Patents // Patent Linkage - Presentation

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Patent Linkage

Introduction

Branko Pejic

Greenblum & Bernstein, USA

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STRENGTHENING THE PRACTICE OF THE INDEPENDENT IP ATTORNEY

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Branko Pejic

USA

Dr. Deepa K. Tiku

India

Alessandro Pontiroli

Italy

Rafał Witek

Poland

STRENGTHENING THE PRACTICE OF THE INDEPENDENT IP ATTORNEY

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Juhua Luo

P.R. China

Patent linkage in EU

Alessandro Pontiroli

Zentiva, Italy

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STRENGTHENING THE PRACTICE OF THE INDEPENDENT IP ATTORNEY

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Rafał Witek

WTS Patent Attorneys, Poland

▸

What is patent linkage

▸

The effects of patent linkage

▸

The applicable legal framework in the EU: the Bolar exemption

▸

The relationship between the Bola

exemption and patent linkage

▸

Examples of patent linkage in the EU

▸

Proposals to eliminate patent linkage

PRESENTATION OUTLINE

▸

Patent linkage involves linking the market authorization decision (but

also, more broadly

the decision regarding the price determination as

well as the reimbursement decision) to the status of the originator’s

patent

▸

Defined by the

European

Commission as “the practice of linking the

granting of [marketing authorisations], pricing and reimbursement

status or any regulatory approval for a generic medicinal product, to

the status of a patent (applications) for the originator reference

product”

WHAT IS PATENT LINKAGE?

▸

Patent linkage in the

is considered anti-competitive (

European

Commission’s

inquiry into the pharmaceutical sector in 2009

)

▸

This

is due to the fact that it can systematically delay generic/biosimilar

market entry, until later than the basic patent/SPC

expiry

date

▸

Problem

when making public decisions on the approval of medicines,

regulatory, P&R and tender authorities are not able to evaluate whether a

patent is valid or relevant, hence they should not base their decisions on the

assumption of patent validity

▸

Patent linkage amplifies the impact of patent strategies aimed at delaying

competition

divisional patent applications and over-patenting

THE EFFECTS OF PATENT LINKAGE

in the EU

‣

Bolar exemption — introduced in EU law in 2004

‣

Art. 126 of Directive 2001/83

/EC

of the

European

Parliament and of the

Council of 6 November 2001 on the Community code relating to medicinal

products for human use

an authorization to market a medicinal product shall not be refused, suspended

or revoked except on the grounds set out in that Directive

‣

Art. 10(6) of Directive 2004/27 amending Directive 2001/83 on the

Community code relating to medicinal products for human use

Conducting the necessary studies and trials with a view to the application of

paragraphs 1, 2, 3 and 4 and the consequential practical requirements shall not

be regarded as contrary to patent rights or to supplementary protection

certificates for medicinal products.

THE APPLICABLE LEGAL FRAMEWORK: BOLAR

EXEMPTION

▸

Problem: harmonization across Member States

in terms of scope of application

(approval for generics only or also innovative medicines using a patented active

ingredient, e.g. for a previously unknown effect?) and of territory (authorizations for

EU,

Europe

only or also for rest of the world)

▸

Two main approaches

to intepretation of Bolar

exemption

Strict approach

for studies directed to the marketing approval for generic

medicines only, and

solely for Europe

(e.g. applied Belgium, the

Netherlands)

Broad approach

Bolar applies also to studies for marketing approval of innovative

medicines and

also for outside Europe

(e.g. Germany, France, Spain, UK,

Switzerland)

THE APPLICABLE LEGAL FRAMEWORK: BOLAR

EXEMPTION

▸

Unified Patent Court (Art 27 (d) UPCA)

literally a strict approach, but a

broad interpretation is possible, case law remains to be established

▸

Which

approach can be applied depends on the type of patent/SPC

▸

Unified patents

Art 27(d) UPCA applies («strict» approach?)

▸

«Classic»

European

patents not opted-out

Art 27(d) UPCA also applies

(«strict» approach?)

▸

National patent and

European

patents opted-out

national Bolar

interpretations apply

THE APPLICABLE LEGAL FRAMEWORK: BOLAR

EXEMPTION

‣

Objective of the Bolar exemption: to “ensure that a generic could

enter the market as soon as possible after the expiry of patent/SPC

protection [...] based on the basic rationale that free competition

should be allowed as soon as protection expires.”

‣

Patent linkage clearly frustrates this objective: a generic medicine

manufacturer cannot participate in procedures required for free and

timely competition, i.e. entry into the market as soon as possible

after the expiry of a patent.

‣

This way, the competition is distorted.

DOES PATENT LINKAGE UNDERMINE THE

BOLAR EXEMPTION?

‣

It is crucial to ensure that the Bolar provisions leave no room for diverging

interpretations in different Member States and provide clear directions and

remove any grey area or legal uncertainty that may prompt the use of

‘patent linkage’ to delay entry of generic players on the market.

‣

Recent cases: in July 2024, the Italian Supreme Court provides a narrow

interpretation of Bolar exemption for API producers (also ruling on

Solifenacin in Germany 2012)

‣

UPC: art 27(d) of UPCA lists the Bolar exemption (Article 13(6) of Directive

2001/82/EC (8) or Article 10(6) of Directive 2001/83/EC) as one of the

limitations to the effects of a patent.

DOES PATENT LINKAGE UNDERMINE THE

BOLAR EXEMPTION?

‣

While

the

uropean Commission position is very clear regarding the

inadmissibility of tying the generic market authorization to the status of the

patent for the original medicine, the situation might be more controversial in the

case of pricing and reimbursement.

The

practice of the

member states is not

coherent in that respect.

AND YET PATENT LINKAGE EXAMPLES ARE

REPORTED IN THE EU

GERMANY :

‣

Dimethyl fumarate for treatment of multiple sclerosis:

P&R authority refused pricing request

due to patents + wholesalers required indemnity agreements from generic manufacturer to

avoid liability for patent infringement.

‣

Ulipristal acetate for emergency contraception and ezetimibe/simvastatin:

generic

manufacturer had to sue IFA to grant P&R decision for generic because of

existing

patents

‣

Lenalidomide for treatment of multiple myeloma, cancer

private entity IFA GmbH required a

declaration that Member and BMS have an agreement allowing generic manufacturer to

launch Gx with full label before relevant patents expire.

‣

Similar declarations were requested by the regulatory authorities to obtain pricing and

reimbursement also in

Denmark, Hungary, Portugal and Poland

EXAMPLES of patent linkage in the EU

FRANCE :

‣

Originators can declare patents/SPCs for their reference products to the pricing

authorities (CEPS). The CEPS will not include a generic in the official list of reimbursed

products until

the 6 months prior to expiry of the patents/SPCs

declared by the

originator, unless the generic company, when requested by the CEPS, states that it the

product launch does not infringe such rights. The CEPS then

informs the originator

that

the generic company has provided such statement. This information from the CEPS to

the originator typically

triggers PI applications

in France.

‣

Sitagliptin & sitagliptin/ metformin for treatment of diabetes and ulipristal acetate for

emergency contraception:

Member had to reassure CEPS its generic would not infringe

patent

‣

Fingolimod for treatment of multiple sclerosis:

P&R authority refused pricing request

due to patents

EXAMPLES of patent linkage in the EU

ITALY :

‣

Brinzolamide timolol for treatment of ocular hypertension or dimethyl fumarate for treatment of multiple sclerosis

P&R authority refused pricing request due to patents

‣

Lenalidomide for treatment of multiple myeloma, cancer

P&R authorities required a declaration that Member and

BMS have an agreement allowing Member to launch Gx with full label before relevant patents expire

‣

The so-called Balduzzi provision (

Decree-law no. 158 of 13 September 2012, converted with amendments into Law

no. 189 of 8 November 2012). In practice, article 11(1) provides that generic drugs cannot be reimbursed by the

National Health Service before the

expiry

date of the patent or SPC of the corresponding original drug.

The

generic

drug, therefore, should be paid 100% by the patients in need of the treatment. In reality, this is equivalent to

preventing the effective launch of the drug.

‣

The

Italian Competition Authority (AGCM) has urged several times Italian Authorities to open up competition in the

pharmaceutical market. Attempts to abrogate the Balduzzi decree by the Parliament were not successful.

EXAMPLES of patent linkage in the EU

POLAND :

‣

Dasatinib for treatment of chronic myeloid leukemia

P&R authorities

required a declaration that Member and BMS have an agreement allowing

Member to launch Gx with full label before relevant patents expire.

‣

Sitagliptin & sitagliptin/ metformin for treatment of diabetes

Authorities

first asked for acknowledgment of existing patents before P&R decision.

EXAMPLES of patent linkage in the EU

PORTUGAL :

‣

A MA application is effectively considered an act of infringement, and originator companies

systematically start IP litigation (within 1 months from MA publication) on each single generic

product.

‣

Fingolimod for treatment of multiple sclerosis

Originator sued P&R authority for P&R contracts

with generic companies over existence patent right

‣

Fesoterodine for treatment of overactive bladder

MA delayed due to existing patent right,

litigation ongoing

‣

Dimethyl fumarate for treatment of multiple sclerosis

Originator sued P&R authority because

listing of generic in hospital catalogue would infringe existing patent right

EXAMPLES of patent linkage in the EU

Hungary :

‣

Sitagliptin, vindagliptin

medicines regulatory agency requires

declaration that (1) Generic companies will not launch product

before

expiration

of relevant patent/SPC and (2) that there are no

other valid patent or SPC rights relevant to planned distribution of

the medicinal product.

EXAMPLES of patent linkage in the EU

‣

Other

examples

were reported in Czech Republic, Denmark,

Estonia,

Finland, Greece, Hungary, Ireland, Lithuania and Romania

‣

Overall

P&R decisions and tenders bids are not covered by national Bolar

exemptions

all 27 Member States

‣

Medicines for Europe documented 48 cases of patent linkage in EU

Member states (report published on 20 October 2023)

EXAMPLES of patent linkage in the EU

Clarify the Bolar exemption

Introduce the ban on patent linkage

HOW TO FIX IT?

Ad. A

CLARIFY THE BOLAR EXEMPTION

Features already permitted by some

Member States should be

explicitly

and clearly included in

the scope of the

existing

Bolar

exemption:

‣

the conduct of studies, trials and activities by all partners for the purpose of seeking

marketing authorisation and subsequent variations

‣

all types of activity necessary for those purposes, e.g. offer, manufacture, supply, storage, import,

export,

use, sale and purchase

‣

the related activities needed to effectively enter the market on day 1 after expiry of the

relevant patent or SPC, e.g., pricing & reimbursement (P&R) approval and listing,

health

technology assessments, tender bids for supply after IP

expiry,

and the conduct of any studies

and trials to generate data in support of these activities.

This

way the Bolar

exemption

would be re-aligned with its objective.

HOW TO FIX IT?

Ad. B

INTRODUCE THE BAN ON PATENT LINKAGE

‣

Formally and

explicitly

prohibiting patent linkage in order to

prevent a situation where the patient access to generic and

biosimilar medicines is unduly and artificially delayed

‣

It could be in line with the ban proposed by the EC in 2012

proposal for Proposal for a Directive of the European Parliament

and of the Council relating to the transparency of measures

regulating the prices of medicinal products for human use and

their inclusion in the scope of public health insurance systems

HOW TO FIX IT?

THANK YOU FOR YOUR ATTENTION!

Alessandro Pontiroli

Zentiva, Italy

Rafał Witek

WTS Patent Attorneys, Poland

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