data exclusivity and marketing protection - unibas.ch · 2018-01-26 · claudia seitz ¦ data...

Data Exclusivity and Marketing Protection

International Conference

Innovation and Competition in Life Sciences Law

University of Basel, Faculty of Law, 9 June 2017

Professor Dr iur Claudia Seitz, M.A. (London), Attorney-at-Law, University of Basel, Faculty of Law

Outline

Claudia Seitz ¦ Data Exclusivity and Marketing Protection ¦ 09 06 2017 University of Basel ¦ Law Faculty 2

I. Background

II. IP Protection vs Data Exclusivity

III. Data Exclusivity and Marketing Exclusivity

IV. Competition Law Assessment

V. AstraZeneca (Losec)

VI. Conclusion


I. Background

bringing a new drug on the market reqquires marketing authorization= approval of authority(ies)

investment in timeon average it takes 10-15 years todiscover and develop a new drug

high investments in time and money

requirements for marketing authorization / R&D include

drugdiscovery

efficacyconfirmatio

n

preclinicalstudies

clinical studies(phases I, II, III)

review/ approval

investment in moneyon average it takes 10-15 years todiscover and develop a new drug

compared to other industries the pharmaceutical industry needs high investments compared with market authorization requirements



= exclusive right to prevent others fromexpoiting an invention without the

consent of the patentholder

patents / SPCs data exclusivity

= protection of drug clinical datasubmitted to the authorities for market

approval to prove safety and efficacy

patent term: 20 years from filing date

patent protected invention cannot beused without market approval

→ patent may only have a few years ofprotection left

→ limitation of use of patent term

→ need for a „patent-term-extension“ mechanism to compensate for thetime lost in obtaining market approval

→ Supplementary Protection Certificate(SPC)

→ drug innovator shall be incentivizedfor time lost in obtaining marketapproval in order to develop newdrugs

under the protection of dataexclusivity the data cannot be reliedon by other companies for a certainperiod of time for obtaining marketapproval without the holder‘sauthorization

→ after the period other companies mayapply for market approval using thesame data and avoid the costsassociated with generating their owndata

3

however: other companies are not precluded from generating their owndata to obtain market approval

→ market entry cannot be prevented








patent term: 20 years from filing date

patent protected invention cannot beused without market approval

→ patent may only have a few years ofprotection left

→ limitation of use of patent term

→ need for a „patent-term-extension“ mechanism to compensate for thetime lost in obtaining market approval

→ Supplementary Protection Certificate(SPC)

→ drug innovator shall be incentivizedfor time lost in obtaining marketapproval in order to develop newdrugs

under the protection of dataexclusivity the data cannot be reliedon by other companies for a certainperiod of time for obtaining marketapproval without the holder‘sauthorization

→ after the period other companies mayapply for market approval using thesame data and avoid the costsassociated with generating their owndata

3

however: other companies are not precluded from generating their owndata to obtain market approval

→ market entry cannot be prevented








exclusivity is absolute exclusivity is relative



time

patent, SPC and data exclusivity

term of patent protection

(20 years)

duration of admission

procedure for market

authorisation

(x months)

SPC for x months

./. 5 years

granting of

patent / start of

patent

protection

approval / granting of market

authorization

(day if approval = day for placing th

product on the market)

end of patent

proctection / start of

SPC protection

end of SPC

protection

co

mp

etitio

n

data exclusivity /

protection of

data package



specific regulations in the regulatory environment ofpharmaceutical products

data exclusivity sunset clause8+2 (+1) formula

European Bolarexemption

data protection(exclusivity) of ori-ginator products

permits to accessdata of a genericapplication but thegeneric versioncannot be laun-ched until thecompletition of theten-year period

originatorproducts aregranted a 8-year data exclusivityand 2-year marketexclusivity

additional 1-year isgranted for newproductindications

permits researchand initiation ofgeneric activitiesprior to patent expiry

possibility tocancel marketauthorization forpharmaceuticalproducts that havenot been in themarket for 3 yearsafter authorisation



data exclusivity and marketing exclusivity according to the EU Commission

= «period during which the dta ofthe original marketing authorisation

holder relating to (pre-) clinicaltesteing is protected. Accordingly, […] ´data exclusivity´ refers to the

eight-year protection periodduring which generic applicant

may not refer to the informationof the original marketing

authorisation holder.»

data exclusivity marketing exclusivity

= «ten-year period after whichgeneric products can be placed on

the market.» [after 2005]

[8 years data exclusivity + 2 yearsMarketing exclusivity (+ 1 year for a

new indication)]



data exclusivity and marketing exclusivity

8 years 2 years 1 year

data/marketing exclusivity formula: 8 + 2 (+ 1)

data exclusivity marketing exclusivity

genericsapplication

genericslaunch



qestionsregarding

dataexclusivity

To what extent (scope and time) should otherpharmaceutical companies (generic companies /

competitors) be allowed to refer to the data?

Is it unfair if competitors rely on the data without costtaking into consideration the high investments (time

and money)?

Should it be possible to competitors to rely on the data(against cost) due to «ethical» aspects (Declaration ofHelsinki considers the duplication of clinical trials of

human research projects as unethical and according tothe legislation in the field of animal welfare duplication

of vertebrate studies is prohibited)?



therapeuticcompetition

3 types of competition in pharmaceutical markets

competitionbetween new, patented and

innovative productsof R&D companies

inter-brand competition

genericcompetition

competitionbetween non-

patented versionsof leading products

on the market ofgeneric companies

competitionbetween parallel

imports of cheaperproducts from low-

priced MS intohigher priced MS





= competition between new, patented and innovative products

→ additional specific protection due to regulatory data protection

→ exclusivity for new pharmaceutical products

→ competition law encourages innovation for these products as well: certain types of joint research and development, licensing, co-marketing and co-distribution are exempted under the BERs (as long as the advantages of cooperation outweigh any negative impact on competition)


genericcompetition





= competition between non-patented versions of leading products on the market of generic companies (= inter-brand competition)

→ competition once IP and data protection has been expired

→ major and substantial impact on prices for pharmaceuticalproducts

→ in general for generic products as successor products(not for biosimilars)


genericcompetition





= competition between parallel imports of cheaper products from low-priced MS into higher priced MS

→ pro-parallel approach of the EU Commission (free movement ofgoods)


genericcompetition



Pharma Sector Inquiry (2008):«examination whether agreements, such as settlements in patent disputes, have blocked

or lead to delays in market entry and whether they have created artificial barriers toentry (through misuse of patent rights, vexatious litigation or other means)»

«EU´s pharmaceutical are not working well: fewer new medicines are beingbrought to market, and the entry of generic medicines seems to be delayed»

market entry of generic drugs isdelayed

decline in the number of novelmedicines reaching the market

«the sector inquiry suggests thatcompany practices are among the causes, but does not exclude other factors such asshortcomings in the regulatoryframework»

findings of the EU Commission´s final sector inquiry report (2009)


III. Strategic Patenting and Registration?

17

patent clusters andpatent thickets

competition lawinfringements

«evergreening» as part of lifecycle

managementintervention in national

regulatory processes

strategic use oflitigation

misleading registrationinformation

pay for delayagreements / patent

settlement agreements

«tool box» (EU Commission): overall strategy: block generic market entry

→ TFEU 101: restriction by object?→ TFEU 102: misuse of dominant position?


IV. Shortcomings in other Legal Frameworks?

patent and registration strategies: competition law infringementor «shortcoming» in the legal framework?

patent law(patents, SPC)

social security law (egreim-bursement re

pharmaceuticalproducts)

«shortcoming» in the legal

framework?

regulatory law / (market

authorization)

other legal frameworks ...



AZ made misleading representationsto certain patent offices in Europe to

obtain or maintain supplementaryprotection certificates (SPCs) that

extended the exclusivity for Losec towhich it was not entitled or only for a

shorter duration

ECJ upheld Commission decision that AZ had abused ist dominant position for Losecin two ways:

AZ misused the regulatory system, bysubmitting requests for deregistrationof the marketing authorisation for Loseccapsules in certain MS in order to block

or delay the entry of generic productsreplicating AZ´s Losec and to prevent

parallel imports of Losec

first case in which to novel abuses were held to infringe TFEU 102 and the first time that the ECJ ruled on an abuse of a dominance case

in the pharmaceutical sector


time

Supplementary Proctection Certificate (SPC)

term of patent protection

(20 years)

duration of admission

procedure for market

authorisation

(x months)

SPC for x months

./. 5 Jahre

co

mp

etitio

n

data exclusivity /

protection of

data package

EU Commission:

AZ has indicated the «date of the first pricing decision» instead of «date of the firstauthorisation to place the product on the market» in order to obtain a longer periodof protection

→ misleading representations to the patent offices of certain MS in order toobtain or maintain SPCs for Losec

→ purpose of extending patent protection to which ist as not entitled in oder to block generic competition

→ outside the scope of «competition on merits»



misleading representations toobtain or maintain SPCs

open questions:

misuse of the regulatory systemby deregistration of marketingauthorisation for Losec capsules

a simple mistake in communicationwith the patent office is unlikely to beenough to find an abuse

highly misleading represantationsmade with the aim of leading publicauthorities into error is abusive

it remains unclear as to whatbehaviour will amount to abusiveconduct between these two extremes

deregistration abuse is of limited relevance because of the change in the laws to avoid a repetition of theAZ case

BUT: question remains whether andif yes, to what extent a dominant position leads to an obligation tomaintain market authorisations forsimplified authorisation proceduresfor competitors (generic companies)


VII. Conclusion


Marketing authorisation procedures are in general national authorisations and have not (entirely) displaced by processesof decentralisation and harmonisation. This has an impact on the inter-brand competition (parallel trade).

There a (still) significant regulatory barriers to free movementand competition in the EU MS.

In the future biopharmaceutical products will play an increasingly important role due to new therapeuticpossibilities. However, the successor products (biosimilars) will to a large extend not be in the scope of the discussion on data and marketing exclusivity.

Competition law should not be used as a tool to cure mistakesfor shortcomings in other legal frameworks.

23

Thank you!

contact:

Professor Dr. iur. Claudia Seitz, M.A., Attorney-at-lawFaculty of Law, University of BaselCenter for Life Sciences Law (CLSL),Peter Merian-Weg 8, CH-4002 Basel/Switzerlandtel 0041 61 267 54 54 mail [email protected]

Claudia Seitz ¦ Data Exclusivity and Marketing Protection ¦ 09 06 2017 University of Basel ¦ Law Faculty

data exclusivity and marketing protection - unibas.ch · 2018-01-26 · claudia seitz ¦ data...

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