Quo vadis, SPC?
ECJ referrals 2011-2019 in context and practical consequences
- Laying the ground: referrals since Medeva
- Eli Lilly, Actavis and Georgetown II: referrals in context, background and interpretation
- From Merck v Sigma to Boston Scientific: further referrals in context, background and interpretation
- Impact on application practice and national court practice
- Pending referrals: from Abraxis to Santen v INPI
- Open questions for further potential referrals
This distinguishes our event
Aims and objectivesThe European Court of Justice has issued many important SPC decisions in the last few years: Medeva, Neurim, Actavis. The latest ones have raised more questions than have given answers. Our speaker, one of the leading SPC experts in Europe, will discuss the referrals with you. He will put the decisions in context and will show you the consequences for national court practice and for your application practice. Dr. Brückner will also give some hints as to pending referrals and yet unsolved questions which might be the subject of future referrals.
- Structure of the EU SPC Regulation for Medicinal Products
- Product - relevant deadlines - basic patent - relevant marketing authorisation
- What can be protected?
- Application for a certificate based on third parties‘ authorisation
- Date of grant of the basic patent and the marketing authorisation
- The ECJ and the SPC: a story of cryptic decisions; the confusion left after Medeva
- Eli Lilly (C-493/12): Markush formula - functional claims
- 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’?
- Merck v Sigma (C-579/13), Pfizer Ireland (C-681/16): referrals 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
- Incyte (C-492/16): date of expiry of an SPC
- Merck Sharp & Dohme (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-560/17): individualized embodiment
- Sandoz v Seale (C-114/18): common general knowledge
- Santen v INPI (C-673/18): 'different application' (Neurim)
- Passive SPCs; SPCs for medical devices
- Further open questions
Dr. Christopher Brückner is a German and European Patent Attorney and Pharmacist with Dennemeyer & Associates based in Munich, Germany. He is the author of the standard reference commentary on SPC law. In addition he is coauthor of the EPC commentary Singer/Stauder. He is a sought-after author, lecturer (Supplementary Protection Certificates, SPC for Beginners) and commentator in this field. In 2012, the Düsseldorf Higher Regional Court appointed Christopher as an independent legal expert in a patent dispute in the pharmaceutical field. In 2016, the Max Planck Institute for Innovation and Competition requested that Dr. Brückner participates in the preparation of a study commissioned by the EU. The purpose of the study is to determine whether the current EU Regulation 469/2009 for SPCs meets today’s technical and legal requirements.
NL 1054 Amsterdam
Phone: +31 20 6075555
Fax: +31 20 60075511
Each participant will receive a copy of the new 3rd edition of the SPC commentary by Dr. Brückner, the standard reference!
Attendees without prior SPC knowledge/education are advised to attend the introduction to SPC pre-course on 9 May 2019.
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