CDMO) in July 2017 regarding Lonza’s patent 1302904, entitled ‘Mammalian Expression Vector Comprising the MCMV Promoter and First Intron of HCMV Major Immediate Early Gene.’
The patent relates to a vector for transferring a gene developed for producing an antibody into a cell line, but Korea’s Intellectual Property Tribunal said this week that “Lonza’s patent does not possess novelty as it resembles previous technologies and does not show creativity as it can be easily created by ordinary technicians based on previous technologies.”
Sarah Holland, head of licensing at Lonza, said the firm is “clearly disappointed” with this decision but is confident in the IP surrounding its GS gene expression system going forward.
“We continually invest and work to improve our expression systems, ensuring our customers have access to advanced technology that is recognized by regulators,” she told this publication. “We have a strong GS intellectual property portfolio that enables us to provide a de-risked platform to support companies, particularly smaller biotech, in developing innovative and increasingly complex medicines.
“Through our internal R&D programs and partnerships we are driving the next generation of molecular biology for manufacturing medicines and we are confident that our customers will continue to appreciate the value of our offering.”
Meanwhile, a spokesperson from Samsung BioLogics told Bioprocess Insider the patent has already been waived in the US, withdrawn in Europe, and rejected in Japan, and this latest decision further boosts Samsung BioLogics’ development services ambition.
“From winning the patent invalidation trial, Samsung BioLogics can now extend its cell line development portfolio in the CDO [contract development organization] sector and provide more diverse services to its customers. Furthermore, we believe we could eliminate the entry barrier in the Korean bio industry market and heighten reputation of K-Bio.”
Samsung BioLogics entered the contract development business in 2017, offering customers cell line and process development (PD) services.
And last month in an exclusive interview with this publication, the firm said it is planning to expand these services into the US in 2020 on the back of high demand, setting up a facility in either the Boston or San Francisco area.