civil enforcement of intellectual property rights: public...
Post on 15-Apr-2018
214 Views
Preview:
TRANSCRIPT
Creation date 29-03-2013
Last update date
User name [SecuredAndAnonymous]
Case Number 011692544221408813
Invitation Ref. 490217236451533412
Status N
Language en
Name of the respondent: European Federation of Pharmaceutical Industries and
Associations (EFPIA)
Identity of the respondent: ASSOCIATION
Country of establishment: BE - Belgique / België
Are you a part of a multinational group? NO
In which Member States do you operate or trade? AT - Österreich
BE - Belgique / België
BG - България
CZ - Česká republika
CY - Κύπρος
DE - Deutschland
DK - Danmark
EE - Eesti
EL - Ελλάδα
ES - España
FI - Suomi/Finland
FR - France
HU - Magyarország
IE - Éire/Ireland
IT - Italia
LT - Lietuva
LU - Luxembourg
LV - Latvija
MT - Malta
NL - Nederland
PL - Polska
PT - Portugal
RO - România
SK - Slovensko
SI - Slovenija
SE - Sverige
UK - United Kingdom
What is the average annual turnover of your
undertaking/association in EURO?
Civil enforcement of intellectual property rights: public consultation on the
efficiency of proceedings and accessibility of measures
Introduction
Background information
Are you registered in the EU Interest Representative
Register?
YES
Number: 38526121292-88
Please provide your contact information (name, address
and e-mail address):
Elise MELON 108/1 Leopold Plaza Building Rue du Trône
P.O. box: 1050 Brussels 1050 elise.melon@efpia.eu
What is your sector of activity (if possible with a 3 digit
NACE classification)?
EFPIA operates as the representative organisation ( NACE
Division 94.1 ) of the pharmaceutical industry in Europe.
What type of IPRs do you hold? COPYRIGHT
TRADEMARK RIGHTS
DESIGN RIGHTS
PATENT RIGHTS (Including rights derived from
supplementary protection certificates)
Copyright
Rights related to copyright
Sui generis right of a database maker
Rights of the creator of the topographies of a
semiconductor product
Trademark rights
Design rights
Patent rights
Geographical indications
Utility model rights
Plant variety rights
Trade names
What is the value of your IPR portfolio?
How do infringements of your intellectual property rights
impact the total value of your IPR portfolio (eg.
estimated annual loss of turnover)? How do you calculate
this impact?
What is the substitution rate between original goods and
counterfeited/pirated goods in your sector according to
your estimation? How do you measure this rate?
How do infringements of your intellectual property rights
impact your investment in research, development and
innovation (eg. estimated loss in investments/amount of
investments not undertaken)?
What is the relevance of the quality of civil enforcement
system for intellectual property rights for your research,
development and innovation investments?
How would you evaluate the significance of your intellectual property rights and
related assets based on the performance and growth?
Efficiency and effectiveness of civil proceedings in cases concerning infringements of
intellectual property rights
Did you pursue alternative dispute resolution
mechanisms before instituting court proceedings in the
cases of intellectual property rights' infringements?
Yes
What kind of alternative dispute resolution mechanisms
did you undertake?
ARBITRATION
MEDIATION
BILATERAL NEGOTIATIONS
OTHER
What were the costs and the length of proceedings? The LENGTH of ADR proceedings widely varies depending
on the country and the type of ADR involved. The COSTS
also depend on the type of ADR at stake and the country
where proceedings are taking place. It further depends
on the number of judges in the case of arbitration for
instance. EFPIA have addressed this question by
collecting and anonymously aggregating the data from its
members who have been involved in significant amount
of litigation. The answers are pan European and are
broken out by country. The online response form does
not facilitate the submission of data in respect of more
than one country. Therefore, as directed by Mrs. L.
Lecesne of DG Markt, we are simultaneously submitting
the multi-country data in a separate document entitled
EFPIA Consolidated Answers.
Were your rights sufficiently safeguarded (including right
to privacy, right to be heard, and due process)? Please
explain:
In most of the ADR proceedings experienced by our
industry, our rights were fully and sufficiently
safeguarded during proceedings. There are however
exceptions to this general remark. EFPIA have
addressed this question by collecting and anonymously
aggregating the data from its members who have been
involved in significant amount of litigation. The answers
are pan European and are broken out by country. The
online response form does not facilitate the submission
of data in respect of more than one country. Therefore,
as directed by Mrs. L. Lecesne of DG Markt, we are
simultaneously submitting the multi-country data in a
separate document entitled EFPIA Consolidated Answers.
Please explain:
Do you consider that alternative dispute resolution
mechanisms in cases of intellectual property rights'
infringements are sufficiently accessible to parties
affected by an infringement?
NO
Please explain: For Patent disputes we do not believe access to ADR
mechanism is an issue for the biopharmaceutical
industry. For TMs, the most frequently used ADR
mechanism is to settle conflicts between trademark
rights and domain names. Where ADR is provided for this
purpose it is sufficiently accessible but some member
states do not provide for ADR at all. E.g. in Germany
enforcement against infringing .de domains is through
injunctions proceedings before ordinary courts which is
unsatisfactory.
Did you take part in litigation of cases concerning the
infringements of IPRs during the period under
examination?
YES
In how many cases per year do you take part on average? Total of 355 cases in the EU over the period under
examination.
How many of these cases were subject to an appeal? 135 cases out of 355 in the EU over the period under
examination.
In which capacity? PLAINTIFF
DEFENDANT
In which countries? Please indicate relevant Member
States:
AT - Österreich
BE - Belgique / België
BG - България
CZ - Česká republika
DE - Deutschland
DK - Danmark
EL - Ελλάδα
ES - España
FI - Suomi/Finland
FR - France
IE - Éire/Ireland
IT - Italia
LV - Latvija
NL - Nederland
PL - Polska
PT - Portugal
RO - România
SI - Slovenija
SE - Sverige
UK - United Kingdom
Did you already launch proceedings concerning
infringements of your IPRs that occurred in another
Member State?
YES
Did you already launch proceedings concerning
infringements of your IPRs that occurred in several
Member States?
YES
Were you able to consolidate all these claims in one
jurisdiction or were you obliged to launch the
proceedings in the jurisdiction of several Member States?
Please explain:
EFPIA have addressed questions no. 16 and 18 by
collecting and anonymously aggregating the data from its
members who have been involved in significant amount
of litigation. The answers are pan European and are
broken out by country. The online response form does
not facilitate the submission of data in respect of more
than one country. Therefore, as directed by Mrs. L.
Lecesne of DG Markt, we are simultaneously submitting
the multi-country data in a separate document entitled
EFPIA Consolidated Answers. No consolidation for any
company in any venue.
Have claims against the validity of infringed/allegedly
infringed intellectual property rights been made in the
context of the litigation you were a party to?
YES
Please explain what was the impact of these
claims on the procedure concerning the infringement:
EFPIA have addressed this question by collecting and
anonymously aggregating the data from its members who
have been involved in significant amount of litigation.
The answers are pan European and are broken out by
country. The online response form does not facilitate the
submission of data in respect of more than one country.
Therefore, as directed by Mrs. L. Lecesne of DG Markt,
we are simultaneously submitting the multi-country data
in a separate document entitled EFPIA Consolidated
Answer
In approximately what percentage of cases
were these intellectual property rights
found to be invalid as a result of these claims?
For what reasons did you refrain from litigating?
Did your decision on whether or not to litigate depend on
the jurisdiction?
Did your decision on whether or not to litigate depend on
the type of court concerned (e.g. courts specialised in
intellectual property as opposed to standard commercial
courts)?
For you, is it more important to stop infringements that
are committed for profit than infringements committed
not for profit?
What is your general intention in instituting civil law
court proceedings concerning infringements of
intellectual property rights?
TO STOP THE INFRINGING ACTIVITY
TO TAKE MEASURES TO PREVENT FURTHER
INFRINGEMENTS
TO BE COMPENSATED FOR THE INFRINGEMENT
TO DISSUADE INFRINGING BEHAVIOUR IN THE FUTURE
OTHER
Please explain: EFPIA have addressed this question by collecting and
anonymously aggregating the data from its members who
have been involved in significant amount of litigation.
The answers are pan European and are broken out by
country. The online response form does not facilitate the
submission of data in respect of more than one country.
Therefore, as directed by Mrs. L. Lecesne of DG Markt,
we are simultaneously submitting the multi-country data
in a separate document entitled EFPIA Consolidated
Answer
What was the amount of a court fees that you had to pay
for instituting first instance proceedings on the merits of
the case concerning an infringement of your IP right?
The amount of court fees to be paid to institute first
instance proceedings on the merits are very variable.
EFPIA have addressed this question by collecting and
anonymously aggregating the data from its members
who have been involved in significant amount of
litigation. The answers are pan European and are broken
out by country. The online response form does not
facilitate the submission of data in respect of more than
one country. Therefore, as directed by Mrs. L. Lecesne
of DG Markt, we are simultaneously submitting the multi-
country data in a separate document entitled EFPIA
Consolidated Answers.
Did you have to pay any other court fees in relation to
the first instance proceedings on the merits of the case
concerning an infringement of your IP right?
YES
Please specify total additional costs and explain
what the fee was paid for and indicate the
Member State(s) where the proceedings took place and
the intellectual property right(s) that constituted the
subject of these proceedings.
Additional costs were paid in AT, BG, CZ, DK, FI, IE, IT
and UK. Those fees were paid for various reasons and
country by country detail can be found in the
simultaneously submitted document entitled EFPIA
Consolidated Answers.
What was the amount of external experts' costs you had
to pay in relation to the first instance proceedings on the
merits of the case concerning infringement of an
IP right?
EFPIA have addressed this question by collecting and
anonymously aggregating the data from its members who
have been involved in significant amount of litigation.
The answers are pan European and are broken out by
country. The online response form does not facilitate the
submission of data in respect of more than one country.
Therefore, as directed by Mrs. L. Lecesne of DG Markt,
we are simultaneously submitting the multi-country data
in a separate document entitled EFPIA Consolidated
Answers.
What was the amount of in-house costs you had to bear
in relation to the first instance proceedings on the merits
of the case concerning infringement of an IP right?
What was the amount of legal representation costs you
had to pay in relation to the first instance proceedings
on the merits of the case concerning infringement
of an IP right?
The amount of legal representation costs paid in relation
to first instance proceedings varies a lot according to
similar factors as those mentioned above: complexity of
the case, number of legal counsels involved. Country by
country detail can be found in the simultaneously
submitted document entitled EFPIA Consolidated
Answers.
Please indicate, if appropriate, other costs that you had
to bear in relation to the first instance proceedings on
the merits of the case concerning infringement
of an IP right:
A variety of other costs may arise in the course of first
instance proceedings. Such circumstances include 1)
translation costs , b) the need to provide an additional
security, a bond or a bank guarantee , 3) the need to
preserve evidence proceedings , 4) Bailiff fees for a
variety of reasons , 5) legal fees of the winning parties ,
6) Enforcement fees . Country by country detail can be
found in the simultaneously submitted document
entitled EFPIA Consolidated Answers.
What was the total amount of costs you had to bear in
relation to the first instance proceedings on the merits
of the case concerning infringement of an IP right?
There is no uniformity in the total amount of costs born
in relation to first instance proceedings. Country by
country detail can be found in the simultaneously
submitted document entitled EFPIA Consolidated
Answers.
Please explain how do these costs change for the
preliminary proceedings:
Overall, preliminary proceedings costs will be lower to
costs incurred in main / merits proceedings and will
represent from 30% to 70% of the latter. EFPIA have
addressed this question by collecting and anonymously
aggregating the data from its members who have been
involved in significant amount of litigation. The answers
are pan European and are broken out by country. The
online response form does not facilitate the submission
of data in respect of more than one country. Therefore,
as directed by Mrs. L. Lecesne of DG Markt, we are
simultaneously submitting the multi- country data in a
separate document entitled EFPIA Consolidated Answers.
Please explain how do these costs change for the appeal
proceedings:
EFPIA have addressed this question by collecting and
anonymously aggregating the data from its members who
have been involved in significant amount of litigation.
The answers are pan European and are broken out by
country. The online response form does not facilitate the
submission of data in respect of more than one country.
Therefore, as directed by Mrs. L. Lecesne of DG Markt,
we are simultaneously submitting the multi-country data
in a separate document entitled EFPIA Consolidated
Answers.
Copyright: COURT FEES FOR INSTITUTING PROCEEDINGS
OTHER COURT FEES
ATTORNEY'S CHARGE
Rights related to copyright:
Sui generis right of a database maker:
Rights of the creator of the topographies of a
semiconductor product:
Please indicate which of the various costs associated with the proceedings on the merits of
the case at first instance were ordered by the court to be reimbursed to the winning party
by the losing party following the final decision:
Trademark rights: COURT FEES FOR INSTITUTING PROCEEDINGS
OTHER COURT FEES
IN-HOUSE COSTS
ATTORNEY'S CHARGE
ADDITIONAL ATTORNEY'S FEES
Design rights: COURT FEES FOR INSTITUTING PROCEEDINGS
OTHER COURT FEES
EXTERNAL EXPERT(S) COSTS
ATTORNEY'S CHARGE
Patent rights: COURT FEES FOR INSTITUTING PROCEEDINGS
OTHER COURT FEES
EXTERNAL EXPERT(S) COSTS
IN-HOUSE COSTS
ATTORNEY'S CHARGE
ADDITIONAL ATTORNEY'S FEES
Geographical indications:
Utility model rights:
Plant variety rights
Trade names:
Do you consider that the general rule, according to
which legal costs and other expenses incurred by the
successful party shall be borne by the unsuccessful party,
is effectively applied by the courts?
NO
Please explain: Cost recovery is beneficial as it prevents frivolous
litigation and ensures only serious issues come to court.
At least 50% of the winning party’s costs should be
recoverable from the losing party. Cost recovery is
regulated in Dir 2004/48 but there is disparity between
MSs. In ES costs recovery is capped and can be only 2-5%
of the costs in a complex patent case. UK has approx 60-
70% recovery. In DE it is ~ 20%. In Sweden full recovery is
given lip service but it is not applied.
Please indicate the average time (months and
days) between the lodging of a request before a
court and the granting of a preliminary injunction
(e.g. cease and desist orders against the
infringer) in civil law cases concerning
infringement of an IP right in your Member
State/in the Member States in which you have been a
party to court proceedings:
The average time between the lodging of a request
before a court and the granting of a preliminary
injunction varies significantly across the different EU
Member States. It mostly depends on whether it is
patent or trademark-related, but it can also depend on
the place where such an application is lodged, on the
appointment of experts, on whether it is ex parte / inter
partes. Country by country detail can be found in the
simultaneously submitted document entitled EFPIA
Consolidated Answers.
Please indicate the average length (months and days) of
court proceedings on the merits of the case (from
lodging the claim to obtaining the final decision of the
court at first instance) in civil law cases concerning
infringement(s) of an IP right(s) in your
Member State/ in the Member States in which you have
been a party to court proceedings:
The average length of court proceedings on the merits
varies significantly depending on the jurisdiction
concerned. In 10 countries, proceedings will be
approximately 1-to-1,5-year long (AT, BE, BG, CZ, DE,
ES, FI, NL, RO, UK) whereas in some countries the
average length of such proceedings will be rather
between 2 and 4 years ( DK, EL, FR, IT, PL, SE, SI). In IE,
proceedings approximate 9 months, as opposed to LV,
where they can be as long as 7 years. Furthermore, Intra-
countries differences can stem from the type of IPR
involved, the court hearing the case or the intervention
of an expert. Country by country detail can be found in
the simultaneously submitted document entitled EFPIA
Consolidated Answers.
Please indicate the average length (months and days) of
the appeal court proceedings (from lodging the
appeal to obtaining the final decision of the court at
appeal) in civil law cases concerning infringement(s)
of an IP right(s) in your Member State/ in
the Member States in which you have been a party to
court proceedings:
According to our sample of data, a majority of countries
seem to process appeal court proceedings in a period of
time ranging from 3 months (RO) to 1-1,5 year (CZ, DE,
EL, ES, SE, SI, UK). Countries such as AT, BG, FI, PL, PT
will process appeals in approximately 6 months. Other
countries will generally need more than 2 years and up
to 4 years for such proceedings: this is the case of BE,
DK, FR, IE, IT or NL. The length can vary nationally
depending on whether a preliminary reference is made
to the CJEU, on whether there are subsequent appeals to
national Supreme Courts. Appeals concerning
preliminary injunctions will also tend to be shorter than
appeals on the merits (FI). Country by country detail can
be found in the simultaneously submitted document
entitled EFPIA Consolidated Answers.
Do you think it would be useful to establish, at EU level,
model rules for fast track proceedings for civil law cases
concerning infringements of IPRs?
YES
Please explain, specifying in particular what types of
infringements of IPRs could be covered, and what kind of
measures should be granted, in the course of such fast
track proceedings:
A fast track at the IP courts for provisional and
precautionary measures (Art 9 EC Dir 48-2004)
specifically for preliminary injunction cases for IP rights
explicitly including Patents would be very useful. We
would also support a fast track to full trial but only if
both parties agree.The speed with which an injunction
halting or preventing an imminent infringement can be
granted is of critical importance to the industry. The
dependable availability of precautionary injunctions is
necessary as significant and irreparable harm can result
following breach of an IP right even for a small period of
time, not only in terms of lost sales and lost profit but
also in terms of mandatory price cuts or other negative
price effects for the originator product dictated by
national price and reimbursement legislation following
the launch of the infringing generic product. In the
pharma sector there are also extraterritorial effects of
an infringement eg mandatory price cuts in other EU
states that cause harm to the enterprise. There is no
consistency within EU in the time taken to decide on
preliminary measures. Examples are from 1- 7 days to >
1year. During the pendency of that application the
infringer is often on the Market. The delay in coming to
a decision is exacerbated by the differential in time
point at which a Preliminary injunction case can be
brought in the various MSs without being dismissed as
too early. This leads to an unacceptable exposure for the
IPR holder. There should not be a material differential in
timing of injunctions before the courts of the MSs and a
unifying minimum standard on fast tracking preliminary Do you think it would be useful to establish, at EU level,
specific (in addition to Regulation (EC) No 861/2007 of
the European Parliament and of the Council of
11 July 2007 establishing a European small
claims procedure) model rules for small claims
proceedings for civil law cases concerning infringements
of IPRs?
YES
Please explain, specifying in particular what types of
infringements of IPRs could be covered by such small
claims proceedings:
Specific model rules for small claims proceedings may be
appropriate for cases involving copyright, trade mark,
passing off and unregistered design right issues. The
rules could be modeled upon those introduced into the
civil procedure for the UK Patents County Court on 1
October 2012 which provide a small claims track for
disputes concerning such IPRs (see
www.justice.gov.uk/downloads/courts/patents-
court/patents-court-small-claims.pdf). Claims involving
other IPRs, such as patents, registered designs and plant
breeders’ rights, should be outside the scope of the
European small claims procedure. However, from the
perspective of EFPIA’s members, it is unlikely that such
small claims proceedings would be appropriate given the
nature of the members’ IP rights and the value of any
claims relating thereto. Therefore, we do not hold any
firm opinion regarding any potential drawbacks of this
system.
Do you think it would be useful to establish rules for fast
track proceedings for litigation of infringements of
community trademarks and community designs?
YES
Please explain: It is unclear from the Survey whether the fast track
proceedings would cover all types of infringements or
only certain types (e.g., use of a confusingly similar
mark, passing off, re-packaged or over- stickered outer
package of parallel import drugs etc.). In any event,
although a number of complex factors are to be assessed
in litigations on community trademarks and designs,
harmonization of fast proceedings to protect TM rights
in the European Union appears desirable.
Do you think it would be useful to establish rules for
small claims proceedings for litigation of infringements
of community trademarks and community designs?
YES
Please explain: The amount of damages involved would most likely
exclude pharmaceutical CTMs from the scope of any
small claims proceedings, regardless of the maximum
threshold. However, we would not oppose any such
rules being implemented.
What safeguards of defendant's rights should be put in
place in case of the EU-level fast track/small claims
proceedings concerning infringements of IPRs?
An EU-wide harmonization of intellectual property
infringement proceedings is welcomed to ensure and
expedite harmonized proceedings that result in an early
resolution of disputes while granting the basic rights of
the parties. The basic rights of the parties after being
heard by the court are in particular: (i) right of
information (Art. 8, Directive 2004/48/EC), (ii) the
injunction of infringing acts by the defendant (Art. 11,
Directive 2004/48/EC), and (iii) for the defendant the
placement of a reasonable bond or cross undertaking by
the plaintiff to compensate for the damage of the
defendant if a preliminary enforceable decision is turned
down in appeal. The Regulation (EC) 861/2007 seems to
fall short to preserve any of these rights and is confined
to claims in the magnitude of EUR 2000 (Art. 2 of said
regulation), anyway. Such small claims hardly appear in
IP infringement proceedings. On the other hand, fast
track proceedings that grant the basic rights of the
parties and comply with the Directive 2004/48/EC are
highly welcomed. This harmonization may attenuate the
impact of the imparity of legal remedies against IPR
infringement that still exists among the EU Member
States.
How do you identify infringers/alleged infringers of your
IPRs?
Do you face problems identifying infringers/alleged
infringers of your IPRs?
N/A
Right of information
Has it been possible for you to obtain information
allowing identification of infringers/alleged infringers
directly from an intermediary?
Has it been possible for you to obtain a court order
obliging an intermediary to disclose the identity of the
infringer/alleged infringer?
Has it been possible for you to obtain a court order
obliging an intermediary to disclose the identity of the
infringer/alleged infringer of your IPRs in case where the
intermediary and/or the infringer/alleged infringer of
your IPRs were incorporated, or resident in a Member
State other than the one in which you operate?
Do you consider the possibility to use notification
mechanisms to be a useful tool to inform the
intermediary about the fact that his services are being
(allegedly) used to infringe an intellectual property right
and thus bring a stop to the infringing/allegedly
infringing activity?
YES
Please explain: Yes, notification mechanisms for intermediaries are
useful tools to the pharmaceutical industry. Experience
from Pharma companies having implemented a system
for notifying internet service providers and domain site
hosts shows that up to 50% of the websites from which
the illegal activity occurs (sale of patented and/or
trademark drugs without authoritization of the right
holder) will be closed (although some of these may later
be revived). A notification mechanism should co-exist
with and thus not replace the notice and action
procedures according to Art 14 of the E-commerce
Directive. However freight companies and wholesalers
who handle Infringing goods appear to be unconcerned
about their role in handling/possessing illegal goods. It
is believed that a greater accountability of these
intermediaries for the products that they possess would
be an assistance in defeating IPR infringement.
Do you consider the possibility to use notification
mechanisms to be a useful tool also where the
infringements/alleged infringements occurred in, or the
intermediaries are incorporated in, a Member State other
than the one in which you operate?
YES
Mechanisms to inform about the alleged infringement and to impede access to goods and
services allegedly infringing IPRs
Please explain: Yes, the effect described in answer to question 2 with
respect to ISPs and Domain site hosts is seen both when
notifying EU based and non-EU intermediaries. For
instance, notification of Chinese based internet service
providers and domain name hosts have been experienced
to have effect. Whether this holds for all countries is not
clear to us; there may differences between countries.
Do you consider the possibility to use notification
mechanisms to be a useful tool to inform the
infringer/alleged infringer about the infringing/allegedly
infringing character of his activity?
YES
Please explain: In the biopharmaceutical sector the most common IPRs
are registered rights which are publically searchable. We
believe that any business wishing to trade has an
obligation to conduct reasonable due diligence that it is
free to do what it proposes to do. So there is no need for
notification. However, we believe that a specific
notification mechanism to inform the infringer about the
infringing character of his activity or potential activity
can be a useful tool in trying to resolve an issue before
Litigation. However, this requires both parties to be
willing to engage and for some patent types it is not
always possible to determine whether infringement
exists without further info or a sample - which in our
experience is seldom provided. We believe that a
notification mechanism, if appropriately set up and
implemented, can help increasing legal certainty,
protect intellectual property rights and encourage
investments, including in the development and launch
of lawful products.
In cases of commercial scale infringements of
intellectual property rights, do you consider that there
should be particular consequences (i.e. including e.g.
suspension of the infringer's/alleged infringer's account)
resulting from a notification mechanism?
YES
Please explain: Yes, particular consequences resulting from a
notification (under a notification mechanism) would have
a positive impact, in particular, in terms of increasing
compliance with and enforcement of such rights.
However, consequences of the kind mentioned in Art
9(2) of Dir 2004/48/EC – including seizure of property
and bank accounts should be used proportionately.
In cases of notorious infringers of intellectual property
rights, do you consider that there should be particular
consequences (i.e. including e.g. suspension of the
infringer's/alleged infringer's account) resulting from a
notification mechanism?
YES
Please explain: Yes. The court should take into account the behavior and
conduct of the alleged infringer when notified of an IPR.
Taking an example from ecommerce - an internet site
that flagrantly encourages or enables the marketing and
distribution of counterfeit or unlicensed medicinal
products should be subject to such particular
consequences.
Have preliminary injunctions been sought in the context
of the litigation you were party to?
YES
In approximately what percentage of cases were these
injunctions granted by the competent judicial
authorities?
Have permanent injunctions been sought in the context
of the litigation you were party to?
YES
In approximately what percentage of cases were these
injunctions granted by the competent judicial
authorities?
Is the urgency of the case taken into account by the
competent judicial authorities when granting a
provisional injunction?
YES
Is the potential harm of the measure for either of the
parties taken into account by the competent judicial
authorities when granting a provisional injunction?
YES
Is the impact of the measure on the market, competition
and consumers taken into account by the competent
judicial authorities when granting a provisional
injunction?
YES
Are claims against the validity of IPRs taken into account
by the competent judicial authorities when granting a
provisional injunction?
What other circumstances are taken into account by the
competent judicial authorities when granting a
provisional injunction?
Have you obtained a preliminary injunction
imposed on an intermediary who was not a party to the
proceedings?
N/A
Have you obtained a permanent injunction
imposed on an intermediary who was not a party to the
proceedings?
Have you obtained a permanent injunction imposed on
an intermediary providing services necessary for the
financing of the infringing activity (e.g. a payment
service provider)?
Have you obtained a permanent injunction imposed on
an intermediary providing services necessary to access
the infringing services/goods?
Requirements for granting injunctions
Injunctions imposed on intermediaries
Have you obtained a preliminary injunction imposed on
an intermediary providing services necessary to access
the infringing services/goods when the intermediary or
the person infringing/allegedly infringing your IPRs were
incorporated in a Member State other than the one in
which you operate?
Have you obtained a permanent injunction imposed on
an intermediary providing services necessary to access
the infringing services/goods when the intermediary or
the person infringing/allegedly infringing your IPRs were
incorporated in a Member State other than the one in
which you operate?
Have corrective measures been ordered in cases in which
you have been a party?
Should the competent judicial authorities privilege one
specific type of corrective measure?
NO
Should the competent judicial authorities be able to
order that the goods that were found to infringe an
intellectual property right should be disposed of outside
the channels of commerce?
YES
Please explain under which conditions should the
competent judicial authorities be able to order disposal
outside the channels of commerce:
It is important to ensure that the infringer cannot
continue the infringing act. This is much more likely if
the infringer is allowed to keep control of the infringing
goods. Conditions would be: -There has been a final
non appealable finding of infringement from the relevant
court - There has not been a final non appealable
finding of infringement from the relevant court but a
reasonable Bond has been placed or cross undertaking
has been made - The infringement has been notified to
the alleged infringer/goods owner as being seized at
customs and infringement has not been contested before
the required deadline (simplified procedure acc to Reg
1383/2003)
Should the consent of the right holder constitute
a conditio sine qua non for disposing of the goods that
were found to infringe an intellectual property right
outside the channels of commerce?
NO
Third party facilitation of infringements of IPRs
Corrective measures
Please explain how in your opinion the infringing goods
could be disposed of outside the channels of commerce:
In the case of pharmaceuticals distribution is highly
regulated to protect public health. It is essential that
infringing products that are prohibited by an IPR are
disposed of responsibly and safely. It is possible that
the infringing goods may not be suitable for consumption
– might be out of date or might not have (ever) been
approved by a European regulatory body. One suitable
option for disposal outside the channels of commerce is
therefore delivery up on the order of the court and
destruction by a third independent body, specifically
indicated by the competent judicial Authorities in order
to prevent any fraud.
Would you be in favour of introducing sanctions for a
party who, notwithstanding that the infringing goods
were subject to corrective measures ordered by the
competent judicial authorities, allowed these goods to
subsequently return to the channels of commerce?
YES
Please explain: If a court issues an order for delivery up or destruction of
the offending goods or an injunction preventing the sale
of the goods and the infringer puts the infringing product
on the market, then the infringer is committing
contempt of court and appropriate sanctions should
follow. However, it is possible that the court might
order an injunction preventing sale of the goods during
the lifetime of the patent; in this case it would appear
that the infringer may be free to put the goods on the
market after the expiry of the patent provided in case of
pharmaceutical products these should be in good
condition (in date and with a current Marketing
authorization etc). However it is essential that the IPR
holder must be put in the position he would have been in
before the infringement had commenced. The
‘released’ Infringer should not gain an advantage by
being able to launch earlier than a non-infringer at the
end of the right. Measures to prevent ‘spring board
effect’ are supported. EFPIA does not agree with
compulsory licences.
How do you determine the amount of damages to be
awarded for the purpose of filing a civil claim concerning
an infringement of an IPR?
Do you take into account the resources invested in
research and development while determining the
damages to be awarded for the purpose of filing a civil
claim concerning an infringement of an IPR?
On what basis do the competent judicial authorities
establish the amount of damages awarded to the right
holder in its final decision in a civil claim concerning an
infringement of an IPR?
Damages
Is the unjust enrichment of the infringer taken into
account by the competent judicial authorities in the
course of establishing the amount of damages to be
awarded to the right holder in its final decision in a civil
claim concerning infringement of an IPR?
Is due diligence of the right holder taken into account by
the competent judicial authorities in the course of
establishing the amount of damages to be awarded to
the right holder in its final decision in a civil claim
concerning infringement of an IPR?
Is it possible for the competent judicial authorities in
civil law cases concerning an infringement of IPRs to
award damages on the joint basis of provisions on
compensation for lost profits and those on unjust
enrichment?
Is it possible for the competent judicial authorities in
civil law cases concerning an infringement of IPRs to
award damages on the basis of the alleged infringement
of a broader portfolio of intellectual property rights,
despite the fact that normally only a very limited
number of these rights are asserted during one particular
court proceeding?
Would you agree that the level of damages awarded to
the right holder in civil law cases concerning an
infringement of IPRs should at least equal the profits
made by the infringer?
YES
Please explain: Yes. Firstly IPR infringement should be stopped without
delay by granting an injunction to confine the damage to
the minimum. EFPIA believes that Damages should be
calculated on an actual prejudice basis, as opposed to a
reasonable royalty basis (unless requested by plaintiff),
and all harm that flows from the infringing act should be
compensatable in damages. These will almost always be
higher than infringer’s profits, which are only acceptable
as a basis for calculation as a lower margin.
Do you consider the award of damages in cases of
intellectual property rights' infringements is sufficient to
compensate for the actual prejudice suffered by the
parties affected by an infringement?
NO
Please explain: No. Damages are not sufficient. Irreparable harm can
result following breach of an IPR even for a small period
of time, through lost sales volumes and, because of the
specific highly regulated environment for biopharma,
lost profit due to mandatory price cuts and international
reference pricing where an infringement in one EU
country can cause a compulsory price cut in another.
Extra territorial damages are not generally recoverable
even if they stem directly from the infringing act.
In approximately what percentage of cases would you
consider that a party used IPR enforcement measures
frivolously and/or for anti-competitive purposes?
Use of IPR enforcement measures for frivolous and/or anti-competitive purposes
top related