advanced strategies for enforcing pharma patents in · pdf fileadvanced strategies for...
TRANSCRIPT
1 Life Science IP Seminar 2017
Dr. Dirk Schüßler-Langeheine
Advanced strategies for enforcing
pharma patents in Europe
German Attorney-at-Law | Partner
2 Life Science IP Seminar 2017
Effective use of competitive intelligence: Early preparation is key
Legal steps based on generic pre-launch activities
Availability of provisional injunctions in various European countries
Use of the „specific mechanism“ against parallel imports
3 Life Science IP Seminar 2017
Effective use of competitive intelligence: Early preparation is key
Legal steps based on generic pre-launch activities
Availability of provisional injunctions in various European countries
Use of the „specific mechanism“ against parallel imports
4 Life Science IP Seminar 2017
Typical time frames
Example of increased activity as patent expiry approaches
Time Patent Expiry
1-2 years
About 160 companies advertising active pharmaceutical ingredient (API) on internet worldwide
Parallel imports from “Specific Mechanism” states (e.g. into UK)
Offers (and possibly sales) of generic products to hospitals (e.g. NL)
Imports by internet pharmacies (e.g. CH)
Early advertising of market entry (e.g. DE)
5 Life Science IP Seminar 2017
W4
Patentee
Time
W1
W4
W3
W2
W1 – W4: Competitors
W1
W4
W3
W2
Patent Expiry
Tu
rno
ve
r
Incentive for early generic launch and patentee‘s corresponding loss
6 Life Science IP Seminar 2017
Requests for preliminary
injunctions (PI)
Preparation by patentee and/or (exclusive) licensee
Requests for inspection
and/or seizure
Information and/or
warning letters
• API manufacturers
• Marketing authorization (MA) applicants/holders
• Manufacturers listed in generic MA documents
• Regulatory authorities (e.g. FOIA requests)
• Health insurance companies (e.g. regarding tenders)
• Pharmaceutical wholesalers
• Hospitals / (online) pharmacies
• Pharmaceutical database providers
• Parallel importers
• Border detention requests at customs authorities
Standard Operating
Procedures (SOPs)
• Reaction to inquiries from parallel importers
• Steps to be taken upon generic product launch, etc.
7 Life Science IP Seminar 2017
Competitive intelligence / How to gain relevant information
• Information on some of the relevant (pre-launch) activities can be
obtained from publicly available sources, such as
– Offerings on the internet
– Databases from European or national drug authorities (e.g., PT and FI
authorities publish MA applications, others information upon MA grant)
• Other information requires specific steps to be taken
– Some drug authorities provide information on MA applicants or details
regarding generic products in response to FOI requests (e.g., PT, IT)
– Offerings can be detected by attending relevant trade fairs (e.g., CPhI)
– Reactions to information/warning letters may reveal information
– Border detention requests may reveal information on involved players
and product streams
Effective monitoring is key!
Taking creative and most likely effective measures is key!
8 Life Science IP Seminar 2017
Example Germany: Recommendable steps include typically …
• Monitoring of database of German drug authority BfArM for granted
generic MAs
(FOI requests regarding pending MA applications possible, but
usually no information on identity of applicant available from BfArM)
• Monitoring of pharmaceutical databases (e.g., IFAP)
• Monitoring reports on rep force activities (GfK reports, etc.)
• Monitoring of public health insurance tenders for rebates
• Monitoring of Lauer-Taxe for generic product offering/launch
• Bi-monthly (1st and 15th), CD version usually obtained a few days in
advance of effective date
• Listing in Lauer-Taxe is accepted as evidence of infringement
• Internet search for online offerings
• of the API (research use disclaimers often considered irrelevant)
• of the relevant product
• Border detention requests (customs authorities are cooperative)
Competitive intelligence / How to gain relevant information
9 Life Science IP Seminar 2017
Competitive Intelligence / How to gain relevant information
• Some types of information can only be obtained through
professional service providers / investigation companies providing
competitive intelligence (CI)
• Fees are substantial, but may help to obtain additional valuable
information early on regarding
– relevant players and their role;
– interrelations among them, in particular vertical structures;
– intermediate product suppliers (possibly revealing processes used);
– pre-launch activities and early entry strategies;
– unpublished regulatory activities, relevant time lines, etc.
• Such information may be helpful in particular for
– border detention or other inspection/seizure requests and/or
– to focus preparatory activities (on markets of key players etc.)
• To obtain a maximum benefit it may be considered to involve CI
company at an early stage of the enforcement project, possibly
even upon launch of the originator product
10 Life Science IP Seminar 2017
• Preparation of a generic launch often starts soon after the
introduction of the originator product
• Generics usually do not disclose strategies before launch
• However, it is generally possible to identify a lot of
information regarding generics developments
• Early start (long duration) and broad geographic/technological
coverage will increase likelihood to obtain relevant information
• Due to a disintegrated industry with competitive markets at each
value chain level, there will be sales activities on every level at
some point in time, opening a window of opportunity for CI
• For example, value chain partnerships and intermediate product
supply contracts may be entered into early on
• Even activities such as testing of the originator product or own
(intermediate) products may be spotted
• (Supplies for) bioequivalence trials may be spotted
• CI can typically benefit from long development times
Competitive Intelligence / How to gain relevant information
11 Life Science IP Seminar 2017
Vertical indicators
• Analysis of originator product
• Partnerships with API producers and/or inter-mediate product suppliers, regulatory agents, dossier developpers, CROs, CMs
• Imports of API, intermediate or final product
Clinical indicators
• Sample testing
• Bioequivalence studies of generic product
Regulatory indicators
• Application in not protected countries pre-warning
• API registration
• MA applications/grants
Patent indicators
• Patent applications by generics companies relating to API, intermediate products, formulations, etc.
Competitive Intelligence / How to gain relevant information
Starting early and combining all relevant pieces of information is often key to
better understand players, markets, products and timing!
12 Life Science IP Seminar 2017
Effective use of competitive intelligence: Early preparation is key
Legal steps based on generic pre-launch activities
Availability of provisional injunctions in various European countries
Use of the „specific mechanism“ against parallel imports
13 Life Science IP Seminar 2017
When to take legal action?
Requirement
of ...
MA Price Approval Approval for
Reimbursement
Austria + + +
Belgium + + +
Denmark + - +
France + + +
Germany + - -
Spain + + +*
UK + - -
Regulatory background
* Additionally marketing declaration necessary
14 Life Science IP Seminar 2017
When to take legal action?
Which measures under regulatory law (possibly in combination with other activities) constitute: patent infringement, or
imminent risk of patent infringement, or
any other reason for legal steps by the patentee
What other generic pre-launch activities may trigger legal action by the patentee?
What legal means are available at what stage?
There is no uniform answer for Europe, but case law in various European jurisdictions provides some country-specific guidance
15 Life Science IP Seminar 2017
When to take legal action in Germany?
Regulatory steps:
• The application for or grant of a marketing authorization
does not create an imminent risk of infringement even if it is
obtained long before patent expiry
• Exception: the authorization expires prior to the end of term
of the patent
• No further regulatory steps required before product launch
Warning letters:
• No imminent risk of infringement because generic MA holder
does not respond (or responds evasively) to a warning letter
(e.g. OLG Düsseldorf, GRUR-RR 2013, 241, 242 – HIV-Medikament;
OLG Düsseldorf, BeckRS 2006, 05129 – Terbinafinin)
16 Life Science IP Seminar 2017
Registration in databases:
• Listing in the Lauer-Taxe during the term of IP constitutes
infringement, even if listed shortly before patent expiry, and even if
product is available only after patent expiry.
• Listing in other databases such as physicians’ software sufficient
Announcement of market entry:
• Serious and unambiguous specific announcement of intended
market entry is generally sufficient for imminent threat of
infringement (can be vis-à-vis patentee, pharmacy, physician, etc.)
• Questionable when intent to enter the market is not sufficiently
clear or marketing authorization has not been obtained at the time
of the notification (OLG Düsseldorf, BeckRS 2016, 03691)
When to take legal action in Germany?
17 Life Science IP Seminar 2017
Trade shows
• The exhibition or advertisement of an infringing product on a trade
show typically constitutes an infringing offer
• This applies even if the product is to be supplied only in a different
country and/or after patent expiry
• However, exceptions may apply:
• The product is not certified/authorized yet (LG Hamburg,
GRUR-RR 2014, 137 – Koronastent)
• There is no commercial objective (questionable whether
applicable to pharma cases)
When to take legal action in Germany?
18 Life Science IP Seminar 2017
When to take legal action in Germany?
Criteria Status
Time • Within 1-3 days; inspection to be carried out within 1 month
Ex parte • Yes
Validity • Registration sufficient for inspection order, but subsequent
discussion possible
Require-
ments
• Certain likelihood of infringement
• Inspection required and reasonable to obtain evidence of
infringement (other means have been exhausted)
• Balancing of interests (typically in favor of patentee)
Comment • Attorney may attend seizure, but must keep info confidential
• May take time until seized information can be accessed
(only after preliminary confirmation of infringement)
If no (imminent threat of) infringement can be demonstrated,
requesting an inspection order may be an option for clarifying
details of the generic product/process or acts carried out in DE.
19 Life Science IP Seminar 2017
When to take legal action in the UK?
Marketing authorization alone no sufficient indication of an
immediate threat of infringement (Upjohn Company v T.
Kerfoot & Co. Ltd.).
However:
“To justify an order for interim relief one does not need to know
precisely when Teva intend to launch, all one needs to know is
that they intend to launch before expiry and before a full trial
could be heard.”
(Merck et al. v Teva, 2012 HC 12 C00541)
Combination of MA (very well in advance) and silence after a
warning letter considered sufficient for a PI
20 Life Science IP Seminar 2017
Regulatory steps:
PI Proceedings – European
Perspective
• A launch can occur 15 days after the marketing declaration has
been filed (not published!)
• Once the marketing declaration has been filed, the Ministry of
Health will create a homogenous group – pharmacies will be obliged
to dispense the Product with the lowest price, etc.
• Nonetheless, the threat of infringement will only be clearly imminent
once the marketing declaration has been filed.
• At an earlier point in time additional evidence is required, e.g.
suspicious answers to warning letters after obtaining reimbursement
status.
When to take legal action in Spain?
21 Life Science IP Seminar 2017
New development: In a decision of February 23, 2017, the
Commercial Court No. 5 of Barcelona accepted a two step ex
parte assessment where the question of infringement was still
unclear (during the 2017 Mobile World Congress in Barcelona):
• Procedure for verification of facts („Diligencias“)
• Seizure of accused product combined with expert opinion on infringement
Step 1 (Immediate) ex
parte PI if expert opinion confirms
infringement
Step 2
When to take legal action in Spain?
22 Life Science IP Seminar 2017
• Product launch occurs approx. 1-2 months after MA grant
• MA only takes effect after publication in the Italian Official
Journal – price needs to be determined before
• Compulsory stickers („Bollini“) need to be obtained
• Finally, generics must inform drug authority AIFA on availability
of product
• „Balduzzi Decree“ – AIFA shall not grant reimbursable price to
generics covered by patent/SPC
• Corresponding application/notification for inclusion in Balduzzi
Index needs to be filed
• Courts have applied narrow interpretation to compound patents –
however these precedents are not binding
When to take legal action in Italy?
Regulatory steps:
23 Life Science IP Seminar 2017
• Refusal to provide undertaking in response to warning letter may
constitute imminent threat of infringement.
When to take legal action in Italy?
Warning letters:
24 Life Science IP Seminar 2017
Regulatory steps:
• As in other countries, there mere grant of an MA does not result in
a threat of imminent infringement justifying a PI, but:
• PI may be triggered by the confirmation of the national drug
authority (CEPS) that the generic MA holder is ready to market its
product before the expiry of the relevant IP rights.
When to take legal action in France
25 Life Science IP Seminar 2017
When to take legal action in the Netherlands
Regulatory steps:
• Publication of price in the G-Standaard of the Z-Index usually
triggers infringement (Supreme Court 22 June 2012
(Pharmachemie v Glaxo))
• Such publication is not compulsory for launch
• PI application can be taken immediately after publication (third
Thursday of each month), in combination with a request for
provisional measure pending decision.
26 Life Science IP Seminar 2017
When is (an imminent threat of) infringement established?
MA Pricing Reimburse-
ment
No-Reply
to Warning
Letter
Attacking
Patent
Public Tender
by Health
Insurance
Announce-
ment to
market
product
AT Yes
BE Yes (if cumulatively present)
DK No No
FR No (even if cumulatively present) (Possibly) Yes
DE No n/a n/a No No (Possibly)
Yes Yes
ES No No (only after
declaration)
(Possibly)
Yes Yes
PT Yes*
NL No Yes
IT No (Possibly)
Yes Yes
UK No (Possibly)
Yes
* Statutory requirement to start arbitrat ion proceedings within 30 days
27 Life Science IP Seminar 2017
Effective use of competitive intelligence: Early preparation is key
Legal steps based on generic pre-launch activities
Availability of provisional injunctions in various European countries
Use of the „specific mechanism“ against parallel imports
28 Life Science IP Seminar 2017
• Identify countries where to take action
• Select IP rights and clarify standing to sue
• Acquisition of infringing product
• Define plaintiff(s) and defendant(s)
• Assessment of the case at hand
• Selection of appropriate court (‘forum shopping’)
• Start of proceedings
• Main proceedings
Purchase Claim for information Inspection
Expert opinion on infringement
Expert opinion on validity
Speed, costs, chances
Cross-border effects
Warning letters
Preliminary injunction (PI)
Preparatory/strategic considerations prior to filing for a PI
29 Life Science IP Seminar 2017
PI Proceedings in Germany: Overview
Criteria Status
Time • Within 1-3 days (ex parte) or 6-12 weeks (inter partes)
Ex parte • Yes, but only if particular urgency is demonstrated
(+) in the event of (imminent) generic market entry, typically
shortly before patent expiry
Validity • Yes, patentee usually has to demonstrate validity of the patent
(+) if patent survived opposition, revocation action or TPO, or
patent is respected by competitors (licenses, undertakings, etc.)
• Under special circumstances (including early generic launch)
assumption of validity may work in favour of petitioner
Require-
ments
• Clear infringement (and sufficiently secured validity)
• Urgency (quick filing of PI request)
• Balancing of interests (typically in favor of patentee/licensee)
Comment • Protective briefs accepted by courts and often used
German PI Proceedings
30 Life Science IP Seminar 2017
Preparation of Documents
• Template for PI Request
• Documents establishing petitioner’s standing to sue
• Affidavit regarding validity/Affidavit regarding urgency
• Bank guarantee (typically only inter partes)
• No detailed economic analysis required
German PI Proceedings
31 Life Science IP Seminar 2017
Sample Timelines
1 day
Filing PI
application Grant of ex parte PI
Service of PI on respondent
1 day
Respondent files objection
1 month
Petitioner’s response to
objection
Oral hearing
14 days 14 days 14 days
1st instance judgment
1 month
Appeal 2nd instance
judgment
5 months
German PI Proceedings
32 Life Science IP Seminar 2017
Scope of Provisional Injunction
• Cease and desist order (relating to all relevant activities)
• Sequestration of infringing products to a court bailiff to
secure destruction claim
• In case of non-compliance: Disciplinary fine of up to
250,000 Euro or detention
(Note: No damages can be obtained in PI proceedings)
German PI Proceedings
33 Life Science IP Seminar 2017
• Sufficient knowledge of infringement/imminent infringement as
starting point for the „urgency clock“
• Urgency period typically one month
• Düsseldorf courts handle urgency requirement more generously
(up to six weeks possible)
Application for
PI
Urgency Period
Sufficent Knowledge
German PI Proceedings
34 Life Science IP Seminar 2017
Diligence vs. Urgency
• Urgency does not require that patentee chose the fastest
possible point in time to file a PI application, but the overall effort
demonstrates that PI protection was sought without unnecessary
delay
• No unreasonable risk of litigation needs to be taken - patentee
must be allowed to obtain sufficient evidence, e.g. obtaining of
samples, test results to be confirmed by an independent expert
etc. as long as these measures can be considered necessary
• Also relevant change of case law in favor of patentee may re -
start “urgency clock”, but change of influential literature opinion is
not sufficient (OLG Dusseldorf, May 5, 2017)
German PI Proceedings
35 Life Science IP Seminar 2017
Sufficiently secured validity
Düsseldorf:
• Preliminary injunctions usually require that patent has “survived”
contradictory proceedings, or at least third party observations.
• Exceptions apply in originator-generics constellations, but the
court must still come to the conclusion that there are better
reasons for the validity of the patent than against it (e.g., OLG
Düsseldorf, GRUR 2013, 236, 240 – Flupirtin-Maleat).
• “Urgency clock” can also be restarted by positive decision on
validity of injunction patent in contradictory proceedings.
Munich:
• More flexible regarding validity, but strict on urgency (no restart
of urgency clock after survival of validity challenge)
German PI Proceedings
36 Life Science IP Seminar 2017
Criteria Status
Time • Days to weeks (inter pares), depending on the urgency
Ex parte • Theoretically yes (without notice), but only in very urgent
cases – good practice to seek an undertaking from the
other party
Validity • Assessment of validity (+), but low threshold
Require-
ments
• Serious case to be tried
• Balance of convenience
Comment • Question of whether damages will provide adequate
compensation is the dominating principle
• Clearing the way doctrine less dominant then it once
was, but still material factor
UK: Overview
PI Proceedings in the UK
37 Life Science IP Seminar 2017
Criteria Status
Time • 3-5 months (inter partes)
Ex parte • Theoretically yes, but rare in practice
Validity • Assessment of validity (+)
Require-
ments
• Prima facie evidence of infringement (and validity)
• Risk of irreparable harm
Comment • Grant of MA itself is no trigger for a PI
• Further pre-marketing acts required, e.g. advertising of
stock-piling, broad Italian Bolar exemption
• Case-by-case analysis
• Sending of warning letters is common
Italy: Overview
Italy Proceedings
38 Life Science IP Seminar 2017
Criteria Status
Time • 3-5 months (inter partes)
Ex parte • Theoretically yes, but rare in practice
• Changing practice?
Validity • Assessment of validity in the context of PI decision
Require-
ments
• Prima facie evidence of infringement (and validity)
• Risk of irreparable harm
Comment • Filed in the context of main infringement proceedings
• Just one round of briefs for both parties even in main
proceedings (no written response in PI proceedings)
• Taking of oral expert witness evidence possible
Spain: Overview
Spanish PI Proceedings
39 Life Science IP Seminar 2017
7 weeks
Filing PI
application Court orders PI
hearing in
3 months
Court orders
filing of
defendant‘s
expert opinion
5 days before
PI hearing
Court
postpones
PI hearing
upon
defendant‘s
request
PI hearing
PI decision Appeal
filed by
defendant
Response
filed by plaintiff
Appeal
decision
20 days 8 days 6 weeks 1 m 11 weeks 2 months 7 months
Spain: Time Line Example Case
Spanish PI Proceedings
40 Life Science IP Seminar 2017
Criteria Status
Time • 1-3 months (inter partes)
Ex parte • Theoretically yes, but rare in practice
Validity • Respondent may (and has to) demonstrate serious validity
challenge (Note: deviation from previous case law where
doubts regarding validity were sufficient to reject PI)
Require-
ments
• Actual or imminent infringement (summary assessment)
• Balancing of interests in favor of patentee (outcome
seems to depend on the personal approach of the judge;
some judges are known to reject PIs against generics in
general)
• No urgency requirement; thorough preparation is key
France: Overview
French PI Proceedings
41 Life Science IP Seminar 2017
2 months
Filing PI application
Defendant files response
10 days
Oral hearing
PI Judgment
1 month
France: Time Line Example Case
French PI Proceedings
42 Life Science IP Seminar 2017
Criteria Status
Time • 1-4 months (inter partes)
Ex parte • Theoretically yes, but rare in practice
Validity • Court may anticipate invalidation in main infringement
proceedings and deny PI for that reason
Require-
ments
• Sufficient likelihood of infringement (and validity)
• Urgency ((+) infringement ongoing)
• Trigger is generally publication of price in the G-
Standaard of the Z-Index (usually soft launch)
Comment • Rather comprehensive proceedings, often anticipating
and replacing main infringement proceedings
• Dutch courts particularly willing to grant cross-border PIs
The Netherlands: Overview
Dutch PI Proceedings
43 Life Science IP Seminar 2017
5 days
Filing PI
application 1st round of
exhibits
by plaintiff Response and
exhibits
by defendant 2nd round of
exhibits
by plaintiff 2nd round of
exhibits
by defendant
Oral hearing
Expert reports
PI Judgment
16 days 5 days 2 days 5 days 1 month 1 month
The Netherlands: Time Line Example Case
Dutch PI Proceedings
44 Life Science IP Seminar 2017
Criteria Status
Time • Court decision within 7 days (by law)
Ex parte • Yes (by law)
Validity • Only if lack of validity is established (also for utility model)
Require-
ments
• Sufficient evidence of infringement
• Necessity that PI is granted (accepted in originator vs.
generics constellation)
Comment • Entirely written procedure (by law)
• No severe sanctions in the event of non-compliance with
PI order (only low court penalty), but border measures
available to enforce IP right effectively
Czech Republic: Overview
Czech PI Proceedings
45 Life Science IP Seminar 2017
7 days 16 days 4 months 17 days
Filing PI
application
PI granted Appeal filed
by defendantt Response filed
by plaintiff Appeal decision
Czech Republic: Time Line Example Case
Czech PI Proceedings
46 Life Science IP Seminar 2017
Criteria Status
Time • Within two weeks
Ex parte • Yes
Validity • Even stay of PI proceedings possible when proceedings
regarding validity (e.g., EPO opposition) are pending
Require-
ments
• Credible evidence of infringement
• Demonstration of legal interest to obtain a PI, i.e. difficulty
to enforce possible later court decision effectively
(accepted in originator vs. generics constellation)
Comment • No severe sanctions in the event of non-compliance with PI
order (only low court penalty)
Poland: Overview
Polish PI Proceedings
47 Life Science IP Seminar 2017
11 days
Filing PI
application
PI granted
13 days
Appeal filed
by defendant
2 months 6 days
Appeal
decision
Poland: Time Line Example Case
Polish PI Proceedings
48 Life Science IP Seminar 2017
Effective use of competitive intelligence: Early preparation is key
Legal steps based on generic pre-launch activities
Availability of provisional injunctions in various European countries
Use of the „specific mechanism“ against parallel imports
49 Life Science IP Seminar 2017
Specific mechanism
2013 2007 2004
Annex to the EU accession treaties
• Import / marketing from
new EU countries
• IP rights in old EU member
states can be enforced even
if the product was put on the
market in a new Member
State for the first time by the
IP right holder or with the IP
right holder ’s consent.
50 Life Science IP Seminar 2017
• Exception to the principle of exhaustion
• Due to concise wording of legal provision, several disputes
on interpretation of the specific mechanism between
originators and parallel importers
• Numerous court decisions underline relevance today
• Here: focus on two issues, namely the application in respect
to SPCs and the consequences of a late assertion
Specific mechanism
Patent or SPC for a pharmaceutical product
New Member States did not provide for “such” protection
at the time of filing
51 Life Science IP Seminar 2017
HRC Dusseldorf, Aug. 6, 2015 – 2 U 21/15 - Ezetimib
Plaintiff had not applied for a
basic patent in Croatia
(although that would have
been possible at the time of
filing) and obtained SPCs in
Germany etc. with
applications filed before SPCs
were introduced in Croatia.
Two issues:
• Does the specific
mechanism apply?
• When was the plaintiff
allowed / required to file a
PI?
December 5, 2014
PI filed
November 5, 2014
Plaintiff discovers AMIS data bank entry
July 23, 2014 / July 30, 2014
2nd and 3rd information letters on the intention of a distribution
23.07.2014
Notice to Federal Ministry of Health on parallel import
Dec 4., 2013
information letter on the intention of a parallel import
52 Life Science IP Seminar 2017
• First instance RC Dusseldorf (4b O 139/14) had decided in the PI
proceedings that it was not possible to rely on SPC protection in
cases where the patentee had failed to apply for basic patent
protection in the new member state
• In contrast, the HRC overturned the decision and granted the PI,
holding that the literal wording of the specific mechanism was
decisive – no room for hypothetical argumentation!
• However, the HRC Dusseldorf does not have the last word on this
issue…
HRC Dusseldorf, Aug. 6, 2015 – 2 U 21/15 - Ezetimib
Availability of SPC protection in the Accession State is relevant for the
application of the Specific Mechanism, irrespective of whether or not basic
patent protection could have (but was not) obtained in the Accession State
53 Life Science IP Seminar 2017
Specific mechanism – CJEU C-681/16 - Etanercept
Current referral from the RC Dusseldorf of December 27, 2016
(GRUR Int. 2017, 321) pending at the CJEU in respect to the
interpretation of the specific mechanism
Parallel import of the pharmaceutical Etanercept to Germany
from Poland, Slovenia, Lithuania and Croatia – SPC
1. Can an SPC holder prevent the
importation of products into Germany,
if the SPC was applied for at a point
in time at which the laws for obtaining
such a supplementary protection
certificate already existed in the
respective accession States but SPC
holder lacked basic patent protection
in the accession states?
54 Life Science IP Seminar 2017
2. Does it make any
difference to the
answer to Question 1
if protection through a
basic patent could not
be obtained in the
accession State at the
time of fi l ing,
but
by the time of
publication of the
application?
3. Can the holder of a
SPC
rely on the specific
mechanism to prevent
the importation of
products if those
products are imported
after the expiry of the
term of the SPC
but before the expiry of
the six-month
extension of the term
of the SPC on the
basis of Regulation
(EC) No 1901/2006 on
medicinal products for
pediatric use?
4. Does it make any
difference to the
answer to Question 3,
in the case of Croatia,
where the specific
mechanism did not
come into force until
after the entry into
force of Regulation
(EC) No 1901/2006 –
unlike in the other
Member States which
acceded prior to 26
January 2007?
Specific mechanism – CJEU C-681/16 - Etanercept
55 Life Science IP Seminar 2017
Specific mechanism – CJEU C-539/13 – Merck/Sigma
“Any person intending to import or market a pharmaceutical product
covered by the above paragraph in a Member State where the product
enjoys patent or supplementary protection shall demonstrate to the
competent authorities in the application regarding that import that one
month's prior notification has been given to the holder or beneficiary of
such protection.”
• Holder/beneficiary of a patent/SPC is not required to give
notification of the intention to oppose a proposed
importation before asserting rights under the first paragraph of
that mechanism
• However, if such intention is not indicated during the one-month
waiting period laid down the person proposing to import the
pharmaceutical product in question may legitimately apply to the
competent authorities for authorisation to import the product and,
where appropriate, import and market it.
• Consequence: Late assertion does only forfeit rights in respect to
past use (i.e. no damages for past use), put not for the future
56 Life Science IP Seminar 2017
Thank you for your attention!
Dr. Dirk Schüßler-Langeheine [email protected]
German attorney-at-law | Partner