Update SPC and UPC

Introduction to the basic terms (pre-course)

• Structure of the EU SPC Regulation for Medicinal Products
• Product - relevant deadlines - basic patent - relevant marketing authorization

Fundamental practical questions (pre-course)

• What can be protected?
• Application for a certificate based on third parties' authorisation
• Date of grant of the basic patent and the marketing authorization

SPC key issues and introduction to the UPC system (advanced course)

SPCs, unitary patents and the UPC (advanced course)

• SPCs and unitary patents; unitary SPCs?
• SPCs before UPC: jurisdiction, opt-out procedure, expired SPCs

Medeva, Eli Lilly, Actavis and Georgetown II referrals: laying the ground (advanced course)

From Merck vs Sigma to Santen (advanced course)

• Boehringer (C-577/13): combination claimed in second patent
• Forsgren (C-631/13): covalent binding of a biologic product
• Seattle Genetics (C-471/14): date of market authorisation
• F. Hoffmann - La Roche (C-572/15): duration of an SPC issued under national law
• Incyte (C-492/16): date of expiry of an SPC
• MSD (C-567/16): end of procedure notice equivalent to market authorisation?
• Teva v Gilead (C-121/17): product protected by a basic patent in force
• Boston Scientific (C-527/17): no SPCs for CE-marked devices
• Abraxis (C-443/17): first marketing authorisation for new formulations
• QH/Royalty Pharma (C 650/17): individualized embodiment
• Santen v INPI (C-673/18): no SPC for new therapeutic applications

Pending referrals: what to expect (advanced course)

• Novartis (C-354/19): further SPC to a new indication
• Teva v MSD (C-119/22): "product" in Art 3(a) and Art 3(c)