UPC_CFI_1830/2026 – Toolgen v Vertex

Expert Commentary

R 190 RoP Application - Alignment of defence dates Facts 1. Infringement proceedings concerning EP 4 397 760. 2. The parties filed a joint request for the alignment of the defence dates for the US and Dutch defendants. 3. Three weeks after the Statement of Claim, the defendants filed a request for the production of the evidence (documents filed in the UK proceedings). 4. The defendants asked for a R. 361 RoP dismissal of the request for injunctive relief. The Court 1. Dismissed the R. 190 RoP request, as the defendants used this to obtain documents from the UK proceedings which, under UK law, can only be used in those proceedings. The defendants should have asked the UK Court for permission to use these documents. They did not do so, which shows that they apparently would not have obtained the documents. 2. R. 361 RoP is only applicable for clear-cut cases. 3. The alignment of the defence dates is granted. Comment 1. The Court does understandably not allow to circumvent UK law by means of an R. 190 RoP request. Comity requires so. That is certainly the case if there is a mechanism under UK law for the UK Court to decide whether the documents can be used in foreign proceedings. 2. R. 361 RoP (early dismissal because a claim is manifestly bound to fail) is only going to work in clear-cut cases. So representatives would be wise to stop wasting the Court’s time on these useless exercises.

Full Decision Text

1 The Hague - Local Division UPC-CFI-1830/2026 Order of the Court of First Instance of the Unified Patent Court issued on 15/09/2026 regarding: rules 9.3, 190 and 361 RoP Claimant/Applicant TOOLGEN, INC., Represented by Mark Didmon (Po:er Clarkson LLP) 8F, 172 Magokjungang-ro, Gangseo-gu, Seoul, 07789, Republic of Korea “Toolgen” Defendants 1. VERTEX PHARMACEUTICALS INCORPORATED, 50 Northern Avenue, Boston, Massachuse:s, 02210 United States of America “Vertex” 2. LONZA NETHERLANDS B.V., Oxfordlaan 70 in 6229 EV Maastricht, The Netherlands “Lonza” Defendants are represented by Nerissa Teeuwen and Rutger Kleemans (Freshfields). PATENT AT ISSUE Patent no. Proprietor/s EP 4 397 760 ToolGen, Inc 2 DECIDING JUDGE The panel consists of: Presiding judge Edger Brinkman Judge-rapporteur Margot Kokke Legally qualified judge Vincenzo Carni This order is issued by the judge-rapporteur. LANGUAGE OF PROCEEDINGS: English Subject-matter of the proceedings: Infringement proceedings POINTS AT ISSUE AND REQUESTS 1. On 26 May 2026, ToolGen initiated infringement proceedings against defendants pending as case UPC_CFI_1830/2026. 2. Toolgen asserts that defendants, with the product Casgevy.13, infringe ToolGen’s patent EP4397760 (“the patent”), which relates to a “Composition for cleaving a target DNA comprising a guide RNA specific for the target DNA and Cas protein -encoding nucleic acid or Cas protein, and use thereof”. 3. On 10 June 2026 the parties filed a joint request to align deadlines for both defendants. This request was provisionally granted by communication of the Court of the same day. 4. Defendants filed a R.190 Application on 19 June 2026, requesting the Court to: 1) Order ToolGen, Inc. to produce within seven (7) days of service of the Court's order: a. the document identified in the UK Proceedings (HP-2025-000013) as ToolGen_01442, including its attachment “Cho 2013a”; b. the documents identified in the UK Proceedings (HP-2025-000013) as ToolGen_00243 and ToolGen_00249; 2) Order that the Documents be produced in electronic form to Applicants' representatives; 3) Order that the Documents be produced without any confidentiality regime or restriction on further use in the UPC Proceedings and the Dutch proceedings; 4) Order that, in the event of non-compliance with the order for production, ToolGen shall pay a penalty payment of EUR 20,000 for each day or part thereof during which the non-compliance continues, subject to a maximum of EUR 2,000.000; 5) Order ToolGen to respond to this Application within seven (7) days of service of the procedural order following the Application. Defendants assert that they intend to file a counterclaim for revocation and want to rely on the documents listed at 1) (collectively “the Documents”). 5. ToolGen responded, requesting the Court to dismiss the application. It argues that the 3 Application is, in substance, an attempt to obtain documents subject to the CPR 31.22 Undertaking in the UK proceedings through a different procedural route, without first pursuing the remedies specifically contemplated by English law. Rule 190 RoP is not intended to function as a mechanism for circumventing such established procedural safeguards. 6. Prompted by the Court’s request for an update, ToolGen by submission of 16 August 2026, informed the Court, inter alia, that the defendants have not made an application to the UK Court seeking permission to use the Documents outside of the UK proceedings. The defendants confirmed this by submission of 24 August 2026. 7. On 3 August 2026, defendants filed a R.361 Application, requesting that the Court: i. dismiss, pursuant to R. 361 RoP, ToolGen's claims for injunctive and corrective relief concerning Casgevy.13 ii.order ToolGen to bear the costs of this application. In response, ToolGen requested the Court to dismiss the R.361 application. GROUNDS The R.190 Application 8. It is undisputed that the Documents requested by the Defendants are not publicly available, that they were obtained through disclosure are restricted in use to what parges refer to as the ‘UK proceedings’. The JR agrees with ToolGen that the Defendants cannot circumvent any restricgons placed on access in the UK proceedings by a R.190 order of the UPC. The appropriate route would have been for the defendants to apply to the Court in the pending UK proceedings for permission to use the Documents in other proceedings. The fact that this route was not pursued, indicates that this would not have led to the desired result. This is deemed sufficient reason to dismiss the applicagon. The requirements of proporgonality, equity and fairness are not met. The R.361 Application 9. Rule 361 RoP, gtled ‘Acgon manifestly bound to fail’, reads as follows: Where it is clear that the Court has no jurisdic2on to take cognisance of an ac2on or of certain of the claims therein or where the ac2on or defence is, in whole or in part, manifestly inadmissible or manifestly lacking any founda2on in law, the Court may, a<er giving the par2es an opportunity to be heard, give a decision by way of order. 10. A R.361 applicagon is thus reserved for clear-cut situagons only, as clarified by the CoA1. This is, also in view of ToolGen’s response and submissions, not the case here. The defendants argue that, in view of pargcular factual circumstances, (only) ToolGen’s request for injuncgve relief should be dismissed as manifestly bound to fail. An assessment of facts, law and evidence is necessary to establish whether this is correct, which makes that the contested relief is not 1 See CoA order of 15 October 2024, UPC_CoA_570/2024, Mocrosoft v Suinno 4 manifestly inadmissible within the meaning of R. 361 RoP.2 The R.361 applicagon is therefore dismissed. The arguments raised by the defendants are to be addressed in the main proceedings. Case management measures 11. The JR uses this opportunity to confirm the deadline for filing the statement of defence by the defendants (pursuant to R.9.3 RoP, see 3. above). Furthermore, as the defendants announced that they intend to file a counterclaim for revocagon together with the statement of defence, parges are invited to express their views on the applicagon of Art. 33(3) UPCA. ORDER The Court, having heard the parties: I. Dismisses the R.190 RoP application; II. Dismisses the R.361 RoP application; III. Confirms that the deadline for filing the statement of defence for both defendants is 25 September 2026 (R.9.3 RoP); IV. Invites the parties to express their views on the application of Art. 33(3) UPCA. INFORMATION ABOUT PANEL REVIEW 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) 2 See LD Lisbon, order of 26 May 2026 ,UPC_CFI_850/202, Ericsson v Transsion.Kokke Margot 15:39:54 +0200

Key Holdings

• A Rule 190 RoP request for production of evidence will be dismissed where it is used to circumvent foreign (e.g., UK) restrictions on documents that can only be used in those foreign proceedings without the foreign court's permission.
• Comity requires respecting foreign court mechanisms for granting permission to use litigation documents abroad before requesting their production under Rule 190 RoP.
• Rule 361 RoP early dismissal of a claim is only applicable in clear-cut cases where a claim is manifestly bound to fail.
• Alignment of defence dates for co-defendants (e.g., US and Dutch defendants) can be granted upon joint request.

Tags

• R 190 RoP Application - Alignment of defence dates
• Production of evidence
• Comity
• Alignment of defence dates

Related Rules

• Rule 1 – Application of the Rules and general principles of interpretation
• Rule 3 – Power of staff of the Registry and a sub-registry to perform functions of the Registry