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Vortrag

„Quo vadis, SPC?“

Day 1

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

Day 2

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

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