AIPPI Hyderabad 2011
– Patent Linkage
Patent Linkage - general
 Allowing the patent status of an original product
to affect regulatory decisions concerning
generic products in respect of marketing
approval, pricing, reimbursement etc.
Patent Linkage - general
 Starting point for applicable EU regulations that
market authorizations shall not be refused,
suspended or revoked except on the grounds
set out in such regulations.
 Article 81 of Regulation (EC) No 726/2004,
Article 126 of Directive (EC) No 2001/83 and
Recital 3 of Regulation (EEC) 2309/93.
 Patent protection is not included as a ground for
refusal
Variants of Formal Patent Linkage
 Notification to IP holder of application for
marketing approval
 File declaration of non-infringement with MA
application
 Restrictions in respect of earliest date for filing
of MA application in relation to lapse of patent
 Generic MA suspended until lapse of patent
rights
’Indirect’ Patent Linkage
 When the actions necessary or desirable in
order to obtain a relevant regulatory decision
concerning a pharmaceutical product can be
actionable under patent law either as
infringement by themself or considered proof of
imminent infringement warranting interlocutory
measures.
Marketing Authorisations pre Bolar
 Swedish case law to the effect that the paper
filing did not involve infringement
 Importation of samples for regulatory purposes
infringed patent rights.
Bolar provision
 Directive 2001/83/EC as amended by
2004/27/EC introduced exemption from patent
protection in respect of measures necessary to
obtain generic marketing authorisation
Marketing Authorisation
 Directive not directly valid in all EU member
states and the precise scope of the national
legislation implementing the Directive varies
 Only generics or all pharmaceuticals?
 EU/EEA marketing authorisations only or a
wider scope?
Marketing Authorisation
 Portugal – actions before the administrative
courts using a specific provision of the
Portuguese constitution against grant of
marketing approval
Price approval/reimbursement
 Not infringing according to Swedish Supreme
Court in Pfizer v Stada (ref NJA 2008 p 1192)
 Should it be viewed as an indication of
imminent infringement warranting interim
measures according to the Enforcement
Directive?
Generic substitution
 Specific MPA decision establishing substitutability
between original and generic product.
 Triggers mandatory substitution at pharmacy level –
switch prescribed pharmaceutical to pharmaceutical
with the lowest price
 Risperidal (Janssen-Cilag) - MPA cannot decide on
substitutability for products protected by patent and
alleging contributory infringement by the MPA –
rejected by the court.