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Launch-at-risk of generics not that risky anymore: when the intellectual property court will refuse to grant security to the holder of a patent for an original drug

Launch-at-risk of generics not that risky anymore: when the intellectual property court will refuse to grant security to the holder of a patent for an original drug

The decision of June 4, 2024 of the Intellectual Property Division of the Regional Court in Warsaw handed in the case regarding rivoraxaban (reference no. XXII GWo 225/24), should be of interest to all producers of generics considering the so-called launch-at-risk.     The launch-at-risk refers to a situation in which a generic product is introduced to the market while...
Patent linkage in the proposed amendment to the Polish Reimbursement Act

Patent linkage in the proposed amendment to the Polish Reimbursement Act

In Poland, the work on the amendment of The Act of 12 May 2011 on the Reimbursement of Medicines, Foodstuffs Intended for Particular Nutritional Uses and Medical Devices is currently in progress. The project developed by the Ministry of Health was published in the Public Information Bulletin of the Government Legislation Center on 30 June 2021. On the same day, an invitation to public...