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AIPPI Hyderabad 2011 – Patent Linkage

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.

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AIPPI Hyderabad 2011 – Patent Linkage

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  1. AIPPI Hyderabad 2011– Patent Linkage

  2. Patent Linkage - general • Allowing the patent status of an original productto affectregulatorydecisionsconcerninggenericproducts in respect of marketing approval, pricing, reimbursementetc.

  3. 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

  4. Variants of Formal Patent Linkage • Notificationto IP holder of application for marketing approval • Filedeclaration of non-infringement with MA application • Restrictions in respect of earliest date for filingof MA application in relation to lapse of patent • GenericMA suspendeduntillapse of patent rights

  5. ’Indirect’ Patent Linkage • When the actionsnecessary or desirable in order to obtain a relevant regulatorydecisionconcerning a pharmaceuticalproductcan be actionableunder patent laweither as infringementby themselfor consideredproof of imminentinfringementwarrantinginterlocutorymeasures.

  6. Marketing AuthorisationspreBolar • Swedish caselaw to the effect that the paperfilingdid not involveinfringement • Importation of samples for regulatorypurposesinfringed patent rights.

  7. Bolar provision • Directive 2001/83/EC as amended by 2004/27/EC introducedexemptionfrom patent protection in respect of measuresnecessary to obtaingeneric marketing authorisation

  8. Marketing Authorisation • Directivenot directly valid in all EU memberstates and the precise scope of the national legislationimplementing the Directivevaries • Onlygenerics or all pharmaceuticals? • EU/EEA marketing authorisationsonly or a widerscope?

  9. Marketing Authorisation • Portugal – actions before the administrative courts using a specific provision of the Portugueseconstitutionagainstgrant of marketing approval

  10. Price approval/reimbursement • Not infringingaccording to Swedish Supreme Court in Pfizer v Stada (ref NJA 2008 p 1192) • Should it be viewed as an indication of imminentinfringementwarrantinginterimmeasuresaccording to the EnforcementDirective?

  11. Generic substitution • Specific MPA decisionestablishingsubstitutabilitybetween original and genericproduct. • Triggersmandatory substitution at pharmacylevel – switchprescribedpharmaceutical to pharmaceutical with the lowestprice • Risperidal (Janssen-Cilag) - MPA cannotdecide on substitutability for productsprotected by patent and allegingcontributoryinfringement by the MPA – rejected by the court.

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