Unified Patent Court
Einheitliches Patentgericht
Juridiction unifiee du brevet
Paris Local Division
UPC CFI 697/2025
FINAL ORDER
of the Court of First Instance of the Unified Patent Court
delivered on 21/11/2025
concerning provisional measures (R.206 RoP)
APPLICANTS
1) Merz Therapeutics GmbH
Eckenheimer Landstrage 100
60318 Frankfurt am Main - DE
2) Merz Pharmaceuticals LLC
Unit 35/36,
6601 Six Forks Road, 4th Floor
27615 Raleigh, North Carolina - US
3) Merz Pharma France
Tour EQHO, 2 Avenue Gambetta
92400 Courbevoie — FR
Represented by
Latitia Benard
Charles Tuffreau
Edward Oates
Agathe Michel-de Cazotte
DEFENDANT
Viatris Sante
1 rue de Turin
69007 Lyon — FR
Represented by
Marc Lauzeral
Denis Schertenleib
1
PATENT AT ISSUE
Patent no. Proprietor
EP2377536 Merz Pharmaceuticals, LLC
Patent no. SPC details
EP2377536 SPC ID FR13C0033
National Designations FR
Patent no. SPC ID National
Designations
Holders
EP2377536 FR13C0033 FR Merz Pharmaceuticals, LLC
COMPOSITION OF PANEL— FULL PANEL
Presiding judge &
Judge-rapporteur
Legally qualified judge
Legally qualified judge
Technically qualified judge
Camille Lignieres
Carine Gillet
Samuel Granata
Rainer Friedrich
LANGUAGE OF PROCEEDINGS: English
ORDER
THE PARTIES
1. The Applicants (hereinafter "MERZ") are part of the MERZ Group, an international pharma-ceutical
group of German origin. Applicant 1 is Merz Pharmaceuticals LLC, a US company settled
in the State of North Carolina. Applicant 2 is Merz Therapeutics GmbH, a German company, spe-cialised
in the research, development and marketing of innovative healthcare products. Merz
Therapeutics' portfolio focuses on (i) neurology, (ii) hepatology and (iii) dermatology. Applicant
3 is Merz Pharma France, a French company settled in Courbevoie.
2
2. The Defendant is VIATRIS Sante (hereinafter "VIATRIS"), a French company settled in Lyon,
which is part of the global Viatris Group, specialised in the development, manufacture, and dis-tribution
of generic pharmaceutical products. VIATRIS is the marketing authorisation holder for
the product "FAMPRIDINE VIATRIS LP 10 mg, comprime a liberation prolongee", which is a ge-neric
of the reference medicinal product FAMPYRA. It is notably responsible for the marketing of
this generic product in France.
PROCEEDINGS
3. On 31 July 2025, MERZ lodged an application (hereinafter "the Application") for provisional
measures (pursuant to Art. 62 UPCA and R. 206 RoP) before the Paris Local Division, against VIA-TRIS,
for infringement of French Supplementary Protection Certificate No. 13C0033 (hereinafter
"SPC 033" or the "SPC") based on European Patent No. 2 377 536 (hereafter "EP 536" or the
"Patent") due to the offering, placing on the market, and using, as well as importing and storing
for those purposes in France of generic medicinal products "FAMPRIDINE VIATRIS LP 10 mg, com-prime
a liberation prolongee", which are alleged as generics of the reference medicinal product
FAMPYRA covered by SPC 033.
4. No protective letter has been filed before the introduction of the Application by VIATRIS.
5. Jurisdiction of the UPC and the internal competence of the Paris Local Division were not
contested by the Defendant. This is a dispute concerning the marketing of a French SPC based on
a European patent, and the Defendant is a French company. The Court confirmed its jurisdiction
to hear the dispute under Articles 32.1(a) and 33.1(a) and (b) of the UPCA.
6. According to a timetable set by the Judge-Rapporteur by procedural order of 17 September
2025, VIATRIS filed its objection on 15 September 2025. MERZ filed its reply to the objection on
29 September 2025, and VIATRIS submitted its Rejoinder on 3 October 2025.
7. A technically qualified judge has been allocated to the panel upon the judge rapporteur's
request at the earliest stage of the proceedings.
SUMMARY OF FACTS
8. MERZ asserts that VIATRIS infringes its French SPC 033 based on EP 536.
9. Merz Pharmaceuticals LLC (Applicant 1) is the owner of the Patent and the SPC in suit, Merz
Therapeutics GmbH (Applicant 2) is the exclusive licensee, and Merz Pharma France (Applicant
3) has been granted an exclusive sub-licence to these rights in France. (Exhibits MERZ n°203 and
204)
10. The accused product, FAMPRIDINE VIATRIS, was introduced on the French market on 10
June 2025, as follows (Exhibit MERZ n°6) after the grant of a marketing authorisation in France
on 19 November 2011 (Exhibit MERZ n° 116):
3
La substance active de FAMPRIDINE VIATRIS LP est la fampridine, qui appartient a un groupe de
medicaments appeles inhibiteurs potassiques. Its agissent en empechant le potassium de sortir des cellules
nerveuses endommagees par la SEP. Ce medicament agirait en normalisant la transmission des influx nerveux,
ameliorant ainsi votre marche.
Groupe(s) generique(s) r
Ce medicament appartient au(x) groupe(s) generique(s) suivants :
• FAMPRIDINE 10 mg - FAMPYRA 10 mg, comprime a liberation prolongee
Composition en substances actives
Comprime ( Composition pour un comprime )
> fampridine 4 10 mg
Presentations t
> plaquette(s) OPA : polyamide oriente aluminium PVC-Aluminium de 28 comprime(s)
Code CIP : 34009 302 422 3 0
Declaration de commercialisation : 10/06/2025
Cette presentation est agrede aux collectivites
11. EP 536, on which SPC 033 is based, is entitled "Methods of using sustained release amino-pyride
compositions". The Patent consists of two independent claims: claim 1 and its dependent
claims 2 to 4 and claim 5 and its dependent claims 6 and 7. MERZ has based its present application
for provisional measures on claims 1 and 5 of the Patent and claims 3 and 7 of the Patent.
12. Claim 1 reads as follows: "1. A sustained release 4-aminopyridine composition for use in a
method of increasing walking speed in a patient with multiple sclerosis, wherein said composition
is administered twice daily in a dose of 10 milligrams of 4-aminopyridine." (Exhibit MERZ n° 205)
13. MERZ argues that since SPC 033 covers the active fampridine, FAMPRIDINE VIATRIS falls
within the scope of the SPC in suit for any of its authorised uses as a medicinal product.
14. The Applicants argue that the requirements for ordering provisional measures are met,
whereas the Respondent objects that the Applicants' requests must be rejected because no pro-visional
measures are necessary in the present case.
PARTIES' REQUESTS
15. In its last submission (Reply dated 29 September 2025), MERZ requests that the Court grant
the following provisional measures:
- The Respondent shall be enjoined in the territory of France, until 25 July 2026 included, from:
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Making, offering, placing on the market or using, or importing or storing for those purposes, the
generic products "FAMPRIDINE VIATRIS LP 10 mg, comprime a liberation prolongee" and any
pharmaceutical composition falling within the scope of French Supplementary Protection
Certificate No. 13C0033, including any sustained release 4-aminopyridine composition for use in
a method of increasing walking speed in a patient with multiple sclerosis, wherein said
composition is administered twice daily in a dose of 10 milligrams of 4-aminopyridine, (Direct
infringement of French Supplementary Protection Certificate No. 13C0033 based on claims 1 and
5 of the Patent)
in particular, if said composition is for administration every 12 hours. (Direct infringement of
French Supplementary Protection Certificate No. 13C0033 based on claim 3 and 7 of the Patent)
B) In the event of failure to comply with the order under item A within 48 hours from service of
the order, the Respondent shall make a (if applicable periodic) penalty payment to the Court of
up to 100,000 euros for each day of failure to comply.
C) The Respondent shall be ordered to deliver up to a bailiff appointed by the Applicant, at its
own expense, any pharmaceutical composition reproducing French Supplementary Protection
Certificate No. 13C0033, in stock and/or otherwise held, owned, or in the direct or indirect
possession of the Respondent in France, in order to prevent their entry into or movement within
the channels of commerce.
D) In the event of failure to comply with the order under item B within 1 week from the date of
service of the order, the Respondent shall make a (if applicable periodic) penalty payment to the
Court of up to 50,000 euros for each day of failure to comply.
E) The Respondent is ordered to provisionally reimburse the Applicants for costs in the amount
of 56,000 euros.
F) The Respondent is ordered to pay the costs of the proceedings.
G) The orders are effective and enforceable immediately.
In addition, the Applicants request that:
H) Any claims, requests and arguments from VIATRIS be rejected.
16. In its last submission (Rejoinder dated 3 November 2025), VIATRIS requests the Court to:
Primarily,
- Hold that the French Supplementary Protection Certificate No. 13C0033 is more likely than not
invalid,
- Hold that the provisional measures requested are disproportionate,
- Consequently, dismiss the application and all of the claims, requests and conclusions of MERZ.
In the alternative,
- Dismiss the request of MERZ for VIATRIS to be enjoined in the territory of France, until 25 July
2026 included, from making, offering, placing on the market or using, or importing or storing for
5
those purposes, the generic products "FAMPRIDINE VIATRIS LP 10 mg, comprime a libeeration
prolongee" and any pharmaceutical composition falling within the scope of French
Supplementary Protection Certificate No. 13C0033, including any sustained release 4-
aminopyridine composition for use in a method of increasing walking speed in a patient with
multiple sclerosis, wherein said composition is administered twice daily in a dose of 10 milligrams
of 4-aminopyridine, in particular, if said composition is for administration every 12 hours,
- Dismiss the request MERZ for VIATRIS to be ordered to make a penalty payment (if applicable
periodic) to the Court of up to 100,000 euros for each day of failure to comply in the event of
failure to comply with the previous request within 48 hours from the date of service of the order.
- Dismiss the requests of MERZ for VIATRIS to be ordered to deliver up to a bailiff appointed by
the Applicants, any pharmaceutical composition reproducing French Supplementary Protection
Certificate No. 13C0033, in stock and/or otherwise held, owned, or in the direct or indirect
possession of the Respondent in France, in order to prevent their entry into or movement within
the channels of commerce at its own expense.
- Dismiss the request MERZ for VIATRIS to be ordered to make a (if applicable periodic) penalty
payment to the Court of up to 50,000 euros for each day of failure to comply with the previous
request 1 week from the date of service of the order.
- Allow the continuation of the making, offering, placing on the market or using, or importing or
storing for those purposes, the generic products "FAMPRIDINE VIATRIS LP 10 mg, comprime a
liberation prolongee" and any pharmaceutical composition falling within the scope of French
Supplementary Protection Certificate No. 13C0033, including any sustained release 4-
aminopyridine composition for use in a method of increasing walking speed in a patient with
multiple sclerosis, wherein said composition is administered twice daily in a dose of 10 milligrams
of 4- aminopyridine, in particular, if said composition is for administration every 12 hours, in the
territory of France, up until 25 July 2026 included.
- Order VIATRIS to lodge a guarantee to MERZ of such amount as the Court shall deem
appropriate, but which shall not be higher than 260.000 euros,
In the further alternative,
- Reduce the sums of the penalty payments requested to such reasonable amount as the Court
shall deem appropriate, but which shall not be higher than 260.000 euros,
- Set the starting points of penalty payments at a reasonable time as the Court shall deem
appropriate, but should be no less than three weeks following the service of the order,
- Order MERZ to provide VIATRIS with a sum of the Court's discretion, but which shall not be less
than 260.000 euros for security for enforcement to VIATRIS SANTE by deposit or bank guarantee,
In any event,
- Dismiss the request of MERZ to order VIATRIS to pay the sum of 56,000 euros as interim award
of costs;
6
- Order MERZ entities jointly and severally to pay EUR 56,000 as reimbursement of costs of the
proceedings.
PRESENTATION OF THE TITLES: the basic Patent and the SPC in suit
17. The Patent titled "Methods of using sustained release aminopyride compositions", was
filed as a divisional application with the European Patent Office on 29 March 2011, claiming the
filing date of its parent application WO2005US12427 dated 11 April 2005, as well as US priorities
dated 9 April 2004 and 8 April 2005. Mention of the grant of the patent at issue was published
on 6 March 2013. (Exhibit MERZ n°205). The Patent expired on 11 April 2025.
18. EP 536 was subject to proceedings before the EPO: the Board of Appeal set aside the Op-position
Division decision, which had revoked the patent for lack of novelty, and ordered the
Opposition Division to maintain the patent in amended form in a decision of 4 September 2019.
(Exhibit MERZ n° 300, EPO T 0799/16 decision).
19. The German Federal Patent Court invalidated on 4 March 2024 the German part of EP'536
for lack of inventive step. (Exhibit MERZ n° 301, and translation in EN. Exhibit n° 302)
20. EP 536 relates generally to a dosage regimen for a sustained release 4-aminopyridine com-position
for use in a method of increasing walking speed in a patient with multiple sclerosis.
21. EP 536 comprises 7 claims, notably Claim 1, an independent purpose-related product (Ar-ticle
54(5) EPC) claim, and Claim 5, an independent purpose-related process (Swiss-type) claim.
22. Claim 1 of the patent, as maintained by the EPO Board of Appeal, reads as follows (the
"feature breakdown" presentation by the Applicants is not contested by the Respondent and
adopted by the Court):
Feature 1.1: A sustained release 4-aminopyridine composition
Feature 1.2: for use in a method of increasing walking speed in a patient with multiple sclerosis,
Feature 1.3: wherein said composition is administered twice daily in a dose of 10 milligrams of 4-
aminopyridine.
Claim 5 is in Swiss-type claim format, and reads as follows:
Feature 5.1: Use of 4-aminopyridine
Feature 5.2: in the manufacture of a sustained release composition for increasing walking speed
in a patient with multiple sclerosis,
Feature 5.3: wherein said composition is administered twice daily in a dose of 10 milligrams of 4-
aminopyridine.
23. The validity of the basic patent, EP 536 is contested by VIATRIS, arguing its lack of inventive
step.
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24. MERZ claims that the EP 536, in its amended version upheld by the EPO BoA, is inventive
and valid.
The SPC in suit:
25. The French SPC 033, filed on 24 June 2013, was granted on 20 November 2015, and it will
expire on 25 July 2026.
26. SPC 033 concerns the marketing authorisation for the product FAMPYRA
(EU/1/11/699/001 granted on 20 July 2011 and notified on 25 July 2011).
27. FAMPYRA covers "Fampridine or a derivative thereof" (as active ingredient).
28. The product FAMPYRA is indicated for the improvement of walking speed in adult patients
with multiple sclerosis.
29. It is not contested by the parties that VIATRIS Fampridine is a generic of the reference me-dicinal
product FAMPYRA covered by SPC 033.
30. VIATRIS contests the validity of the SPC at hand, asserting that this SPC is void due to prior
marketing of PYMADIN in Bulgaria and Poland.
31. MERZ responds that Bulgarian and Polish sales at the time of the registration of SPC 033
were illegal.
APPLICANT's ENTITLEMENT
32. MERZ explains that following bankruptcy proceedings initiated on 1 April 2024 by Acorda
Therapeutics, Inc. (the initial patent owner), Merz Pharmaceuticals LLC acquired on 10 July 2024
by way of an assignment agreement the rights (Exhibit MERZ n° 212) to the reference medicinal
product FAMPYRA (fampridine).
33. Acorda Therapeutics, Inc. ceased to exist as an operational entity as of the effective date
of its court-approved liquidation plan, namely as of 23 August 2024.
34. Since 2 January 2025, Merz has assumed all management, distribution and marketing re-sponsibilities
for the FAMPYRA product in 45 countries, including France.
35. MERZ mentions also that on 28 March 2025, the assignment of the French designation of
EP 536 and of SPC 033 from Acorda Therapeutics, Inc. to Merz Pharmaceuticals LLC was published
in the French Official Intellectual Property Bulletin. (Exhibits MERZ n°200 and 201)
36. MERZ's entitlement regarding EP 536 and SPC 033 at the time of filing the present applica-tion
is not contested by VIATRIS.
8
THE REQUIREMENT of "any unreasonable delay in seeking provisional measures" under R.211.4
RoP
Legal framework:
37. Rule 211 — Order on the Application for provisional measures foresees in its point 4: "The
Court shall have regard to any unreasonable delay in seeking provisional measures. "
38. UPC CoA ORD_44387/2024, Mammut Sports v Ortovox, Order of 25 September 2024,
Headnotes 5, states that: "The delay within the meaning of R. 211.4 RoP shall be calculated from
the day on which the applicant became aware, or should have become aware, of the infringe-ment
that would enable him, in accordance with R. 206.2 RoP, to file an application for provi-sional
measures with a reasonable prospect of success. Thus, the decisive point in time is when
the applicant has, or should have had, after exercising due diligence, the necessary facts and
evidence within the meaning of R. 206.2(d) RoP." (English translation of the Order in the German
language)
39. UPC CoA, 446/2025, Order of 13 August 2025, Boehringer v Zentiva indicates:
in its HEADNOTES 1 to 3 regarding the assessment of an imminent infringement in the context
of marketing a generic medicine, that:
"In the context of marketing of generic medicines, the mere application for a marketing
authorisation by a generics company does not amount to an imminent infringement, nor does
the grant of such an authorisation create one.
Completion of the national procedures for health technology assessment, pricing and reim-bursement
for a generic medicine can amount to an imminent infringement. The assessment
must be made with due regard to the national regulatory and legislative context and consid-ering
the circumstances of the case. "
And regarding the requirement of R. 211.4 RoP, the UPC Court of Appeal states in § 87 that:
"The delay within the meaning of R. 211.4 RoP shall be calculated from the day on which the
applicant became aware, or should have become aware, of the infringement that would en-able
him, in accordance with R. 206.2 RoP, to file an Application for provisional measures with
a reasonable prospect of success. Thus, the decisive point in time is when the applicant has,
or should have had, after exercising due diligence, the necessary facts and evidence within
the meaning of R. 206.2(d) RoP. (CoA, order of 25 September 2024, UPC_CoA_182/2024,
APL_21143/2024, Mammut vs Ortovox). a
Parties' arguments:
40. According to MERZ, the starting date to be considered is the letter dated 2 July 2025 re-ceived
from VIATRIS informing that they have just started marketing FAMPRIDINE VIATRIS in
France (Exhibits MERZ 125 and 126). MERZ argues that the launch in France without clearing the
way by a revocation action of the patent on which the SPC is based was a surprise for them. (§43-
77 of the Application). MERZ notes in its application (§18) that VIATRIS obtained a marketing
authorisation for FAMPRIDE VIATRIS in France on 10 November 2021 and was granted a price
and a reimbursement rate in November 2024 (Exhibits MERZ n° 118 and 120).
9
41. MERZ adds that undue delay must be assessed by reference to the knowledge of the actual
infringement, not its imminence. A restrictive interpretation, encouraging the patent holder to
file an application when infringement is imminent, would be contrary to Article 47 of the Charter
of Fundamental Rights of the EU and Article 6 of the European Convention on Human Rights, as
it would deprive the applicant of effective access to a court. Factual circumstances did not allow
the applicant to consider that its application for interim measures, based on imminent infringe-ment,
had any chance of success in the absence of a real and concrete risk of infringement.
42. According to VIATRIS, the starting point to be considered is 22 November 2024, the date
on which FAMPRIDINE VIATRIS' price was published (§61-75 of the Objection):
At this date, MERZ should have been aware of the imminent infringement and thus able to apply
for provisional remedies. VIATRIS argues that they were contacted by the CEPS (French Economic
Committee of Health Products) in the course of their application for pricing and reimbursement
of FAMPRIDINE VIATRIS and were informed of MERZ's intellectual property rights (Communica-tion
between the CEPS and VIATRIS and that VIATRIS replied that they will not infringe MERZ's
intellectual property rights (Communication between the CEPS and VIATRIS - Exhibit n°135, page
1).
43. In its letter dated 2 July 2025 to MERZ, VIATRIS stated that it had already begun selling its
product in France (Letter from Viatris to Merz dated 2 July 2025 - Exhibit n°146, page 1). They
argue that MERZ was aware that the contested product was marketed in France on 10 June 2025
(Extrait de la Base de Donnees Publiques des Medicaments Fampridine Viatris 10 mg 3- Exhibit
n°82, pages 1 and 2).
44. VIATRIS adds that imminent infringement and ongoing infringement are distinct situations
and cannot constitute two separate starting points for assessing the patentee's time limit for
bringing a PI application. This is a matter of legal certainty for the defendant and for third parties,
who may be required to recall all products and find themselves in difficulty if the infringed prod-ucts
have been distributed on the market for a long time.
Grounds for the order:
45. The rules of procedure of the UPC require that applicants seeking provisional measures
justify that they have been sufficiently diligent to have access to an expedited procedure before
this Court. Such expedited procedure implies on the one hand that the defendants defend them-selves
within a stringent timeframe according to the schedule drawn up by the judge-rapporteur,
setting strict deadlines for the exchange of submissions (R. 209.1 RoP) and, on the other hand,
that the Court deal with the case as a matter of urgency, in priority over the substantive cases
brought before it. As the Hague UPC LD has already explained in a recent decision: "R. 211.4 RoP
thus ensures that an applicant whose conduct already indicates that it is not in a hurry, cannot
expect assistance in the form of an order for provisional measures. In other words, given that the
main proceedings at the UPC are (to be) concluded within a little over one year, a patent holder
who acts with unreasonable delay, shall not be allowed to jump the queue." (UPC_CFI_374/2024,
29 August 2025, Cilag v Rivolution, §38). Once the applicant is in possession of all the knowledge
10
and documents that are reasonably likely to lead to a successful prosecution of the case, it must
normally file an application for provisional measures without delay (LD Munich 21 May 2024,
UPC_CFI_443/2023 and 27 August 2024, UPC_CFI_201/2024).
46. The UPC has previously had to interpret what may be considered to be a lack of diligence
by an applicant seeking a Pl. Thus, on two occasions the UPC Court of Appeal stated that to de-termine
the starting point of the reasonable time limit for taking action, the Court should con-sider
the following question: 'When did the applicant become aware, or should have become
aware, of the infringement that would enable him, in accordance with R. 206.2 RoP, to file an
Application for provisional measures with a reasonable prospect of success?'
This question requires that the case in concreto be examined.
47. The case in dispute has two distinctive features:
- the product alleged to be infringing is a generic version of a product protected by an SPC,
- the rights to the title on which the application is based were repurchased by the Defendant
during the same period when the administrative procedure for authorising the generic product
to be placed on the French market was ongoing.
48. This prompts the following question: In the context of a generic product, at what point
was or should the person who purchased the rights have been informed of an event that could
justify an application for interim measures?
49. The Applicants argue that the UPC texts provide for two possible starting points regarding
the reasonable time limit for taking PI action, which are successive points in time: a first starting
point would be that of becoming aware of imminent infringement, and a second starting point
would be the act of infringement itself.
50. The court does not follow this line of reasoning, given that Article 62.1 UPCA and Rule 211.2
RoP mention the following condition: 'the right is infringed or such infringement is imminent',
and do not make a distinction between two separate and consecutive situations that would cre-ate
two phases likely to trigger the urgency criterion. Rather, the aforementioned Article and
Rule provide for two alternative situations that allow for a preliminary injunction (PI) claim to be
brought before the UPC. Accordingly, establishing the existence of either situation allows for a PI
action to be taken with a reasonable chance of success.
51. The criterion of imminent risk of infringement is particularly relevant in the context of a
generic product being placed on the market. Indeed, the applicant need not wait for the product
to be placed on the market in order to analyse it and gather sufficient evidence to demonstrate
that such product infringes, at least prima facie, the claims of their title (patent or SPC). Such a
product automatically falls within the scope of protection once it is classified as a generic version
of the product protected by said title and declared as such.
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52. In the present case, it is necessary to determine the event in the French administrative
procedure allowing the generic manufacturer to place its product on the market. The parties
agree that this event is the obtaining of the price and reimbursement rate.
53. A review of the chronology of events demonstrates that:
- On 19 November 2021, VIATRIS obtained an authorisation to market the generic version of
Fampridine Viatris in France (Exhibit VIATRIS n° 82) for its product Fampridine Viatris, which is
undisputedly the generic version of the product FAMPYRA protected by the French SPC in
question, which is in force until 25 July 2026.
- On 19 September 2024, Fampridine Viatris was published as a generic speciality in the Group's
generic directory (Exhibit MERZ n° 117).
- On 22 November 2024, further to its inclusion on the official lists of reimbursable and approved
pharmaceutical products (Exhibit MERZ n°118), the product was assigned a price and a
reimbursement rate (Exhibit MERZ n° 120).
54. The administrative procedure required for Fampridine Viatris to be authorised for market-ing
in France was therefore finalised on 22 November 2024.
55. The documents in the file also show that, in accordance with the French administrative
procedure for the marketing of a medicinal product protected by an SPC, the Health Products
Economic Committee (CEPS or the Committee), i.e. the interministerial body that sets the prices
of medicines and medical devices for individual use covered by compulsory health insurance (see
Viatris Exhibit 148), had informed VIATRIS that the generic product for which a marketing author-isation
had been requested was protected by a patent. VIATRIS responded (by email) on 3 Octo-ber
2024 that Fampridine Viatris would be marketed on the French market within six months, as
follows: (Exhibit VIATRIS n°135)
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Thursday, August 21, 2025 at 10:22:41AM Central European Summer lime
Objet: RE: Fampridine
Date: jeudi 3 octobre 2024 a 14:30:18 heure d'ate d'Europe centrale
De:
k.
Pieces Jointee: image002.png, image003.png, image004.png, image005.png
Monsieur
Nous vous confirmons que notre specialite Fampridine Viatris n'enfreint pas les brevets revendiques et que la
commercialisation sera effective dans les 6 mois suivant la publication au JORF.
Cordialement
Directeur des Affaires Economiques
A compter du 1' avril 2023, la denomination sociale de Viatris Medical devient Viatris Sante.
Viatris Sante
1, bis place de la Defense, Tour Trinity,
92400 Courbevoie
VIATRIS
SCHERTENLEIB
Piece n°135
56. It has therefore been demonstrated that VIATRIS had informed the Committee of its inten-tion
to market the generic drug within six months, i.e. by April 2025 at the latest, that is to say,
before the expiry of the SPC on 25 July 2026.
57. The Committee is required to inform the rights holder of the generic manufacturer's re-sponse
indicating its intention to market its product (Art. 3 of the LEEMS CEPS agreement - §23
Objection. PJ 5 and PJ 5bis VIATRIS), as can be seen from the extract from the agreement:
Article 3. Intellectual property
Companies exploiting chemical or biological specialities for which they hold one or more
patents or CCPs shall declare, for information purposes, to the Committee in Annex 7 of the
multi-annual agreement the titles concerned and their expiry dates for the three years following
the initial signature and that of each update.
The Committee shall make these statements available to any pharmaceutical company that
requests them.
No generic or biosimilar speciality shall be included on the list of specialities eligible for
reimbursement to persons covered by social security and, where applicable, on the lists
provided for in Articles L.162-22-7 of the Social Security Code and L.5126-6 of the Public
Health Code shall be published more than six months before the declared date of expiry of
intellectual property rights if it has been notified to the Committee.
However, a pharmaceutical company that believes it can market the generic or biosimilar
products in question without infringing the declared rights may apply for their registration. In
this case, it must notify the Committee in writing, which shall immediately inform the operator
of the product or products referred to in the first paragraph above and initiate the registration
procedure.
13
58. It was clarified at the oral hearing, in response to a question from the panel, that BIOGEN
was responsible for marketing FAMPYRA on the French market at that time. Moreover, MERZ
does not dispute that BIOGEN was necessarily informed of this response by the Committee.
59. It seems clear to the Court that BIOGEN informed the patent holder for which it held the
rights that an infringement was imminent on the French market, further to the letter sent on 3
October 2024 by VIATRIS to the Committee.
60. In any event, upon acquiring the basic patent and the SPC in question, it should have carried
out an audit (due diligence) of the rights it intended to acquire. Furthermore, MERZ was aware
that BIOGEN was responsible for marketing FAMPYRA in France. This acquisition was important
for MERZ, as evidenced by the announcement made by the MERZ group on its website on 10 July
2024 - Exhibit MERZ n° 6, as follows:
A&O Shearrnan
Ex. No. 6
11
NEWS RELEASE
Merz Therapeutics Closes $185M Asset
Purchase Agreement with Acorda
Therapeutics
• eeuiruhen ul II. a., (flAMP•Pat 'tare situ:rine, tsp..* youctset, neurology portfolio
• Lays groundwork for Parkhuon's disease francium arra • N(.• In mail Fpl. at urrhsst1MR.I
• Plane include growth of U.S. workforce by TOM Own SOW
Frankfurt, Germany - July 10, 2024 Idea Thereon...es announces today the successful acquisition of 1110014,? (levodopa inhalation
powder, and IFIAMPYRA. darnpridlnel.and related assets horn Acorda Therapeutics Inc AMPYRA'hlallasnptidurel is Food and Drug
Administration (FDA' approved in the 11 S and commercialized as FAMPYRA in the European boron and other terrirones throughout the world.
This r anuotion was conducted through a tom t structur ed Jfi3 sale under the U 5 Banlo u pity Code. The completion of this deal valued at
USD its million in [UN bolsters Merz Therapeutics' market position by enhancing offerings for people living with Parkinson's disasse and
rApallOllrg Into the multiple sclerosis dati spate.
61. This date of acquisition by the MERZ group in 2024 is also set out in the warning letter sent
to VIATRIS on 18 June 2025: (Exhibit MERZ n° 125)
III 5‘viatris.com; reception(rDviatris.com
Copy by courier
Your ref
Our ref G072608PT
Date 18 June 2025
Dear Sirs,
GENERIC FAMPRIDINE - VIATRIS
We act for Merz Pharmaceuticals, LLC ("Merz Pharmaceuticals"), Merz Therapeutics GmbH and
associated affiliates which together form part of the Merz group of companies (together, "Merz"). In
2024, Merz acquired, inter alia, the product Fampyra (fampridine) and associated assets from
14
62. MERZ claims that it did not recover the direct exploitation of FAMPYRA from the licensee
BIOGEN until 2 January 2025.
63. This information was announced on its website as follows: (Exhibit MERZ n° 100)
Merz Therapeutics
Launches FAMPYRA® in
Canada, EMEA, LATAM
and APAC
As part of its strategic vision to become a leader in the specialty neurology space, Merz Therapeutics has launched FAMPYRA. (fampridine)
extended-release tablets (10 mg) in Canada, EMEA, LATAM, and APAC by transitioning the licensing rights to commercialize the product from
Biogen. Effective January 2, 2025, Merz Therapeutics assumed full management, distribution, and marketing responsibilities for FAMPYRA° in
45 countries. These territories include Canada, Austria, Bahrain, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, France,
Germany, Hungary, Iceland, Ireland, Israel, Italy, Jordan, Kuwait, Latvia, Lithuania, Luxembourg, Malta, Morocco, Netherlands, Norway, Poland,
Portugal, Qatar, Romania, Saudi Arabia, Slovakia, Slovenia, Spain, Sweden, Switzerland, United Arab Emirates, United Kingdom, Australia, New
Zealand, Argentina, Chile, Colombia, and Mexico.
FAMPYRA. is an extended-release tablet indicated for the symptomatic improvement of walking in adult patients with multiple sclerosis
experiencing walking disabilities. This launch aligns with Merz Therapeutics' mission to enhance patient outcomes and address unmet needs
in the neurology field.
64. At the latest on the date of recovery of the direct exploitation rights, MERZ necessarily
reviewed with its licensee BIOGEN the status of the exploitation of the product FAMPYRA, for
which the generic manufacturer VIATRIS had already obtained authorisation to enter the French
market with a fixed price and reimbursement rate and had indicated its intention to enter the
French market by spring 2025 at the latest.
65. Since at least the recovery of direct exploitation rights on 2 January 2025, MERZ was or
should have been aware of the imminent infringement of the SPC it holds.
66. However, MERZ did not send a warning letter to VIATRIS until 18 June 2025, five months
after it regained direct exploitation rights from its licensee BIOGEN. This warning letter was
drafted in these terms: (Exhibit MERZ n°125)
15
It has come to Merz's attention that Viatris. either directly or via one of its group companies or
affiliates has obtained the following marketing authorisations in the jurisdictions identified below for
fampridine 10 mg prolonged-release tablets
Table 2
Country MA applicant/holder Product Description Registration
Number
Denmark Viatris Limited Fampridine 'Viatris- 72870
France Viatris Limited Fampridine "Viatris- No. CIP: 34009 302
422 3 0 34009 302
422 4 7 (and others -
according to the
number of tablets
per pack)
Iceland Viatris Limited Fampridine Viatris IS/1/25/077/01
Netherlands Viatris Limited Fampridine Viatris RVG 134386
Portugal Viatris Limited Fampridina Mylan 5904669 - 28 tablets
5904651 - 56 tablets
UK Generics (UK) Limited
to/a Mylan
Fampridine Mylan PL 04569/1868
Merz is furthermore aware that Viatns has listed a price for its generic version of FAMPYRA in the
French Journal Office] in relation to the products for which the CIP numbers are provided above.
Based on this publicly available information. Merz understands that Viatris' marketing authorisations
are for a generic version of FAMPYRA. Merz's position is that Viatris's generic fampndine product
falls within the scope of protection conferred by the SPCs detailed above. It is therefore Merz's
position that any making, disposing of, offering to dispose of. use. importation and/or any other
related activity in respect of genenc fampridine in the jurisdictions set out above will infnnge the
relevant SPCs while they remain in force. Any such infringement would be unacceptable to Merz.
In order to avoid unnecessary litigation and legal expenses, and for Merz to be able to protect its
SPC rights, please confirm as soon as possible. and in any event by 2 July 2025. that Viatris and/or
any affiliates thereof and/or any third parties with whom Viatris is collaborating or may in future
collaborate in relation to generic fampridine will:
(a) respect Merz's SPC rights: and thus
(b) not seek to market and/or launch a generic fampridine in the any of the countries listed
above in Table 1 while the relevant SPC is in force, whether approved under the marketing
authorisation 1 CIP numbers listed above, or otherwise_
67. The Court notes that the Applicants did not take provisional measures before the present
UPC division until 31 July 2025, i.e. six months after it became or should have become aware of
the imminent launch of the generic product on the French market, as announced by VIATRIS for
spring 2025.
68. And yet MERZ should have been particularly vigilant in view of the imminent risk of in-fringement
on French territory, since the validity of its title was weakened by the revocation in
Germany of the national part of the patent in question for lack of inventive step by the German
Federal Court in March 2024, as is clear from VIATRIS' official response to MERZ (Exhibit VIATRIS
n°146):
16
Carpmaels & Ransford LLP
One Southampton Row
London
WC1B 5HA
Your ref: G072608PT
By e-mail
2 July 2025
Dear Sirs
Re: famprldlne
We refer to your letter dated 18 June 2025.
We note that your letter does not refer to the decisions of the German Federal Patent Court which
held that EP '548 and EP 536 were invalid. We understand theta number of generic products am
currently on the market in Germany
In view of the German invalidity decisions and the absence of any warning letters from Acorda,
Biogen or your client, Viatrls Sante has already launched Its fampricine product in France
Yours fa.tnitilly
Senior ent Litigation Counsel
Viatris
69. In this context, the fact that the first act of infringement on the French market did in fact
occur on 10 June 2025 (date of publication of the French market launch - Exhibit MERZ n° 6)
cannot be considered as a new starting point that creates urgency and justifies a diligent filing of
the application for provisional measures by MERZ. Thus, to quote the terms of The Hague LD, this
fact "was already (to be) expected and does not revive urgency". (UPC_CFI_374/2024, 29 August
2025, Ci lag v Rivolution)
70. The Court further notes that MERZ, in defending itself against a lack of diligence, cannot
legitimately argue that being denied access to an application for provisional measures due to
insufficient diligence constitutes a breach of the principle of access to justice under the Charter
of Human Rights. Indeed, it has been demonstrated above that MERZ had the opportunity to act
more promptly in interim measures. Furthermore, MERZ is not deprived of all rights since it has
access to an infringement action on the merits before the UPC (with a targeted period of 12
months for processing the case).
71. Moreover, MERZ cannot rightly argue that the CoA's decision of 13 August 2025 created a
new legal situation that cannot be invoked in the present dispute in the name of legal certainty,
as this change in the UPC case law would set new conditions for the characterisation of imminent
infringement in the context of a generic product. Indeed, this decision of the Court of Appeal was
merely an interpretation of existing rules. (Art. 62.1 UPCA and R. 211.2 RoP). In addition, when
questioned by the panel at the oral hearing, MERZ's representatives admitted that the
Boehringer v Zentiva decision merely assessed the facts of the case in accordance with Portu-guese
administrative procedure and did not create a new legal situation for applicants for provi-sional
measures before the UPC.
72. In view of these elements, MERZ fails to demonstrate that it was seeking provisional
measures against VIATRIS within the reasonable delay provided for by Rule 211.4 RoP. Conse-quently,
MERZ's request for provisional measures against VIATRIS shall be rejected, as well as all
of its other subsequent requests.
73. As MERZ's claims have been rejected, it is not necessary to examine VIATRIS's subsidiary
claims, in particular the claim for a guarantee.
17
COSTS
74. The application for provisional measures is rejected. The consequence of this for the costs
is that MERZ shall be ordered to pay the legal costs of the proceedings incurred by VIATRIS.
R.211.1(d) RoP provides the opportunity to give an interim award of costs in these proceedings.
In this case, both parties asked for reimbursement of the costs for the amount of 56.000 euros
to be awarded to the winning party. The Court considers this amount as reasonable and propor-tionate
in the present case. MERZ will be ordered to pay to VIATRIS this amount as an 'interim'
award of costs.
ORDER
1. The Application for provisional measures is rejected.
2. The Court orders the Applicants to pay to the Defendant interim costs of the proceedings
for 56.000 euros.
An appeal to this order may be brought in accordance with Art. 73 (2) (a) UPCA and R. 220.1 (c)
and 224.1(b) RoP within 15 calendar days of the notification of the order to the Applicants.
Issued in Paris, on 21 November 2025.