Comprehensive Economic andTrade Agreement (CETA):Impact on PharmaceuticalProductsJune 2013Dentons Canada LLPBy: Xavier Van Overmeire andSaminda Pathmasiri
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Table of ContentsJune 2013 Dentons Canada LLP Document reference # 2802705v2 41) Economic and political context of CETA2) Overview of the existing legal framework governing pharmaceuticalproducts• Current state of cooperation between Canada and European Union• Legal aspects of Intellectual property in Canada• Comparative analysis of the levels of intellectual property protection in the European Union and Canada• The generic industry3) Expectative vision of CETA: the new intellectual property landscape forpharmaceutical products• Understanding CETA• Status of negotiations on the protection of intellectual property• Political and economic issues• Outline of the legal consequences of this agreement
Dentons Canada LLP Document reference # 2802705v2 5Why a global economic and commercialagreement?June 2013
What is the political context?• October 16, 2008: a joint study evaluatingthe costs and benefits of a closereconomic partnership between the EU andCanada• March 5, 2009: Canada-European UnionJoint Report: Towards a ComprehensiveEconomic Agreement• May 6, 2009: Prague Summit to launchnegotiations on the conclusion of aComprehensive Economic and TradeAgreement (CETA)• Between 2009 and 2012: Nine rounds ofnegotiations took place alternativelybetween Ottawa and Brussels.Dentons Canada LLP Document reference # 2802705v2 6June 2013
What is the economic context?• The European Union is the largest singlemarket in the world• European Union is the second largestsource of direct foreign investment inCanada• 503 million consumers• 20% increase in bilateral trade• $12 billion in GDP growth for CanadaDentons Canada LLP Document reference # 2802705v2 7June 2013
NAFTA Vs CETA“First generation” agreement• Elimination of customs barriers ontrade in goods and services• Facilitation of trade and investmentbetween party States• Provisions on intellectual property law• “Second generation” agreement• Elimination of customs barriers ontrade in goods and services• Removal of non-tariff barriers (thevarious standards, procedures andregulations between each partner)• New areas: investment, education,recognition of professionalqualifications…• Harmonization of standardsDentons Canada LLP Document reference # 2802705v2 8June 2013
00 Month 2013 Dentons Canada LLP Document reference # 9IP importers vs. IP exporters?They have ≠ economic and IP interests??
Dentons Canada LLP Document reference # 2802705v2 12June 2013Generic market shares % (in value and in volume)
The European MarketDentons Canada LLP Document reference # 2802705v2 13June 2013
The Canadian Pharmaceutical MarketDentons Canada LLP Document reference # 2802705v2 14June 2013
00 Month 2013 Dentons Canada LLP Document reference # 15Just over half of Canadian production is exported (primarily to the United States)and a significant portion of the Canadian market is supplied by foreign imports(29 percent from the U.S. and 57 percent from EU).Total Canadian Pharmaceutical Trade (2001 to 2011) (in $ billions)Year Domestic Exports Imports Trade Deficit2001 2.0 6.4 4.42002 2.1 7.3 5.22003 2.8 8.2 5.42004 3.6 8.6 5.22005 3.9 9.1 5.22006 5.0 10.4 5.72007 6.3 11.3 5.22008 6.0 11.6 5.62009 6.7 13.4 6.72010 5.1 12.2 7.12011 4.3 12.5 8.2
Intellectual property in bilateral agreementsDentons Canada LLP Document reference # 2802705v2 16• The new bilateral agreements systematically devote sections pertaining to intellectualproperty rights• CETA provisions provide for a higher standard of protection of intellectual property rightsthan those in TRIPS• The European Union asks its commercial partners to offer levels of protection equivalent toits ownCanada European UnionPatent term20 years 20 yearsPatent lifetime extensionN/A 0-5 yearsExclusive data protection8 yr + 6 months for paediatric use drugs 10 yr + 1 years for new indicationsPatent liaison to notice ofcompliance requestsYes NoJune 2013
00 Month 2013 Dentons Canada LLP Document reference # 17Negotiations = Tug of WarThere will be a winner and a loser at thetable
00 Month 2013 Dentons Canada LLP Document reference # 18What have been the benefits of increased collaboration between Canadaand the EU for the pharmaceutical industry?
Retrospective of the existing legal frameworkgoverning pharmaceutical products• History1976: Framework Agreement for Commercial and EconomicalCooperation1990: Transatlantic Declaration1998: Agreement on Mutual Recognition in relation toConformity Assessment between European Community andCanada:“The European Community shall accept the results ofconformity assessment procedures, includingcertifications of compliance, as required by theEuropean Community and Member States legislationand regulations identified in the SectoralAnnexes, produced by designated conformityassessment bodies or authorities in Canada inaccordance with this Agreement.”Dentons Canada LLP Document reference # 2802705v2 19June 2013
Measures put in place to facilitate access forCanadian pharmaceutical products wishing to enterthe European marketDentons Canada LLP Document reference # 2802705v2 20• Section XV of the Mutual Recognition Agreement: this agreementstipulates that a partner must grant access to its market to all productsoriginating from the other partner which have met the requirements of aconformity assessment to good manufacturing practices.• Sectoral Annex on drugs: certification of the compliance of the drugs togood manufacturing practices.• Acceptance of authorisations and licences directly issued by HealthCanada• A certificate demonstrating the equivalency of compliance programmesfor good manufacturing practices would suffice for the other Party torecognize the compliance of the products.• Section 2.1 of the Sectoral Annex on drugs: “… It should be understoodthat equivalent does not mean identical but it does mean leading to thesame result.”June 2013
What are the legal aspects of Canadian policy onintellectual property rights?Dentons Canada LLP Document reference # 2802705v2 21• Intellectual property rights on drugs are protected by:TrademarksPatentsData protection mechanismsTrade secrets• This framework is conditioned by the obligations to which Canada isbound (NAFTA, GATT and TRIPS), and which it must comply with.June 2013
How effective are patents in the protection ofpharmaceutical products in Canada?Dentons Canada LLP Document reference # 2802705v2 22• What is patentable? An invention• An invention is “any new and useful art, process, machine, manufactureor composition of matter, or any new and useful improvement in any art,process, machine, manufacture or composition of matter”Broad interpretation of “new” and “useful” which encourages“evergreening” by means of :• Patenting improvements on existing drugs,• Advanced patenting of a drug through the application ofthe doctrine of “sound prediction” and;• Patenting a second use for an existing drug.June 2013
What is the legal term of a pharmaceutical patent?Dentons Canada LLP Document reference # 2802705v2 23Before1989, patentlifetime of17yearsWTO Agreement onTrade-Related Aspectsof Intellectual PropertyRights (TRIPS)provides a minimalprotection of 20 years.Section 44 of thePatent Act modifiedin 1989, provides fora protection of 20yearsJune 2013
Effective duration of a patentDentons Canada LLP Document reference # 2802705v2 24PatentPatentrequestRequest for anotice ofcompliancefor aninnovativedrugHealthCanadaissues anotice ofcomplianceExpiration of thepatent0 10 20Duration in yearsJune 2013
NOC Regulations or Patented Medicines Regulations,a new infringement action offered to patent holders?June 2013 Dentons Canada LLP Document reference # 2802705v2 25• This regulation ties notice of compliance requests to a preliminary verification of the patentregistry kept by the Minister of Health. It forbids generic manufacturers from marketing theirproducts prior to the expiration of the patent. They can however seek to demonstrate thatthe patent is invalid or expired.• “If a second person files a submission for a notice of compliance in respect of a drug and the submission directly orindirectly compares the drug with, or makes reference to, another drug marketed in Canada under a notice of complianceissued to a first person and in respect of which a patent list has been submitted, the second person shall, in thesubmission, with respect to each patent on the register in respect of the other drug,• (a) state that the second person accepts that the notice of compliance will not issue until the patent expires; or• (b) allege that• (i) the statement made by the first person under paragraph 4(4)(d) is false,• (ii) the patent has expired,• (iii) the patent is not valid, or• (iv) no claim for the medicinal ingredient, no claim for the formulation, no claim for the dosage form and no claim forthe use of the medicinal ingredient would be infringed by the second person making, constructing, using or sellingthe drug for which the submission is filed.”
NOC RegulationsDentons Canada LLP Document reference # 2802705v2 26Denunciationto the patentholderSection 5.3The injunction automatically block thenotice of compliance issuance procedurefor 24 monthsSection 7.1Court may declarethe patent valid orinvalidThe patent holder has 45 days torequest a Court order to preventthe issuance of a NOCSection 6.1June 2013
What protection for non-patented pharmaceuticalproducts? Are they neglected from the intellectualproperty system?Dentons Canada LLP Document reference # 2802705v2 27• Exclusive data protection allows the manufacturer of an innovative drug to benefitfrom an exclusivity period for its clinical data, which prevents of competitors fromusing it to quickly obtain a notice of compliance.• Distinct protection from the one conferred by a patent but has a similar effect• Protection of exclusive data stems from international agreements which Canadahas agreed to.June 2013
June 2013 Dentons Canada LLP Document reference # 2802705v2 28“5. If a Party requires, as a condition for approving the marketing of pharmaceutical oragricultural chemical products that utilize new chemical entities, the submission ofundisclosed test or other data necessary to determine whether the use of such productsis safe and effective, the Party shall protect against disclosure of the data of personsmaking such submissions, where the origination of such data involves considerableeffort, except where the disclosure is necessary to protect the public or unless steps aretaken to ensure that the data is protected against unfair commercial use.6. Each Party shall provide that for data subject to paragraph 5 that are submitted to theParty after the date of entry into force of this Agreement, no person other than the personthat submitted them may, without the latters permission, rely on such data in support ofan application for product approval during a reasonable period of time after theirsubmission. For this purpose, a reasonable period shall normally mean not less than fiveyears from the date on which the Party granted approval to the person that produced thedata for approval to market its product, taking account of the nature of the data and thepersons efforts and expenditures in producing them. Subject to this provision, there shallbe no limitation on any Party to implement abbreviated approval procedures for suchproducts on the basis of bioequivalence and bioavailability studies.Where a Party relies on a marketing approval granted by another Party, the reasonableperiod of exclusive use of the data submitted in connection with obtaining the approvalrelied on shall begin with the date of the first marketing approval relied on.”The section 1711 NAFTA, provides a minimum protection of five years:Minimumperiod of 5yearsData protectionstarts on the dateon which the firstNotice ofcompliance isissued
For which drugs? … Innovative drugsDentons Canada LLP Document reference # 2802705v2 29• Section C.08.004.1 (1) of the Food and Drug Regulations:"Innovative drug" means "a drug that contains a medicinalingredient not previously approved in a drug by the Minister and thatis not a variation of a previously approved medicinal ingredientsuch as a salt, ester, enantiomer, solvate or polymorph."June 2013
For what duration?Dentons Canada LLP Document reference # 2802705v2 30• Before June 2006: five years protection with no real effectiveness Strict interpretation of exclusive data protection by the Federal Court in Bayer Inc. v.Canada• After June 2006: No new drug submission may be made on the basis of an innovative drug for aperiod of 6 years"If a manufacturer seeks a notice of compliance for a new drug on the basis of a direct or indirectcomparison between the new drug and an innovative drug :a) the manufacturer may not file a new drug submission, a supplement to a new drugsubmission, an abbreviated new drug submission or a supplement to an abbreviated new drugsubmission in respect of the new drug before the end of a period of six years after the day onwhich the first notice of compliance was issued to the innovator in respect of the innovativedrug" Section C.08.004.1.(3) a) No Notice of compliance shall be issued by the Minister of Health before the expiry ofa period of eight years;"the Minister shall not approve that submission or supplement and shall not issue a notice of compliancein respect of the new drug before the end of a period of eight years after the day on which the first noticeof compliance was issued to the innovator in respect of the innovative drug." Section C.008.004.1.(3) b)This period is lengthened to eight years and six months for paediatric use drugs (section C.008.004.1 (4a)June 2013
00 Month 2013 Dentons Canada LLP Document reference # 31Can the European Union claim to have higher standards of IP protection?
Can the European Union claim to have higherstandards of IP protection?Dentons Canada LLP Document reference # 2802705v2 32Canada European UnionPatent term 20 years 20 yearsOctober 5, 1973 Munich AgreementSection 63Patent life timeextensionN/A 0-5 ansMay 6, 2009, Paliament and Council Regulation CE n°469/2009“Protection Supplementary Certificate" The product is protected by a basic patent The drug has received approval to market The drug has not been the subject of a certificate For the first authorization of issued marketingExclusive dataprotection8 yr (innovative drugs)+ 6 months for paediatric usedrugs)No additional protection fororphan drugs10 yr (any drug)( + 1 year for new indications)Directive 2001/83/CE as amended in 2004 by Directive 2004/27/CEExclusivity of full 10 years for orphan drugsDecember 16, 2009, European Parliament and Council Regulation CEn°141/2000Patent liaison toNOC requestsYes NoJune 2013
00 Month 2013 Dentons Canada LLP Document reference # 33The CETA vision: a new legal landscape of pharmaceutical products– what are the benefits in terms of economic growth for Canada?
The CETA vision: a new legal landscape ofpharmaceutical products• 20% increase in trade through the elimination of tariffand non-tariff barriers;• GDP growth of $12 billion in Canada;• Wealth Increase of $360 per Canadian resident;• The EU is the second largest source of foreign directinvestment in Canada;• The EU welcomes 23.6% of Canada’s foreign directinvestment.Dentons Canada LLP Document reference # 2802705v2 34What are the benefits in terms of economic growthfor Canada?June 2013
00 Month 2013 Dentons Canada LLP Document reference # 35How will the CETA agreement affect intellectual property rights inCanada?
How will the future CETA agreement affectintellectual property rights in Canada?Dentons Canada LLP Document reference # 2802705v2 36• Consolidated Draft of AECG 2010 “Section 9.2 Supplementaryprotection Certificates :The Parties recognise that medicinal and plant protection products protectedby a patent on their respective territory may be subject to an administrativeauthorisation procedure before being put on their market. They recognise thatthe period that elapses between the filing of the application for a patent andthe first authorisation to place the product on their respective market, asdefined for that purpose by the relevant legislation, may shorten the period ofeffective protection under the patent.The Parties shall provide for a further period of protection for a medicinal orplant protection product which is protected by a patent and which has beensubject to an administrative authorisation procedure, that period being equal tothe period referred to in paragraph 1 second sentence above, reduced by aperiod of five years.Notwithstanding paragraph 2, the duration of the further period of protectionmay not exceed five years.A medicinal product for which paediatric studies have been carried out may beentitled to a six months extension of the period mentioned in paragraphs 2 and3.]”… An extension of the legal term of patents…Extension of 5years of the lifeterm of a patentFive years andsix months forpaediatric usedrugsJune 2013
00 Month 2013 Dentons Canada LLP Document reference # 2802705v2 37• Section 10 : Protection of Data Submitted to Obtain anAuthorisation to put a Pharmaceutical Product on the MarketThe Parties shall guarantee the confidentiality, non-disclosure and non-reliance of data submitted for the purpose of obtaining an authorisation toput a pharmaceutical product on the market.[EC: 2. For that purpose, the Parties shall ensure in their respectivelegislation that any information submitted to obtain an authorisation to put apharmaceutical product on the market will remain undisclosed to thirdparties and benefit from a period of at least ten years of protectionagainst unfair commercial use starting from the date of grant ofmarketing approval in either of the Parties.(a) during a period of at least eight years, no person or entity (public orprivate), other than the person or entity who submitted such undiscloseddata, will, without the explicit consent of the person or entity who submittedthis data, rely directly or indirectly on such data in support of an applicationfor the authorisation to put a pharmaceutical product on the market;(b) during a ten-year period, a marketing authorization granted for asubsequent application will not permit placing a pharmaceutical product onthe market, unless the subsequent applicant submitted his/her own data(or data used with authorization of the right holder) meeting the samerequirements as the first applicant. Products registered without submissionof such data would be removed from the market until the requirementswere met.Extending the duration of protection for exclusivedataNew protection term: 10years from the issuanceof the Notice ofCompliancePossibility for a genericmanufacturer to beginproceedings for theissuance of a NOC, twoyears before the protectionexpiryJune 2013
Dentons Canada LLP Document reference # 2802705v2 38• Data protection as provided for by the EU applies to ALL drugs• Canadian data protection applies only to innovative drugs:• “ “Innovative drug“ means a drug that contains a medicinal ingredient not previously approved in adrug by the Minister and that is not a variation of a previously approved medicinal ingredient suchas a of salt, ester, enantiomer, solvate or polymorph"To broaden the scope of protection of exclusive data, the term "innovativedrug" could be replaced by "existing drug" which would be defined as anydrug already approved by the Minister.A small yet significant change in terminologyJune 2013
Dentons Canada LLP Document reference # 2802705v2 39• “In addition, the ten-year period referred shall be extended to a maximum of eleven yearsif, during the first eight years after obtaining the authorisation in either of the Parties, theholder of the basic authorisation obtains an authorisation for one or more new therapeuticindications which are considered of significant clinical benefit in comparison with existingtherapies.”Lengthened to 11 years if, during the first eightyears of protection, the company receivedapproval to treat one or more therapeuticindicationsJune 2013
Dentons Canada LLP Document reference # 2802705v2 40Section 10 « [EC: 4. If a Party relies on "patent linkage" mechanisms whereby the granting ofmarketing authorizations (or notices of compliance or similar concepts) for generic medicinesis linked to the existence of patent protection, it shall ensure that the patent holders and themanufacturers of generic medicines are treated in a fair and equitable way, includingregarding their respective rights of appeal.]Strengthening the protection granted to rightsholders in the NOC RegulationsEstablishment of aneffective right of appealagainst the CourtdecisionJune 2013
NOC RegulationsDentons Canada LLP Document reference # 2802705v2 41Denunciationto the patentholderSection 5.3The injunction automatically block thenotice of compliance issuance procedurefor 24 monthsSection 7.1Court may declarethe patent valid orinvalidThe patent holder has 45 days torequest a Court order to preventthe issuance of a NOCSection 6.1June 2013Injunction refused!AppealprocessNew!
What are the political and economic implications ofCETA?Dentons Canada LLP Document reference # 2802705v2 42• Recoup cost of research through an extension of the exclusivemarketing period;• Encourage innovators to push their innovative research further;• Attract more investment in R & D in Canada• These benefits may be tempered (e.g. increased protection for data in 2006 didnot lead to higher R&D)Premise: greater protection promotes R & DJune 2013
A difficult pill to swallow for drug usersDentons Canada LLP Document reference # 2802705v2 43• Significant shortfalls for the generic industry• Impact on the cost of drugs for provinces andprivate insurers• Delays in the marketing of generics couldimpose costs on prescriptions estimated at$2.8 billion• Impact on the cost to consumersThe case of Crestor molecule: if CETA had come into force, this molecule would still not bemarketed as a generic. Its patent expired on June 2, 2012, but with the extension of thepatent term provided for in CETA, it would have only expired on January 2, 2018. Theestimated cost for the province of Alberta, before accessing this drug in 2018, would be$145,3 millionJune 2013
Outlining the legal consequences of the agreement:Dentons Canada LLP Document reference # 2802705v2 44• Section 44 of the Patent Act:"Subject to section 46, where an application for a patent is filed under this Act on or after October 1,1989, the term limited for the duration of the patent is twenty years from the filing date."• Section 45 (2) of the Patent Act:"Where the term limited for the duration of a patent referred to in subsection (1) had not expired before theday on which this section came into force, the term is seventeen years from the date on which the patent isissued or twenty years from the filing date, whichever term expires later.“This section must be repealed. The new regulation will have to provide for the legal statusgoverning existing patents when a certificate extending its term enters into force, and alsolimit the lifespan of a patent to 15 years after the first issuance of a notice of compliance.A new reform of the Patent Act?Adding a paragraph referring to theRegulations which will provide for thepossibility of obtaining a certificate to extendthe patent term by 5 years.June 2013
Dentons Canada LLP Document reference # 2802705v2 45• Actual section C.08.004.1"(3) If a manufacturer seeks a notice of compliance for a new drug onthe basis of a direct or indirect comparison between the nwe drug and aninnovative drug:a) The manufacturer may not file a new drug submission, a supplementto a new drug submission, an abbreviated new drug submission or asupplement to an abbreviated new drug submission in respect of thenew drug before the end of a period of six years after the day on whichthe first notice of compliance was issued to the innovator in respect ofthe innovative drug; andb) The Minister shall not approve that submission or supplement andshall not issue a notice of compliance in respect of the new drug beforethe end of a period of eight years after the day on which the first noticeof complance was issued to the innovator in respect of the innovativec) the Minister shall not approve that submission or supplementand shall not issue a notice of compliance in respect of the newdrug before the end of a period of eleven years if, during the firstthree years following the issuance of the notice of compliance themanufacturer of the existing drug obtained an authorization toprocess one or several new therapeutic indications."Changes to the Food and Drug Regulation?Becomes 8yearsBecomes 10ansAdding aparagraphJune 2013To broaden the scope of protection of exclusive data, the term"innovative drug" could be replaced by "existing drug" which wouldbe defined as any drug already approved by the Minister.
Dentons Canada LLP Document reference # 2802705v2 46• Adjusting section C.08.004.1 (4) that provides for a protection period ofeight years and six months for paediatric use drugs. This protectionperiod will have to be extended to ten years and six months.• Provide for an expedited special approval process?Are other changes needed?June 2013
Dentons Canada LLP Document reference # 2802705v2 471) A more strict interpretation of the patentability criteriaPatenting of simple improvementsAdvanced patenting of inventionsPatenting a new use of a drug1) Impose conditions on the extension of patents.2) Grant additional time only on the first patent for an innovative productor;Proposals for achieving a new balance in the PatentActEnding thepractice of"evergreening"June 2013
IPInvestmentprotectionGov.procurementIncrease inimportquotasCETA is much more than an IP agreement….Canada will win on certain issues, will lose or compromise on others….Labour andinvestment
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