Module 6

03/10/2024

Exception to Patent Protection

EU Roche-Bolar

• Permits generic companies to conduct bio-equivalence and bio- availability trials in the EU (“necessary studies and trials with a view to” applying for a marketing authorization – Art. 10(6)) even if patent and data exclusivity protection exists • Does not permit manufacturing or warehousing of product prior to patent expiry of the innovative product

The Organisation for Professionals in Regulatory Affairs

Patents

11

Patents – What do you get?

Duration

•

• 20 years from date of filing (not date of grant)

• Supplementary protection certificates & Paediatric Extensions – up to 5½ years more

The Organisation for Professionals in Regulatory Affairs

Patents

12

6