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Earlier this year (17 July 2019) in Takeda UK Limited v F. Hoffmann-La Roche AG Mr Justice Colin Birss of the Patents Court of the English High Court of Justice handed down a judgment holding that Roche’s European ...
Ewan explored the legal issues which arise at various stages of the lifecycle of a medical device; from product concept, though prototyping, testing, refinement, manufacture, marketing and placing on the market.
The excitement around the potential for the UK cannabis market – medicinal and nutritional – to continue opening up has really intensified in the first half of 2019.
Each Belgian biobank will have to be declared at the Federal Agency for Medicines and Health Products (FAMHP) in order to operate. It also imposes binding content for agreements on the transfer of human biological ...
Last month, the Belgian Parliament voted in favour of a set of measures that are notably meant to clarify the regulatory landscape of the operators active in the manufacturing of Advanced Therapy Medicinal Products ...
Since liberalisation at the beginning of 2017, industrial and medical Cannabis have experienced a boom in Germany.
Diverging from the previous decision, the Court pointed out that the relevance of the file history to construe the scope of protection of a patent and then the infringement of equivalence has to be carefully and ...
A majority postulates a new "outward presentation test" to deal with the infringement of second medical use patents.
On 17 July 2020, the Hong Kong ("HK") Legislative Council enacted the Pharmacy and Poisons (Amendment) Ordinance 2020 ("Amendment Ordinance") that introduced specific provisions covering Advanced Therapy Products ...
The restating of the expedited review pathways, and the recently published work procedures, appear to be a step toward improving a process that has seemingly changed numerous times over the years.