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The Federal Court has delivered a landmark judgment, applying the "same invention" principle from the UK and Europe to assess the priority date of ToolGen's patent application. Key takeouts In crowded research areas like gene editing, especially CRISPR, it may be essential to secure an early priority date, to avoid prior art and ensure a valid patent.
The protracted litigation history The litigation began 16 years ago, when Apotex applied to revoke Sanofi's patent covering clopidogrel, a blockbuster drug sold by Sanofi as Plavix®. We detailed the protracted litigation history in our article on Nicholas J's first instance decision in the Commonwealth's damages claim in 2020. In summary: In 2007, Sanofi obtained an interlocutory injunction (ie, preliminary injunction or PI) preventing Apotex's launch of its generic clopidogrel product.
We explore the implications of the Full Court decision in the Commonwealth's damages claim against Sanofi for enforcing an invalid patent. Key takeouts The Commonwealth of Australia faces significant challenges establishing that generic/biosimilar pharmaceuticals would have listed on the PBS but for any interlocutory injunction, particularly where the generic/biosimilar supplier does not pursue its own damages claim to trial.
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