Data Exclusivity and Marketing Protection - unibas.ch · 2018-01-26 · Claudia Seitz ¦ Data...
Transcript of 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
Claudia Seitz ¦ Data Exclusivity and Marketing Protection ¦ 09 06 2017 University of Basel ¦ Law Faculty 3
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
Claudia Seitz ¦ Data Exclusivity and Marketing Protection ¦ 09 06 2017 University of Basel ¦ Law Faculty 4
II. IP Protection vs Data Exclusivity
= 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
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however: other companies are not precluded from generating their owndata to obtain market approval
→ market entry cannot be prevented
Claudia Seitz ¦ Data Exclusivity and Marketing Protection ¦ 09 06 2017 University of Basel ¦ Law Faculty 5
II. IP Protection vs Data Exclusivity
= 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
Claudia Seitz ¦ Data Exclusivity and Marketing Protection ¦ 09 06 2017 University of Basel ¦ Law Faculty 6
II. IP Protection vs Data Exclusivity
= 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
exclusivity is absolute exclusivity is relative
Claudia Seitz ¦ Data Exclusivity and Marketing Protection ¦ 09 06 2017 University of Basel ¦ Law Faculty 7
II. IP Protection vs Data Exclusivity
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
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II. IP Protection vs Data Exclusivity
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
Claudia Seitz ¦ Data Exclusivity and Marketing Protection ¦ 09 06 2017 University of Basel ¦ Law Faculty 9
III. Data Exclusivity and Marketing Exclusivity
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)]
Claudia Seitz ¦ Data Exclusivity and Marketing Protection ¦ 09 06 2017 University of Basel ¦ Law Faculty 10
III. Data Exclusivity and Marketing Exclusivity
data exclusivity and marketing exclusivity
8 years 2 years 1 year
data/marketing exclusivity formula: 8 + 2 (+ 1)
data exclusivity marketing exclusivity
genericsapplication
genericslaunch
Claudia Seitz ¦ Data Exclusivity and Marketing Protection ¦ 09 06 2017 University of Basel ¦ Law Faculty 11
III. Data Exclusivity and Marketing Exclusivity
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)?
Claudia Seitz ¦ Data Exclusivity and Marketing Protection ¦ 09 06 2017 University of Basel ¦ Law Faculty 12
IV. Competition Law Assessment
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
Claudia Seitz ¦ Data Exclusivity and Marketing Protection ¦ 09 06 2017 University of Basel ¦ Law Faculty 13
IV. Competition Law Assessment
therapeuticcompetition
3 types of competition in pharmaceutical markets
= 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)
inter-brand competition
genericcompetition
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IV. Competition Law Assessment
therapeuticcompetition
3 types of competition in pharmaceutical markets
= 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)
inter-brand competition
genericcompetition
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IV. Competition Law Assessment
therapeuticcompetition
3 types of competition in pharmaceutical markets
= 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)
inter-brand competition
genericcompetition
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IV. Competition Law Assessment
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)
Claudia Seitz ¦ Data Exclusivity and Marketing Protection ¦ 09 06 2017 University of Basel ¦ Law Faculty 17
III. Strategic Patenting and Registration?
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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?
Claudia Seitz ¦ Data Exclusivity and Marketing Protection ¦ 09 06 2017 University of Basel ¦ Law Faculty 18
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 ...
Claudia Seitz ¦ Data Exclusivity and Marketing Protection ¦ 09 06 2017 University of Basel ¦ Law Faculty 19
V. AstraZeneca (Losec)
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
Claudia Seitz ¦ Data Exclusivity and Marketing Protection ¦ 09 06 2017 University of Basel ¦ Law Faculty 20
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»
V. AstraZeneca (Losec)
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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)
V. AstraZeneca (Losec)
VII. Conclusion
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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.
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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