IV. PATIENTS GROUPS, FARMERS, DOCTORS, HEA
LTH
AUTHORJTIES, AGRICULTURAL AUTHORfl1ES, INSURER
S
/TENDERERS
Intellectualproperty (1F), such as patents or trademarks,
plays a key role in
encouraging investment in innovation. A 2013 study (lP Righ
ts intensive
industries: Contribution to economic performance and emp
loyment in
Europe, EUIPO,2013) revealed that 39% of économic activ
ity in the EU is
generated by lP-intensive industries, while 26% of all emp
loyment is
provided directly by these industries.
Industry sectors whose products are subject to regulated
market
authorisations, such as the pharmaceutical, medical devi
ces and
agroche.mical jndustries, rely heavily on industrial property
protection
through patents, Supplementary Patent Certificates (SPC
s) and data
/market exclusivity.
SPCs are a sui generis IP right that constitute an extension
(of up to five
years) to the term of a patent right (of twenty years). SPCs
aim to offset
the loss ofeffective patent protection that occurs due to the
compulsory
and lengthy testing and clinical trials that products require
prior to obtaining
regulatory marketing approval. The relevant EU legislation
is Regulation
(EO) No 469/2009 and Regulation (EO) No 1610/96 on SPO
covering
pharmaceutical and plant protection products respectively.

t rie bolar patent exemption aims at speeding up tne entry ot generic

medicines into the market by allowing early preparatory development on
generics to obtain pre-market regulatory approval even when the SPC of
the reterence medicine is stiJl in force. It is regulated at EU level for the
pharmaceutical industry only through Article 13(6) of Directive 2001 /82/EC
and Article 10(6) of Directive 2001/83/EC. The scope of the EU Bolar
exemption has been updated in someEU MS, inter alia, to meet new
pharmaceutical-related requirements.
The specific industrial property legal framework in the EU for industry
sectors w’hose products are subject to regulated market authorisations
might present several features not fit for purpose in todays global
econorny and in the light of new regulatory requirements.
Firstly, existing SPCs are granted and enforced at national level, which can
result in Single Market fragmentation. There are cases where some
Member States have granted SPÇ applications while the very same
application has been either refused or granted with a different scope in
other Member States.
Secondly, Member States implement the ‘Bolar exemption’ in different
ways: on the onë hand, some Member States do not allow the supply of
active pharmaceutical ingredients to EU-based generic manufacturers for
the purpose of seeking marketing authorisation, and on the other hand, in
a numberof Member States, it is not certain whether testing in the EU by
originators and biosimilars can benefit from these exemptions for the
purpose of seeking marketing authorisation in the EU and in non-EU
countries, or for meeting emerging regulatory requirements such as those
related to health technology assessment.

60

t niraty, manuTacturers or generic and oiqsim

nar medicines asea in non
EU countries where SPC protection does not exist
(e.g. in Brazil, Russia,
India and China) enter markets in which patent protect
ion expired up to
five years earlier than EU-based manufacturers. Thi
s is possible because
EU-based manufacturers are not allowed to produc
e in EU Member States
during the period of the SPC protection of the referen
ce medicine. Such a
situation could lead to a lack of playing field between
EU and non EU
manufacturers with an advantage for non EU man
ufacturers.
The Single Market Strategy, adopted in October 201
5 (COM(2015)550),
announced that the Commission will “consult, con
sider and propose further
measures, as appropriate, to improve the patent sys
tem in Europe, notably
for pharmaceutcaI and other industries whose pro
ducts are subject to
regulated market authorisations”. In particular, the Stra
tegy undertook to
explore a recalibration of certain aspects of patent and
SPC protection,
and announced that this recalibration could mainly öom
prise the following
three elements: the creation of a European SPC title;
an update of the
scope of the EU patent research exemptions; and the
introduction of an
SPC manufacturing waiver (the so-called ‘SPC man
ufacturing waiver’ for
export purposes would allow EU based manufactur
ers of generics
/biosimilars manufacturing their products during the
EU SPC term of the
reference medicine to export their products to countri
es with no SPC
protection). The European Commission published an
“inception impact
assessment” on 15 February 2017.
The current public consultation seeks to gather feed
back of all
stakeholders on the way thé SPC system currently, fun
ctions in the EU and
is effects on trade and competitiveness in particular.
The Commission will report on the resuits of its consult
ation which,
together with ongoing evaluation studies, will help the
Commission assess
whether the EU SPC framework is stili fit for purpose
or needs to be
recalibrated, notably as regards the aspects set out in
Single Market
Strategy.

61

Disclaimer
Please note that this document has been pre
pared by the Commission
services for information and consultation pur
poses only. It has not been
adopted or in any way approved by the Comm
ission and should not be
regarded as representative of its views. It doe
s not in any way prejudge, or
constitute the announcement of, any position
on the part of the
Corn mission on the issues covered. The Co
mmission döes not guarantee
the accuracy of the information provided, nor
does it accept responsibility
for any use made thereof.

The followng questions relate to the proffle of
*

your company/organisation:

1. Which best describes you?
HeaIth, mci. medicines (human and/or veter
inary medicines)
(J) Plant protection products (pesticide
s)
C) Other: please specify
Please specify
Ministry of Health

62

*

1.1. 1f the health sector, are you a:
Individual
National patients’ organisation
European patients’ organisation
0 Pubc pricing authority
0 Consumers’ association
Procurement authority
Public health authority (e.g. Ministry of Health)
0 Private company organising/launching procur
ement
Health technology assessment authority
0 Veterinary association
Health care professionals (e.g. doctors, associations of health
care professionals)
Hospita! or hospital association/group
Insurance health provider
0 Other: please specify
-

Please specify
MinistryofHealth

1.1. 1f the agrochemical sector, are you a:
0 Farmer
National farmers’ organisation
European farmers’ organisation
Legal counsellor representing tarmers
O Consumers’ association
0 Public authority for agriculture
Other: please specify
Please specify

63

The next few questions are about how effective suppiementary protection certificates (SPCs
) and Bolar
exemptions are in the EU.
We want to find Out how much progress has been made in meeting the following objecti
ves (from SPC
legislation adopted in the 1990s):

•

attracting research

•

preventing delocalisation

•

protection for long enough to recover investment

•

promoting essential innovation for patients

•

competition through innovation

•

limiting the negative effects of fragmentation.

The SPC is an incentive for innovation investment in pharmaceutical and plant protection
products. The
SPC legislation was introduced in the EU in the 1990s.
In most of the following questions, wed like to find out your views on how innovation
and market
competition are progressing for these products since SPC legislation was introduced
in the EU.

64

2. In the last two decades in the EU, how do you perc

eive the progress made in

Down
alot

Down
abit

Stable

UpUp
a
a
bit
lot

No
opinion

investments in pharmaceutical innovation
in general
•

. .

•

. .

investments in clinical trials

.investments in pharmaceutcal
manufacturing
•

.

0

0

investments in innovation in plant
protection products
•

0

•

0

•..investments in the manufacturing of plant
protection products

C)

.competition in the pharmaceutical sector
based on innovation
•

.

• .competition in plant protection products
based on innovation

0

competition based on the quick market
entry of generics/biosimilars following the
expiry of SPC protection?
dependency of supply of active
pharmaceutical ingredients (APls)
manufactured outside the EU
healthy supply of end products (e.g.
vaccines, pesticides) manufactured in the EU
dependency of supply of end products
manufactured outside the EU

q
L)

3. What do you think are the effects of SPC protection on
investment in developing innovative medicines
/plant protection products] with added value for patients
[/farmers and consumers]?
0 1 (Negative)
2

o

(Positive)

‘ilmpossible to know

O We don’t know
O No opinion
0 Answer2

65

Please explain your answer (max. 2 000 characters, mcl.

spaces).

2000 character(s) maxi’nurn
It is impossible to say what products would not have
been

developed in the absence of SPC protection.

SPCs apply to patented pharmaceutical and plant protection
products that have been authorised by
regulatory authorities not earlier than 5 years after filing their
basic patent’ (i.e. the patent to be extended
with the SPC). As explained in the introductory part of the questio
nnaire, the aim is to offset the loss of
effective patent protection that occurs due to the compulsory
and lengthy testing and clinical trials that
products require prior to obtaining regulatory marketing approv
al.
4. Should the EU SPC system be available for other innova
tive products subject to Iengthy regulatory
approval?

O Yes
(No

o No opinion
1f your answer is Yes’, please provide examples (max. 1 500
/500 c/iaracter(s) maxLrrn,m

characters, mci. spaces).

Generics and biosimilars enter the market when the patent/SPC
for that market expires (subject to other
industrial property rights that could still be in force). A transpa
rent SPC system can make t easier for
generics/biosimilars to compete.
5. About your use of databases to monitor the status of SPC protect
ion of your products across EU
Member States...

Agree

Dsagree

Don’t
know/no
opinlon

to our knowledge, there are no databases available to
conduct such monitoring
specialised databases are very costly

0

0

In the next few questions, we’d like to find out how much comple
xity SPC applicants face when filing
SPCs in the EU (of course, some complexity is always expect
ed in the highly technical fields such as
pharmaceutical or plant protection products innovation).
6. How would you rate the degree of complexity of court litigati

on for SPCs in the EU?

ig h
0 Reasonable
0 Low
O Don’t know/no opinion

66

How could liligation be improved? (max. 1 500 char

acters, md. spaces)
1500 c/laracter(”s) maxfrrnin7
It is dear that the complexity of the litigation is mainly
due to the high volume of jurispruclence that exists for
certain parts of the regulation. The complexity will
remain high as long as the uncertainties arounci seve
ral
Larticles keep existing. This requires not
just guidelines, but preferably a clarification in the legis
lative text.

7. Have yöu ever decided not to enter into litigation
relating to SPC infringement or SPC validity because.
of a lack of economic resources to litigate?
() Yes

C’ No
Don’t know
Please provide examples of the total cost of enfo
rcement that you were faced with (max. 2 000
characters, mci. spaces).
2000 character4,) maximum

rz-zz

SPC protection could have had unintended adverse effec

ïzz:

ts in other sectors.

EU-based generics and biosimilar manufactures argu
e that the EU SPC protection puts them at a
disadvantage compared with foreign-based manufac
turers.
They want to see the introduction of an ‘SPC man
for more details).

ufacturing waiver’ (see introduction to this questionn

aire

In the next few questions, we’d like to find out abou
pharmaceuticals industry.

t the chailenges faced by this sector of the

8. Does the EU SPC framework put EU based gene
rics/biosimilars manufacturing at a disadvantage
comp,red with toreign—based manufacturers when expo
rting generics and biosimilars outside the EU?
Yes
No

0 Don’t know/no opinion
Please explain your answer (max. 2 000 character
s, mcl.

spaces).
2000 character(s) maximum
EU based manufacturers are unable to produce for
export during the SPC ieriod. This gives non-EU base
d
manufacturers the advantage during the SPC period
, but also for entering the EU market directly after expiry
of
the SPC term.
9. Does the EU SPC framework put EU based gene
rics/biosimilar manufacturing at a disadvantage
compared with foreign-based manufacturers when
t comes to placing generics and biosimilars on the
EU
market when SPC protection in the EU expires?
‘JYes

0 No
0 Don’t know/no opinion

67

Please explain your answer (max. 1 500 characters, mci. spaces).
/500 characfer(’s) maximum
EU based manufacturers are unable to produce for export during the SPC period. This gives non-EU based
manufacturers the advantage during the SPC period, but also for entering the EU market directly after exiry c
-j
theSPCterm.
-

10. 1f you answered yes’ to Questions 8 or 9, does the issue matter more for biosimilars than for
generics?

C’ Yes
No

1 Don’t know/no opinion
1f you answered yes’ to Question 10, please explain why (max. 2 000 characters, mci. spaces).
2000 character(s) maxi’num
1

SPC legislation aims to ensure adequate protection for innovation and improving public health.
We want to evaluate whether the objectives of the SPC regulation match current needs and problems (e.g.
only some types of innovations are eligible for SPC protection; new regulatory requirements did not exist
when the SPC regulation came into force and some activities linked to new regulatory requirements are
not covered by the Bolar exemption).
11. In your experience, is SPC protection sufficient to encourage investment in certain types of
innovations (e.g. antibiotics, medicines for the treatment of negiected diseases and orphan diseases)?
1) In our opinion, SPC protection is not the right trigger for certain types of innovatior
Yes
especially antibiotics and neglected diseases. 1f a low return-on-investment is already
No
anticipated because of e.g. very low or unpredictable sales of certain antibiotics, extn
C Don’t know/no opinionSPC protection will not really change the path for innovation. Therefore also other
incentives have been put in place with the intention to incentivize these types of
innovations, such as market exclusivity for orphan drugs.
Please explain your answer (max. 1 500 characters, mci. spaces).
1500 character(s) maximum
2) However, whetheror not such incentives have positlve or negative effects on innovation and access to patien
is subject of investigation, based on the Council Conclusions during the Dutch Presidency. We therefore support
the Commission’s work to study the effects of these incentives in a coherent manner instead of individually.

‘I

We’re interested in how the SPC and EU Bolar exemptions work in relation to national legislation.
12. Please give exampies of any inconsistencies between national legisiation and EU legisiation on
SPCs and Bolar exemptions, if you know of any.
Do you have any suggestions on how to overcome those inconsistencies? Please explain your answer
(max. 2 000 characters, mcl. spaces.)
2000 characters maximum
N/A

68

__

13. Have the EU SPC and Bolar exemptions brought
added
0 Yes

value compared with national initiatives?

ONo
‘!Don’t know
Please explain your answer (max. 2 000 characters, mcl.
2000 character(s) maximum
YN/A, similar provisions did not exist.

spaces)
—

-

The following questions focus on the matters addressed

by the European Commission’s inception
‘SPC manufacturing waiver’ (see explanation in
the introduction to this questionnaire), the unitary SPC, and
specific issues related to the Bolar and
research patent exemptions.
impact assessment’ published on 15 February 2017: the

In the following questions, wed like to find Out your views
Bolar systems in the EU:

on some options for improving the SPC and

14. Please indicate which of the following actions would
be enough on its own to ensure consistent
nterpretation throughout the EU of the scope and eligibi
lity of the SPC regulation?

Yes

No

n’t know/no
opmnion

1

Arnendment of the SPC Regulations to bring adtional clarity
Creation of a unitary SPC for the unitary patnt

0

Guidelines developed by the European Commission and EU
countries
Other actions

Other actions

—

—

please explain (max. 2 000 characters)

0

0

0

please explain ( max. 2 000 characters)

2000 character(’s) maximum

15. Do you favour the creation of a unitary SPC title for the
unitary

patent?

Yes

0 No, there’s no need
0 No opinion
Please explain your answer (max. 1 500 characters, mcl.

spaces).
1500 characrer(’s) maximum
rTheadvantagesofwunitary patent are also applica
ble to SPCs. A unitary system could lessen the complexity
of
the process, both in administrative terms as in the difficu
lties that arise from difference in interpretation.

69

16. Which language combination would you prefer for the public
ation of the unitary SPC?
0 The notice of granting a SPC should be published
in all official languages of the EU
English, German and French would be sufficient (Commission
working languages)
0 English only would be sufficient
•C: Other options, please explain:
Other actions

—

please explain (max. 2 000 characters)

2000 characters) max/mum

In the following question, wed like to find out your views on some
options for improving the SPC and
Bolar systems in the EU.
17. What would be the benefits of a unitary SPC?
1
(min.)

31

2

4

5
(max.)

Reduce cost and red tape relating to monitoring SPC
protected products (freedom to operate)
Reduce cost of SPC-related litigation
Legal certainty
Existence of a specialised court
Make joint procurement by a group of EU countries easier

V. NATIONAL PATENT OFFICES, JUDGES AND IP PROFES

SIONALS

Intellectual property (IP), such as patents or trademarks, play
s a key role in
encouraging investment in innovation. A 2013 study (IP Rights
intensive
industries: Contribution to economic performance and employm
ent in
Europe, EUIPO, 2013) revealed that 39% of economic activ
ity in the EU is
generated by IP-intensive industries, while 26% of all employm
ent is
provided directly by these industries.

70

Industry sectors wnose proclucis are subject to regulat
ea marKet
authorisations, such as the pharmaceutical, medical
devices and
agrochernical industries, rely heavily on industrial pro
perty protection
through patents, Suppiementary Patent Certificates
(SPCs) and data
Jmarket exclusivity.
SPCs are a sui generis IP right that constitute an exte
nsion (of up to five
years) to the term of a patent right (of twenty years).
SPCs alm to offset.
the loss of effective patent protection that occurs due
to the compulsory
and lengthy testing and clinical trials that produdts req
uire prior to obtaining
regulatory marketing approval. The relevant EU legis
lation is Regulation
(EO) No 469/2009 and Regulation (EC) No 1610/9
6 on SPC covering
pharmaceuticai and plant protection products respecti
vely.
The Bolar patent exemption aims at speeding up the
entry of generic
medicines into the market by allowing early preparator
y development on
generics to obtain pre-market regulatory approval eve
n when the SPC of
the reference medicine is stili in force. It is regulat
ed at EU level for the
pharmaceutical industry only through Article 13(6) of
Directive 2001/82/EC
and Article 10(6) of Directive 2001/83/EC. The sco
pe of the EU Bolar
exemptionhas been updated in some EU MS, interali
a, to meet new
pharmaceutical-related requirements.
The specific industrial property legal framework in the
EU for industry
sectors whose products are subject to regulated mar
ket authorisations
might present several features not fit for purpose in
today’s global
economy and in the light of new regulatory requiremen
ts.
Firstly,-existing SPOs aregranted and enforced at natio
nal level, whic.h can
result in Single Market fragmentation. There are cas
es where some
Member States have granted SPC applications whil
e the very same
application has been either refused or granted with
a ditferent scope in
other Member States.

71

Secondly, Member States implement the ‘Bolar exe
mption’ in different
ways: on the one hand, some Member States
do hot aHow the supply of
active pharmaceutica ingredients to EU-based
generic manufacturers for
the purpose of seeking marketing authorisation,
and on the other hand, in
a number of Member States, It is not certain whether
testing in the EU by
originators and biosimilars can benefit from thes
e exemptions for the
purpose of seeking marketing authorisation inth
e EU and in non-EU
countries, or for meeting emerging regulatory req
uirements such as those
related to health technology assessment.
Thirdly, manufacturers oi generic and biosimilar
medicines based in non
EU countries where SPC protection does not exis
t (eflg. in Brazil, Russia,
India and China) enter markets in which patent
protection expired up to
five years earlier than EU-based manufacturers.
This is possible because
EU-based manufacturers are not allowed to pro
duce in EU Member States
during the period of the SPC protection of the refe
rence medicine. Such a
situation could lead to a lack of playing field betw
een EU and non EU
manufacturers with an advantage for non EU man
ufacturers.

72

The Single Market Strategy, adopted in October 2015 (COM(2
01 5)550),
announced that the Commission will consult, consider and prop
ose further
measures, as appropriate, to improve the patent system in Euro
pe, notably
for pharrnaceutical and othêr industries whose products are subj
ect to
regulated market authorisations”. In parficular, the Strategy unde
rtook to
explore a recalibration of certain aspects of patent and ‘SPC
protection,
and announced that this recalibration could mainty comprise the
following
three elements: the creation of a European SPC title; an upda
te of the
scope of the EU patent research exemptions; and the introduction
of an
SPC manufacturing waiver (the so-called ‘SPC manufacturing waiv
er’ for
export purposes would allow EUbased manufacturers of gene
rics
/biosimilars manufacturing their products during the EU SPD
term of the
reference medicine to export their products to countries with
no SPC
protection): The European Commission published an “inception
impact
assessment” on 15 February 2017.
The current public consultation seeks to gather feedback of all
stakeholders on the way the SPC system currently functions in
the EU and
its effects on trade and competitiveness in particular.
The Commission will report on the resuits of its consultation
which,
together with ongoing evaluation studies, will help the Commiss
ion assess
whether the EU SPC framework is still fit for purpose or need
s to be
recalibrated, notably as regards the aspects set out in Single Mark
et
Strategy.

Disclaimer

73

Hease note mat mis document rias neen prepared
b iiie ommission
services for information and consultation purposes
onty. It has not been
adopted or in any way approved by the Commission
and should not be
regarded as representative of its views. It does not
in any wayprejudge, or
constitute the announcement of, any position on the
part of the
Corn mission on the issues covered. The Commis
sion does not guarantee
the accuracy of the information provided, nor doesit
accept responsibility
for any use made. thereof.

The following questions relate to the profile of your
*

company/organisation:

1. hich best describes you?
National patent office
C Professional having dealt with both regis

tration and litigation of SPCs
Professional having dealt with SPC litigation but not
with registration
Judge dealing with SPC enforcement
0 Professional having dealt with registratio
n of SPCs but not with litigation
0’ Other: please specify
Please specify
Nationa Patènt Office of thé

74

The next few questions are about how effective suppiementary protection
certificates (SPCs) and Bolar
exemptions are in the EU.
We want to find out how much progress has been made in meeting the follow
ing objectives (from SPC
legislation adopted in the 1990s):

•

attracting research

•

preventing delocalisation

•

protection for long enough to recover investment

•

promoting essential innovation for patients

•

competition through innovation

•

limiting the negative effects of fragmentation.

SPCs are regulated under EU law (Regulation (EC) No 469/2009 and Regula
tion (EC) No 1610/96), but
granted in each EU country by a national authority.

• They are enforced nationally in
national courts.
•

Registration procedures can vary between EU countries.

•

Sometimes, authorities (grant authority or court) in different EU countries
can reach different
conciusions ôn the validity or scope of the SPC protection they grant (or
refuse) in their country for
the same product.

•

National courts have referred several questions on the interpretation of SPC
legislation to the Court
of Justice of the EU.

In the next few questions, we’d like to hear about your experience of how harmo
nised SPC protection is
across the EU.

75

2. Have authorities in different EU countries ever taken
different decisions on SPC applications for one
(or more) of products)?
Examples: some EU countries granted SPC national applica
tions for one of your products but refused
others; you were granted different durations of SPC protect
ion for one of your products in different EU
countries; national grant authorities interpreted EU Court of
Justice rulings differently.
lYes
) No
) Don’t know
1f you answered yes’ to Question 2, please explain in the

box below.

1500 c/iaracte,7s) maxhnum

Every expert in this field will acknowledge that the interpretation
of the Regulation is not uniform throughout
Europe. Numerous examples could be given. In our practic
e, when we reject an SPC application the applicant wil
often point to the fact that It was granted in other member
states. Referrals to the CJEU also often highlight the
fact that the SPC was granted in some member states, but
refused in others.
3. Has an EU country’s courts ever taken a different decisio
n in relation to the SPC of a specific product
(e.g. you observe the validity of an SPC upheld by some
EU countries’ courts but revoked by others; some
EU countries’ courts conciuded that there was intringem
ent of a specific SPC, while others did not)?
lYes

0 No
0 Don’t know
1f you answered ‘yes’ to Question 3, please explain in the

box below.

1500 c/aracter(s) /77axirntJrn

Every expert in this field will acknowledge that the interpr
etation of the Reulation is not uniform throughout
Europe. Numerous examples could be given. In our practic
e, when we reject an SPC application the applicant wil
often point to the fact that it was granted in other member
states. Referrals to the CJEU also often hghlight the
fact that the SPC was granted in some member states,
but refused in others.
Generics and biosimilars enter the market when the patent/
SPC for that market expires (subject to other
industrial property rights that could still be in force). A transpa
rent SPC system can make it easier for
generics/biosimilars to compete.
4. About your use of databases to monitor the status of your
Member States...

competitors’ SPC protection across EU

Agree

Disagree

Don’t
know/no
opinion

to our knowledge, there are no databases available to
conduct such monitoring
specialised databases are very costly
We’d like to hear your views on how fragmented you think
potential improvements (e.g. a unitary (single) SPC).

[ (
the EU SPC system is so that we can consider

76

5. Has your country enacted legislation on SPCs to transpose
the EU regulations on SPCs?
0 Yes
No, the national authority that grants the SPC relies directly
on the SPC regulations
0 Don’t know/no opinion
5.1. 1f you answered ‘yes’ to Question 5, has your EU countr
y ever updated that legislation following a
judgment from the Court of Justice of the EU?
Yes
•(-‘ No
0 Don’t know/no opinion
6. Has your country (e.g. your national patent office) adopte
d implementirig guidelines for examining and
registering SPCs?
0 Yes
the national authority that grants the SPC relies direcfly on
the SPC regulations
0. Don’t know/no opinion
6.1. 11 you answered ‘yes’ to Question 6, do you usually
update the guidelines following a judgment from
the Court of Justice of the EU?
OYes
0 No
0 Don’t know/no opinion
The efficiency of the current EU SPC system could be improv
ed, for example by using a unitary (single)
sPc.
In the next few questions, we’d like to find Out how much compl
exity SPC applicants face when filing SPCs
in the EU (of course, some degree of complexity is always
expected in highly technical fields such as
pharmaceutical or plant protection products innovation).
7 How would you rate the degree of complexity of registration
procedures for SPCs in the EU?
uH igh
0 Reasonable
0 Low
0 Don’t know! no opinion
How could procedures be improved? (max. 1 500 characters,

md. spaces)

/500 cliaracter(s) /na)(/»71/n)
The registration procedures could be improved by remov
ing uncertainties -stemming from the extensive
jurisprudence surrounding the regulation.

t

-

77

__

_

SpC protection could have had unintended adverse effec

ts in other sectors.

EU-based generics and biosimilar manufacturer argu
s
e that EU SPC protection puts them at a
disadvantage compared with foreign-based man
ufacturers.
They want to see the introduction of an SPC man

ufacturing waiver’ (see ntroduction to this questionn

for more details).

aire

In the foliowing questions, wed like to find Out abou
t the challenges faced by this sector of the
pharmaceuticals industry.
8. Do you agree or disagree with the following state

ments?
—.._

___

Agree

Disagree

opinion

SPCs inadvertently disadvantage EU-based gene
rics and
biosimilars manufacturing compared with countries with
no SPC (e.g.
for exports outside the EU and for entry in the EU follow
ing the
expiry of the SPC)
When placing generics and biosimilars on the EU mark

et after the
and
biosimilars manufacturing compared with generic com
panies based
in countries with no SPC

SPC expires, SPCs disadvantage EU-based generics

The EU SPC, in its current form, increases reliance
on imports of
medicines and active pharmaceutical ingredien from
ts
outside the EU

.

1

The following questions relate to the cost of regis

tration and enforcement of SPCs, and whether the
viour (e.g. whether It limits the number of registratio
ns).

current cost level impacts on SGP holders’ beha

9. Have you ever known an SPC applicant to aban

don an SPC registration in an EU country owing

Yes

No

to...

Don’t know/no
opinion

the cost of registration/maintenance?
burdensome administrative
procedures?

10. Does the geographical scope of SPCs generally
match the geographical scope of the territory in
which the protected pharmaceutical product is mark
eted?
Q Yes

D No

sometimes it’s larger (i.e. we sometimes obtain
SPC protection in countries where the
protected product will not be marketed)
—

—

it’s usually narrower

V Don’t know

78

1f you are an IP professional/lawyer, please give examples
of the total cost of registration and
maintenance in multiple jurisdictions based on your experience
(max. 5 000 characters, mci. spaces).
5000 character(s) maximum

11. It an SPC is entorced in only one EU country, is the cost

of enforcement proportionate?
the potential cost is always exceeded by potential sales
No it’s very high and sometimes SPC hoiders give up enforc
ing t
Don’t know/no opmnion
Yes

—

—

1f you answered ‘no’ to Question 1 1 and 1f you are an IP profess
ional/lawyer, please give examples of
total Oost of enforcement (max. 2 000 characters, mcl. spaces
).
2000 character(’s,) maximum

12. 1f an SPC is enforced in multiple EU countries, is the Oost
of enforcement proportionate?
0 Yes the potential oost is always exceeded by
potential sales
0 No it’s very high and sometimes SPC holders
give up enforcing It in some EU countries
lDon’t know/no opinion
—

—

1f you answered ‘no’ to Question 12 and ii you are an IP profess
ional!lawyer, please give examples of
total Oost of enforcement in multiple jurisdictions (max. 3 000
characters, mcl. spaces).
3000 character(s maximum

13. Is the length of proceedings relating to the enforcement

of SPCs satisfactory?

0 Yes
0 No

—

It depends on the EU country

ïDon’t know/no opinion
In the next few questions, we’d like to find out how the compe
tent EU country authorities manage SPC
registrations.
Some authorities have greater administrative resources than others.
14. For national patent offices, do the administrative fees relatin
g to SPCs cover the Oost of handling SPC
appllcations and their registration?
0 Yes
No
0 No opinion

79

15. 1f the national patent office in your country
has a backiog of SPC applications, what do you
think are
the 2 main reasons for this?
between t and2 choi’es

Ei Insufficient administrative resources at the national paten
t office
Ei Insufficient technical abilities of the national patent offic
e

lncreasing complexity of the subject matter of
the

Ei Delays caused by the applicant
Ei There is no backlog

application

Other, please specify:
Other, please specify:
Opposition procedures against the basic patent.

16. Does the national patent office in your country
sometimes need to rely on the work of another
patent
office in the EU to make a decision on granting
an SPC?
Yes
No

C.’ Don’t know/no opinion
SPC legislation aims to ensure adequate prote

ction for innovation and to improve public health.

We want to evaluate whether the objectives of

the SPC regulation match current needs and prob
lems (e.
g. only some types of innovations are eligible for SPC
protection; new regulatory requirements did not
exist when the SPC regulation came into t orce
and some activities linked to new regulatory requ
irements
are not covered by the Bolar exemption).
17. Is SPC protection not available for some type
s of innovations (e.g. certain categories of medical
9
dev
s
ic,
, veterinary medicines, or plant-related products)
?
Yes

C No
Don’t know

1/2 OnIy two SPC regulations, 469/2009
and 1610/96, exist and it is self-evident
that no SPC protection is available to
Please give examples if possible (max. 1 500 char
acters, mcl. spaces).
products which fali outside the scope of
1500 c/7aracter(s) maximum
these regulations.
2/2 Whether certain medical devices fall under
the scope of Regulation 469/2009 is the subject of
referral
C-527/17, now pending before the CJEU. Many inno
vations in completely different areas of technolog
y (e.g.
consumer products, vehicles, electronics, materials
) may require some kind of regulatory approval
and testing fo
safety or efficacy before they can be sold onto the
market.
18. In your experience, is SPC protection sufficient
to encourage investment in certain types of vital
innovations (e.g. antibiotics, medicines for treat
ing neglected or orphan diseases)?
Yes
(No

Q Don’t know

80

Please give examples 1f possible (max. 1
500

characters, mci. spaces).
1500 chaiacter(s) maximum
In our opinion, SPC protection does not enco
urage investment in certain types of inno
vations, especially
antibiotics and neglected diseases. 1f a low
return-on-investment is already anticipated
because of e.g. very lo
or unpredictable sales of certain antibiotic
s, extra SPC protection will not change the
return-on-investment fron
negative to very positive
19. To your knowledge and in your experienc
e, do other jurisdictions provide certain
types of innovations
that are not EU SPC—eligible with SPC
type protection?
/Yes
No
() Don’t know
Please give examples 1f possible (max. 1
500

characters, mcl. spaces).
7500 c/iaracteiy’s) maximum
In the US the Drug Price Competition and Pate
nt Restoration Act also known as the Hatc
h-Waxman Act permits
patent term extensions not only to human drug
products but also medical devices, food addi
tives, and colour
additives.

We want to find out how the SPC and Bola

r EU frameworks work in relation to natio

nal legislation.

20. Please give examples of any inconsist
encies between national legislation and
EU legislation on
SPCs and Bolar exemptions, It you are know
of any. Do you have suggestions on how
to overcome these
inconsistencies? Examples & suggestions
(max. 2 000 characters, mcl. spaces)
2000 character(s,) maximum
N/A

21. Have the EU SPC and Bolar exemption
Yes

s brought added value compared with natio

nal initiatives?

O No
*/‘Don’t know
Please provide an explanation/examples 1f
poss
2000 character’s,) maximum
N/A, similar rdvisiöhsdtd1Tbt €xî

ible (max. 2 000 characters, mcl. spaces).

The following questions focus on the matt

ers addressed by the European Commiss
ion ‘inception impact
assessment’ published on 15 February 2017
: the ‘SPC manufacturing waiver’ (see expl
anation in the
introduction to this questionnaire), the unita
ry (single) SPC, and specific issues relat
ed to the Bolar and
research patent exemptions
There’ is no specific provision dedicated to
SPCs in the package of legislative instrume
nts related to the
unitary patent. We would like to get feedback
from you on whether national authorities,
in applying the
SPC Regulations, could grant SPCs on the
basis of unitary patents.

xl

22. Would t be possible to grant national SPCs for a product covered by the
future European patent with
unitay effect (unitary patent) without legislative changes?
Yes
No, EU legislation is needed to clarify the relationship between the unitary
patent and the current
SPC framework
0 Don’t know
Some aspects of the EU Bolar patent exemption could be upgraded in line
with best practice in some EU
countries in view of changes in the way generics and biosimilars are developed
in the EU, and in view of
the future establishment of the Unified Patent Court which may not foflow those
best practices.
The Bolar patent exemption is not explicitly available for the plant protection
products industry in the EU,
but it might be available in the US.
23. In your experience, and in your country, is the Bolar exemption availab

le for....

Yes, stipulated
in patent law or
jurisprudence
• •originators’ activities related to
health technology assessment’?

No, neither
stipulated in patent
law nor in
jurisprudence

lts
uncertain

Don’
t
know

,

development of a generic
product (e.g. medicines or
pesticides) for its registration
outside the EU?

‘1
-:

development of generic plant
protection products for its
registration in your country?
24. Do you think that there is a risk that the future Unified Patent Court could
develop a practice in terms
of the Bolar patent exemption that conflicts with the one cemented in Irish,
UK and German law/practice?
0 Yes, and it’s undesirable
0 Yes, but it wou ldn’t be an issue for us
ONo
fDon’t know
In the following questions, wed like to find out your views on some option
s for improving the SPC and
Bolar systems in the EU.

82

25. Please indicate which of the following actions would
be enough on its own to ensure consistent
interpretation throughout the EU of the scope and eligibi
lity of the SPC regulation.

Yes
Amendment of the SPC Regulations to bring additional

clarity

No

Don’t
know

1 3

Creation of a unitary SPC for the unitary patent
Guidelines developed by the European Commission and
EU
countries
Other actions

Other actions

—

please explain

please explain

26. Based on your experience, do you think that all EU
countries’ national patent offices should conduct
substantive examination (i.e. actual verification of the
conditions stipulated in the SPC Regulation) of SPC
applications?
Yes
No, some of them might not have the necessary resou

rces

0 No, it’s unnecessarily cumbersome even for the
offices with enough resources
0 No opinion
27.,o you favour the creation of a unitary SPC title

for the unitary patent?

Yes

0 No, there’s no need
0 No opinion
Please provide an explanation (max. 2.000 character
s, mci.

spaces).
2000 charcter(s) rnaxhnum
The advantages of a unitary patent are also applicable
to SPC’s. A unitary systern could lessen the corn plexity
o
the process, both in administrative terms as in the difficu
lties that arise from difference in interpretation.
28. Which granting authority would you favour to

0 EU lntellectual Property Office
0 European Medicines Agency
0 European Patent Office

grant and register a unitary SPC?

EU countries’ patent offices (e.g. virtual office appr
oach or mutual recognition with reference
offices, under EU rules)

0 A new EU agency
0 None of the above, please indicate your alternativ

e preference

83

__
__
—
__
_
__
_

Please indicate your a[ternative preference

29. Which language combination would you prefe

r for...

English, French,
German, ltalian
and Spanish (as for
the EU Intellectual
Property Office

English,
French, and
German (as
for the
European
Patent 0ff ce)

All EU official
languages (as
for centralised
marketing
authorisations)

English
only

Noneof
these
(please
indicate
your
alternative
preference)

unitary
sPc
applications

publishing
unitary

30. Should the unitary SPC be available only
for products authorised by way of a centralise
d marketing
authorisation (e.g. assessed by the European
Medicines Agency)?
Yes
(3 No
0 No opinion
31. Would It be useful for a more consistent/inte
grated EU approach on the patent Bolar and
research
exemptions 1f a group of Commission and EU
country experts is set up to monitor developments
relating to
these exemptions?
0 Yes
0 No legislative action would still be
needed
CNo and no legislative action is needed
Don’t know/no opinion
—

—

In the following questions, wed like to find Out
your views on some options for improving the
SPC and
Bolar systems in the EU.
32. 1f you are an EU country’s patent office,
would a unitary SPC have a significant impa
ct on your
organisation’s budget (e.g. significant loss of
income or staff redundancies)?
0 Yes
fNo

0 Don’t know/no opinion

84

_

Please provide an explanation/examples (max. 2
000 char

acters, mci. spaces).

2000 character(’s) maxhrnirn

Total amount of work spent on SPCs at the Netherlands
Patent Office is about 1500 hours, which is divided
over 4 patent examiners, 1 legal advisor, and two adm
inistrators.
33. 1f you are an EU country’s patent office, would your
organisation be abie to participate in the
implementation of a decentralised procedure to gran
t the unitary SPC?
(Yes
No

o Dont know/no opinion
34. What would be the benefits of a unitary SPC?

1

1
Strongly
disagree

lmprove value of
investments

2
Disagree

3 Neither
agree
disagree

o

1

4
Agree

5
Strongly
agree

Don’t
know
/no
opmnion

Reduce red tape
relating to litigation
Reduce red tape
relating to registration

0

o

Same protection in
all EU countries

0

0

0

o

o

c

o

Legal certainty
Reduce
maintenance costs
Specialised court

1
•

a.

o.

C

‘/‘

0

Make licensing

Lasier

VI. PUBLIC AUTHORITIES RELATED TO SCIENCE
, INDUSTRY,
TRADE AND COMPETITION

85

InteectuaI property (1F-’), sucr as patents or trademarks, plays a Key role
in
encouraging investment in innovation. A 2013 study (lP Rights intensive
industries: Contribution to economic performance and employment in
Europe, EUIPO, 2013) revealed that 39% of economic activity in the
EU is
generated by IP-intensive industries, while 26% of all employment is
provided directly by these industries.
Industry sectors whose products are subject to regulated market
authorisations, such as the pharmaceutical, medical devices and.
agrochemical industries, rely heavily en industrial property protection
through patents, Suppiementary Patent Certificates (SP.Cs) and data
/market exclusivity.
SPCs are a sui generis IP right that constitute an extension (of up
to five
years) to the term of a patent right (of twenty years). SPOs aim to offse
t
the loss of effective patent protection that occurs due to the compuls
ory
and Iengthy testing and clinical trials that products require prior to obta
ining
regulatory marketing approval. The relevant EU legislatibn is Regulatio
n
(EO) No 469/2009 and Regulation (EC) No 161 0/96 on SPO covering
pharmaceutical and plant protection products respectively.
The Bolar patent exemption aims at speeding up the entry of generic
medicines into the market by allowing early preparatory development
on
generics to obtain pre-marketregulatory approval even when the SPC
of
the reference medicine is still in force It isregulated at EU level for the
pharmaceutical industry only through Article 13(6) of Directive 2001/82/E
O
and Article 10(6) of Directive 2001/83/EO. The scope of the EU Bolar
exemption has been updated in some EU MS, inter alia, to meet new
pharmaceütical-relatëd requirements.

86

t ne specmc industnal property legal trarneworK in flie IzU ror industry

sectors whose products are subject to regulated market authorisations
might present several features not fit for purpose in today’s global
economy and in the light of new regulatory requirernents.
Firstly, existing SPCs are granted and enforced at national level, which can
result in Single Market fragmentation. There are cases where some
Member States have granted SPC applications while the very sme
appilcation has been either refused or granted with a different scope in
other Member States.
Secondly, Member States implement the ‘Bolar exemption’ in different
ways: on the one hand, some Member States do not allow the supply of
active pharmaceutical ingredients to EU-based generic manufacturers for
the purpose of seeking marketing authorisation, and on the other hand, in
a number of Member States, it is not certain whether testing in the EU by
originators and biosimilars can benefit from these exemptions for the
purpose of seeking marketing authorisation in the EU and in non-EU
countries, or for meeting emerging regulatory requirements such as those
related to health technology assessment.
Thirdly, manufacturers of generic and biosimilar medicines based in non
EU countries where SPC protection does not exist (e.g. in Brazil, Russia,
India and China) enter markets in which patent protection expired up to
five years earlier than EU-based manufacturers. This is possible because
EU-based manufacturers are not allowed to produce in EU Member States
during the period of the SPC protection of thè reference medicine. Such a
situation could lead to a lack of playing field between EU and non .EU
manufacturers with an advantage for non EU manufacturers.

87

The Single Market Strategy, adopted in October 2015 (COM(201 5)550),
announced that the Commission will “consult, consider and propose further
measures, as appropriate, to improve the patent system in Europe, notably
for pharmaceutical and other industries whose products are subject to
regulated market authorisations”. In parficular, the Strategy undertook to
expkre a recalibration of certain aspects of patent and SPC protection,
and announced that this recalibration could mainly comprise the following
three eiements: the creation of a European SPC title; an update of the
scope of the EU patent research exemptions; and the introduction of an
SPC manufacturing-waiver (the so-called ‘SPC manufacturing waiver’ for
export purposes would allow EU based manufacturers of generics
/biosimilars manufacturing their products during the EU SPC term of the
reference medicine to export their products to countries with no SPC
protection). The European Commission published an “inception irnpact
assessment” on 15 February 2017.
The current public consultation seeks to gather feedback of all
stakeholders on the way the SPC system currently functions in the EU and
its effects on trade and competitîveness in particular.
The Commission will report on the resuits of its consultation which,
together with ongoing evaluation studies, will help the Commission assess
whether the EU SPCframework is stili fit for purpose or needsto be
recalibrated, notably as regards the aspects set out in Single Market
Strategy.

Disclaimer

88

____
_____

Hease note that this document has been prepared b me Uommiss
ion
services for information and consultation purposes only. It has
not been
adopted or in any way approved by the Commission and should not
be
regardçd as representative of its views. It does not in any way preju
dge, or
constitute the announcement of, any position on the part of the
Commission on the issues covered. The Commission does not
guarantee
the accuracy of the information provided, nor does It accept respo
nsibility
for any use made thereof.

The foliowing questions relate to the profile of your company/organisati

on:

*

1. You are a ministry or public agency dealing with...
0 Science and innovation policies
lndustrial policy
0 Competition policy
0 Trade policy
0’ Other: please specify
Please specify

L_.___.___

89

The next few questions are about how effective supp
lementary protection certificates (SPCs) and Bolar
exemptions are in the EU.
We want to find out how much progress has been mad
e in meeting the following objectives (from SPC
legislation adopted in the 1990s):

•

attracting research

•

preventing delocalisation

•

protection for long enough to recover investment

•

promoting essential innovation for patients

•

competition through innovation

•

limiting the negative effects of fragmentation.

The SPC is an incentive for innovation investment in phar
maceutical and plant protection products. The
SPC legislation was introduced in the EU in the 1990s.
In mast of the following questions, wed like to find out
your views on how innovation and market
competition are progressing for these products since SPC
legislation was introduced in the EU.

90

2. In the last two decades in the EU, how do you perceive the progress made in

Down
a lot

Down
a bit

Stable

Up
a
bit

Up
a
lot

No
opinion

.investments in pharmaceutical innovation
in general
• investments in pharmaceutical
manufacturing
• .investments in innovation in plant
protection products
...investments in the manufacturing of plant
protection products

t)

.competition in the pharmaceutical sector
based on innovation
• .

.competition in the pharmaceutical sector
based on generic market entry
•

.

• .competition in plant protection products
based on innovation

1

dependency of supply of active
pharmaceutical ingredients (APIs)
manufactured outside the EU

The SPC is not the only factor that influences decision 0fl investment on innova
tion, location of innovation
activities and manufacturing. The European Commission would like to get feedba
ck from stakeholders on
the relative importance of the SPC in comparison with other factors in influencing
the geographical
location of their innovation and manufacturing- related decision.

3. Select the 4 most relevant drivers among the ones listed ifi the first column for
each of the investment
types indicated.
between 1 and4 answeredrows

lnvestment in
research (mcl.
clinical/field
trials) for
pharmaceutical
products

lnvestment in
research (md.
clinical/field
trials) for plant
protection
products

lnvestment in
manufacturing
for
pharmaceutical
products

Investment
in
manufacturing
for plant
protection
products

91

AvailabUity of SPC
type protection in the
country where the
investment is made

i

Availability of
regulatory exclusivities
(marketldata
exclusivities) in the
country where
investment is made

1

Health infrastructure
Proximity of research
universities
An effective regulatory
agency

c

‘1

Less strict regulatory
control

0

0

Proximitytoyour
manufacturing plants

C)

Availability of public
!private funding

!‘

0

0

C)

Labourcosts
Access to high skilled
labour

j

Easier to recruit
patients or access to
treatment groups
Large market (in terms
of potential sales in the
country where the
investment is made)
Taxation
Proximity to the place
where the product
research was carried out

Ci

1

6

6)
6)

6)

6)

Proximity to the place
where the clinical trials
(or fiefd trials) for the
product were carried Out

92

i

Possibility of getting
‘good manufacturing
practices’ (GMP) from
the FDA and/or EMA for
the factories based in
that country

Next, we’d like to ask you some questions about the costs and benefits of

SPCs.

SPC protection could have had unintended adverse effects in other sectors.
EU-based generics and biosimilar manufacturers argue that EU SPC protect
disadvantage compared with foreign-based manufacturers.
They want to see the introduction of an SPC manufacturing waiver’ (see
for more details).
In the next few questions, we’d like to find out about the challenges faced
pharmaceuticals industry.

ion puts them at a

introduction to this questionnaire

by this sector of the

4. Based on your experience, do you agree with the claims below on how
the SPC system s performing
in the EU?

Agree

Disagree

No
opinion

In its current form, the SPC in the EU unintendedly discriminates
against EU-based generics & biosimilars manufacturing compared
with manufacturers located in non-EU countries with no SPC type
protection (e.g. for exports outside the EU)
In its current form, the SPC in the EU increases reliance on imports
of medicines and active pharrnaceutical ingredients from outside the
EU

SPC legislation aims to ensure adequate protection for innovation and improv

ing public hea)th.

We want to evaluate whether the objectives of the SPC regulation match curren
t needs and problems (e.g.
only some types of innovations are eligible for SPC protection; new regulat
ory requirements did not exist
when the SPC regulation carne into force and some activities linked to new
regulatory requirements are
not covered by the Bolar exemption).
5. In your experience, is SPC protection sufficient to encourage investm
ent in certain types of innovations
(e.g. antibiotics, medicines for the treatment of neglected diseases and orphan
diseases)?
C Yes
No
Don’t know/no opinion

93

Please explain your answer (max. 1 500 characters, mci. spaces.)
/500 cha/acter(s max/,rnum
In our opinion, SPC protection does not encourage investment in certain types of innova
tions, especially antibioti
and neglected diseases. 1f a low return-on-investment is already anticipated
because of e.g. very low or
unpredictable sales of certain antibiotics, extra SPC protection will not change the returnon-investment from
negative to very positive.

6. In your experience, do some jurisdictions (e.g. the US or Japan) provide SPC
type protection for some
types of innovation that you develop that are not eligibie for an SPC in the EU?
IYes
No

C Don’t know/no opinion
Please give examples if possibie (max. 2 000 characters, mci. spaces.)
2000 c/iaracter(s) max/mum
In the US the Drug PriceCompetition and Patent Restoration Act also known as the
Hatch-Waxman Act permits
patent term extensions not only to human drug products but also medical device
s, food additives, and colour
additives.,,
,,,_

.,,

_

We’re interested in how the SPC and Bolar EU exemptions work in relation

to national legislation.

7. Please give examples of any inconsistencies between national legislation
and EU legislation 0fl SPCs
and Bolar exemptions, It you know of any.
Do you have any suggestions on how to overcome these inconsistencies? Please
, explain your answer
(max. 2 000 characters mcl. spaces).
2000 character4,) maximum
N/A

8. Have the EU SPC and Bolar exemptions brought added value compared with
nation

al initiatives?

(_)

Yes

() No
‘iDon’t know
Please explain our answer (max. 2 000 characters, mci. spaces.)
2000 character4) maximum
N/A, similar provisions did not exist.

_•*_____•__•

__•

-

The following questions focus on the matters addressed by the European Comm
ission’s inception
impact assessment’ published on 15 February 2017: the SPC manufacturin waiver
g
’ (see explanation in
the introduction to this questionnaire), the unitary SPC, and specific issues related
to the Bolar and
research patent exemJtions.
In the following questions, we’d like to find out your views on some options for improv
ing the SPC and
Bolar systems in the EU.

94

9.

9p you favour the creation of a unitary SPC title for the unitary patent?

NVYes

No, there’s no need
() No opinion
10. Which granting authority would you favo

ur to grant and register a unitary SPC?

0’ EU Intellectual Property 0ff ice
0 European Medicines Agency
(,European Patent 0ff ice

• EU countries’ patent offices (e.g. virtual offic
e approach or mutual recognition with reference
offices, under EU rules)

0 A new EU agency
None of the above, please indicate your alter

native preference

Please indicate your alternative preference

11. Which language combination would you
English, French,
German, ltalian and
Spanish (as for the
EU lntellectual
Property 0ff ce

registering
unitary
sPc
applications

prefer for...

English,
French and
German (as
for the
European
Patent 0ff ce)

.

All EU official
languages (as
for centralised
marketing
authorisations)

English
only

Noneof
these
(please
indicate
your
alternative
prelerence

•

publishing
unitary
SPCs

Please ndicate your alternative preference

In the following questions, we’d like to find out
Bolar systems in the EU.

your views on some options for improving the

SPC and

95

12. What would be the benefits of a unitary SPC?
1
Strongly
disagree

2
Disagree

3 Neither
agree nar
disagree

5
Strongly

4
Agree

agree

Don’
t
know

Boost value of
investments
-

Reduce red tape
relating to litigation
Reduce red tape
relating to registration
Same protection
across the EU
Legal certainty
Reduce maintenance
costs
Specialised court
Make ilcensing easier

13. What impact would the introduction of an SPC manufacturing waiver* have in the EU?
*

See explanation in the introduction to this questionnaire.

1
Strongly
disagree
•
It would reduce protection to
recoup our investments in R&D
in the EU
In the short term, t would
reduce our sales in countries
outside the EU when protection
abroad expires
In the long term, it would
reduce our sales in countries
outside the EU when protection
abroad expires

2
Disagree

Neither
agree
nor
disagree

4
Agree

‘

5
Strongly
agree

Don’
t
know