civil enforcement of intellectual property rights: public...

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 [email protected]

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









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.


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


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?










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:










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


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


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.


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.


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


What other circumstances are taken into account by the

competent judicial authorities when granting a


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)?


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


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?



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

civil enforcement of intellectual property rights: public...

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