Enforcement of patent rights in the EU: Finding the right ... · EGA aim: right to be heard Achieve...
Transcript of Enforcement of patent rights in the EU: Finding the right ... · EGA aim: right to be heard Achieve...
Enforcement of patent rights in
the EU: Finding the right balance
between innovation and fair
competition
Lidia Mallo
EUROPEAN GENERIC MEDICINES ASSOCIATION
Japan, December 2012
EGA Key Fact and Figures
Ensuring a balanced patent system
• Patent Protection
• Innovation
• Free Competition
• No delays
• Free Trade
GENERIC PRODUCERS ORIGINATORS
1.Abuse of injunctions and weak patents
2.Patent linkage
3.Detention of legitimate generic
medicines at EU borders
4.TRIPs+ provisions in Free Trade Agreements
Current threats that delay
generic competition in the EU
1. Misuse of Injunctions:
Through Directive 2004/48/EC on
the Enforcement of IP Rights
6
Context: Definitions
Important to keep counterfeit separate and
distinct from patent infringement:
Copyright infringement: piracy
Trademark infringement: counterfeiting
Patent infringement: Potential infringement of
patents is a commercial practice issue with no
criminal implications for consumers’ health
NATURE OF IP RIGHTS
INFRINGEMENT
Infringement of a
Pharmaceutical Patent
in the legal supply chain
POTENTIAL IMPLICATIONS
FOR CONSUMERS
Absence of risk
FORMAL REGISTRATION &
APPROVAL PROCESS Q,S&E
–ie, REGULATED INDUSTRY
SECTOR with PRODUCT QUALITY
CONTROL
TRANSPARENCY
LEGITIMATE COMPETITION
COMPLEX COMMERCIAL
DISPUTE
eg: challenge of weak patents
The difference
A counterfeit “fake”
Louis Vuitton hand bag is
an obvious trademark/design infringement!
Patent infringements are not crystal clear: it can take up to 3 years to solve case & decisions can be different in each country
Should alleged patent infringers be confused with criminals i.e. pirates/counterfeiters?
2004/48/EC Enforcement
Directive: difficulties
IPRED1 was established to implement effective
measures against counterfeits and piracy.
IPRED1 facilitates the application of harsh
measures such as injunctions/ seizures and
delivery up many times granted on low
standards of proof
Undermines competition
Delays generic entry
European Commission Pharma Inquiry
Identifies Generic Delays
10
EC Inquiry Report 2009 (I)
Misuse of injunctions were identified in the EU pharma
inquiry report as way to create unjustifiable restraints
on generic access to the market:
Inquiry Report, par. 583
However, the grant of interim injunctions can become
particularly relevant when examined in the light of
originator companies’ overall patent and life cycle
strategies which are aimed at maximising profit and
shielding their products from competition”
Inquiry, par. 657
“in almost half of the closed cases the grant of an
interim injunction might not have been justified.”
Duration of injunctions proceedings
Table of duration of interlocutory injunction
proceedings demonstrating just how long generics
can be kept off the market:
MS Duration of PI
proceedings
(at first instance)
Duration of
revocation
proceedings (at
first instance)
France 2-3 months 18-24 months
Poland 2 weeks to 3 months Up to 4 years for
the 1st instance
decision
Finland 2-3 months 12-18 months
Belgium 2-6 months 9-12 months
Patent system: difficulties
Generic companies success rate in patent
actions on the merits is approximately 66%
There are a significant number of patents
that should never have been granted.
Case studies
Recent examples delayed generic market
entry due to interlocutory injunctions
based on ‘poor quality patents’
- Alendronate BE
Branded sales (12 months) 14.7 million Euros
Time off the market 6 months
- Perindopril UK
Branded sales (12 months) 108.8 million Euros
Time off the market 11 months
Patent system: difficulties
EU legislation
focused on piracy
andcounterfeiting
EPO
Originators:
• patent strategies
• frivolous litigation
• abuse of injunctions
• Injunctions
easy to obtain
• Granting of
weak patents
• Generic competition
disrupted
• Serious delays
• Lost savings for health
budgets
EC Inquiry Report
In the period 2000 to 2007, the European
Commission has calculated the additional
costs / lost savings caused by delayed generic
entry:
“additional savings of some €3 billion could
have been attained, had entry taken place
immediately”
Solutions proposed:
Review EU
legislation
Recommendation I: Invalidity
defense
Generic companies must be able to defend
themselves against poor quality patents: “the
asserted patent does not meet the
substantive criteria for patentability”
The Court will seriously consider the invalidity
defense
Such an invalidity defense can actually
prevent the handing down of the injunction
Recommendation II: protective
letters
Introduce a harmonized European system of
protective letters:
Filed with first instance court
Contain arguments on non infringement or
invalidity against the ex parte injunction
Arguments shall be valued by the court before
granting the injunction
System well established in Germany.
Adds a higher threshold for allowing an ex
parte interlocutory injunction.
Seizure and Delivery up
Seizure & delivery up are harsh measures,
harsher than PI.
Appropriate safeguards against abuse should
be implemented in EU legislation :
• Refuse seizures if they consider that there is
a serious chance that the invoked patent is
invalid
• Ensure that validity is not assumed just
because the IP right is granted
Compensation for injury
No guarantee or insufficient guarantee to
adequate compensation of injury caused by
unjustified measures.
Recommendations:
• Mandatory compensation if measures are
revoked/lapse or where it is found that there has
been no infringement of valid IPRs.
• Compensate not only those directly affected but
also third parties who have suffered loss as a
consequence of unjustified measures, e.g.
national health services and health insurance
companies.
2. Patent Linkage
23
What Is Patent Linkage?
By PATENT LINKAGE we understand
linking the marketing approval or any
other procedure related to price,
reimbursement and substitution for
generics to the patent status of the
reference product
24
How? and by Whom?
Pressure by
European + American originator industry
US Government/US Trade Office
EC through FTAs
Pressure on National Regulatory/Health
Authorities to
link generic medicines procedures to
patent status of reference products
become indirect ‘enforcers’ of patents
25
Two Different Areas of
Competence
Patent Offices (PO) assess patents PO have no power and competence to assess
quality, safety and efficacy of medicines or agree
on price & reimbursement
National Authorities assess quality,
safety and efficacy of medicines +
agree on price & reimbursement no power to judge validity of patents of
medicines
To delay generic competition
PATENT and SPC protection: MONOPOLY
MA Price,
Reimbursement,
generic
substitution
AT PATENT EXPIRY: LAUNCH OF
GENERIC MEDICINES
Free competition from generic medicines
PATENT and SPC protection hindering
administrative acts
DELAYED LAUNCH
Free competition DELAY: Monopoly
1. No patent linkage
2. Patent linkage
Aim of Patent Linkage
AT PATENT EXPIRY: NO LAUNCH
OF GENERIC MEDICINES
27
TRIPS Agreement
TRIPS Agreement
No reference to any obligation to link patents to registration or reimbursement of medicinal products
on the contrary
Preamble recognises that IP rights are ‘private rights’
– i.e. it is up to patent holders to enforce their rights, NOT Regulatory Authorities
28
WHO Briefing Note
Access to Medicines March 2006
‘Linkage between patent status and generic
registration would be
problematic….regulators may not have the
expertise to assess whether the patent is
valid and would be infringed. As a result, it
is likely that they will enforce all patents,
even invalid ones - and this creates additional
and unnessary hurdles for generic
competition’…….
29
WHO Contd.
‘From the perspective of access to
medicines, this is a worrying
trend; countries should be vigilant
and should not ‘trade away’ their
people’s right to have access to
medicines.’
30
Portugal example
Portuguese Medicinal Agency sued by originators
for granting MA for generics during patent period
despite Bolar
Generic companies sued for applying for a MA
RESULT: existence since several years of many
court cases (900!) blocking the approval of MA
and impeding the marketing of generic medicines
Now they have proposed an arbitration
mechanism
Real way is to stop patent linkage with an
improved and harmonized Bolar
31
Italy example
New attempt of PL in Italy in view of the recent
adoption by the Gov. of Law Decree n. 158
(13/09/2012), at the moment in discussion in
Parliament to be converted into ordinary law.
Free English Translation:… generic medicines
cannot be classified as medicines reimbursed by
the national health system before the date of
patent or SPC expiry of the originator medicine
published by the Ministry of Economic
Development.
32
We will Continue to Challenge
Patent Linkage !!!
3. Detention of generic
medicines in transit:
Review of Regulation on
Customs Enforcement of IP
rights
Netherlands: detention of medicines en route to Brazil/Colombia/Peru from India Dr Reddy’s: Losartan Potassium
Bftalactamicos S.A: Clopidogrel
Cipla: Rivastigmine/Olanzapine
Warning letters from originators asking for destruction of the goods detained based on patent infringement in the NL
In some cases samples were taken during detentions and handed to originator
Diplomatic incident EU-India/Brazil
Legitimate generic medicines detained
at EU borders and confused with
counterfeit/falsified medicines.
35
Review Customs Regulation on
Enforcement of IP Rights:
Customs authorities should, when assessing a
risk of infringement of intellectual property
rights, take account of any substantial
likelihood of diversion of these goods on to the
market of the Union. Guidelines according to
Nokia/Phillips case (ECJ Judgment 2011):
• Proof of goods sold to a customer, offered or
advertised for sale
• Destination of goods not declared
• Lack of information on identity/address of
consignor of goods/ Lack of cooperation
36
EGA aim: right to be heard
Achieve proper balance between the rights
of patent holder and product holder
Essential component of the right of defence
and, by providing additional elements of
information to the customs authorities, it
helps them in the decision making process.
Will avoid situations in which undue
detentions might take place
Ensure samples are not taken during
detentions
4. Free Trade Agreements
-FTAs-
FTAs “Trips Plus” Caution
Concerns that TRIPs Plus obligations are
“pushed” by EU into FTAs
extensive data exclusivity,
patent linkage,
patent extensions
criminalization of patent disputes
TRIPs plus can limit the market where we
are operating such as for ex. Canada
European Commission DG Trade
Pharmaceuticals Fiche (16/12/2011) stating:
‘The EU should also seek to find the correct
balance in bilateral and multilateral trade
agreements, in order that it does not
impose TRIPS+ requirements on countries
where this may have an adverse effect on
their public health or the ability of the EU
to import its own generic medicines.’
EU & US IP Systems
40
IP Elements EU USA
Data Exclusivity
(DE), Market
Exclusivity (ME)
(years) and Filing
Moratorium (FM)
Generics and
Biosimilars:
8 (DE) +2 (ME) +1
(New Indication)
• Generics: 5 years (FM), 3
years for changes to an
application supported by a
clinical study
• Biologics: 12 years (ME)
Bolar Restricted Bolar
(only since 2004)
Broad Bolar (since 1987)
Patent Linkage NO YES
First Mover
Incentive
NO YES (6 months exclusivity)
Supplementary
Protection
Certificate (SPC)
YES (up to 15 years) YES (up to 14 years)
Pediatric
Extension
YES (+ 6 months
SPC)
YES (6 months of DE)
Market Share
(volume)
50 % 80%
Differences between USA and
EU approaches to IP and DE
Mix and match of the 2 systems
A) Country signs an FTA with US and
incorporates patent linkage
B) Same country signs FTA with the EU with high
DE (8 years for ex.)
Data Exclusivity Patent Linkage
EU 8+2+1 years No, against EU
Law
US 5 years Yes
Country X 8 years (EU FTA) Yes (US FTA)
Differences between USA and
EU approaches to IP and DE
Result of excessive DE combined with PL:
•Country ends up with an IP system much
stricter than the EU and US systems.
•Ability of companies to supply affordable
medicines to population is hindered
•Serious constraints to the activities of
European generic medicines companies to
develop local markets.
Challenges following EU
IP reforms
A review of the Enforcement Directive giving the
opportunity to the companies to present invalidity
defenses and protective letters.
FTAs : end of Trips plus provisions
Prevent detentions of generic medicines at EU
borders by facilitating right to be heard
Continue fighting patent linkage
THANK YOU
www.egagenerics.com