Europaudvalget 2017-18
EUU Alm.del Bilag 257
Offentligt
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Public consultation on Supplementary Protection Certificates
(SPC) and patent research exemptions for sectors whose
products are subject to regulated market authorisations.
Fields marked with * are mandatory.
PRELIMINARY FILTER
Given the technical, complex nature of the patent and supplementary
protection certificate (SPC) framework, we recommend that respondents
enlist the help of in-house or external experts.
*
Which one of the following categories best describes you?
I. You are a citizen and do not fall into any of the categories below
II. You represent a research-based organisation/company ("innovator" or "originator"). For
example: - Large pharmaceutical company focused mainly on original pharmaceutical or plant
protection products - Start up or SME focused on innovative products; - An innovator in products
not eligible for SPC protection (e.g. medical devices) - An association of the above type of
companies - Research organisation other than a university - University or technology transfer office
- Contracting research organisation conducting clinical trials.
III. You represent a generics and/or biosimilars organisation/company. For example: - Large
pharmaceutical company focused mainly on generic and/or biosimilar pharmaceutical or plant
protection products - Start-up or SME focused on generics/biosimilars - Contracting research
organisation conducting bioequivalence studies - An association of companies - Producers of
active pharmaceutical ingredients (APIs) for third parties (whether the third party is an originator or
generics/biosimilars company).
IV. You are a large/specialised consumer of medicines or pesticides (individual consumer or a
purchaser of large lots), a health professional, or you help set the regulated prices of medicines,
negotiate reimbursement quotas of medicines, or distribute medicines or pesticides, etc. For
example: - Patients' association, or individual patients with specialised knowledge of industrial
property relating to pharmaceutical products - Farmers' association, or individual farmers with
specialised knowledge of industrial property relating to plant protection products - Hospital or
hospital association - Health Ministry - Doctor or doctors' association - Wholesaler or distributor of
medicines or pesticides - Pharmacist or pharmacists associations - Health Technology
Assessment Agency - Agency involved in setting the price of medicines - Health provider or health
insurer - Agency involved in medicine tenders.
V. You represent a patent office, judge or IP attorney or agent
VI. You are a public authority not falling under categories IV or V. For example: a ministry or
agency dealing with e.g. science, industry, trade or competition policies at international, national or
local level.
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*
Please indicate how you prefer your response to be published on the
Commission’s
website
Regardless of the option you choose, your contribution may be subject to a request for access to documents under Regulation 1049
/2001 on public access to European Parliament, Council and Commission documents. In this case, the request will be assessed
against the conditions set out in the Regulation and in accordance with applicable data protection rules.
With your name: I consent to the publication of all information in my contribution and I declare that
none of it is subject to copyright restrictions that prevent publication
Anonymously: I consent to the publication of all information in my contribution and I declare
that none of it is subject to copyright restrictions that prevent publication
*
Is your organisation registered in the Transparency Register of the European Commission and the
European Parliament?
If you are not answering this questionnaire as an individual, please sign up to the
TransparencyRegister.
If your organisation/institution answers the questionnaire and is not registered, the Commission will process your contribution under a
separate category
‘non-registered
organisations/businesses’.
Yes
No
Not applicable
Please indicate your organisation's identification number in the Transparency Register.
20 character(s) maximum
I. GENERAL QUESTIONS, ESPECIALLY ADDRESSED TO THE
GENERAL PUBLIC
Intellectual property (IP), such as patents or trademarks, plays a key role in
encouraging investment in innovation. A 2013 study (IP 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.
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 EUU, Alm.del - 2017-18 - Bilag 257: Høringssvar om supplerende beskyttelsescertifikater (SPC) og patentfritagelser på forskningsområdet
Industry sectors whose products are subject to regulated market
authorisations, such as the pharmaceutical, medical devices and
agrochemical industries, rely heavily on industrial property protection
through patents, Supplementary Patent Certificates (SPCs) 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 of effective 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
(EC) No 469/2009 and Regulation (EC) No 1610/96 on SPC 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-market regulatory approval even when the SPC of
the reference medicine is still 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 some EU MS, inter alia, to meet new
pharmaceutical-related requirements.
The specific industrial property legal framework in the EU for 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 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 SPC applications while the very same
application has been either refused or granted with a different scope in
other Member States.
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 EUU, Alm.del - 2017-18 - Bilag 257: Høringssvar om supplerende beskyttelsescertifikater (SPC) og patentfritagelser på forskningsområdet
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 the 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.
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The Single Market Strategy, adopted in October 2015 (COM(2015)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 particular, the Strategy undertook to
explore a recalibration of certain aspects of patent and SPC protection,
and announced that this recalibration could mainly comprise 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
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 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 results of its consultation which,
together with ongoing evaluation studies, will help the Commission assess
whether the EU SPC framework is still fit for purpose or needs to be
recalibrated, notably as regards the aspects set out in Single Market
Strategy.
Disclaimer
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Please note that this document has been prepared by the Commission
services for information and consultation purposes only. 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 way prejudge, 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 responsibility
for any use made thereof.
1.
Did you know what a “supplementary protection certificate” (SPC) for pharmaceutical and/or plant
protection products was before you read the introductory part of this survey?
Yes
No
*
2. Are you aware of the existence of EU legislation on SPCs for pharmaceutical products such as
medicines?
Yes
No
2.1. Do you agree that SPC legislation has encouraged investments for innovation in pharmaceuticals?
Yes
No
2.2. Do you feel that SPC legislation might not be efficient in encouraging the development of some types
of pharmaceutical/health products for certain types of health-related treatments or conditions?
Yes
No
Don't know/no opinion
Please specify in which treatments or health conditions (maximum 100 characters with spaces)
100 character(s) maximum
2.3. Should SPC legislation be extended to apply to additional types of pharmaceutical/health products
not currently covered?
Yes
No
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Don't know/no opinion
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Please specify which types of products (maximum 100 characters with spaces)
100 character(s) maximum
2.4. Do you think that SCP legislation has contributed, among other things, to the growth of the
pharmaceutical industry in the EU?
Yes
No
*
3. Are you aware of the existence of EU legislation on SPCs for plant protection products such as
pesticides?
Yes
No
3.1. Do you agree that SPC legislation has encouraged investments for innovation in plant protection
products such as pesticides?
Yes
No
3.2. Do you feel that SPC legislation might not be efficient in encouraging the development of some types
of plant protection products for certain types of uses required by crop treatment?
Yes
No
Don't know/no opinion
Please specify which crop treatments (maximum 100 characters with spaces)
100 character(s) maximum
3.3. Do you think that SPC legislation has contributed, among other things, to the growth of the plant
protection products industry in the EU?
Yes
No
Sometimes the medicines we buy (or their
‘active
pharmaceutical
ingredient(s)’,
i.e. the main component
(s) of the medicine) are manufactured on another continent. Factories that manufacture pharmaceutical
products outside the EU need to comply with the
EU’s strict criteria/rules to
be able to sell their products
in the EU. Many pharmaceutical companies are global players with a safe and global supply system that
produce and distribute medicines all around the world.
It’s been argued that SPC
protection in the EU
might encourage certain pharmaceutical companies (producers of generic medicines) to produce their
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medicines outside the EU and sell them in the EU.
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4. Do you usually know where the medicines that you buy are made?
Yes, and I do care where they're produced
Yes, but I don't care where they're produced
No, but I do care where they're produced even if I'm not aware most of the
time
No, and I don't care where they're produced
Please explain your answer, e.g. if you are worried about safety/quality issues (max. of 1.000 characters
including spaces)
1000 character(s) maximum
II. INNOVATORS
Intellectual property (IP), such as patents or trademarks, plays a key role in
encouraging investment in innovation. A 2013 study (IP 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 on industrial property protection
through patents, Supplementary Patent Certificates (SPCs) and data
/market exclusivity.
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 EUU, Alm.del - 2017-18 - Bilag 257: Høringssvar om supplerende beskyttelsescertifikater (SPC) og patentfritagelser på forskningsområdet
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 of effective 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
(EC) No 469/2009 and Regulation (EC) No 1610/96 on SPC 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-market regulatory approval even when the SPC of
the reference medicine is still 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 some EU MS, inter alia, to meet new
pharmaceutical-related requirements.
The specific industrial property legal framework in the EU for 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 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 SPC applications while the very same
application has been either refused or granted with a different scope in
other Member States.
11
 EUU, Alm.del - 2017-18 - Bilag 257: Høringssvar om supplerende beskyttelsescertifikater (SPC) og patentfritagelser på forskningsområdet
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 the 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.
12
 EUU, Alm.del - 2017-18 - Bilag 257: Høringssvar om supplerende beskyttelsescertifikater (SPC) og patentfritagelser på forskningsområdet
The Single Market Strategy, adopted in October 2015 (COM(2015)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 particular, the Strategy undertook to
explore a recalibration of certain aspects of patent and SPC protection,
and announced that this recalibration could mainly comprise 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
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 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 results of its consultation which,
together with ongoing evaluation studies, will help the Commission assess
whether the EU SPC framework is still fit for purpose or needs to be
recalibrated, notably as regards the aspects set out in Single Market
Strategy.
Disclaimer
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1839562_0014.png
Please note that this document has been prepared by the Commission
services for information and consultation purposes only. 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 way prejudge, 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 responsibility
for any use made thereof.
The following questions relates to the profile of the respondent:
*
1. Mark the type of company/organisation that you represent:
Company
(250+ employees
annual turnover =
€50
million+
annual balance sheet =
€43
million+)
Start-up
Association - European
Research organisation (other
than university)
Other (please specify)
Free Text Question
50 character(s) maximum
Small/medium company (except start-
up) (fewer than 250 employees
annual turnover
– €50
million or less
annual balance sheet =
€43
million or less)
Association - National
University or university technology transfer office
Contracting research organisation (other than
a university), e.g. that conducts clinical trials
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*
1.1. If you represent a company, is it a:
Parent company
Subsidiary
Independent company
*
1.2. Is the parent company (i.e. global headquarters) registered in the EU?
Yes
No
1.2.1. If “yes”, in which EU country?
20 character(s) maximum
1.3. Where is your company/organisation based?
United States
Switzerland
India
Canada
China
Please specify
50 character(s) maximum
EU
Japan
Korea
Singapore
Other
1.4. Your company (or a branch) is:
research-based only ("originator")
Mostly originator - but we also own a separate branch or business activity that develops or markets
generics and/or biosimilars.
 EUU, Alm.del - 2017-18 - Bilag 257: Høringssvar om supplerende beskyttelsescertifikater (SPC) og patentfritagelser på forskningsområdet
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1.5. If you represent a company, please tell us about these products:
Does your business work on these product types?
*
Human medicinal
*
Veterinary medicinal
*
Plant protection
*
Medical devices
*
All your products
Which product(s) best represent(s) of your
business?
% of your total turnover worldwide
(approximately)
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2. What is the geographical scope of your commercial activity?
Mostly worldwide
One EU country only
Please specify
50 character(s) maximum
EU-wide
Other: please specify
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3. Tell us more about your business activities in these geographical areas:
% of your total employees
EU
Switzerland
Korea
Japan
United States
China
Singapore
Canada
India
% of your turnover
% of your manufacturing output
(whether outsourced or not)
% of your investment in clinical
trials, or field trials for crop
products
% of your inve
(excluding
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The next few questions are about how effective supplementary 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 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.
One indicator of trends in innovation in pharmaceutical/plant protection products is the number of
marketing authorisations granted.
This information is publicly
available. But we’d like
to find out more about marketing authorisations from
you.
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4. How many marketing authorisations were granted to you in the periods below?
Please include (if possible) any authorisations granted to companies that have since changed structure
due to mergers, acquisitions or other modifications.
Number of marketing authorisations
1980 and 1990 (Introduction of SPC-type protection in
the US)
1991 and 2000 (Introduction of SPC protection in the
EU)
2001 and 2010
After 2010
Don't know/not applicable
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5. What percentage of your sales take place during the SPC protection period compared with the whole
protection period (patent and SPC)?
Please select the 2 most representative ranges.
Typically over 75% of the
product sales occur during the
SPC term
51%
to
75%
26%
to
50%
0%
to
25%
Too much
variation in our
SPC portfolio to say
Don't
kno
w
Sales
value
-
6. For innovative products or potential innovative products, does the possibility of getting EU SPC
protection play a role when your company/organisation is deciding on the following investments?
between 5 and 5 answered rows
YES, but only if
the investment will
take place in the
EU
NO
Don't
know
Other:
please
specify
YES,
YES,
always
to
some
extent
R&D (excluding clinical
/field trials)
Clinical trials (medicinal
products), or field trials (for
plant protection products)
Manufacturing
Distribution
Marketing in EU Countries
If other, please specify:
Please give examples of the SPC protection importance to recoup your investment, if possible (max.
1 500 characters, incl. spaces):
1500 character(s) maximum
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7. Has a prospective product's eligibility for SPC protection ever been a decisive factor in its development
(i.e., without an SPC you would have discarded it despite having already invested in part of its
development)?
Yes
No
Don't know
If
you answered ‘yes’ to
Question 7, please give examples of such products and the SPC importance, if
possible, in the box below.
1500 character(s) maximum
If
you answered ‘yes’ to
Question 7, was the prospective product being developed (or did most of its
development take place) in the EU?
Yes
No
Don't know
Please give examples of such products and SPC importance, if possible, in the box below.
1500 character(s) maximum
8. Have the SPC regulations influenced the prioritisation of certain types of innovation in your
organisation? (e.g. oncology or highly sought-after treatments)
Yes
No
Don't know
If
you answered ‘yes’
to Question 8, please give examples, if possible, in the box below.
1500 character(s) maximum
The SPC is not the only factor that influences decision-making on investment in innovation, the location
of innovation activities and manufacturing.
We’d
like to find out how much you think the SPC affects your
company’s/organisation’s
decisions on
where to locate innovation and manufacturing activities.
9. Select the 4 most relevant drivers that affect your decisions on the geographical location/allocation of
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investments in innovation and manufacturing.
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between 1 and 4 answered rows
Investment in
research
(excluding
clinical trials
/field trials)
Availability of SPC-type protection
Availability of regulatory data
protection
Availability of orphan incentives (e.
g., market exclusivity)
Good health infrastructure (e.g.
modern hospitals)
Proximity of research universities
An effective regulatory agency
Less strict regulatory legislation
Proximity to your manufacturing
plants
Availability of public/private
funding for our activities
Labour cost
Access to high-skilled labour
Easier to recruit patients or
access to treatment groups
Large market (in terms of potential
sales in the country where we
decide to invest)
Taxation
Proximity to the place where the
product research was carried out
Proximity to the place where the
clinical trials (or filed trials) for the
product were carried out
Possibility of getting “good
manufacturing practices” (GMP)
from the FDA and/or EMA for the
factories based in that country
Investments in clinical
trials (for medicines) or
field trials (for plant
protection products)
Investments
in
manufacturing
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We outsource most of our
manufacturing
Other, please specify
Please substantiate your answers (max. 2 500 characters, incl. spaces).
2500 character(s) maximum
SPC protection is designed to encourage innovation.
But since its introduction in the 1990s, major investments in innovation have taken place in countries with:
no SPC protection
no data or market exclusivity (e.g. some Asian countries).
In
Question 10, we’d like
to find out what other factors have encouraged you to invest in countries with no
SPC protection
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10. When you invest on innovation or manufacturing in countries that do not grant SPC protection, what
are the 4 main drivers that influence your decision?
between 1 and 4 answered rows
In relation to
investments in
research
(excluding clinical
trials/field trials)
Good health infrastructure (e.g.
modern hospitals)
Proximity of research universities
An effective regulatory agency
Less strict regulatory legislation
Proximity to your manufacturing
plants
Availability of public/private
funding
Labour cost
Access to high-skilled labour
Easier to recruit patients/easier
access to treatment groups
Large market (in terms of
potential sales in the country where
we decide to invest)
Taxation
Proximity to the place where the
product research was carried out
Proximity to the place where the
clinical trials (or filed trials) for the
product were carried out
Possibility of getting “good
manufacturing
practices” (GMP)
from the FDA and/or EMA for the
factories located in those countries
We outsource most of our
manufacturing
Other, please specify
Investments in
clinical (for
medicines)/field
trials (for plant
protection products)
Investments
in
manufacturing
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Please explain why those drivers are more important that SPC (max. 2 500 characters, incl. spaces)
2500 character(s) maximum
SPCs are regulated under EU law (Regulation (EC) No 469/2009 and Regulation (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
conclusions on 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 harmonised SPC protection is
across the EU.
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11. Have authorities in different EU countries ever taken different decisions on SPC applications for one
(or more) of your products?
Examples: some EU countries granted SPC national applications for one of your products but refused
others; you were granted different durations of SPC protection for one of your products in different EU
countries; national grant authorities interpreted EU Court of Justice rulings differently).
Yes
No
Don't know
If you answered
‘yes’ to Question
11, please explain in the box below.
1500 character(s) maximum
12. Have courts in different EU countries ever taken different decisions on the SPC of one of your
products (e.g. the validity of your SPC was upheld by courts in some EU countries but revoked by others;
some EU country courts concluded that your SPC had been infringed while others did not)?
Yes
No
Don't know
If you answered
‘yes’ to Question
12, please explain in the box below.
1500 character(s) maximum
The efficiency of the current EU SPC system could be improved, for example by using a unitary (single)
SPC.
In the next few questions,
we’d like to
find out how much complexity 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).
13. How would you rate the degree of complexity of registration procedures for SPCs in the EU?
High
Reasonable
Low
Don't know/No opinion
How could procedures be improved? (max. 1 500 characters, incl. spaces)
1500 character(s) maximum
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14. How would you rate the degree of complexity of court litigation of SPCs in the EU?
High
Reasonable
Low
Don't know/No opinion
How could court litigation be improved?
1500 character(s) maximum
Next,
we’d like to
ask you some questions about the costs and benefits of SPCs.
15. Is the cost of registering and maintaining an SPC in all 28 EU countries proportionate?
YES, the cost is always relatively low compared with product sales
The cost of SPC protection barely exceeds the value of sales in some small markets. But we
always register the SPC in all EU countries where the corresponding patents are in force.
The cost of SPC protection barely exceeds the value of sales in some small markets. So we do not
register the SPC in all EU countries where the corresponding patents are in force.
NO, the administrative burden to register and maintain it in all EU countries is
high
Other: please specify
If “Other”, please specify.
1500 character(s) maximum
16.
Have you ever abandoned (or avoided) applying for SPC registration in an EU country owing to…
Don't know/no
Yes
…. the cost of registration/maintenance?
…. burdensome administrative
procedures?
No
opinion
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17. Please give if possible a breakdown of all costs in euros of registering/maintaining your SPCs (e.g.
patent
agents’
fees for each country, in-house staff costs, administrative fees).
Euro
administrative fees
Patent agent fees
In house staff
Others
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Sometimes SPC holders only file SPC protection in a few EU countries.
This may be because the basic patent is not in force in all EU countries.
But
we’d like you to
tell us about any other reasons you may have for not registering your SPC in all EU
countries
–
e.g. the cost of SPC protection, or varying levels of coverage in each country.
18. Does the geographical scope of your requested SPC generally match the geographical scope of the
territory in which you market the pharmaceutical products?
Yes
No, it is sometimes larger (i.e, we sometimes obtain SPC protection in countries where we do not
market the protected product)
No, it's usually
narrower
Don't know
19. In your experience, when enforcing an SPC in only one EU country, is the cost of enforcing SPCs
proportionate?
Yes, the potential cost is always covered by potential
sales
No, it's very high so sometimes we do not enforce it
Don't know/no opinion
If
you answered ‘no’ to Question
19, please give examples of the total cost of enforcement in the box
below (in a max. of 2.000 characters).
2000 character(s) maximum
20. When enforcing an SPC in multiple EU countries, is the cost of enforcing SPCs proportionate?
Yes - potential cost is always covered by potential sales
No - it's very high. Sometimes we do not enforce in all EU countries.
Don't know/no opinion
If
you answered ‘no’ to Question
20, please give examples of the total cost of enforcement in multiple
jurisdictions in the box below (in a max. of 3.000 characters).
3000 character(s) maximum
21. Is the length of proceedings relating to enforcing SPCs satisfactory?
Yes
No, it depends on the EU country
Don't know/No opinion
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EU-based generics and biosimilar manufacturers argue that EU SPC protection puts them at a
disadvantage compared with foreign-based manufacturers.
They want to see the introduction of
an ‘SPC manufacturing waiver’ (see
introduction to this questionnaire
for more details).
The next few questions are about this manufacturing waiver.
22. Does the EU SPC framework put EU based generics/biosimilars manufacturing at a disadvantage
compared with foreign-based manufacturers when exporting generics and biosimilars outside the EU?
Yes
No
Don't know/no opinion
Please explain your answer (max. 2 000 characters, incl. spaces).
2000 character(s) maximum
23. Does the EU SPC framework put EU based generics/biosimilar manufacturing at a disadvantage
compared with foreign-based manufacturers when it comes to placing generics and biosimilars on the
EU market when SPC protection in the EU expires?
Yes
No
Don’t
know/no opinion
Please explain your answer (max. 2 000 characters, incl. spaces).
2000 character(s) maximum
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24. If
you answered ‘yes’ to
Questions 22 or 23, does the issue matter more for biosimilars than for
generics?
Yes
No
Don’t
know/no opinion
If
you answered ‘yes’
to Question 24, please explain why (max. 2 000 characters, incl. spaces).
2000 character(s) maximum
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).
25. Is SPC protection available for all your innovation types? (e.g. certain categories of medical devices,
veterinary medicines, or plant-related products)
Yes
No
Don’t
know/no opinion
If
you answered ‘no’ to
Question 25, please give examples (max. 1 500 characters, incl. spaces).
1500 character(s) maximum
26. In your experience, do other jurisdictions (e.g., the US or Japan) provide for SPC-type protection to
certain types of innovations you develop that are not eligible for an SPC in the EU?
Yes
No
Don’t
know/no opinion
If
you answered ‘yes’
to Question 26, please give examples (max. 1 500 characters, incl. spaces).
1500 character(s) maximum
27. Please give examples of SPC-protected products of yours that have significantly improved public
health and where the SPC played a key role in their development.
2000 character(s) maximum
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28. Are there some types of products that you do not invest in despite the possibility of getting a SPC, or
that you invest in but for which an SPC is not relevant (e.g. antibiotics, medicines for the treatment of
orphan or neglected diseases)?
Yes
No
Don’t
know/no opinion
If
you answered ‘yes’
to Question 28, please give examples (max. 2 000 characters, incl. spaces).
2000 character(s) maximum
We’re
interested in how the SPC and EU Bolar exemptions work in relation to national legislation.
29. Please give examples of any inconsistencies between national legislation and EU legislation
on SPCs and Bolar exemptions, if you know of any.
Do you have suggestions on how to overcome these inconsistencies?
2000 character(s) maximum
30. Have the EU SPCs and Bolar exemptions brought added value compared with national
initiatives?
No
Don't know
Please explain your answers (max. 2 000 characters, incl. spaces)
2000 character(s) maximum
Yes
The following questions focus on
the matters addressed by the European Commission ‘inception impact
assessment’
(http://ec.europa.eu/smart-regulation/roadmaps/docs
/2017_grow_051_supplementary_protection_certificates_en.pdf)
published on 15 February 2017: the
‘SPC
manufacturing waiver’ (see explanation in the introduction to this questionnaire), the unitary SPC,
and specific issues relating to Bolar and research patent exemptions.
Some originators produce, or plan to produce,
biosimilars. We’d like to
get feedback from you on where
your biosimilars are manufactured.
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31.
On biosimilar products…
Please, reply
“Yes”
or
“
We have no plans to develop biosimilars
We plan to start developing biosimilars
We are developing biosimilar(s) but have not started marketing
them
We market biosimilars
Don't know
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32. When you develop a biosimilar, do you always conduct the R&D and manufacturing in the same
location?
Yes
–
it's essential
No
–
we often choose a different country for the manufacturing, then years later we move the
manufacturing
No
–
we often choose different country for the manufacturing, but we never consider moving the
manufacturing later because it would highly complex, risky and costly
Don't know/no opinion
There is no specific provision dedicated to SPCs in the package of legislative instruments related to the
unitary
patent. We’d like
to get feedback from you on whether national authorities, when applying the SPC
Regulations, could grant SPCs on the basis of unitary patents.
33. Would it be possible to grant national SPCs for a product covered by the future European patent with
unitary 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
Don't know
In some EU countries, pharmaceutical originators, when conducting certain tests to meet new regulatory
requirements to demonstrate efficiency for price purposes (health technology assessment / HTA), may
infringe
competitors’
patents/SPCs.
Some EU countries have adapted their patent laws to exempt those testing requirements from patent/SPC
infringement. However, some EU countries have not taken specific measures and the future Unified
Patent Court may not exempt those testing requirements.
34. In all EU countries, do you have certainty on whether your activities relating to HTA are exempt from
patent/SPC infringement?
Yes
No, we only have certainty in some EU countries, such as the UK and Ireland, which adopted
specific national patent rules on this
Don't know/no opinion
Please provide a brief explanation if you wish (max. of 2 000 characters, incl. spaces).
2000 character(s) maximum
35. Have you ever moved to another country clinical trials or testing relating to HTA because of
uncertainty about the scope of the Bolar/research patent exemption in the country requiring the
HTA?
Yes
No
Don't know
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If
you answered ‘yes’
to Question 35, please give examples (max. 2 000 characters, incl. spaces).
2000 character(s) maximum
36. Is there a risk that the future Unified Patent Court could develop a practice regarding the Bolar patent
exemption that conflicts with the one consolidated in Irish, UK and German law/practice?
Yes - and that is undesirable
Yes - but it would not be an issue for
us
No
Don't know/no opinion
In
the following questions, we’d
like to find out your views on some options for improving the SPC and
Bolar systems in the EU.
37. What would be your preferred option to improve consistent interpretation throughout the EU of the
‘substantive’
provisions of the SPC regulation (e.g. the scope of protection, eligibility of SPC protection)?
Amend the SPC Regulations to provide extra
clarity
Create a unitary SPC for the unitary patent
Guidelines developed jointly by the European Commission and EU countries
Don't change the current SPC system - rely on referrals to the Court of Justice of the
EU
None of the above, please explain
Do not know/no opinion
Please explain
38. Which granting authority would you favour to grant and register a unitary SPC?
EU Intellectual Property Office
European Patent Office
A new EU agency
European Medicines Agency
EU countries' patent offices (e.g. virtual office approach or mutual recognition with reference
offices, under EU rules)
None of the above, please indicate your alternative preference
Please explain your choice (max. 2 000 characters, incl. spaces).
2000 character(s) maximum
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39.
Which language combination would you prefer for…
English, French,
German, Italian
and Spanish (as
for the EU
Intellectual
Property Office)
English,
French, and
German (as
for the
European
Patent Office)
All EU official
languages (as
for the
centralised
marketing
authorisations)
English
only
None of
these
(please
state your
alternative
preference
)
…registering
unitary SPC
applications?
…publishing
unitary
SPCs?
Please state your alternative preference
40. Should the unitary SPC be available only for products authorised by way of a centralised marketing
authorisation (e.g. assessed by the European Medicines Agency)?
Yes, it would be the only way to maintain unitary protection
No, some products are not eligible for centralised authorisation and therefore would not be eligible
for protection under the unitary SPC
Don't know/no opinion
Any other comments? (max. 3 000 characters, incl. spaces).
3000 character(s) maximum
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41. Some experts believe that no legislation is needed for the future unitary patent system to work with
the current SPC framework (i.e. the unitary patent would be extended in each participating EU country by
applying for the national SPC).
Would you use the unitary patent system if…
Don't
know
Yes
No
/no
opinion
… there is EU legislation on a “unitary-SPC”
… there is EU legislation,
or a judgement from the Court of Justice of the
EU, stating that the current SPC framework is compatible with the “unitary
patent”
…. if the Commission issues a communication stating that the current SPC
framework is compatible with the “unitary patent”
42. Would it be useful for a more consistent/integrated EU approach on the patent Bolar and research
exemptions if a group of Commission and EU country experts is set up to monitor developments relating to
these exemptions?
Yes
No - legislative action would still be
needed
needed
No - and no legislative action is
Don't know/no opinion
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44. What would be the impact of the introduction of an SPC manufacturing waiver* in the EU?
*
See explanation in the introduction to this questionnaire.
3
1
Strongly
disagree
2
Disagree
Neither
agree
nor
disagree
It would increase the risk of
infringement of my SPCs in
the EU
It would reduce protection to
recoup our investments in
R&D in the EU
In the short term, it 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
4
Agree
5
Strongly
agree
Don't
know
/no
opinion
III. GENERICS AND BIOSIMILARS
Intellectual property (IP), such as patents or trademarks, plays a key role in
encouraging investment in innovation. A 2013 study (IP 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.
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Industry sectors whose products are subject to regulated market
authorisations, such as the pharmaceutical, medical devices and
agrochemical industries, rely heavily on industrial property protection
through patents, Supplementary Patent Certificates (SPCs) 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 of effective 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 (EC) No 469/2009 and Regulation (EC) No 1610/96 on SPC
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-market regulatory approval even when the SPC of
the reference medicine is still 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 some EU MS, inter alia, to meet new
pharmaceutical-related requirements.
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The specific industrial property legal framework in the EU for 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 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 SPC 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 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 the 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.
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The Single Market Strategy, adopted in October 2015 (COM(2015)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 particular, the Strategy
undertook to explore a recalibration of certain aspects of patent and SPC
protection,
and announced that this recalibration could mainly comprise 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
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
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.
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The Commission will report on the results of its consultation which,
together with ongoing evaluation studies, will help the Commission assess
whether the EU SPC framework is still fit for purpose or needs to be
recalibrated, notably as regards the aspects set out in Single Market
Strategy.
Disclaimer
Please note that this document has been prepared by the Commission
services for information and consultation purposes only. 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 way prejudge, 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 responsibility
for any use made thereof.
The following questions relate to the profile of your company/organisation:
*
1. Which best describes you?
Company
(250+ employees
annual turnover =
€50
million+
annual balance sheet =
€43
million+)
Start-up
Association - European
Contracting research organisation, e.g.
that conducts clinical trials only for
biosimilars
Free Text Question
50 character(s) maximum
Small/medium company (except start-
up) (fewer than 250 employees
annual turnover
– €50
million or less
annual balance sheet =
€43
million or less)
Association - National
Contracting research organisation, e.g.
that conducts bioequivalence studies
Other (please specify)
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*
1.1. If you represent a company, is it a:
Parent company
Subsidiary
Independent company
*
1.2. Is the parent company (i.e. global headquarters) registered in the EU?
Yes
No
1.2.1. If “yes”, in which EU country?
20 character(s) maximum
*
1.3. Where is your company/organisation branch based?
United States
Switzerland
India
Canada
China
Please specify
50 character(s) maximum
EU
Japan
Korea
Singapore
Other
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1.4. If you represent a company, please tell us about these products:
Does your business work on these product types?
*
Human medicinal
*
Veterinary medicinal
*
Plant protection
*
Medical devices
*
All your products
Whi c
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2. What is the geographical scope of your commercial activity?
Mostly worldwide
One EU country only
Please specify
50 character(s) maximum
EU-wide
Other: please specify
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3. Tell us more about your business activities in these geographical areas:
% of your total employees
EU
Switzerland
Korea
Japan
United States
China
Singapore
Canada
India
% of your turnover
% of you
(wheth
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The next few questions are about how effective supplementary 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 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 Regulation (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
conclusions on 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 harmonised SPC protection is
across the EU.
47
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4. Have authorities in different EU countries ever taken different decisions on SPC applications for one
(or more) of your products?
Examples: some EU countries granted SPC national applications for one of your products but refused
others; you were granted different durations of SPC protection for one of your products in different EU
countries; national grant authorities interpreted EU Court of Justice rulings differently).
Yes
No
Don't know
If you answered
‘yes’ to Question
4, please explain in the box below.
1500 character(s) maximum
5. Have courts in different EU countries ever taken different decisions on the SPC of one of your
products (e.g. the validity of your SPC was upheld by courts in some EU countries but revoked by others;
some EU country courts concluded that your SPC had been infringed while others did not)?
Yes
No
Don't know
If you answered
‘yes’ to Question
5, please explain in the box below.
1500 character(s) maximum
About your use of databases to monitor the status of your
competitors’
SPC protection across EU
Member States…
6. About your use of databases to monitor the status of your
competitors’
SPC protection across EU
Member States…
Don’t
Agree
… to our knowledge, there are no databases available to
conduct such monitoring
… specialised databases are very costly
Other reasons: ………
Disagree
know/no
opinion
In recent decades, there has been major investment in developing and manufacturing generics in
countries outside the EU. The same thing may be happening now for biosimilars.
We’d
like to find out about other factors that encourage you to invest in non-EU countries.
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7. When you decide to invest outside the EU in development products (research, field trials,
bioequivalence studies, etc.), what are the 4 main drivers?
Please mark maximum 4 choices
Scope of SPC type protection for the reference medicine (i.e. there is no SPC type protection in
the country or it has a manufacturing SPC waiver (see explanation in the introduction to this
questionnaire)
Regulatory data and market
exclusivity
exemption
medicine
Health
infrastructure
Labour costs
Tax
Less strict regulatory
control
(large)
facilities
Size of market
Existence of a Bolar patent
Regulatory approval laws
Public funding
Price paid for the
Proximity to manufacturing
Other: please specify
If you
answered ‘Other’
to Question 7, please explain in the box below.
1500 character(s) maximum
The aim of the Bolar patent exemption is to speed up the development and market entry of generics
/biosimilars.
In the next few questions,
we’d like
to find out:
(i) whether generics and biosimilars are making effective use of the Bolar exemption in the EU
(ii) whether sectors like the plant protection products use/rely on Bolar exemptions (there is no specific EU
legislation on Bolar patent exemption for plant protection products).
8. Have you ever obtained marketing authorisations in the EU for generics and/or biosimilars before
the expiry of the SPC protection of the reference product?
Yes
–
because of the Bolar exemption
Yes
–
even though I was not sure whether a Bolar patent/SPC exemption (e.g. in the case of plant
protection products) was in place
No
Don’t
know
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The efficiency of the current EU SPC system could be improved, for example by using a unitary (single)
SPC.
In the next few questions,
we’d like to find
out how much complexity 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).
9. How would you rate the degree of complexity of registration procedures for SPCs in the EU?
High
Reasonable
Low
Don't know/No opinion
How could procedures be improved? (max. 1 500 characters, incl. spaces)
1500 character(s) maximum
SPC protection could have had unintended adverse effects in other sectors.
EU-based generics and biosimilar manufacturers argue that EU SPC protection puts them at a
disadvantage compared with foreign-based manufacturers.
They want to see the introduction of
an ‘SPC manufacturing waiver’ (see
introduction to this questionnaire
for more details).
In the next few questions, we'd like to find out about the challenges faced by this sector of the
pharmaceuticals industry.
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10. Do you agree or disagree with the following statements (if they apply to your business):
No
opinion
Agree
Disagree
/not
applicable
Longer SPC duration in the EU compared with other non-EU
countries makes manufacturing in the EU less interesting for us
When it comes to exporting generics and biosimilars outside the
EU, SPCs disadvantage EU-based generics and biosimilars
manufacturing compared with generic companies based in
countries with no SPC.
When placing generics and biosimilars on the EU market when
the SPC expires, SPCs disadvantage EU-based generics and
biosimilars manufacturing compared with generic companies
based in countries with no SPC
The EU SPC, in its current form, increases our reliance on
imports of medicines and active pharmaceutical ingredients from
outside the EU
11. The entry into force of the EU SPC regulations in an EU country (note: in some countries, this was
after 2004) mostly…
... does not have an impact on our future decisions about manufacturing in that EU country
… triggers the delocalisation to another country or licensing of our manufacturing to a country with
no or less stringent SPC type protection
… triggers the delocalisation or licensing of our manufacturing to a country with no or less stringent
SPC type protection, but only for the initial launch in the EU
Don’t
know
opinion
No
Some reports suggests that biosimilars tend to be developed and manufactured in the
same location. We’
d like to find out your experience of this.
12. When you develop a biosimilar, do you always conduct the R&D and manufacturing in the same
location?
Yes
–
it's essential
No
–
we often choose a different country for the manufacturing, then years later we move the
manufacturing
No
–
we often choose different country for the manufacturing, but we never consider moving the
manufacturing later because it would highly complex, risky and costly
Don't know/no opinion
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SPC legislation aims to ensure adequate protection for innovation and to improve 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).
13. In your experience, do some jurisdictions (e.g., the US or Japan) provide for SPC type protection for
some types of innovation that you develop that are not eligible for an SPC in the EU?
Yes
No
Don’t
know/no opinion
If
you answered ‘yes’
to Question 13, please give examples (max. 1 500 characters, incl. spaces).
1500 character(s) maximum
The next few questions relate to the potential impact of applying the Bolar patent exemption and the SPC
to the source of supply of active pharmaceutical ingredients for EU-based manufacturers (e.g. the
Astellas case in Germany and Poland).
14. Has the implementation of the Bolar research exemption in EU countries affected your decisions
regarding your sources of supply of active pharmaceutical ingredients (APIs)? (e.g. opting for in-house
manufacturing or outsourcing, being forced to outsource outside the EU or from a particular EU country)
Yes
No
Don't know
Please give an explanation/examples if possible (max. 2 000 characters, incl. spaces).
2000 character(s) maximum
15. Has the implementation of SPCs in EU countries affected your decisions regarding your sources of
supply of active pharmaceutical ingredients (APIs)? (e.g. opting for in-house manufacturing or outsourcing,
being forced to outsource outside the EU or from a particular EU country)
Yes
No
Don't know
Please give an explanation/examples if possible (max. 2 000 characters, incl. spaces).
2000 character(s) maximum
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16. How significant are the following drivers when you are deciding on your sources of supply of active
pharmaceutical ingredients (APIs) (whether manufactured in-house or bought from a third-party
manufacturer)? (score from 1 to 3)
1
Minimum
significance
Compliance with regulatory standards
Scope of Bolar and indirect patent infringement rules
in the country where the APIs are manufactured
Security of supply (e.g. having more than one supplier)
SPC protection (lack of)
Proximity to the manufacturing facilities of our final
product
2 Medium
significance
3
Maximum
significance
We’re
interested in how the SPC and EU Bolar exemptions work in relation to national legislation.
17. Please give examples of any inconsistencies between national legislation and EU legislation
on SPCs and Bolar exemptions, if you know of any.
Do you have suggestions on how to overcome these inconsistencies?
2000 character(s) maximum
18. Have the EU SPC and Bolar exemptions brought added value compared with national
initiatives?
No
Don't know
Please provide an explanation/examples if possible (max. 2 000 characters, incl. spaces)
2000 character(s) maximum
Yes
The following questions focus on the matters addressed by the European Commission ‘inception impact
assessment’
(http://ec.europa.eu/smart-regulation/roadmaps/docs
/2017_grow_051_supplementary_protection_certificates_en.pdf)
published on 15 February 2017: the
‘SPC manufacturing waiver’
(see explanation in the introduction to this questionnaire), the unitary (single)
SPC, and specific issues related to Bolar and research patent exemptions.
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19. Do you favour countries with no SPC protection when looking for a location to base or outsource your
biosimilars manufacturing?
Yes
No
Depends on the circumstances but it is a key
factor.
No
opinion/Don’t
know
There is no specific provision dedicated to SPCs in the package of legislative instruments related to the
unitary
patent. We’d like
to get feedback from you on whether national authorities, when applying the SPC
Regulations, could grant SPCs on the basis of unitary patents.
20. Would it be possible to grant national SPCs for a product covered by the future European patent with
unitary 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
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 follow 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.
21. Have you ever based your defence in a patent/SPC infringement case in multiple jurisdictions
(taking place in several EU Member States) on the Bolar exemption?
Yes, and the courts always interpreted the Bolar exemption in the same
way
No
Don’t
know/no opinion
If you answered
‘Yes,
and there were conflicting
judgments’,
please provide examples (e.g. reference
court cases, max. of 2 000 characters, inc. spaces).
2000 character(s) maximum
Yes, and there were conflicting judgments
22. Are you always able to find a supplier of active pharmaceutical ingredients (APIs) manufactured in
the EU?
Yes
No
Don't know
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23. If you are in the plant protection products sector, is there a Bolar-type or research exemption in EU
countries in this sector?
Yes, in some EU countries this is stipulated in their patent law or
jurisprudence
jurisprudence
It is not
clear
No
opinion
24. If you are in the plant protection products sector, have you ever based your defence in a patent/SPC
infringement case on the Bolar exemption?
Yes, and the court recognised my allegedly infringing activities as Bolar-exempted
Yes, but the court did not recognise my allegedly infringing activities as Bolar-
exempted
No
Don’t
know/no opinion
25. Have you ever been sued for developing a product in the EU for its registration outside the EU?
Yes, and the courts always ruled that this development was Bolar-exempted
Yes, and on at least in one occasion a court ruled that this development was not Bolar-exempted
No
Don’t
know/no opinion
26. Do you think that there is a risk that the future Unified Patent Court could develop a practice regarding
the Bolar patent exemption that conflicts with the one consolidated in the Irish, UK and German law
/practice?
Yes
–
and that is undesirable
Yes
–
but it would not be an issue for
us
No
Don’t
know/no opinion
In
the following questions, we’d
like to find out your views on some options for improving the SPC and
Bolar systems in the EU.
27. Please indicate which of the following actions would be enough on its own to ensure
consistent interpretation throughout the EU of the scope and eligibility of the SPC regulation?
Don’t
know/no
Yes
Amendment of the SPC Regulations to bring additional clarity
Creation of a unitary SPC for the unitary patent
Guidelines developed by the European Commission and EU
countries
Other actions
–
please explain:
No
opinion
Only in a few of them it is stipulated in their patent law or
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Other actions
–
please explain:
28. 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 administrative
capacity/resources
enough resources
No opinion
29. Do you favour the creation of a unitary SPC title for the unitary patent?
Yes
No,
there’s
no need
No opinion
30. Which granting authority would you favour to grant and register a unitary SPC?
EU Intellectual Property Office
European Patent Office
A new EU agency
European Medicines Agency
EU countries' patent offices (e.g. virtual office approach or mutual recognition with reference
offices, under EU rules)
None of the above, please indicate your alternative preference
Please explain your choice (max. 2 000 characters, incl. spaces).
2000 character(s) maximum
No
– it’s unnecessarily cumbersome,
even for the offices with
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31.
Which language combination would you prefer for…
English, French,
German, Italian
and Spanish (as
for the EU
Intellectual
Property Office)
English,
French, and
German (as
for the
European
Patent Office)
All EU official
languages (as
for the
centralised
marketing
authorisations)
English
only
None of
these
(please
state your
alternative
preference
)
…registering
unitary SPC
applications?
…publishing
unitary
SPCs?
32. Should the unitary SPC be available only for products authorised by way of a centralised marketing
authorisation (e.g. assessed by the European Medicines Agency)?
Yes
No
No opinion
33. Would it be useful for a more consistent/integrated EU approach on the patent Bolar and research
exemptions if a group of Commission and EU country experts is set up to monitor developments relating to
these exemptions?
Yes
No - legislative action would still be
needed
needed
No - and no legislative action is
Don't know/no opinion
In
the following questions, we’d
like to find out your views on some options for improving the SPC and
Bolar systems in the EU.
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34. What would be the impact of the introduction of an SPC manufacturing waiver* in the EU?
* See explanation in the introduction to this questionnaire.
1
(min)
We would increase our manufacturing in the EU
We would not decrease our future manufacturing in the EU
It would increase the risk of infringement of SPCs in the EU
It would increase our sales in countries outside the EU when
protection abroad expires
In the short term, it would reduce originators’ sales in countries
outside the EU when protection abroad expires
In the long term, it would reduce
originators’
sales in countries
outside the EU when protection abroad expires
2
3
4
5
(max)
35. What would be the benefits of a unitary SPC?
3
1
Strongly
disagree
2
Disagree
Neither
agree
nor
disagree
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 licensing easier
4
Agree
5
Strongly
agree
36. Please indicate from 1 (disagreement) to 3 (agreement) to what extent you agree with the following
statement:
If the supply of patented active pharmaceutical ingredients (APIs) were allowed under the Bolar patent
exemption, we would increase our share of purchases from EU-based suppliers of APIs
1
2
3
Don't know
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IV. PATIENTS GROUPS, FARMERS, DOCTORS, HEALTH
AUTHORITIES, AGRICULTURAL AUTHORITIES, INSURERS
/TENDERERS
Intellectual property (IP), such as patents or trademarks, plays a key role in
encouraging investment in innovation. A 2013 study (IP 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 on industrial property protection
through patents, Supplementary Patent Certificates (SPCs) 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 of effective 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
(EC) No 469/2009 and Regulation (EC) No 1610/96 on SPC covering
pharmaceutical and plant protection products respectively.
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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-market regulatory approval even when the SPC of
the reference medicine is still 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 some EU MS, inter alia, to meet new
pharmaceutical-related requirements.
The specific industrial property legal framework in the EU for 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 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 SPC 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 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.
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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 the 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.
The Single Market Strategy, adopted in October 2015 (COM(2015)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 particular, the Strategy undertook to
explore a recalibration of certain aspects of patent and SPC protection,
and announced that this recalibration could mainly comprise 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
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 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 results of its consultation which,
together with ongoing evaluation studies, will help the Commission assess
whether the EU SPC framework is still fit for purpose or needs to be
recalibrated, notably as regards the aspects set out in Single Market
Strategy.
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Disclaimer
Please note that this document has been prepared by the Commission
services for information and consultation purposes only. 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 way prejudge, 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 responsibility
for any use made thereof.
The following questions relate to the profile of your company/organisation:
*
1. Which best describes you?
Health, incl. medicines (human and/or veterinary
medicines)
Plant protection products (pesticides)
Other: please specify
Please specify
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*
1.1. If the health sector, are you a:
Individual
National
patients’
organisation
European
patients’
organisation
Public pricing authority
Consumers’
association
Procurement authority
Public health authority (e.g. Ministry of Health)
Private company organising/launching procurement
Health technology assessment authority
Veterinary association
Health care professionals (e.g. doctors, associations of health care professionals)
Hospital or hospital association/group
Insurance health provider
Other: please specify
Please specify
1.1. If the agrochemical sector, are you a:
Farmer
National
farmers’
organisation
European farmers’ organisation
Legal counsellor representing farmers
Consumers’
association
Public authority for agriculture
Other: please specify
Please specify
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The next few questions are about how effective supplementary 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 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 pharmaceutical and plant protection products. The
SPC legislation was introduced in the EU in the 1990s.
In most of the following questions, we'd 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.
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2. In the last
two decades in the EU, how do you perceive the progress made in……
Up
Stable
a
bit
Up
a
lot
No
opinion
Down
a lot
…investments in pharmaceutical innovation
in general
…investments in clinical trials
…investments in pharmaceutical
manufacturing
…investments in innovation in plant
protection products
...investments in the manufacturing of plant
protection products
…competition in the pharmaceutical sector
based on innovation
…competition in plant protection products
based on innovation
… competition based on the quick market
entry of generics/biosimilars following the
expiry of SPC protection?
… dependency of supply of active
pharmaceutical ingredients (APIs)
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
Down
a bit
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]?
1 (Negative)
2
3 (Positive)
Impossible to know
We
don’t
know
No opinion
Answer 2
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Please explain your answer (max. 2 000 characters, incl. spaces).
2000 character(s) maximum
N/A
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 questionnaire, 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 approval.
4. Should the EU SPC system be available for other innovative products subject to lengthy
regulatory approval?
Yes
No
No opinion
If your answer
is ‘Yes’, please
provide examples (max. 1 500 characters, incl. spaces).
1500 character(s) maximum
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 transparent SPC system can make it easier for
generics/biosimilars to compete.
5. About your use of databases to monitor the status of SPC protection of your products across EU
Member States…
Don’t
Agree
… to our knowledge, there are no databases available to
conduct such monitoring
… specialised databases are very costly
Disagree
know/no
opinion
In the next few questions,
we’d like to find
out how much complexity SPC applicants face when filing
SPCs in the EU (of course, some complexity is always expected in the highly technical fields such
as pharmaceutical or plant protection products innovation).
6. How would you rate the degree of complexity of court litigation for SPCs in the EU?
High
Reasonable
Low
Don’t
know/no opinion
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How could litigation be improved? (max. 1 500 characters, incl. spaces)
1500 character(s) maximum
N/A
7. Have you ever decided not to enter into litigation relating to SPC infringement or SPC validity because
of a lack of economic resources to litigate?
Yes
No
Don’t
know
Please provide examples of the total cost of enforcement that you were faced with (max. 2 000
characters, incl. spaces).
2000 character(s) maximum
N/A
SPC protection could have had unintended adverse effects in other sectors.
EU-based generics and biosimilar manufactures argue that the EU SPC protection puts them at a
disadvantage compared with foreign-based manufacturers.
They want to see the introduction of
an ‘SPC manufacturing waiver’ (see
introduction to this questionnaire
for more details).
In the next few questions,
we’d like to find
out about the challenges faced by this sector of the
pharmaceuticals industry.
8. Does the EU SPC framework put EU based generics/biosimilars manufacturing at a disadvantage
compared with foreign-based manufacturers when exporting generics and biosimilars outside the EU?
Yes
No
Don’t
know/no opinion
Please explain your answer (max. 2 000 characters, incl. spaces).
2000 character(s) maximum
No opinion
9. Does the EU SPC framework put EU based generics/biosimilar manufacturing at a disadvantage
compared with foreign-based manufacturers when it comes to placing generics and biosimilars on the EU
market when SPC protection in the EU expires?
Yes
No
Don’t
know/no opinion
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Please explain your answer (max. 1 500 characters, incl. spaces).
1500 character(s) maximum
No opinion
10. If
you answered ‘yes’ to
Questions 8 or 9, does the issue matter more for biosimilars than for
generics?
Yes
No
Don’t
know/no opinion
If
you answered ‘yes’
to Question 10, please explain why (max. 2 000 characters, incl. spaces).
2000 character(s) maximum
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 neglected diseases and orphan diseases)?
Yes
No
Don’t
know/no opinion
Please explain your answer (max. 1 500 characters, incl. spaces).
1500 character(s) maximum
We’re
interested in how the SPC and EU Bolar exemptions work in relation to national legislation.
12. Please give examples of any inconsistencies between national legislation and EU legislation
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, incl. spaces.)
2000 character(s) maximum
No answer
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13. Have the EU SPC and Bolar exemptions brought added value compared with national
initiatives?
Yes
No
Don’t
know
Please explain your answer (max. 2 000 characters, incl. spaces).
2000 character(s) maximum
No answer
The following questions focus on the matters addressed by the European
Commission’s ‘inception
impact
assessment’
published on 15 February 2017: the
‘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.
In
the following questions, we’d
like to find out your views on some options for improving the SPC and
Bolar systems in the EU:
14. Please indicate which of the following actions would be enough on its own to ensure
consistent interpretation throughout the EU of the scope and eligibility of the SPC regulation?
Don’t
know/no
Yes
Amendment of the SPC Regulations to bring additional clarity
Creation of a unitary SPC for the unitary patent
Guidelines developed by the European Commission and EU
countries
Other actions
–
please explain ( max. 2 000 characters)
No
opinion
Other actions
–
please explain ( max. 2 000 characters)
2000 character(s) maximum
No answer
15. Do you favour the creation of a unitary SPC title for the unitary patent?
Yes
No,
there’s
no need
No opinion
Please explain your answer (max. 1 500 characters, incl. spaces).
1500 character(s) maximum
No answer
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16. Which language combination would you prefer for the publication of the unitary SPC?
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)
English only would be sufficient
Other options, please explain:
Other actions
–
please explain ( max. 2 000 characters)
2000 character(s) maximum
No opinion
In
the following question, we’d
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.)
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
2
3
4
5
(max.)
V. NATIONAL PATENT OFFICES, JUDGES AND IP PROFESSIONALS
Intellectual property (IP), such as patents or trademarks, plays a key role in
encouraging investment in innovation. A 2013 study (IP 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.
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Industry sectors whose products are subject to regulated market
authorisations, such as the pharmaceutical, medical devices and
agrochemical industries, rely heavily on industrial property protection
through patents, Supplementary Patent Certificates (SPCs) 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 of effective 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
(EC) No 469/2009 and Regulation (EC) No 1610/96 on SPC 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-market regulatory approval even when the SPC of
the reference medicine is still 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 some EU MS, inter alia, to meet new
pharmaceutical-related requirements.
The specific industrial property legal framework in the EU for 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 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 SPC applications while the very same
application has been either refused or granted with a different scope in
other Member States.
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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 the 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.
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The Single Market Strategy, adopted in October 2015 (COM(2015)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 particular, the Strategy undertook to
explore a recalibration of certain aspects of patent and SPC protection,
and announced that this recalibration could mainly comprise 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
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 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 results of its consultation which,
together with ongoing evaluation studies, will help the Commission assess
whether the EU SPC framework is still fit for purpose or needs to be
recalibrated, notably as regards the aspects set out in Single Market
Strategy.
Disclaimer
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Please note that this document has been prepared by the Commission
services for information and consultation purposes only. 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 way prejudge, 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 responsibility
for any use made thereof.
The following questions relate to the profile of your company/organisation:
*
1. Which best describes you?
National patent office
Professional having dealt with both registration and litigation of SPCs
Professional having dealt with SPC litigation but not with registration
Judge dealing with SPC enforcement
Professional having dealt with registration of SPCs but not with litigation
Other: please specify
Please specify
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The next few questions are about how effective supplementary 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 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 Regulation (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
conclusions on 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 harmonised SPC protection is
across the EU.
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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 applications for one of your products but refused
others; you were granted different durations of SPC protection for one of your products in different EU
countries; national grant authorities interpreted EU Court of Justice rulings differently.
Y
es
No
Don’t
know
If you answered
‘yes’ to Question
2, please explain in the box below.
1500 character(s) maximum
With respect to the duration of a certificate based on a national marketing authorization the DKPTO uses the decision
date unless an official notification date exists whereas the Dutch Office uses the date where applicant received the
marketing authorization for the calculation of the duration of the certificate.
An example is:
Product: Solifenacin
MA: RVG 29151, RVG 29152 (NL)
Date of MA in DK: 16/12/2003
Date of MA in NL: 22/12/2003
With respect to the EU Court of Justice rulings, the national offices interpret the Neurim (C-130/11) ruling differently.
Some interpretations follow the ruling very strictly i.e. an MA for a product for veterinary use does not preclude a grant
of an SPC on the basis for a later MA for the same product for human use.
3. Has an EU
country’s courts
ever taken a different decision 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 concluded that there was infringement of a specific SPC, while others did not)?
Y
es
No
Don’t
know
If you answered
‘yes’ to Question
3, please explain in the box below.
1500 character(s) maximum
In case A-23-17, Gilead Sciences v Accord Healthcare Limited, the Danish Maritime and Commercial High Court issued a decision
rejecting Gilead's motion for preliminary injunction against Accord Healthcare Limited based on Gilead's Danish SPC. Accord had
defended the motion for preliminary injunction by arguing non-infringement and invalidity of the asserted SPC.
The Court supported Accord's argument that the SPC's combination was not protected by the basic patent, and, accordingly, the
SPC had been granted in contrary to Article 3(a) of the SPC Regulation. The SPC is still in effect in the UK, but has since been
challenged.
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 transparent SPC system can make it easier for
generics/biosimilars to compete.
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4. About your use of databases to monitor the status of your competitors’ SPC protection across EU
Member States…
Don’t
Agree
… to our knowledge, there are no databases available to
conduct such monitoring
… specialised databases are very costly
Disagree
know/no
opinion
We’d
like to hear your views on how fragmented you think the EU SPC system is so that we can consider
potential improvements (e.g. a unitary (single) SPC).
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5. Has your country enacted legislation on SPCs to transpose the EU regulations on SPCs?
Yes
No, the national authority that grants the SPC relies directly on the SPC regulations
Don’t
know/no opinion
5.1. If
you answered ‘yes’
to Question 5, has your EU country ever updated that legislation following a
judgment from the Court of Justice of the EU?
Yes
No
Don’t
know/no opinion
6. Has your country (e.g. your national patent office) adopted implementing guidelines for examining and
registering SPCs?
Yes
No, the national authority that grants the SPC relies directly on the SPC
regulations
Don’t
know/no opinion
6.1. If
you answered ‘yes’
to Question 6, do you usually update the guidelines following a judgment from
the Court of Justice of the EU?
Yes
No
Don’t
know/no opinion
The efficiency of the current EU SPC system could be improved, for example by using a unitary (single)
SPC.
In the next few questions,
we’d like to find
out how much complexity 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?
High
Reasonable
Low
Don’t
know/ no opinion
How could procedures be improved? (max. 1 500 characters, incl. spaces)
1500 character(s) maximum
In Denmark the registration procedures are relatively easy.
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SPC protection could have had unintended adverse effects in other sectors.
EU-based generics and biosimilar manufacturers argue that EU SPC protection puts them at a
disadvantage compared with foreign-based manufacturers.
They want to see the introduction of
an ‘SPC manufacturing waiver’ (see
introduction to this questionnaire
for more details).
In the following questions, we'd like to find out about the challenges faced by this sector of the
pharmaceuticals industry.
8. Do you agree or disagree with the following statements?
No
Agree
SPCs inadvertently disadvantage EU-based generics and
biosimilars manufacturing compared with countries with no SPC (e.g.
for exports outside the EU and for entry in the EU following the
expiry of the SPC)
When placing generics and biosimilars on the EU market after the
SPC expires, SPCs disadvantage EU-based generics and
biosimilars manufacturing compared with generic companies based
in countries with no SPC
The EU SPC, in its current form, increases reliance on imports of
medicines and active pharmaceutical ingredients from outside the EU
Disagree
opinion
The following questions relate to the cost of registration and enforcement of SPCs, and whether the
current cost level impacts on
SCP holders’
behaviour (e.g. whether it limits the number of registrations).
9.
Have you ever known an SPC applicant to abandon an SPC registration in an EU country owing to…
Don’t
know/no
Yes
… the cost of registration/maintenance?
… burdensome administrative
procedures?
No
opinion
10. Does the geographical scope of SPCs generally match the geographical scope of the territory
in which the protected pharmaceutical product is marketed?
Yes
No
– sometimes it’s larger (i.e.
we sometimes obtain SPC protection in countries where the
protected product will not be marketed)
No
–
it's usually narrower
Don’t
know
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If 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, incl. spaces).
5000 character(s) maximum
N/A
11. If an SPC is enforced in only one EU country, is the cost of enforcement proportionate?
Yes
–
the potential cost is always exceeded by potential sales
No
– it’s very high
and sometimes SPC holders give up enforcing it
Don’t
know/no opinion
If
you answered ‘no’ to Question
11 and if you are an IP professional/lawyer, please give examples of
total cost of enforcement (max. 2 000 characters, incl. spaces).
2000 character(s) maximum
N/A
12. If an SPC is enforced in multiple EU countries, is the cost of enforcement proportionate?
Yes
–
the potential cost is always exceeded by potential sales
No
– it’s very high and
sometimes SPC holders give up enforcing it in some EU countries
Don’t
know/no opinion
If
you answered ‘no’ to Question
12 and if you are an IP professional/lawyer, please give examples of
total cost of enforcement in multiple jurisdictions (max. 3 000 characters, incl. spaces).
3000 character(s) maximum
N/A
13. Is the length of proceedings relating to the enforcement of SPCs satisfactory?
Yes
No
–
it depends on the EU country
Don’t
know/no opinion
In the next few questions,
we’d like to
find out how the competent EU country authorities manage SPC
registrations.
Some authorities have greater administrative resources than others.
14. For national patent offices, do the administrative fees relating to SPCs cover the cost of handling SPC
applications and their registration?
Yes
No
No opinion
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15. If the national patent office in your country has a backlog of SPC applications, what do you think are
the 2 main reasons for this?
between 1 and 2 choices
Insufficient administrative resources at the national patent office
Insufficient technical abilities of the national patent office
Increasing complexity of the subject matter of the application
Delays caused by the applicant
There is no backlog
Other, please
specify:
Other, please specify:
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
Don’t
know/no opinion
SPC legislation aims to ensure adequate protection for innovation and to improve 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).
17. Is SPC protection not available for some types of innovations (e.g. certain categories of medical
devices, veterinary medicines, or plant-related products)?
Yes
No
Don’t
know
Please give examples if possible (max. 1 500 characters, incl. spaces).
1500 character(s) maximum
I De
ark a SPC a ’t e gra ted for
edical
devices.
18. In your experience, is SPC protection sufficient to encourage investment in certain types of vital
innovations (e.g. antibiotics, medicines for treating neglected or orphan diseases)?
Yes
No
Don’t
know
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Please give examples if possible (max. 1 500 characters, incl. spaces).
1500 character(s) maximum
N/A
19. To your knowledge and in your experience, 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 if possible (max. 1 500 characters, incl. spaces).
1500 character(s) maximum
N/A
We want to find out how the SPC and Bolar EU frameworks work in relation to national legislation.
20. Please give examples of any inconsistencies between national legislation and EU legislation on
SPCs and Bolar exemptions, if you are know of any. Do you have suggestions on how to overcome
these inconsistencies? Examples & suggestions (max. 2 000 characters, incl. spaces)
2000 character(s) maximum
N/A
21. Have the EU SPC and Bolar exemptions brought added value compared with national
initiatives?
Yes
No
Don’t
know
Please provide an explanation/examples if possible (max. 2 000 characters, incl. spaces).
2000 character(s) maximum
N/A
The following questions focus on the matters addressed by the European Commission ‘inception impact
assessment’
published on 15 February 2017: the
‘SPC
manufacturing
waiver’
(see explanation in the
introduction to this questionnaire), the unitary (single) SPC, and specific issues related to the Bolar and
research patent exemptions .
There is no specific provision dedicated to SPCs in the package of legislative instruments 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.
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22. Would it be possible to grant national SPCs for a product covered by the future European patent with
unitary 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
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 follow 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 available for….
Yes, stipulated
in patent law or
jurisprudence
…originators’ activities related to
‘health technology assessment’?
…development of a generic
product (e.g. medicines or
pesticides) for its registration
outside the EU?
… development
of generic plant
protection products for its
registration in your country?
No, neither
stipulated in patent
law nor in
jurisprudence
It’s
uncertain
Don’
t
know
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?
Yes, and it's undesirable
Yes, but it
wouldn’t
be an issue for us
No
Don’t
know
In the following questions, we'd like to find out your views on some options for improving the SPC and
Bolar systems in the EU.
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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 eligibility of the SPC regulation.
Don’t
Yes
Amendment of the SPC Regulations to bring additional clarity
Creation of a unitary SPC for the unitary patent
Guidelines developed by the European Commission and EU
countries
Other actions
–
please explain
No
know
Other actions
–
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 resources
No,
it’s unnecessarily
cumbersome even for the offices with enough resources
No opinion
27. Do you favour the creation of a unitary SPC title for the unitary patent?
Yes
No,
there’s
no need
No opinion
Please provide an explanation (max. 2.000 characters, incl. spaces).
2000 character(s) maximum
We understand that the European Commission intends to issue a notice in this regard and we await to see the outcome.
28. Which granting authority would you favour to grant and register a unitary SPC?
EU Intellectual Property Office
European Medicines Agency
European Patent Office
EU
countries’
patent offices (e.g. virtual office approach or mutual recognition with reference
offices, under EU rules)
A new EU agency
None of the above, please indicate your alternative preference
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Please indicate your alternative preference
29.
Which language combination would you prefer for…
English, French,
German, Italian
and Spanish (as for
the EU Intellectual
Property Office
English,
French, and
German (as
for the
European
Patent Office)
None of
All EU official
languages (as
for centralised
marketing
authorisations)
English
only
these
(please
indicate
your
alternative
preference)
… unitary
SPC
applications
…
publishing
unitary
SPCs
30. Should the unitary SPC be available only for products authorised by way of a centralised marketing
authorisation (e.g. assessed by the European Medicines Agency)?
Yes
No
No opinion
31. Would it be useful for a more consistent/integrated EU approach on the patent Bolar and research
exemptions if a group of Commission and EU country experts is set up to monitor developments relating to
these exemptions?
Yes
No
–
legislative action would still be needed
No
–
and no legislative action is needed
Don’t
know/no opinion
In
the following questions, we’d
like to find out your views on some options for improving the SPC and
Bolar systems in the EU.
32. If you are an EU country's patent office, would a unitary SPC have a significant impact on your
organisation's budget (e.g. significant loss of income or staff redundancies)?
Yes
No
Don’t
know/no opinion
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 EUU, Alm.del - 2017-18 - Bilag 257: Høringssvar om supplerende beskyttelsescertifikater (SPC) og patentfritagelser på forskningsområdet
Intellectual property (IP), such as patents or trademarks, plays a key role in
encouraging investment in innovation. A 2013 study (IP 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 on industrial property protection
through patents, Supplementary Patent Certificates (SPCs) 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 of effective 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
(EC) No 469/2009 and Regulation (EC) No 1610/96 on SPC 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-market regulatory approval even when the SPC of
the reference medicine is still 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 some EU MS, inter alia, to meet new
pharmaceutical-related requirements.
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The specific industrial property legal framework in the EU for 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 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 SPC 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 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 the 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.
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The Single Market Strategy, adopted in October 2015 (COM(2015)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 particular, the Strategy undertook to
explore a recalibration of certain aspects of patent and SPC protection,
and announced that this recalibration could mainly comprise 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
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 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 results of its consultation which,
together with ongoing evaluation studies, will help the Commission assess
whether the EU SPC framework is still fit for purpose or needs to be
recalibrated, notably as regards the aspects set out in Single Market
Strategy.
Disclaimer
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Please note that this document has been prepared by the Commission
services for information and consultation purposes only. 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 way prejudge, 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 responsibility
for any use made thereof.
The following questions relate to the profile of your company/organisation:
*
1.
You are a ministry or public agency dealing with…
Science and innovation policies
Industrial policy
Competition
policy
policy
Trade
Other: please specify
Please specify
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The next few questions are about how effective supplementary 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 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 pharmaceutical and plant protection products. The
SPC legislation was introduced in the EU in the 1990s.
In most of the following questions, we'd 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.
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2.
In the last two decades in the EU, how do you perceive the progress made in……
Up
Stable
a
bit
Up
a
lot
No
opinion
Down
a lot
…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
…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
… dependency of supply of active
pharmaceutical ingredients (APIs)
manufactured outside the EU
Down
a bit
The SPC is not the only factor that influences decision on investment on innovation, location of innovation
activities and manufacturing. The European Commission would like to get feedback 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 in the first column for each of the investment
types indicated.
between 1 and 4 answered rows
Investment in
research (incl.
clinical/field
trials) for
pharmaceutical
products
Investment in
research (incl.
clinical/field
trials) for plant
protection
products
Investment in
manufacturing
for
pharmaceutical
products
Investment
in
manufacturing
for plant
protection
products
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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 protection puts them at a
disadvantage compared with foreign-based manufacturers.
They want to see the introduction of
an ‘SPC manufacturing waiver’ (see
introduction to this questionnaire
for more details).
In the next few questions, we'd like to find out about the challenges faced by this sector of the
pharmaceuticals industry.
4. Based on your experience, do you agree with the claims below on how the SPC system is performing
in the EU?
No
Agree
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 pharmaceutical ingredients from outside the
EU
Disagree
opinion
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).
5. In your experience, is SPC protection sufficient to encourage investment in certain types of innovations
(e.g. antibiotics, medicines for the treatment of neglected diseases and orphan diseases)?
Yes
No
Don’t
know/no opinion
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Please explain your answer (max. 1 500 characters, incl. spaces.)
1500 character(s) maximum
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 eligible for an SPC in the EU?
Yes
No
Don’t
know/no opinion
Please give examples if possible (max. 2 000 characters, incl. spaces.)
2000 character(s) maximum
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 on
SPCs and Bolar exemptions, if you know of any.
Do you have any suggestions on how to overcome these inconsistencies? Please, explain your answer
(max. 2 000 characters incl. spaces).
2000 character(s) maximum
8. Have the EU SPC and Bolar exemptions brought added value compared with national initiatives?
Yes
No
Don’t
know
Please explain your answer (max. 2 000 characters, incl. spaces.)
2000 character(s) maximum
The following questions focus on the matters addressed by the European
Commission’s ‘inception
impact
assessment’
published on 15 February 2017: the
‘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.
In
the following questions, we’d
like to find out your views on some options for improving the SPC and
Bolar systems in the EU.
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9. Do you favour the creation of a unitary SPC title for the unitary patent?
Yes
No,
there’s
no need
No opinion
10. Which granting authority would you favour to grant and register a unitary SPC?
EU Intellectual Property Office
European Medicines Agency
European Patent Office
EU
countries’
patent offices (e.g. virtual office approach or mutual recognition with
reference offices, under EU rules)
A new EU agency
None of the above, please indicate your alternative
preference Please indicate your alternative preference
11.
Which language combination would you prefer for…
English, French,
German, Italian and
Spanish (as for the
EU Intellectual
Property Office
English,
French and
German (as
for the
European
Patent Office)
None of
All EU official
languages (as
for centralised
marketing
authorisations)
English
only
these
(please
indicate
your
alternative
preference
…
registering
unitary
SPC
applications
…
publishing
unitary
SPCs
Please indicate your alternative preference
In
the following questions, we’d
like to find out your views on some options for improving the SPC and
Bolar systems in the EU.
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