Spring Intro 2023

16/02/2023

Navigating Patents

Art. 10(6) of Directive 2001/83/EC: conducting the necessary studies and trials with a view to the application … to a generic medicinal product and the consequential practical requirements shall not be regarded as contrary to patent rights or to supplementary protection certificates for those medicinal products.” … and this means • Development can be done during patent term (including manufacture of development batches, BE and other necessary studies) • Marketing authorisation application can be submitted during patent term

The Organisation for Professionals in Regulatory Affairs

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Navigating Patents

• Generic innovation ensures launch at the earliest opportunity. E.g. • Formulation patent? Use a different composition • Synthetic route patent? Use a different one • Manufacturing process? Use different process/technology • Polymorphic form? Use a different physical form • Article 10(1) includes some further opportunities in relation to indication, “salt” form or dosage form related patents…

The Organisation for Professionals in Regulatory Affairs

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