2015 11 30 Arbitration: the Portuguese System for Settlement of Disputes Derived from Industrial Property Rights Where Reference eaedicines and Generic Medicines are in Question

TheFutureofIntellectualPropertyArbitration?ACaseStudyonIPArbitration:thePortugueseSystem

forSettlementofDisputesDerivedfromIndustrialPropertyRightsWhereReferenceMedicinesand

GenericMedicinesareinQuestion

EmmanuelGILLET,PhDTeachingFellow,TheHongKongPolytechnicUniversity–[email protected]

UNCITRALEmergenceConference30November2015Macau

Genericdrug

“A pharmaceutical product, usually intended to beinterchangeable with an innovator product, that ismanufactured without a licence from the innovatorcompanyandmarketedaftertheexpirydateofthepatentorotherexclusiverights.”(WorldHealthOrganization).Sold under its International Nonproprietary Name (INN):“of\icial generic and nonproprietary name given to apharmaceutical drug or active ingredient” (World HealthOrganization).

UNCITRALEmergenceConference,30Nov.2015,MacauCCBY-NC-ND4.0|[email protected]

Anethicalissue


Genericsindustrydynamics



Trendinshareofgenericsinthepharmaceuticalmarket,selectedcountries,2000to2011



Trendinshareofgenericsinthepharmaceuticalmarket,selectedcountries,2000to2011


Law no. 62/2011 of 12th December 2011creating a “system for settlement ofdisputes derived from industrial propertyrights where reference medicines andgenericmedicinesareinquestion”

Legislativeandregulatorybackground


Article2oftheLawno.62/2011of12thDecember2011

“CompulsoryarbitrationLitigations derived from the claim of industrial propertyrights, including preliminary injunction proceedings,regarding reference medicines (…) and generic medicines,irrespective ofwhether process patents, product patents orpatents of use are at issue, as well as SupplementaryProtection Certi\icates, shall be subject to compulsoryarbitration,whetherornotinstitutionalised.”.”



Compulsoryarbitration

•  Parties’autonomy:limited

•  However,someprovisionsoftheUNCITRALrulesmayapply(particularlyincaseofanadhocarbitration)

Natureofthearbitralproceedings


PublishedonthewebsiteoftheNationalAuthorityofMedicinesandHealthProducts

(Infarmed)Applicant

MarketingApplication(MA)toobtainamarketing

authorization

30daystosubmitanarbitralrequest

PatentOwner

ArbitraltribunalAdhoc

Arbitrationinstitution

PatentOwner 30daystoreplytothearbitralrequest

or


ArbitraltribunalAdhoc

Arbitrationinstitution

or

(1)


(1) After 30 days: patent holders are prevented fromenforcing their IP rights against generics manufacturers(LisbonCourtofAppeal,30September2014)

/Thelegalprovisionsestablishingacompulsory30daystermto initiate mandatory arbitration procedures for theenforcementofpatents,areunconstitutional,ifinterpretedinthe sense that patent owners are not allowed to initiateprocedures against the MA applicant beyond such deadline(Constitutionalcourt,12February2015)

Proceduralissues:deadlines


Proceduralissues:designationofarbitrators

LisbonCourtofAppeal,24March2015– Arbitratordesignatedin50arbitrationproceedingsbythesameparty

–  LisbonCourtmakingreferencetotheIBARules–  Internationalstandards:•  Article16UNCITRALRules

•  IBAGuidelinesonCon\lictsofInterestinInternationalArbitration,GeneralStandardsRegardingImpartiality,IndependenceandDisclosure.

•  A“nichearbitration”issue


ReferringaQuestiontotheCJEUforaPreliminaryRuling(CJEU,13February2013,C-555/13,MerckCanada)þ Whichdiffersfromthegeneralrule.

Proceduralissues:powersofthearbitraltribunal


Decidingonthevalidityofapatent(CourtofAppealofLisbon,13February2014)ý

Substantiveissues


Confiden'alityissues

•  Communicationtothenationalindustrialpropertyof\iceandtoINFARMED

•  PublishedintheIndustrialPropertyBulletin


Lack of power to decide on the validity/existence/opposabilityofapatent(LisbonCourtofAppeal,13February2014)

Powersofthearbitraltribunal


Conclusion

•  Auniquemodel– Necessity to imagine new models for IParbitration

•  Critics– Limitedpartyautonomy:arbitration?– Limitedresources(numberofquali\iedarbitrators)

–  ImpossibilityforthearbitratortoruleonthevalidityorexistenceoftheIPR
