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Samsung Bioepis commences second AU revocation action against Fresenius Kabi adalimumab patent

Jun 24, 2022

Samsung Bioepis filed a suit against Fresenius Kabi in the AU Federal Court, seeking to revoke AU2020201090 ‘Liquid pharmaceutical composition’ (‘090 patent) which was granted 2 days earlier, on the grounds of novelty, obviousness, lack of utility, lack of best method, lack of clarity and lack of support.

The ‘090 patent is related to Fresenius Kabi’s AU 2015263246 (‘246 patent), which Samsung sought to revoke in 2019.  The proceedings were discontinued in early 2020 after Fresenius Kabi surrendered the patent, with Fresenius ordered to pay Samsung’s costs.

The recently granted ‘090 patent, like the earlier granted ‘246 patent, relates to a specific composition of adalimumab, including a histidine buffer, specified sugar and polysorbate.

There is a third granted family member (AU2018222887), which Samsung has not sought to revoke to date, nor has Fresenius asserted it against Samsung.

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