Please log in to add tags.
Please log in to add notes.
Sanofi Winthrop Industrie, Sanofi S.r.l., Sanofi B.V., Sanofi AB, Sanofi-Aventis GmbH, Sanofi-Aventis Deutschland GmbH, Sanofi Mature IP, Sanofi Belgium, Sanofi A/S, Sanofi - Produtos Farmaceuticos Lda v. Accord Healthcare AB, Accord Healthcare S.L.U., Accord Healthcare GmbH, Accord Healthcare Italia Srl, Accord Healthcare BV, Accord Healthcare B.V., Accord Healthcare, Unipessoal Lda.
ORD_3577/2025
Munich (DE) Local Division
Generic Order
EN
EP2493466
Local Division Munich UPC_CFI_145/2024 UPC_CFI_146/2024 UPC_CFI_147/2024 UPC_CFI_148/2024
of the Court of First Instance of the Unified Patent Court Local Division Munich issued on 22 January 2025
Sanofi SA as successor of Sanofi Mature IP
Sanofi Winthrop Industrie
Sanofi Winthrop Industrie as successor of Sanofi-Aventis France
(not a party in UPC_CFI 145/2024)
Sanofi-Aventis GmbH
Sanofi Belgium
Sanofi-Aventis Deutschland GmbH
Sanofi S.r.l.
Sanofi B.V.
Sanofi - Produtos Farmaceuticos Lda
Sanofi AB
Sanofi A/S
represented by:
Frédéric Chevallier (Herbert Smith Freehills).
represented by: Jules Fabre, Arjan Reijns, Louise Millot (Pinsent Mason).
UPC_CFI_145/2024
UPC_CFI_146/2024
UPC_CFI_147/2024
UPC_CFI_148/2024
STADAPHARM GmbH
STADA Arzneimittel AG
STADA Nordic ApS
Daniel Hoppe (Bonabry).
Dr. Christian Meyer (Maiwald)
Dr. Andreas Ledl (Maiwald).
Zentiva France
Zentiva Pharma GmbH
Zentiva, k.s.
Dr. Anja Lunze (Taylor Wessing)
Dr. Elisabeth Greiner (df-mp).
PATENT AT ISSUE
European patent n° 2 493 466
Panel 1 of the Local Division Munich
This order has been issued by the Presiding Judge Dr. Matthias Zigann acting as judgerapporteur.
English
Patent infringement - order following an oral argument hearing ('preliminary interim conference') - R 105.5 RoP
•
Accord requests in APP_36781/2024 (R 19) and App_38125/2024 (R 334 h, 361, 363 and APP_55895/2024 (R 9):
Alternatively, should the Court decide to proceed with the current proceedings in the main action initiated by the Claimants despite the request for dismissal, it is requested to:
More alternatively, should the Court decide to proceed with all or part of the claims made in the current proceedings in the main action despite these requests for dismissal, it is requested to:
assertions of infringement and on validity of EP 466 in a counterclaim, when such claim is filed by the Defendants.
On invitation by the Judge-rapporteur Accord clarified:
The requests for dismissal for lack of jurisdiction or competence under Rule 19 RoP (Section 2 of the written submissions filed by the Defendants on 1 July 2024) are to be attributed to the Preliminary Objections (workflow 36781/2024).
The requests for dismissal under Rules 13, 334(h), 361 and 363 RoP and for lack of standing of Claimants 2 to 10 (Sections 3 and 4 of the written submissions filed by the Defendants on 1 July 2024) and the case management requests under Rule 334 RoP (Section 5 of the written submissions filed by the Defendants on 1 July 2024) are to be attributed to the General Procedural Application (workflow 38125/2024).
The Defendants will confirm the orders and requests they are seeking under workflow 38125/2024 once they will be given an opportunity to provide their comments to Sanofi's Reply to the Generic Procedural Application. For the information of the Court, the Defendants intend to maintain all of their requests made in workflow 38125/2024, with the exception of the request for alignment of the deadlines for filing the SoD and CfR, which has now become obsolete. The Defendants will also request that a decision is made on all such requests immediately and that an oral hearing is held in accordance with Rule 334(d) RoP, preferably together with the oral hearing on the Preliminary Objections.
I. grant the preliminary objection to the extent requested and declare the action partially inadmissible and exclude those parts of the claimants' requests which relate to the territories of Ireland, Poland, Czech Republic, Slovakia, Hungary, Romania,Spain, Croatia, Greece and Cyprus;
IV. in the event that the claimants fail to act within the time limit provided for in the Rules of Procedure or set by the Local Division or fails to appear at an oral hearing after being duly summoned, to issue a default judgment against the claimants.
claims for damages (paragraph 52 et seq. of the Statement of Claim),
claims for corrective measures (paragraph 57 of the Statement of Claim), and
request for information (paragraph 58) of the Statement of Claim,
asserted by the plaintiffs which relate to a period prior to the entry into force of the UPC on 1 June 2023, and
and to rule on the Preliminary Objection by way of interlocutory decision pursuant to R. 20.1 UPC-RoP.
Together with the reply to the statement of defence Sanofi filed applications pursuant to Rule 263 RoP (App_57841/2024, App_57844/2024, App_57842/2024, App_57845/2024).
Unipessoal Lda., and Accord Healthcare AB to pay jointly to Sanofi Mature IP, Sanofi Winthrop Industrie, Sanofi-Aventis GmbH, Sanofi Belgium, Sanofi-Aventis Deutschland GmbH, Sanofi S.r.l., Sanofi B.V., Sanofi Produtos Farmaceuticos Lda, Sanofi AB, and San ofi A/S €4,142,256 as damages subject to further assessment;
The Unified Patent Court has issued a first instance decision ruling that Accord Healthcare has committed acts of infringement of Sanofi's patent rights on Jevtana® and cabazitaxel. An appeal can be lodged against the decision of the Unified Patent Court available at the following link: [insert link towards the full decision].
The Unified Patent Court has issued a first instance decision ruling that Zentiva has committed acts of infringement of Sanofi's patent rights on Jevtana® and cabazitaxel. An appeal can be lodged against the decision of the Unified Patent Court available at the following link: [insert link towards the full decision].
Pursuant to Articles 59 and 67 UPCA, and Rules 13(o), 101, 103, 104, 190 and 191 RoP, the Claimants request the Judge-rapporteur to issue an order regarding the production by the Defendants of the documents and information relating to the infringing products in suit for all designations of EP 466 covered by the exclusive competence of the Unified Patent Court where EP 466 is in force, including for national designations of States in which the UPCA shall enter into force, [in ACT_16112/2024 UPC_CFI_145/2024 with the exception of the French designation of EP 466 and the French territory], in order notably to be able to calculate the damages requested by Sanofi. Sanofi has indeed presented reasonably available and plausible evidence in support of its damages claim, but the remaining information concerning notably precise quantities, margins and third parties involved in the infringing acts lies in the control of the Defendants.
These applications have not been filed in dedicated workflows.
The defendants did not object. The Court has no objections either. Sanofi Mature IP has therefore been substituted by Sanofi SA in the present and all related proceedings by separate orders in the respective dedicated workflows.
The Court found that it was possible to carve out France and that the UPC had jurisdiction for damages claims relating to periods prior to 1 June 2023. It was also noted that the remaining concerns depend on the understanding of the territories for which formal reliefs are requested. Sanofi announced that it would submit amended formal reliefs within 7 days, as requested by the Court. It was further discussed whether and why an immediate decision on the preliminary objections was necessary.
The Court questioned why the right to sue might be an issue in the present case as all relevant parties, the patent proprietor, the exclusive licensee and the non-exclusive licensees, filed the infringement actions jointly. Accord noted that even if joint filing were to be considered as implied consent, it would still not qualify as "expressly permitted" under Art. 47(3) UPCA.
The Court set out in detail the deficiencies of the formal reliefs filed (undefined Contracting Member States, no entitlement to a declaration that the patent is valid, undefined "acts of infringement", undefined attacked embodiment, lack of claim language, unclear "at least claims 1, 2, 5, 6, 7, 8 and 9"), lack of clarification as to which claimant is seeking which relief from which defendant for which territory, undefined "affiliates and third parties", undefined whether and why claimants are joint creditors and defendants are joint debtors, concerns about an order that defendants publish the judgment on their websites, lack of timeframe for some of the relief sought, "information listed in Art. 67 UPCA" is undefined, award of legal costs should be specified or formulated as a declaration that costs are owed. Sanofi
announces that it will submit amended formal requests as requested by the Court within 7 days.
The Court noted that the calculation of damages under Art. 68 UPCA does indeed differ from national practice. According to Art. 68(3) UPCA, the court shall determine the amount of damages taking into account all appropriate aspects, such as (a) the negative economic consequences, including lost profits, incurred by the injured party, any unfair profits made by the infringer and, in appropriate cases, elements other than economic factors, such as the moral prejudice caused to the injured party by the infringement; (b) as an alternative to subparagraph (a), it may, in appropriate cases, fix the damages as a lump sum on the basis of elements such as at least the amount of royalties or fees that would have been due if the infringer had applied for authorisation to use the patent in question. In order for the court to assess damages in this way, the patent owner must meet his burden of proof. Therefore, the patentee may indeed make a preliminary claim for damages based on lost profits and request additional disclosure of the infringer's profits in the same proceedings. However, these requests must be made in the dedicated workflows and not in the statement of claim. In any event, the Court noted that when deciding on a request for disclosure in the context of ongoing proceedings, a balance must be struck between the competing interests of the parties. Data relating to the infringer's profits are by their nature particularly sensitive. Therefore, the prospects of the patentee's case must be weighed against the prospects of the defendant's case. In this context, the Court took note of the decision of the French courts of first instance invalidating the French designation of the patent in dispute, the rejection of the opposition by the Opposition Division of the EPO and the date set for the oral proceedings before the Boards of Appeal of the EPO on 1-3 April 2025. The parties informed the Court that a preliminary opinion from the Boards of Appeal is expected shortly. Consequently, no disclosure of infringers' profits will be ordered before that preliminary opinion is issued, even if those requests are subsequently filed in the dedicated workflows.
Some of the defendants suggested that there should be separate proceedings for the calculation of damages. The Court noted that under Rule 118(1)(2) of the Rules of Procedure, separation is at the discretion of the Court. The claimants argued that damages should, if possible, be calculated in the main proceedings. In another context, the Claimants stated that the formal reliefs for damages should be understood as a request for an interim award of damages pursuant to Rule 119 of the Rules of Procedure. The Court noted that this was not currently reflected in the pleadings and should not be so understood until a formal amendment is made.
In some of the counterclaims, the defendants requested that the patent in suit be declared invalid in its entirety and/or that the " claimants " be ordered to pay the costs of the proceedings. The Court held that the territorial scope of the counterclaim must be made clear by naming the territories. It should also be made clear who, on the claimant side, should bear the costs. If the requests include claimants other than the patentee, it should be explained why they should also bear the costs and, if so, whether and why they are jointly and severally liable with the patentee. In any event, the costs incurred for the infringement action and the counterclaims must be kept separate and claimed separately. The defendants concerned shall address this issue in their observations on Sanofi's next submission.
The Court noted that the filing of a witness statement does not count as a pleading. If the accompanying pleading is filed in the future, it will be necessary to consider whether this could have been done earlier. All parties stated that they would not request a panel review of the confidentiality order in respect of D4.
The parties informed the Court that an appeal hearing in France is expected in late 2026/early 2027. The oral hearing before the BoA is scheduled for 1-3 April 2025. A preliminary opinion is expected shortly. A written decision is expected in late June/early July 2025. Sanofi informed the Court that it has not filed any request for amendment of the patent with the Court, but reserves the right to do so following a decision by the BoA. The court did not comment on whether this approach complied with the Rules of Procedure. Accord argued that the first instance invalidation decision for France had immediate effect, even for the period during which an appeal was pending. Therefore, no protection was now available for the French territory. Reddy argued that no stay of proceedings was necessary. Zentiva's lawyer said that this issue needed to be discussed with the client first.
The Court invited the parties to consider using the PMAC. However, no agreement to do so could be reached prior to a decision by the BoA.
Sanofi argued that the claims for damages were requests for an interim award of damages that could increase or decrease depending on further information. The defendants disagreed with this interpretation based on the wording of the formal reliefs filed. The Court noted that this was not now reflected in the pleadings and therefore should not be understood in this way until a formal amendment is made.
In any event, the claims relate to a specific amount of money to be paid and therefore the value of the claims for damages is the amount of money to be paid. The other remedies sought, such as injunctive relief, recall and destruction, add to this value. In the absence of better figures, the Court estimates that these other remedies add 100 per cent to the value.
As to the value of the counterclaims, the defendants disagreed with the Court's view that the value of each counterclaim should be the sum of all four values of the infringement actions plus 50 per cent. However, this is precisely the calculation method set out in point 2.b of the Guidelines. The value of the patent must be determined. In the absence of relevant information, the value of the counterclaim may be assumed to be equal to the value of the infringement action plus up to 50 per cent. In the case of multiple infringement actions, the values should be added together. As the parties have not provided a better method of calculation, the values shall be increased as follows:
Value of the infringement actions:
Accord:
4,13 Mio increased to 8,5 Mio. EUR
Stada
15,77 Mio. increased to 32 Mio. EUR
8,05 Mio. increased to 16,5 Mio. EUR
Zentiva
7,779 Mio. increased to 16 Mio. EUR
Value of the counterclaims:
The value of each counterclaim is increased to 109.50 mio. EUR.
The value of the counterclaims is only relevant for the recoverable costs cap. The value of the infringement actions is also relevant for the court fees. Sanofi will have to pay an additional fee within 30 days.
The Court encouraged the parties to reach an out-of-court agreement on the amount of the recoverable costs prior to any decision by the Boards of Appeal or the Court of First Instance.
It was agreed that, for the purposes of further proceedings, it would be sufficient for the Court to invite only one of several claimants or defendants to submit observations in the CMS, and that it would be sufficient for only one of several claimants or defendants to file a brief in the CMS, as long as it was clear from the PDF file submitted which party or parties were intervening.
The Court has asked the parties not to repeat what has already been written and filed, and to make clear which parts of the briefs are common to all four parallel cases and all claimants and defendants, and which parts relate only to the particular circumstances of each procedural relationship. This will save reading time for both the parties and the Court.
The defendants informed the Court that there is currently no joint defence group in place and that it is unlikely that there will be one in the future.
It was discussed that, as a first step, Sanofi should address the issues with the formal relief. The defendants will be invited to comment. The Court will then give guidance on further deadlines. All other time limits, including the time limit for the rejoinder, currently due on 13 February 2025, will therefore be suspended.
Accord: 8.5 million EUR
Stada: 32 million EUR
Reddy: 16.5 million EUR
Zentiva: 16 million EUR
Any party may request that this Order be referred to the panel for a review pursuant to R. 333 RoP. Pending review, the Order shall be effective (R. 102.2 RoP).
Should a party fail to comply with the present Order within the time period specified, a decision by default may be given in accordance with R. 355 RoP (R. 103.1, last subparagraph and .2 RoP).
The value of the infringement actions and counterclaims must be adjusted in the CMS. Additional fees shall be charged for infringement actions.
The Court will announce the next deadlines for the filing of any briefs and will rule on the open applications in due course after the parties have filed their briefs as ordered. However, the parties are invited to provide the Court with any information on the French invalidity proceedings and the BoA proceedings without delay. The dates for the interim conference (17 July 2025) and the oral hearing (14-17 October 2025) are confirmed.
Order no. ORD_3577/2025 in ACTION NUMBER: ACT_16112/2024
UPC number: UPC_CFI_145/2024
Action type:
Infringement Action
Order no. ORD_3580/2025 in ACTION NUMBER: ACT_16116/2024
UPC number: UPC_CFI_146/2024
Order no. ORD_3582/2025 in ACTION NUMBER: ACT_16119/2024
UPC number: UPC_CFI_147/2024
Order no. ORD_3586/2025 in ACTION NUMBER: ACT_16120/2024
UPC number: UPC_CFI_148/2024
Matthias ZIGANN Digital unterschrieben von Matthias ZIGANN Datum: 2025.01.22 14:55:49 +01'00'
Dr. Zigann Presiding Judge