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.