Advanced strategies for enforcing pharma patents in · PDF fileAdvanced strategies for...

1 Life Science IP Seminar 2017

Dr. Dirk Schüßler-Langeheine

Advanced strategies for enforcing

pharma patents in Europe

German Attorney-at-Law | Partner


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


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)


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


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.


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!


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


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


• 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



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.


Starting early and combining all relevant pieces of information is often key to

better understand players, markets, products and timing!


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


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


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)


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)



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)




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.


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


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?


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?


• 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:


• Refusal to provide undertaking in response to warning letter may

constitute imminent threat of infringement.

When to take legal action in Italy?

Warning letters:


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


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.


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


• 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


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


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



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



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)



• 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



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)



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)



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


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


Criteria Status



• 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


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


Criteria Status



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


2 months

Filing PI application

Defendant files response

10 days

Oral hearing

PI Judgment

1 month

France: Time Line Example Case

French PI Proceedings


Criteria Status



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


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


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


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


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


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


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.


• 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


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


• 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


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?


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


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


Thank you for your attention!

Dr. Dirk Schüßler-Langeheine [email protected]

German attorney-at-law | Partner

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