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Rivaroksaban_kiri_05_06_2024_-_final.asice

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KRISTER TAMM PNOEE-38012302742 2024-06-05 10:57:26

TANEL KUUSMANN PNOEE-37707150309 2024-06-05 12:01:05

Notice_letter_to_Tamro_Eesti_OU.pdf

Ellex Raidla Advokaadibüroo OÜ Kaarli pst 1 / Roosikrantsi 2, Tallinn EE-10119, Estonia T. +372 640 7170 estonia@ellex.legal ellex.legal

Reg. 10344152 VAT EE100101799

Mari Must T. +372 6407170 mari.must@ellex.legal

Estonia • Latvia • Lithuania

The following terms (available on our website) apply to all our services.

Ellex Raidla is part of Ellex, Baltic circle of legal excellence ellex.legal

Tamro Eesti OÜ

Pärnu mnt. 501, Laagri, 76401, Harjumaa, Estonia

e-mail: info.ee@tamro.com

9 February 2024

DNo. F039

Bayer Intellectual Property GmbH intellectual property rights related to rivaroxaban in Estonia

Dear Sirs

We hereby notify you that Bayer Intellectual Property GmbH (“Bayer”), with its registered office in Monheim

am Rhein, has instructed us to represent its rights and interests in the above-mentioned matter.

1.

Our client's parent company, Bayer AG, based in Leverkusen, Germany, holds a European marketing

authorisation No EU/1/08/472 for Xarelto® (active ingredient rivaroxaban), which was granted on 30

September 2008.

Xarelto® is approved in various dosages for the following indications:

• Xarelto® 1 mg/ml granules for oral suspension: Treatment of venous thromboembolism (VTE) and

prevention of VTE recurrence in term neonates, infants and toddlers, children, and adolescents aged

less than 18 years after at least 5 days of initial parenteral anticoagulation treatment.

• Xarelto® 2.5 mg film-coated tablets: (a) Xarelto, co-administered with acetylsalicylic acid (ASA) alone

or with ASA pius clopidogrel or ticlopidine, is indicated for the prevention of atherothrombotic events in

adult patients after an acute coronary syndrome (ACS) with elevated cardiac biomarkers; (b) Xarelto, co-

administered with acetylsalicylic acid (ASA), is indicated for the prevention of atherothrombotic events in

adult patients with coronary artery disease (CAD) or symptomatic peripheral artery disease (PAD) at high

risk of ischaemic events.

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• Xarelto® 10 mg film-coated tablets: (a) Prevention of venous thromboembolism (VTE) in adult patients

undergoing elective hip or knee replacement surgery; (b) Treatment of deep vein thrombosis (DVT) and

pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults.

• Xarelto® 15 mg film-coated tablets: Adults: (a) Prevention of stroke and systemic embolism in adult

patients with non-valvular atrial fibrillation with one or more risk factors, such as congestive heart failure,

hypertension, age > 75 years, diabetes mellitus, prior stroke or transient ischaemic attack. (b) Treatment

of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE

in adults. Paediatric population: Treatment of venous thromboembolism (VTE) and prevention of VTE

recurrence in children and adolescents aged less than 18 years and weighing from 30 kg to 50 kg after

at least 5 days of initial parenteral anticoagulation treatment.

• Xarelto® 20 mg film-coated tablets: Adults: (a) Prevention of stroke and systemic embolism in adult

patients with non-valvular atrial fibrillation with one or more risk factors, such as congestive heart failure,

hypertension, age > 75 years, diabetes mellitus, prior stroke or transient ischaemic attack; (b) Treatment

of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE

in adults. Paediatric population: Treatment of venous thromboembolism (VTE) and prevention of VTE

recurrence in children and adolescents aged less than 18 years and weighing more than 50 kg after at

least 5 days of initial parenteral anticoagulation treatment.

• Xarelto® 15 mg film-coated tablets + Xarelto 20 mg film-coated tablets: Treatment of deep vein

thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults.

2.

Our client is the sole and exclusive owner of the following property rights relating to the drug Xarelto® and

its active ingredient rivaroxaban.

• The Estonian patent No 05169 (hereinafter "EE05169") entitled "Substituted oxazolidinones and their

use " protects in particular new oxazolidinone derivatives, methods for their production and their use as

active substances in medicinal products. EE05169 was filed on 11 December 2000. The patent was

granted on 15 June 2009 with priority date of 24 December 1999. For your Information, we attach the

patent specification as Exhibit 1.

Although the original patent term of EE05169 has expired, the supplementary protection certificate No

00025 (hereinafter "the SPC") was granted in Estonia on the basis of EE05169. The SPC was filed on

12 August 2009 and granted on 15 October 2009. The SPC is valid until 2 April 2024. For your

information, we enclose an extract from the Estonian Patent Office’s SPC register as Exhibit 2.

• The European patent EP 1 845 961 B1, validated in Estonia under the registration No E010728

("EP'961") entitled "Treatment of thromboembolic disorders with rivaroxaban" protects in claim 1 the use

of a rapid-release tablet of the compound 5-Chloro-N-({(5S)-2-oxo-3-[4-(3- oxo-4-morpholinyl)phenyl]-

1,3- oxazolidin-5-yl}methyl)-2-thiophenecarboxamide for the manufacture of a medicament for the

treatment of a thromboembolic disorder administered no more than once daily for at least five

consecutive days, wherein said compound has a plasma concentration half-life of 10 hours or less when

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orally administered to a human patient. The patent application was filed on 19 January 2006 and the

mention of the grant of the patent was published on 22 April 2015. EP'961 was maintained as granted

by decision of the Technical Board of Appeal of the European Patent Office dated 27 October 2021 (case

number T1732/18). Currently, a revocation action by KRKA d.d., Novo mesto against the EP ‘961

validated in Estonia has been filed to the Industrial Property Board of Appeal which Bayer considers

unfounded. For your information, we enclose the patent specification as Exhibit 3. The patent is valid

until 19 January 2026.

• The European patent EP 1 720 866 B1, validated in Estonia under the registration No E005910

("EP'866") entitled "Production method" protects a process for preparing 5-Chloro-N-({(5S)-2-oxo-3-[4-

(3- oxo-4-morpholinyl)phenyl]-1,3- oxazolidin-5-yl}methyl)-2-thiophenecarboxamide of the formula

known from claim 2 of 05169 for the active substance rivaroxaban by reacting 4-{4-(5S)-5-(aminomethyl)-

2-oxo-1,3-oxazolidin-3-yl]phenyl}morpholin-3-one (VII) hydrochloride with 5-chlorothiophene-2-carbonyl

chloride (IV). The patent application was filed on 31 December 2004 and the mention of the grant of the

patent was published on 3 August 2011. The patent is in force and valid until 31 December 2024. For

your information, we enclose the patent specification as Exhibit 4.

• The European patent EP 1 689 370 B2, validated in Estonia under the registration No E005910

(EP'370") entitled "Method for the production of a solid, orally applicable pharmaceutical composition

comprising 5-chlor-N-({(5-2-oxo-3-[4-(3-oxo-4-morpholinyl)-phenyl]-1,3-oxazolidin-5-yl}-methyl)-2-

thiophenecarboxamide protects a method for the production of solid, orally an applicable pharmaceutical

composition containing 5-chlor-N-({(5-2-oxo-3-[4-(3-oxo-4-morpholinyl)-phenyl]-1,3-oxazolidin-5-yl}-

methyl)-2-thiophenecarboxamide in hydrophilized form, the corresponding pharmaceutical composition

and its use for the prophylaxis and/or treatment of thromboembolic diseases. The patent was filed on 13

November 2004 and the mention of the grant of the patent was published on 13 February 2008. By

decision of the Technical Board of Appeal of 9 June 2015, the patent was maintained in amended form.

The mention of maintenance of the patent in amended form was published on 14 September 2016. For

your information, we enclose the patent specification in the amended form after the opposition and appeal

proceedings as Exhibit 5. The patent is in force and valid until 13 November 2024.

3.

According to the Estonian Agency of Medicines (Ravimiamet) medicinal product database following

marketing authorisations for generic rivaroxaban medicinal products have been granted:

strength and form MA holder MA No

ENKIA 15mg, 20mg tablet Medochemie Limited 1098323, 1098223

KARDATUXAN 2,5mg, 10mg, 15mg, 20mg

tablet

Gedeon Richter Plc. 1069922, 1070822, 1071422,

1072022

RAZARXO 2,5mg, 10mg, 15mg, 20mg

tablet

TAD Pharma GmbH 1140424, 1139024, 1139224,

1140524

RIVAROXABAN

ACCORD

2,5mg, 10mg, 15mg, 20mg

tablet

Accord Healthcare S.L.U. EU/1/20/1488

4

RIVAROXABAN

ALEMBIC

2,5mg, 10mg, 15mg, 20mg

tablet

Alembic Pharmaceuticals

Europe Limited

1045921, 1046021, 1046121,

1046221

RIVAROXABAN

ALIUD

15mg, 20mg, 15mg/20mg

capsule

Stada Arzneimittel AG 1098423, 1098623, 1098523

RIVAROXABAN

AUXILIA

2,5mg, 10mg, 15mg, 20mg

tablet

Auxilia Pharma OÜ 1032721, 1032521, 1032821,

1032621

RIVAROXABAN

G.L. PHARMA

10mg, 15mg, 20mg tablet G.L. Pharma GmbH 1015120, 1014920, 1015020

RIVAROXABAN

ORION

15mg, 20mg tablet Orion Corporation 1108823, 1108923

RIVAROXABAN

STADA

2,5mg, 10mg, 15mg, 20mg,

15mg/20mg tablet

Stada Arzneimittel AG 1076622, 1076822, 1077022,

1076722, 1076922

RIVAROXABAN

TEVA

10mg, 15mg, 20mg tablet Teva B.V. 1020521, 1020421, 1020321

RIVAROXABAN

VIATRIS

2,5mg, 10mg, 15mg, 20mg

15mg/20mg tablet

Viatris Limited EU/1/21/1588

RUNAPLAX 2,5 mg, 10mg, 15mg, 20mg

tablet

Sandoz Pharmaceuticals

d.d.

1017820, 952617, 952717,

952517

XABOPLAX 2,5mg, 10mg, 15mg, 20mg,

15mg/29mg tablet

Sandoz Pharmaceuticals

d.d.

1132323, 1132223, 1131323,

1132123, 1132023

XANIRVA 10mg, 15mg, 20mg capsule Zentiva k.s. 1006520, 1006620, 1006720

XANIRVA 10mg, 15mg, 20mg tablet Zentiva k.s. 1000820, 1000720, 1000620

XERDOXO 2,5mg, 10mg, 15mg, 20 mg

tablet

KRKA, d.d., Novo mesto 1005220, 1005120, 1005320,

1005020

Listed generic medicinal products have been approved for the indications covered by Xarelto®. Estonian

Agency of Medicines decides on the bases of criteria given in the Medicinal Products Act and may refuse

granting the marketing authorisation only when any of the conditions provided in § 74 of the Medicinal

Products Act exist. Medicinal Products Act § 74 does not allow to take into consideration whether importing,

marketing, offering, storing of generic rivaroxaban in Estonia is infringing existing patent rights. Therefore,

decision by the Estonian Agency of Medicines does not legitimize or exclude a patent infringement even if

the agency grants marketing authorisation for a generic rivaroxaban. Same applies to marketing

authorisations granted by the European Medicines Agency.

4.

Our client has become aware that several generic rivaroxaban marketing authorisation holders have filed a

request to the Health Insurance Fund (Tervisekassa) for the inclusion of their generic medicinal products in

the reimbursement list, including (the list is not exhaustive):

KARDATUXAN 2,5mg, 10mg, 15mg, 20mg

tablet

Gedeon Richter Plc. 1069922, 1070822, 1071422,

1072022

5

RIVAROXABAN

ACCORD

2,5mg, 10mg, 15mg, 20mg

tablet

Accord Healthcare S.L.U. EU/1/20/1488

RIVAROXABAN

STADA

2,5mg, 10mg, 15mg, 20mg,

15mg/20mg tablet

Stada Arzneimittel AG 1076622, 1076822, 1077022,

1076722, 1076922

RIVAROXABAN

TEVA

10mg, 15mg, 20mg tablet Teva B.V. 1020521, 1020421, 1020321

RUNAPLAX 2,5 mg, 10mg, 15mg, 20mg

tablet

Sandoz Pharmaceuticals

d.d.

1017820, 952617, 952717,

952517

XANIRVA 10mg, 15mg, 20mg capsule Zentiva k.s. 1006520, 1006620, 1006720

XERDOXO 2,5mg, 10mg, 15mg, 20 mg

tablet

KRKA, d.d., Novo mesto 1005220, 1005120, 1005320,

1005020

The Board of the Health Insurance Fund decides on the bases of criteria given in the Health Insurance Act §

43 (2) that does not allow to take into consideration whether importing, marketing, offering, storing of generic

rivaroxaban in Estonia is infringing existing patent rights. Therefore, decision by the Board of the Health

Insurance Fund does not legitimize or exclude a patent infringement even if the board decides to satisfy a

request to include generic rivaroxaban in the reimbursement list.

5.

According to Estonian Patents Act § 15 (1) the exclusive right of the proprietor of a patent means that during

the term of validity of the patent and without the permission of the proprietor of the patent no person shall:

• manufacture, use, distribute, sell or offer for sale products protected by the patent or acquire (incl.

by way of importation) such products for the aforesaid purposes;

• use, distribute, sell or offer for sale a product manufactured according to the patented process, or to

acquire (including by way of importation) such products for the aforesaid purposes.

Bayer has sent notice letters to all marketing authorisation holders of generic rivaroxaban in Estonia and

asked the holders to confirm that they and/or their affiliates will respect Bayer’s intellectual property rights

and will not interfere with the scope of their protection. In addition, Bayer has sent reminders to marketing

authorisation holders that have filed a request to the Health Insurance Fund for the inclusion of their generic

rivaroxaban medicinal products in the reimbursement list.

In order to protect its patent rights Bayer is preparing for a request of preliminary injunction against marketing

authorisation holders trying to enter the Estonian market with their generic rivaroxaban products that are

infringing its patent rights. Bayer will vigorously defend its patent rights including bringing preliminary

injunction requests against marketing authorisation holders trying to enter the Estonian market with generic

rivaroxaban products that infringe its patent rights. All rivaroxaban products offered or brought to the market

prior to 3 April 2024 will infringe SPC No 00025. As of 3 April 2024, every generic rivaroxaban product that is

administered once daily will also infringe EP 961, particularly rivaroxaban products with the strengths 10 mg,

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15 mg and 20 mg. Bayer currently does not have sufficient information to determine whether also EP 866

and EP 377 are infringed by certain generic products.

Due to the above, we would like to draw your attention to the fact that buying, wholesale, offering for sale

and distributing generic rivaroxaban medicinal product in Estonia may lead to unwanted legal consequences

for the wholesalers. If you purchase, wholesale, offer for sale or distribute generic rivaroxaban medicinal

product in Estonia, you, as a wholesaler, may also become an infringer of Bayer’s patent rights.

If you infringe Bayer’s patent rights, then Bayer is entitled to use available legal remedies to protect its rights

which we would like to avoid. Therefore, we ask you to confirm by

by 23 February 2024 at the latest

that your company respects and observes the property rights of our client listed in this letter and will

not purchase, wholesale, offer for sale or otherwise distribute generic rivaroxaban medicinal

products in Estonia. Please send the corresponding confirmation by e-mail to mari.must@ellex.legal latest

by 21 February 2024.

Yours sincerely

/signed digitally/ /signed digitally/

Mari Must Ants Nõmper

Counsel Managing Partner

Rivaroksaban_kiri_05_06_2024_final.pdf

TAMRO EESTI OÜ Pärnu mnt 501, Laagri 76401 Harjumaa E-mail: info.ee@tamro.com Tel: 650 3600

Sotsiaalministeerium, e-post: info@sm.ee Ravimiamet, e-post: info@ravimiamet.ee Tervisekassa, e-post: info@tervisekassa.ee 05.06.2024 Tamro Eesti OÜ on Eesti Vabariigis ravimite hulgimüügiga tegelev ettevõte ja pöördume teie poole, et paluda teil kujundada omapoolne seisukoht seoses mõnede ravimitootjate poolt ravimite hulgimüüjale saadetud teavitustega ning nõudekirjadega teatud toimeainet sisaldavate ravimite müügi takistamiseks Eesti Vabariigis. Näiteks oleme saanud nõudekirja advokaadibüroolt ELLEX. Kirjas nõutakse Bayer Intellectual Property GmbH/Bayer AG nimel (esindajaks ELLEX Advokaadibüroo), et ravimite hulgimüüjad ei turustaks geneerililisi rivaroksabaan ravimeid, sh ka siis, kui neid on lubatud turustada Eesti Vabariigi ravimiameti poolt (omavad müügiluba Eestis turustamiseks) ja nende osas on sõlmitud hinnakokkulepe Tervisekassaga. Bayeri toodetav rivaroksabaani sisaldav ravim, mille kaitseks selline kiri on genereeritud, on nimega Xarelto. Advokaadibüroo kirja koopia lisatud. Ravimite hulgimüüjana peame oma kohuseks tagada apteekidele sama toimeainega ravimite kättesaadavus, mis on soodusravimite nimekirjas või mille kohta on ravikindlustuse seaduse § 45 alusel sõlmitud hinnakokkulepe. Oleme seisukohal, et ravimite hulgimüüjana on meil õigus ja kohustus pakkuda võimalusel kõiki Eesti Vabariigis kehtivat müügiluba omavaid ravimeid, sh geneerililisi rivaroksabaan ravimeid, mis on Tervisekassa soodusravimite nimekirjas ning hulgimüüja ei tohi advokaadibüroo kirja peale lõpetada geneeriliste rivaroksabaan ravimite turustamist kuni ei ole keelavat kohtulahendit Eesti kohtult. Käesolevaks hetkeks on Tamro teinud Eestis kättesaadavaks järgnevad rivaroksabaani sisaldavad geneerilised ravimid:

TOOTE NIMETUS TOOTJA Kardatuxan kaetud tbl 10mg N28 Gedeon Richter Kardatuxan kaetud tbl 15mg N28 Gedeon Richter Kardatuxan kaetud tbl 20mg N28 Gedeon Richter Rivaroxaban Stada kaetud tbl 10mg N30 Stada Rivaroxaban Stada kaetud tbl 15mg N28 Stada Rivaroxaban Stada kaetud tbl 15mg/20mg N42+N7 Stada Rivaroxaban Stada kaetud tbl 2,5mg N56 Stada Rivaroxaban Stada kaetud tbl 20mg N28 Stada Rivaroxaban Teva kaetud tbl 10mg N30 Teva Rivaroxaban Teva kaetud tbl 15mg N28 Teva

TAMRO EESTI OÜ Pärnu mnt 501, Laagri 76401 Harjumaa E-mail: info.ee@tamro.com Tel: 650 3600

Rivaroxaban Teva kaetud tbl 20mg N28 Teva Runaplax kaetud tbl 2,5mg N56 Sandoz Xerdoxo kaetud tbl 2,5mg N56 KRKA

Käesoleval hetkel Tamrol oleva info kohaselt on ühe tootja osas 23.05.2024 tehtud ringkonnakohtu määrus, mis hagi tagamise korras keelab KRKA, d.d., Novo mesto kuni lõpliku kohtulahendi jõustumiseni, kuid mitte kauem kui 19. jaanuar 2026 ravimi XERDOXO (tablett) tugevusega 10 mg, 15 mg ja 20 mg impordi Eestisse, selle levitamise, kasutamise, müügiks pakkumise ja müümise Eestis. Käesolevaks hetkeks meile teadaolevalt teiste tootjate osas sarnast hagi tagamise määrust tehtud ei ole. Ravimiameti kodulehel avaldatud andmete kohaselt on ravimi Xarelto osas Ravimiamet keelanud selle väljaveo Eestist1. Eeldatavasti võimalike tootjapoolsete ravimi tarneraskuste tõttu. Seda enam on oluline turustada Eestis geneerililisi rivaroksabaan ravimeid, et tagada rivaroksabaan toimeainet sisaldavate geneeriliste ravimite kättesaadavus Eesti patsientidele. Kuna ravimite kättesaadavuse tagamine Eesti elanikele on meie esmane ülesanne ja arvestades eelkirjeldatut, palume teie seisukohta, kas käesolevas olukorras ravimite hulgimüüja on kohustatud tagama geneerililiste rivaroksabaan ravimite kättesaadavuse Eesti Vabariigis, st ravimid ostma ning võimaldama apteekidesse müüki, kui vastavate geneeriliste ravimite tootjad pakuvad hulgimüüjale nimetatud ravimeid ning koheselt oleks võimalik tagada nende kättesaadavus Eesti patsientidele. Hulgimüüjana peame arvestama ka asjaoluga, et näiteks ravimite 01.07.2024 hinnakokkuleppe nimekirja lisamisel ning tagamaks selle kättesaadavus Eesti patsientidele koheselt, peame ravimeid tellima juba enne 01.07.2024. Lugupidamisega, /allkirjastatud digitaalselt/ /allkirjastatud digitaalselt/ Tanel Kuusmann Krister Tamm Juhatuse liige juhatuse liige

1 https://www.ravimiamet.ee/ravimite-kaitlemine/ravimi-kaitlemine/sisse-ja-valjavedu#keelatud-on- jargmist:~:text=Xarelto%2015%20mg%20%C3%B5hukese%20pol%C3%BCmeerikattega%20tabletid%20N28%20(B ayer,N28%20(Bayer%20AG)%20%2D%C2%A0kuni%20Ravimiameti%20otsuseni%20v%C3%A4ljaveokeelu%20l%C3 %B5petamiseks