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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
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...
The ban on patenting of NGT plants?
On February 7, 2024 the European Parliament voted on the first reading in favor of the proposal for a regulation on plants obtained by certain new genomic techniques (NGT) and their food and feed. This method involves breeding plants by introducing specific changes to the DNA; in many cases it does not require the use of foreign genetic material from species that cannot interbreed naturally....
Data exclusivity
Despite the title of our series (“Patents without secrets”), this entry is dedicated to market monopoly, which concerns a specific group of products, and its source is pharmaceutical law rather than industrial property law. Data exclusivity is a special institution that provides additional protection to manufacturers of medicinal products. It is justified, as indicated by Prof. Du Vall...