Pre-course: 15 May 2017, 14:00-18:00
- Introduction to the basic terms
- Structure of the EU SPC Regulation for Medicinal Products
- Product – relevant deadlines – basic patent – relevant marketing authorisation
- Fundamental practical questions
- What can be protected?
- Application for a certificate based on third parties‘ authorisation
- Date of grant of the basic patent and the marketing authorisation
16 May 2017, 09:00-17:00
Laying the Ground: referrals since Medeva
- The ECJ and the SPC: a story of cryptic decisions
Eli Lilly, Actavis and Georgetown II
- Eli Lilly (C-493/12): Markush formula – functional claims: possible?; what about passive SPCs?
- Actavis (C-443/12): no second SPC for same active ingredient in combination; abstract combination?
- Georgetown II (C-484/12): second SPC for individually protected active ingredient; how to accommodate ‘Actavis’?
From Merck vs Sigma to F. Hoffmann – La Roche
- Merck v Sigma (C-579/13): first referral on Specific Mechanism
- Synflorix (C-631/13): definition of adjuvant
- 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
Pending Referrals: What to Expect
- Incyte (C-492/16): date of expiry of an SPC
- Merck Sharp & Dohme (C-567/16) end of procedure notice equivalent to market authorisation?
- Pfizer Ireland (C-681/16): second referral on Specific Mechanism
- Teva v Gilead (C-121/17): product protected by a basic patent in force
- Abraxis (C-443/17): first marketing authorisation for new formulations
Open questions for further potential referrals
- Passive SPCs; SPCs for medical devices
- Further open questions