UPC CFI 17/2023 – 10x Genomics, Inc. and President and Fellows of Harvard College v NanoString Technologies Inc, NanoString Technologies Germany GmbH, NanoString Technologies Netherlands B.V., Brad Gray, Mark James Daniel, and Björn Kristian Johnson

Court
Local Division Munich
Date
Outcome
Denied
Sector
Pharma/Bio
Decision Type
PROCEDURAL

Expert Commentary

Full Decision Text

1 Local Chamber Munich Guiding principles: 1. The formation of opinion required under Article 62(4) EPC and Rule 211(2) IR with regard to the validity of the patent in suit does not concern the question whether the patent in suit could have been granted in an amended version, but the question whether the patent in suit is valid in its granted version. 2. With regard to the present application for interim measures, it does not appear sufficiently certain to find infringement on the basis of an interpretation of the patent claim that deviates from the understanding conveyed by the mere wording of the claim in conjunction with a specific example of an embodiment. 2 Arrangement of the Court of First Instance of the Unified Patent Court in the proceedings for interim measures concerning EP 2 794 928 Procedure number UPC CFI 17/2023 issued on: 10/10/2023 Date of receipt of the application: 01/06/2023 APPLICANT 1) 10x Genomics, Inc. Represented by: (Applicant) - 6230 Stoneridge. Tilman Müller-Stoy Mall Road - 94588-3260 - Pleasanton - US 2) President andFellows of Harvard Represented byCollege Tilman Müller- Stoy (Applicant) - Suit 727E, 1350 Massachussetts Avenue - 02138 - Massachusetts - US APPLICANT 1) NanoString Technologies Inc Represented by: (Respondent) - 530 Fairview AveOliver Jan Jüngst N - 98109 - Seattle (WA) - US 2) NanoString Technologies GermanyRepresented by: GmbH (defendant) - Birketweg Oliver Jan Jüngst 31 - 80639 Munich - DE 3 3) NanoString Technologies Netherlands B.V. (Respondent) - Paasheuvelweg 25 - 1105BP - Amsterdam - NL Represented by: Oliver Jan Jüngst 4) Brad Gray (Respondent), CEO of Represented by: NanoString Technologies Inc. Oliver Jan Jüngst 5) Mark James Daniel (defendant), Represented by: Director of NanoString Technologies Oliver Jan Jüngst Netherlands B.V. 6) Björn Kristian Johnson(Antragsgeg- Represented by: ner), Managing Director of NanoString Oliver Jan Jüngst Technologies Germany GmbH PATENT AT ISSUE Patent no. EP2794928 Owner President and Fellows of Harvard College DECISIVE JUDGES COMPOSITION OF THE PANEL - FULL COMPOSITION Presiding judge Judge-rapporteur Legally qualified judge Technically qualified judge Matthias Zigann Tobias Pichlmaier Andràs Kupecz Eric Enderlin 4 PROCEDURAL LANGUAGE" German ORAL NEGOTIATION: 19 September 2023 TERMINATED ON: 10 October 2023 5 Facts On 1 June 2023, the applicants applied to the Unified Patent Court (Munich Local Chamber) for interim measures, claiming that EP 2 794 928 (patent in suit) was directly and indirectly infringed by the respondents. The patent in suit was filed on 21 December 2012, claiming the priority of US 201161579265 P of 22 December 2011. It is entitled "Compositions and methods for the detection of analytes". The patent application underlying the patent in suit was published on 29 October 2014. The notice of grant of the patent in suit with effect, inter alia, for the Federal Republic of Germany, France and the Netherlands was published by the European Patent Office on 20 February 2019. Claim 1 of the patent in suit reads: A method for detecting a plurality of analytes in a sample, comprising: a. contacting the sample with a composition comprising a plurality of detection reagents, wherein each subpopulation of the detection reagents targets at least one different analyte, wherein the analyte is fixed on a solid substrate or support and wherein the solid substrate or support is a chip, a microarray, a blotting membrane or a microscopic slide, and wherein each detection re- agent comprises: at least one probe reagent targeting an analyte and at least one nucleic acid label comprising a plurality of pre-determined subsequences, wherein said at least one probe reagent and said at least one nucleic acid label are conjugated together; and wherein at least a portion of said plurality of pre-determined subsequences form an identifier of said at least one probe reagent; b. removing any unbound detection reagents; C. detecting in a temporally-sequential manner said plurality of pre- determined subsequences of said detection reagent, wherein said detection of the sub-sequences comprises: i) hybridizing a set of decoder probes with a subsequence of the detec- tion reagents, wherein each subpopulation of said decoder probes is 6 comprises an optical detectable label, each optical detectable label generating an optical signal signature corresponding to each subsequence; ii) detecting said optical signal signature produced upon the hybridization of said set of decoder probes and obtaining an image; iii) removing said optical signal signature produced by the hybridization of said set of decoder probes; iv) repeating steps (i) through (iii) for other subsequences of said detection reagents, thereby producing a temporal order of optical signal signatures corresponding to the plurality of pre-determined subsequences, wherein the temporal order of the optical signal signatures corresponds to said plurality of pre-determined subsequences of said detection reagent identifies a subpopulation of the detection reagents and is unique for each subpopulation of the detection reagents; and d. comparing said temporal order of the optical signal signatures with different identifiers of said at least one probe reagent, wherein an agreement between the temporal order of the optical signal signatures and a particular identifier of said at least one probe reagent identifies the analyte in the sample. With regard to the German part of the patent in suit, an invalidity action with file number 3 Ni 20/22 (EP) is pending before the German Federal Patent Court (BPatG). In its qualified opinion of 7 February 2023, the 3rd Senate of the BPatG sets out its preliminary view according to which the German part of the patent in suit is capable of being maintained to the extent of the auxiliary request 1 filed in the proceedings before the BPatG. The applicant asserts patent claim 1 as limited in the German invalidity proceedings (auxiliary request 1 and in the relevant language of the proceedings, English) as follows (the amendments to the granted version are highlighted by the applicant by means of underlining for additions and strikethrough for deletions): 7 A method used in (i) immunohichemistry and/or (ii) fluorescence in situ hybridi- zation for detecting a plurality of analytes in a sample, comprising: a. contacting the sample with a composition comprising a plurality of detection reagents, wherein each subpopulation of the detection reagents targets at least one different analyte, wherein the analyte is fixed on a solid substrate or support and wherein the solid substrate or support is a chip, a microarra¿ or a microscopic slide, and wherein each detection re- agent comprises: at least one probe reagent targeting an analyte and at least one nucleic acid label comprising a plurality of pre-determined subsequences, wherein said at least one probe reagent and said at least one nucleic acid label are conjugated together; and wherein at least a portion of said plurality of pre-determined subsequences form an identifier of said at least one probe reagent; b. removing any unbound detection reagents; c. detecting in a temporally-sequential manner said plurality of pre- determined subsequences of said detection reagent, wherein said detection of the sub-sequences comprises: i) hybridizing a set of decoder probes with a subsequence of the detec- tion reagents, wherein each subpopulation of said decoder probes comprises an optical detectable label, each optical detectable label generating an optical signal signature corresponding to each subsequence; ii) detecting said optical signal signature produced upon the hybridization of said set of decoder probes and obtaining an image; iii) removing said optical signal signature produced by the hybridization of said set of decoder probes; iv) repeating steps (i) through (iii) for other subsequences of said detection reagents, thereby producing a temporal order of optical signal signatures corresponding to the plurality of pre-determined subsequences, wherein the temporal order of the optical signal signatures corresponds to said plurality of pre-determined subsequences of said detection reagent identifies a subpopulation of the detection reagents and is unique for each subpopulation of the detection reagents; and 8 d. comparing said temporal order of the optical signal signatures with different identifiers of said at least one probe reagent, wherein an agreement between the temporal order of the optical signal signatures and a particular identifier of said at least one probe reagent identifies the analyte in the sample; wherein said sample is a biolooical samole comprising one or more cells and/or one or more tissues: and wherein said analvtes are selected from the oroup consistino of proteins, peptides and nucleic acids, wherein said nucleic acids are selected from the orouo consisting of cellular RNA. messenger RNA. microRNA, ribosomal RNA. and anV combinations thereof. The research underlying the patent in suit was also financed with public funds from the US National Institute of Health (NIH). This funding gives rise to contractual obligations of the second applicant vis-à-vis the NIH, the concrete scope of which is subject to differing opinions between the parties to the present application proceedings. The second applicant is registered as proprietor of the patent in suit. It has granted the first applicant an exclusive licence to the patent in suit for the territory of the Federal Republic of Germany with effect from 14 February 2023 and an exclusive licence to the patent in suit for France and the Netherlands with effect from 30 May 2023. The parties to these injunction proceedings have different views on whether these licences are legally valid. The applicants have successfully brought an action for an injunction against respondents 1) and 2) based on the German part of the patent in suit before the Munich Regional Court I under reference numbers 7 O 2693/22 and 7 O 5812/22. The judgements are dated 17 May 2023. Appeal proceedings are pending before the Munich Higher Regional Court. The first defendant is an American company. It is the parent company of a group of companies operating under the name "NanoString". Respondent 2) is the German sales and marketing company in this group of companies. The third defendant is the European headquarters of the group. The 4th defendant is the CEO of the 1st defendant, the 5th defendant is the managing director of the 2nd defendant and the 3rd defendant is the German sales and marketing company in this group of companies. the director of the respondent to 3), and the respondent to 6) is the second managing director of the respondent to 2). In addition to the analysis systems "nCountero Analysis System", "GeoMxo Digital Spatial Profiles" (DSP) and "Spatial Molecular Imager" (SMI), the defendants offer the product in dispute "CosMx Spatial Molecular Imager", abbreviated as "CosMx". "CosMx SMI" (hereinafter referred to as "contested embodiment 1"). The challenged embodiment 1 enables highly sensitive, subcellular imaging of a variety of RNAs or proteins directly from individual cells in mor- phologically intact tissue samples. The challenged embodiment 1 allows samples, in particular biological samples such as fixed cells and tissue sections, to be automatically analysed for the presence of certain analytes, namely RNA and proteins. According to the applicants, the product has been offered on the market since December 2022. It is also used in the so-called CX-Lab of the defendants in Amsterdam. This is evident from the presentation of the CX-Lab on the website https://nanostring.com/about-us/cx- Iabs/cxIab-amsterdam/; in the section "Platforms Designed to Accelerate Sample to Disclosure", the products available in the laboratory in Amsterdam are named, including the contested embodiment 1. The challenged embodiment 2 is a detection reagent. It can only be used for the detection of RNA. The challenged embodiment 2 is sold in a kit as a so-called "CosMx RNA Panel" in a standard variant ("off-the-shelf RNA Add-On") as well as according to customer specifications ("Custom RNA Add-On Probes"). The challenged embodiment 3 is a probe that binds as a secondary probe to the primary probe that h a s already bound to its analyte (RNA or protein); the challenged embodiment 3 is used in so-called "CosMx RNA Imaging Trays". These products are available for the detection of 100 RNAs (100-pIex) or 1000 RNAs (1000-pIex), each for 2 or 4 slides. The challenged embodiment 3 can be used for the detection of RNA as well as for the detection of proteins. 10 The challenged embodiments are also offered in combination. They have been supplied to the Max Delbrück Center in Berlin, for example, which offers available services and technologies under the name Nanostring-CosMx. In the second half of April 2023, the defendants carried out a promotional tour through Europe with regard to the contested embodiments (European Summit, including events in Hanover, Würzburg, Paris, Marseille and Utrecht). The defendants are holding numerous other events at research institutions to demonstrate the contested embodiments and are also planning such events for the coming weeks and months. The defendant repeatedly requested the second applicant to submit a licence offer on reasonable terms with regard to the patent in suit. In the meantime, the applicants have filed a main action for patent infringement before the EPG (Munich Local Chamber) on account of the infringement of the patent in suit. The applicants claim that the "CosMx Spatial Molecular Imager" (and similar models) offered and used by the respondents and also used by their customers and the associated detection reagents and decoder probes are devices for carrying out the method protected by the patent in suit. The applicants describe the core of the invention according to the patent in suit in that it takes a fundamentally different approach compared to the prior art. Whereas the prior art methods for in situ analysis combined fluorophores in order to increase the number of detectable analytes, in the invention according to the patent in suit a probe was not directly labelled with a fluorophore; rather, a nucleic acid sequence (so-called predetermined partial sequence) was attached to the probe. 11 The second applicant was entitled to file an application as the registered proprietor of the patent in suit. The entry in the register was also decisive. Irrespective of this, the second applicant had fulfilled all legal requirements in connection with the invention in dispute here. This applied in particular to the requirements arising from the Bayh-Dole Act. The documents submitted showed that the second applicant had disclosed the invention to the NIH in due time, had claimed the right to the invention in accordance with the requirements of the Bayh-Dole Act and had filed a patent application for the invention. To date, the NIH has not raised any objections. The applicants' most recent applications are as follows: A. The respondents are ordered to, I. In the Contracting Member States of the Federal Republic of Germany, France and the Netherlands, to refrain from and to discontinue the use of a method used in fluorescence in situ hybridisation for the detection of a plurality of analytes in a sample, comprising: 1. Contacting the sample with a composition comprising a plurality of detection reagents, wherein each subpopulation of the detection reagents targets at least one different analyte, wherein the analyte is fixed to a solid substrate or support, and wherein the solid substrate or support is a chip, a microarray or a microscopy slide, and wherein each comprises a detection reagent: at least one probe reagent targeting an analyte, and at least one nucleic acid label comprising a plurality of predetermined partial sequences, wherein said at least one probe reagent and said at least one nucleic acid label are conjugated to each other; and wherein at least a portion of said plurality of predetermined partial sequences forms an identifier of said at least one probe reagent; 2. Remove any unbound detection reagents; 12 3. detecting the plurality of predetermined subsequences of the detection reagent in a sequential manner, wherein the detection of the subsequence comprises: i) Hybridising a set of decoder probes with a subset of the detection reagents, wherein each subset of the decoder probes comprises an optically detectable label, wherein each optically detectable label generates an optical signature corresponding to each subset; ii) Detecting the optical signal signature produced during hybridisation of the set of decoder probes and obtaining an image; Removal of the optical signal signature produced by the hybridisation of the set of decoder probes; ÏV) repeating steps (i) through (iii) for other subsequences of the detection reagents, thereby producing a temporal sequence of optical signal signatures corresponding to the plurality of predetermined subsequences, wherein the temporal sequence of optical signal signatures corresponding to the plurality of predetermined subsequences of the detection reagent identifies a subpopulation of the detection reagents and is unique for each subpopulation of the detection reagents; and 4. comparing the temporal order of the optical signal signatures with different identifiers of the at least one probe reagent, wherein a match between the temporal order of the optical signal signatures and a particular identifier of the at least one probe reagent identifies the analyte in the sample, wherein the sample is a biological sample comprising one or more cells and/or one or more tissues, and wherein the analytes are nucleic acids, wherein the nucleic acids are selected from the group consisting of cellular RNA, 13 messenger RNA, microRNA, ribosomal RNA and any combination thereof, in Germany, France and/or the Netherlands or to offer them for use in Germany, France and/or the Netherlands; (direct infringement of limited claim 1 of EP 2 794 928) ii. with respect to defendants 3) to 6) in the Contracting Member States of the Federal Republic of Germany, France and the Netherlands, and with respect to defendants 1) and 2) in the Contracting Member States of France and the Netherlands, respectively, to cease and desist from using devices capable of performing a procedure used in fluorescence in situ hybridisation for the detection of a plurality of analytes in a sample: 1. Contacting the sample with a composition comprising a plurality of detection reagents, wherein each subpopulation of the detection reagents targets at least one different analyte, wherein the analyte is fixed to a solid substrate or support, and wherein the solid substrate or support is a chip, a microarray or a microscopy slide, and wherein each comprises a detection reagent: at least one probe reagent targeting an analyte, and at least one nucleic acid label comprising a plurality of predetermined partial sequences, wherein said at least one probe reagent and said at least one nucleic acid label are conjugated to each other; and wherein at least a portion of said plurality of predetermined partial sequences forms an identifier of said at least one probe reagent; 2. Remove any unbound detection reagents; 3. detecting the plurality of predetermined subsequences of the detection reagent in a sequential manner, wherein the detection of the subsequence comprises: 14 i) Hybridising a set of decoder probes with a subset of the detection reagents, wherein each subset of the decoder probes comprises an optically detectable label, wherein each optically detectable label generates an optical signature corresponding to each subset; ii) Detecting the optical signal signature produced during hybridisation of the set of decoder probes and obtaining an image; ÏÏ) Removal of the optical signal signature produced by the hybridisation of the set of decoder probes; iv) repeating steps (i) through (iii) for other subsequences of the detection reagents, thereby producing a temporal sequence of optical signal signatures corresponding to the plurality of predetermined subsequences, wherein the temporal sequence of optical signal signatures corresponding to the plurality of predetermined subsequences of the detection reagent identifies a subpopulation of the detection reagents and is unique for each subpopulation of the detection reagents; and 4. comparing the temporal order of the optical signal signatures to different identifiers of the at least one probe reagent, wherein a match between the temporal order of the optical signal signatures and a specific identifier of the at least one probe reagent identifies the analyte in the sample, wherein said sample is a biological sample comprising one or more cells and/or one or more tissues, and wherein said analytes are nucleic acids, said nucleic acids being selected from the group consisting of cellular RNA, messenger RNA, microRNA, ribosomal RNA and any combinations thereof, for use in the territory of the Contracting Member States of the Federal Republic of Germany, France and/or the United Kingdom. The Netherlands (with regard to applicants 3) to 6)) or the Contracting Member States France and/or the Netherlands (with regard to applicants 1) and 2)) for use in Germany, France and/or the Netherlands (with regard to applicants 3) to 6)) or France and/or the Netherlands (with regard to applicants 1) and 2)), respectively, without (1) to state explicitly, conspicuously and prominently on each offer, on the first page of the operating instructions, in the delivery documents and on the packaging that the devices may not be used for the detection of cellular RNA, messenger RNA, microRNA, ribosomal RNA and any combinations thereof in a procedure according to section A. II. without the consent of the second applicant as owner of EP 2 794 928 B1.II. and the use for the detection of cellular RNA, messenger RNA, microRNA, ribosomal RNA and any combinations thereof is to be prohibited without the consent of applicant 2), (2) the purchasers with the imposition of a fee payable to the applicant. 2) to pay a reasonable contractual penalty to be determined by the second applicant and, if necessary, to be reviewed by the competent court, to impose a written obligation for each case of infringement not to use the devices for the detection of cellular RNA, messenger RNA, microRNA, ribosomal RNA and any combinations thereof without the prior consent of the second applicant; (indirect infringement of limited claim 1 of EP 2 794 928) III. with regard to defendants 3) to 6) in the Contracting Member States of the Federal Republic of Germany, France and the Netherlands and with regard to defendants 1) and 2) in the Contracting Member States of the European Union, it is 1/' 16 Contracting States France and the Netherlands, respectively, to refrain from and to discontinue the use of detection reagents for the detection of RNA suitable for carrying out a method used in fluorescence in situ hybridisation for the detection of a plurality of analytes in a sample, comprising: 1. Contacting the sample with a composition comprising a plurality of detection reagents, wherein each subpopulation of the detection reagents targets at least one different analyte, wherein the analyte is fixed to a solid substrate or support, and wherein the solid substrate or support is a chip, a microarray or a microscopy slide, and wherein each comprises a detection reagent: at least one probe reagent targeting an analyte, and at least one nucleic acid label comprising a plurality of predetermined subsequences, wherein said at least one probe reagent and said at least one nucleic acid label are conjugated to each other; and wherein at least a portion of said plurality of predetermined subsequences forms an identifier of said at least one probe reagent; 2. Remove any unbound detection reagents; 3. detecting the plurality of predetermined subsequences of the detection reagent in a sequential manner, wherein the detection of the subsequence comprises: i) Hybridising a set of decoder probes with a subset of the detection reagents, wherein each subset of the decoder probes comprises an optically detectable label, wherein each optically detectable label generates an optical signature corresponding to each subset; ii) detecting the optical signal signature produced during hybridisation of the set of decoder probes and obtaining an image; iii) removing the optical signal signature, 17 which was pro- duced by hybridising the set of decoder probes; ÏV) \/repeating steps (i) through (iii) for other subsequences of the detection reagents, thereby producing a temporal sequence of optical signal signatures corresponding to the plurality of predetermined subsequences, wherein the temporal sequence of optical signal signatures corresponding to the plurality of predetermined subsequences of the detection reagent identifies a subpopulation of the detection reagents and is unique for each subpopulation of the detection reagents; and 4. Comparing the temporal order of the optical signal signatures with different identifiers of the at least one probe reagent, wherein a match between the temporal order of the optical signal signatures and a particular identifier of the at least one probe reagent identifies the analyte in the sample, wherein the sample is a biological sample comprising one or more cells and/or one or more tissues, and wherein the analytes are nucleic acids, wherein the nucleic acids are selected from the group consisting of cellular RNA, measuring RNA, microRNA, ribosomal RNA and any combinations thereof, for use in the territory of the Contracting Member States of the Federal Republic of Germany, France and/or the Netherlands (with respect to applicants), microRNA, ribosomal RNA and any combinations thereof, for use in the territory of the Contracting Member States of the Federal Republic of Germany, France and/or the Netherlands (in respect of applicants 3) to 6) and of the Contracting Member States of France and/or the Netherlands (in respect of applicants 1) and 2)) for use in Germany, France and/or the Netherlands (in respect of applicants 2) for use in Germany, France and/or the Netherlands (in respect of applicants 3) to 6), France and/or the Netherlands (with regard to applicants 3) to 6)) or France and/or the Netherlands (with regard to applicants 1) and 2)), (indirect infringement of limited claim 1 of EP 2 794 928) 18 IV. with respect to defendants 3) to 6) in the Contracting Member States of the Federal Republic of Germany, France and the Netherlands, and with respect to defendants 1) and 2) in the Contracting Member States of France and the Netherlands, respectively, to cease and desist from using decoder probes suitable for carrying out a procedure used in fluorescence in situ hybridisation for the detection of a plurality of analytes in a sample: 1. Contacting the sample with a composition comprising a plurality of detection reagents, wherein each subpopulation of the detection reagents targets at least one different analyte, wherein the analyte is fixed on a solid substrate or support, and wherein the solid substrate or support is a chip, a microarray or a microscopy slide, and wherein each comprises detection reagent: at least one probe reagent targeting an analyte, and at least one nucleic acid label comprising a plurality of predetermined partial sequences, wherein said at least one probe reagent and said at least one nucleic acid label are conjugated to each other; and wherein at least a portion of said plurality of probe reagents is of the predetermined partial sequences forms an identifier of the at least one probe reagent; 2. Remove any unbound detection reagents; 3. detecting the plurality of predetermined subsequences of the detection reagent in a sequential manner, wherein the detection of the subsequence comprises: i) Hybridising a set of decoder probes with a subset of the detection reagents, wherein each subpopulation of the decoder probes comprises an optically detectable label, 19 wherein each optically detectable marker generates an optical sig- nal signature corresponding to each subsequence; ii) detecting the optical signal signature produced by the hybridisation of the set of decoder probes and obtaining an image; iii) removing the optical signal signature produced by the hybridisation of the set of decoder probes; iV) repeating steps (i) through (iii) for other subsequences of the detection reagents, thereby producing a temporal sequence of optical signal signatures corresponding to the plurality of predetermined subsequences, wherein the temporal sequence of optical signal signatures corresponding to the plurality of predetermined subsequences of the detection reagent identifies a subpopulation of the detection reagents and is unique for each subpopulation of the detection reagents; and 4. comparing the temporal order of the optical signal signatures with different identifiers of the at least one probe reagent, wherein a match between the temporal order of the optical signal signatures and a particular identifier of the at least one probe reagent identifies the analyte in the sample, wherein the sample is a biological sample comprising one or more cells and/or one or more tissues, and wherein the analytes are nucleic acids, wherein the nucleic acids are selected from the group consisting of cellular RNA, measuring RNA, microRNA, ribosomal RNA and any combinations thereof, for use in the territory of the Contracting Member States of the Federal Republic of Germany, France and/or the Netherlands (in respect of applicants 3) to 6) and the Contracting Member States of France and/or the Netherlands (in respect of applicants 1) and 2)) respectively, for use in Germany, France and/or the Netherlands (in respect of applicants 3) to 6). 20 Applicants 3) to 6)) and France and/or the Netherlands (in respect of Applicants 1) and 2)), respectively, without (1) to state explicitly, conspicuously and prominently on each offer, on the first page of the operating instructions, in the delivery documents and on the packaging that the decoder probes may not be used for the detection of cellular RNA, messenger RNA, microRNA, ribosomal RNA and any combinations thereof in a procedure pursuant to section A. IV without the consent of the second applicant.IV. and the use for the detection of cellular RNA, messenger RNA, microRNA, ribosomal RNA and any combinations thereof must be prohibited without the consent of applicant 2), (2) the purchasers with the imposition of a fee payable to the applicant. 2) to pay a reasonable contractual penalty to be determined by the second applicant and, if necessary, to be reviewed by the competent court, to impose a written obligation for each case of infringement not to use the devices for the detection of cellular RNA, messenger RNA, microRNA, ribosomal RNA and any combinations thereof without the prior consent of the second applicant; (indirect infringement of restricted claim 1 of EP 2 794 928). B. In the event of any infringement of the orders under clause A.I. to A.IV., the respective defendant shall pay a penalty payment (repeated if necessary) to the court in the amount of up to EUR 250,000 per infringement (Rule 354.3 of the Rules of Procedure). C. Order the respondents to pay the costs for the time being. D. This order is immediately enforceable. 21 Da. in the alternative to D: This order is only enforceable for the applicants if the respective applicant has provided security in the form of a deposit or a bank guarantee in favour of the applicants. The amount of the security shall be determined separately with regard to the respective defendant. The respondents have applied for, 1. Reject the application for interim measures dated 1 June 2023 as inadmissible and/or in any event unfounded; - alternatively - 1.1. pursuant to Rule 295 (I) of the Rules of Procedure of the Unified Patent Court, stay the proceedings pending a decision in the nullity case 3 Ni 20/'22 and decisions of the Munich Higher Regional Court in the appeal proceedings 6 U 2359/23 and 6 U 2360/23; - further alternatively - 1.2. allow the defendants to continue the alleged infringement actions against the provision of a security, the amount of which is left to the discretion of the court, but should not exceed € 1,000,000.00; - most alternatively - 1.3. make the granting of interim measures dependent on the provision of a security by the applicants, the amount of which is to be determined by the court, but should not be less than € 15,000,000. 22 The respondents have argued against the application for an order: The Munich local chamber of the EPG was not competent. The Board of Appeal lacked jurisdiction because the application was precluded by proceedings pending elsewhere and there had been no conclusive submission on the existence of a relevant act of infringement (at least in Germany). Since two first-instance judgments of the Munich I Regional Court (Case No. 7 O 5812/22 and Case No. 7 O 2693/22) were issued and enforced in Germany prior to the filing of the present application, at least the attack against the second defendant was manifestly unfounded, since relevant acts of infringement in Germany as a result of compliance with the prohibition pronounced by the Munich I Regional Court were not conclusively shown. The challenged proceedings were not carried out in Germany by the defendants. Therefore, there is no relevant reference to Germany. Since the request was obviously unfounded with regard to Germany and the second applicant, the board seised also lacked jurisdiction; an obviously unfounded request against a party - who was clearly not carrying out an infringing act - only in order to be able to pursue local jurisdiction via Article 33(b) EPC in the case of several defendants/respondents by way of "forum shopping", as it were, was not worthy of protection and not within the meaning of the law. - The application for interim measures is inadmissible. The proceedings here are inadmissible because infringement proceedings on the basis of the patent in suit are already pending before another court, the Munich Higher Regional Court. There was therefore neither cause nor justification for opening proceedings at the EPC in Germany on the basis of the (German part of the) patent. The proceedings here were already inadmissible due to the pendency of the case, and in the alternative, the opening of proceedings was abusive of rights and had to be rejected due to the lack of a need for legal protection. 23 The request did not comply with the mandatory procedural requirements of the Rules of Procedure of the Unified Patent Court because it did not contain the information required under Rule 206(2)(a), (c), (d) and (e) Verfo. The respondents object to the petitioners' lack of active legitimacy (entitlement to file an application). The defendants are of the opinion that the patent in suit is not legally valid. dig. The validity of the patent in suit could not be presumed on the basis of its grant. The applicants asserted a limited - and thus in every respect unexamined - version of the patent in suit. There could be no "presumption" of this, if only from a logical point of view. The subject-matter of claim 1 of the patent in suit as amended by the auxiliary request was inadmissibly broadened, not inventive and also insufficiently disclosed. - The respondents claim that the patent in suit is not infringed by the contested products. The challenged embodiments were designed in such a way that essential steps of the process (creation of a temporal sequence of signal signatures, identification of the analyte) were not carried out on the device itself, but on a computer-aided system (cloud computing platform AtoMx Spatial Informatics) abroad and thus outside the scope of application of the UPCA. The request for an injunction was therefore already unfounded because the central step of the contested method and thus the advantage sought under the patent was carried out abroad. The process claimed in the patent in suit is also not realised from a technical point of view. The following claim features were not realised by the process which could be carried out with the contested products: o each subpopulation of detection reagents targets a different analyte; 24 o at least a portion of the plurality of predetermined subsequences forms an identifier of the at least one probe reagent; o repeating steps (i) to (iii) for other subsequences of the detection reagents, thereby producing a temporal sequence of optical signal signals corresponding to the plurality of predetermined subsequences, o Comparing the temporal order of the optical signal signatures with different identifiers of the at least one probe reagent. - From the point of view of the respondents, there is in any case no need to order interim measures. The requested measures are also neither urgent nor necessary, in particular the applicants in the Netherlands and France have not proceeded against the contested products under the patent in suit since March 2022. With regard to further details of the parties' submissions, reference is made to their written submissions and to their submissions at the oral hearing. 25 Reasons for the order The Munich Local Chamber of the Unified Patent Court (hereinafter "EPC") is competent to decide on the request for interim measures at issue here. The request is admissible, but not well-founded. A. I. The Munich Local Chamber of the EPG is responsible for the decision on the application. The court has jurisdiction to order interim measures. The jurisdiction of the Munich Local Chamber of the UPC is based on Article 33(1)(a) UPC. Pursuant to Article 32(1)(a) UPCA, the applicants have filed a request for provisional measures on account of the infringement of the patent in suit by the respondents in, inter alia, Germany. The applicants have argued that patent-infringing products are offered via the internet presence under the URL https://nanostring.com. This offer of immediate dispatch ("Shipping now") refers, inter alia, to all Member States of the European Union, i.e. also the EPC contracting states and thus also Germany. In the "Legal" section of the website, the terms and conditions of sale refer in particular to shipping to the Member States of the European Union. There it says ("Sa- les Terms", available at https://nanostring.com/about-us/IegaI/termsofs- ale/#saIes-of-products): "Unless otherwise set forth in writing by NanoString or otherwise agreed by the parties, all shipments are made EXW (Incoterms 2010) NanoString's manufacturing facility, except for shipments to member countries of the European Union, the United Kingdom, and Canada, which are made DDP (In- coterms 2010) excluding VAT." (underlining by the court) Contrary to the defendants' submission, this is not merely "general information", but offers for delivery relevant under patent law. 26 According to the applicants, the contested designs were also supplied to Germany, for example to the Max Delbrück Center in Berlin. Furthermore, in the second half of April 2023 the defendants carried out a promotional tour for the contested products in Europe; events were also held in Germany (Hanover and Würzburg). The respondents are holding numerous other events at research institutions to demonstrate the challenged embodiments and are also planning such events for the coming weeks and months. The Local Chamber assumes that the challenged embodiments and their offer in Europe are attributable to all respondents. This establishes the jurisdiction of the Munich Local Chamber of the EPC. In this respect, it is not relevant for the question of jurisdiction whether, according to the legal assessment by the court, a patent infringement also follows from the conclusively presented allegation. The legal assessment of the assertion of an act performed in Germany as a patent infringement is not the subject of the examination of jurisdiction; in this respect, conclusive submission is sufficient. li. The application for interim measures is admissible. The respondents correctly point out that an application for interim measures may also be dismissed as inadmissible by default if the application does not comply with certain formal requirements; this follows from Rules 206(2), 208(1), 16(2), (3), (4) and (5) of the Rules of Procedure and applies to the formal requirements referred to therein. However, the registry responsible for the examination of these formal requirements (Rule 208 no. 1 sentence 1 of the Rules of Procedure) did not find any deficiencies in the application. As a result, there was no request to remedy the deficiencies pursuant to Rule 16 no. 3 of the Code of Civil Procedure and no submission to the judge pursuant to Rule 16 no. 5 of the Code of Civil Procedure. The application for a default judgment required under Rule 355 of the Rules of Procedure was also not filed. Irrespective of this, the deficiencies complained of by the respondents do not exist. 27 For the examination of the formal requirements of the application by the Registry, the only decisive factor is whether the information required by the Verfo is available in form. Whether the information is also correct in terms of content is reserved for judicial review; in this respect Rule 211 no. 2 Verfo applies. Having said this, the following is to be said about the individual formal objections: 1. The second applicant submitted in the request that she is the proprietor of the patent in suit and that she has granted the first applicant an exclusive licence to the patent in suit. Thus, the formal requirements according to Rules 206 No. 2 (a), 13 No. 1 (f) Verfo are fulfilled. The validity of the patent or licence ownership is not to be assessed by the registry within the framework of the formal examination, but is the subject of the court's decision on the merits. A dismissal of the application under Rule 206 No. 2 (a), 13 No. 1 (f}, 16 Verfo as inadmissible is therefore not made even if the court denies the status as patent proprietor or (exclusive) licensee on the merits. 2. Even if, in the opinion of the opposing parties, the applicant's side only made a cursory statement in the application regarding the necessity of interim measures, the formal requirements under Rule 206 no. 2 are not met. (c) of the Rules of Procedure. Rule 206 No. 2 (c) IR is not subject to the formal examination by the Registry. Rules 208(1) and 16 of the Rules of Procedure apply to the Registry's examination programme; Rule 206(2)(c) of the Rules of Procedure (corresponding to the grounds to be stated in the application in the main proceedings under Rule 13(1)(n) of the Rules of Procedure) is not mentioned there. Rule 206 no. 2 (c) Verfo only requires the statement of reasons for the necessity of the requested measures; whether these statements convince the court as to their content is not the subject of the examination of the formal requirements of the application, but of the court's decision on the merits. Dismissal of the application as inadmissible because the information in question is cursory or are "not comprehensible" are therefore out of the question. 28 3. The objection with regard to Rule 206 no. 2 (d) of the Constitutional Rules is also unfounded. The submission of facts and evidence are - as in the case of a statement of claim in the main proceedings (Rule 13(m) of the Rules of Procedure) - not subject to the formal examination by the Registry under Rules 208(1), 16 Verfo. a. The applicants based their application on certain evidence (BP 1 annexes etc.) and announced their submission in an admissible manner (cf. ORD 566193/2023 UPC CFI 14/2023; appeal pending under APL 572929/2023 UPC CoA 320/2023) for the time of the possibility of electronic service on the respondents; the order of interim measures without hearing the opponents (Rule 209 no. 4 Verfo) was not applied for. Irrespective of the fact that the evidence was finally submitted, a dismissal of the application as inadmissible due to the fact that the evidence was not submitted at the time the application was filed is also out of the question because Rule 211 no. 2 of the Rules of Procedure expressly provides that the court may order the applicant to submit the available evidence if this was not already done when the application was filed. To the extent that the respondents complain that the annexes were only submitted in response to the written procedural order of the Judge-Rapporteur of 27 June 2023, this also does not lead to the inadmissibility of the application for an injunction. At least in the initial phase of the EPC's activities relevant here, the applicants' representative and the Local Chamber assumed that the opening of a workflow by the court was required for the uploading of documents in the EPC's case management system; therefore, the aforementioned procedural order of the reporter was issued in order to enable the applicants' side to upload the annexes. b. The statements on the body of law objected to by the applicants with regard to Rule 206 no. 2 (d) of the Rules of Procedure as being missing in the application do not lead to the inadmissibility of the application either. 29 It is correct that Rule 206 No. 2 (d) Verfo also refers to the validity of the patent in suit; this already follows from the express reference to Rule 211 No. 2 Verfo. In their request for an order, the applicants stated that an action for revocation under file number 3 Ni 20/22 (EP) was pending before the German Federal Patent Court (BPatG) in respect of the German part of the patent in suit and that the BPatG had set out its preliminary view in its qualified reference dated 7 February 2023, according to which the patent in suit was patentable to the extent of auxiliary request 1. In view of the principles on the burden of presentation and proof that apply to the submission on the body of law - at least in proceedings conducted on two sides, as in the present case - on the basis of Article 54 UPCA (see point A. IV. 3. of decision 2/2023), the requirements for the submission on the validity of the patent in suit set out in Rule 206 No. 2(d) IR must not be overstretched. By submitting the facts relevant to the patent in suit (invalidity action; qualified reference of the BPatG), the applicants have met the formal requirements of Rule 206 No. 2(d) of the Implementing Rules with regard to statements on the legal validity of the patent in suit. 4. The objection with regard to Rule 206 no. 2 (e) Verfo (requirement of a brief description of the action to be filed in the main action already in the application for an order) is also not valid. The corresponding information is again not subject to the formal examination pursuant to Rules 208 No. 1, 16 of the Rules of Procedure; a complaint by the Registry and a submission by the judge pursuant to Rule 16 No. 5 of the Rules of Procedure were therefore not made. Notwithstanding this, Rule 206(2)(e) Verfo cannot, in its spirit, apply to requests for provisional measures under Art. 62(1) UPCA, since in this case the objective of the request (injunction) is no different from the final order on the merits (Art. 63(1), first sentence, UPCA); it would be mere formality to require the applicant to state that he will base the action on the merits on the same facts and evidence as the request for provisional measures. 63(1), first sentence, UPCA); it would be mere formality to require the applicant to state 30 that he will base the action on the merits on the same facts and evidence as the application for an injunction under Art. 62(1) UPCA. According to its meaning 31 Rule 206(2)(e) of the RP appears to cover requests under Articles 60 and 61 of the UPCA which may precede the commencement of main proceedings; in such cases it is indeed useful to briefly describe the subsequent main action in accordance with Rule 206(2)(e) of the RP. Rule 206 No. 2 (e) Verfo is to be reduced teleologically to the effect that requests under Art. 62(1) UPCA are not affected by this requirement. 5. Contrary to the view of the respondents (opposition, paragraph 89 et seq.), the application cannot be dismissed as inadmissible on the grounds of obvious lack of merit. Whether the applicants' submission is convincing in terms of content is not the subject of the formal examination, but of the decision-making in the case. Consequently, it is not a question of the admissibility of the application. 6. Insofar as the respondents justify the inadmissibility of the application with reference to a decision of the Federal Court of Justice (BGH NJW-RR 2015, 541) on the basis of a lack of need for legal protection from the respondents' point of view, this argument also fails. It is irrelevant whether the enforcement of a judgment already given in one of the contracting states of the UPCA enables simpler enforcement than obtaining a decision of the UPC. While the enforcement of a judgment of the court of a contracting state of the UPCA only concerns infringements of the judgment in that contracting state, decisions of the UPCA in the case of a European patent according to Art. 34 UPCA are in principle valid for the territory of all contracting states for which the European patent has effect. Thus, with regard to the territorial scope of decisions of the UPC in relation to decisions of the courts in the contracting states, there is generally a need for recourse to the UPC. III. Both applicants are eligible to apply. In view of their legal position, both applicants are also entitled to appeal to the EPC for the asserted patent infringement. 1. According to the patent in suit, the second applicant is its proprietor. Her entitlement to file a petition thus follows from Article 47(1) UPCA. 32 In their statement of opposition, the respondents contested the legal validity of the second applicant's ownership with regard to possible infringements of US law, namely the Bayh-Dole Act. The related submission of the second applicant in her reply that she had complied with the corresponding requirements resulting from the Bayh-Dole Act, in particular that she had disclosed the invention to the NIH in due time, The respondents did not dispute that they had claimed the right to the invention in accordance with the requirements of the Bayh-Dole Act and had filed a patent application for the invention, especially since the second applicant had submitted an affidavit by Ms Karen Sinclair, Director of Intellectual Property at the second applicant. The Local Board therefore considers the 2nd applicant's submission on compliance with the requirements of the Bayh-Dole Act to be undisputed. In view of this, the question as to whether the infringements initially alleged by the opposing parties under the relevant US law actually result in the second applicant losing its position as patent proprietor can remain open. Furthermore, the question of whether the formal legal position according to the entry in the register is sufficient for entitlement under Article 47(1) EPC or whether the substantive entitlement is ultimately decisive can also remain open. 2. The first applicant is at least entitled to file an application under Article 47(3) EPC as the holder of a non-exclusive licence. a. The local division can leave open whether - as claimed by the applicants - an exclusive licence in favour of the first applicant was agreed in a legally effective manner. According to Art. 62(4) UPCA, the court would have to be sufficiently convinced that the first applicant is the holder of an effective exclusive licence pursuant to Art. 47(2) UPCA and, in this respect, has the same rights as the second applicant. 2) can bring an action before the court for infringement of the patent in suit. However, on the basis of the judgement of the US District Court of the District of Delaware (hereinafter "District Court of Delaware"), there are doubts as to whether the second applicant has validly granted an exclusive licence to the first applicant. 33 because, in the opinion of the District Court of Delaware, the second applicant had committed itself to the NIH, "...to offer non-exclusive patent licenses.... " In the event that the second applicant has committed itself to granting non- exclusive patent licences to the NIH with respect to the patent in suit, the local division cannot be convinced with sufficient certainty in the summary proceedings that it was possible to grant an exclusive licence contrary to this commitment; this question is therefore reserved for a detailed examination of the relevant US law in the main proceedings in the event that it is relevant for a decision. The court is also not convinced by the applicants' argument that the grant of an exclusive licence under the Bayh-Dole Act was not precluded in view of the decision of the District Court of Delaware. According to Art. 47(3) and (4) EPC, the simple licensee is also entitled to claim an injunction in his own name under Art. 62 EPC; according to Art. 47(3) EPC, the only decisive factor in this respect is that the licence agreement with the patent proprietor permits this. This is obviously the case here. b. However, to the court's certainty, the first applicant is entitled to file a petition under Article 47(3) EPCÜ. According to Article 47(3) EPC, the proprietor of a non-exclusive licence is also entitled to file a request if the patent proprietor has been informed of the request to the court by the patent proprietor and the licence agreement expressly allows the request to the court. The court is convinced that both are the case here: the second applicant was informed of the reference to the court by the first applicant; the application was filed together with the first applicant. According to the submission in the written statement of 11 August 2023, both applicants also agree that there is at least a non-exclusive licence agreement between them concerning the patent in suit, which allows the first applicant to bring the matter before the court in the sense of the asserted request. It is also neither apparent nor supported by the 34 The defendant argued that any violations of NIH grant conditions resulting from the award of an exclusive licence would prevent a later agreement on a simple licence. IV. The Local Board is not convinced with sufficient certainty that the respondents infringe the patent in suit. The realisation of several features of the asserted version of the patent claim is in dispute between the parties. The local board exceptionally refrains from presenting the subject-matter of the patent in suit, from structuring the features, from interpreting the asserted patent claim in its entirety and, on this basis, from finally assessing the realisation of the individual features by the challenged embodiments. For a rough orientation, reference can be made to the decision of 19 September 2023 (UPC CFI 2/2023) in the parallel case concerning the branched-off patent EP "782. From the point of view of the local division, this is not relevant with regard to the interim measures applied for, since one of the disputed features of the claim already precludes the formation of a sufficiently certain conviction of the infringement within the framework of the summary proceedings. This is the characteristic according to which ". .at least a portion of the plurality of predetermined subsequences forms an identifier of the at least one probe reagent...". According to the claim wording, the predetermined partial sequences form an identifier of the probe reagent. This is confirmed in the description [284] as a patent definition for certain embodiments. According to the applicants' interpretation, the claim should nevertheless be interpreted in such a way that not the probe reagent but the analyte is identified. The applicants are of the opinion that a "lapse", i.e. an oversight in the wording of the claim, occurred in the group of features, which can be remedied by way of interpretation; what is meant is that the claim should be interpreted in such a way that the analyte is identified rather than the probe 35 reagent. 36 not the "probe reagent", but the "analyte". The claim would then have to read ". .at least a portion of the plurality of predetermined subsequences constitutes an identifier of the at least one analyte..." These different possibilities of interpretation come into play when - as in the challenged embodiment - several probe reagents bind to different sites of the same analyte, the several probe reagents having the same predetermined partial sequences. In this case, the predetermined partial sequences do not identify the (different) probe reagents but the analyte. If the board followed the applicants' interpretation, the feature would be found to be fulfilled. If the board followed the interpretation of the respondents, the characteristic would not be fulfilled. This question raised by the parties to the dispute as to the interpretation and realisation of this feature of the claim cannot therefore be left unexamined and open, as seems to have happened in the case of the judgments of the Landgericht München I of 17 May 2023. It cannot be ruled out that the interpretation of this feature proposed by the applicants is ultimately correct. In this respect, the chairman of the local division pointed out at the oral proceedings that, in principle, an understanding of the patent claim that deviates from the one conveyed by the mere wording of the claim is possible. However, in the context of ordering provisional measures, it does not seem sufficiently certain to the local board to affirm a patent infringement on the basis of an interpretation of the patent claim that deviates from the understanding conveyed by the wording of the claim in connection with a specific embodiment. In particular, it must be taken into account that the chosen interpretation of the patent claim must always be compatible with the requirements of Art. 69 EPC and its Protocol on Interpretation. Accordingly, the requirement of sufficient legal certainty for third parties must also be t a k e n into account in the interpretation of the claim; as a rule, it may be expected that the applicant will be able to understand the claim. 37 applicant sufficiently clearly expresses what he wishes to have protected. Thus, with regard to the interpretation on which the applicants based their infringement claim, difficult questions arise both from a technical and a legal point of view, which cannot be answered conclusively and satisfactorily in the context of summary proceedings. The comprehensive consideration required in this respect must therefore be reserved for the main proceedings. The ordering of interim measures is not appropriate in this situation. v. The Local Board is also not convinced with the certainty required to order provisional measures that the patent in suit is legally valid. The validity of the patent is not expressly mentioned in Art. 62(4) UPCA, in contrast to Rule 211(2) IR, as a subject of persuasion; however, only a person who relies on a patent which is valid to the satisfaction of the court can be deemed to be the right holder within the meaning of Art. 62(4) UPCA. The formation of conviction required under Art. 62(4) EPC and Rule 211(2) Verfo with regard to the validity of the patent in suit (for the criterion of "sufficient certainty" of the judge's conviction, see decision UPC CFI 2/2023) does not concern the question of whether the patent in suit could have been granted in an amended version, but the question of whether the patent in suit is valid in its present version (in this case, the version granted by the European Patent Office). 2 Verfo accordingly refers explicitly to "the patent in question". The applicants, on the other hand, are of the opinion that it follows from the qualified reference of the Federal Patent Court (BPatG), with which the asserted version of the claim (amended in comparison to the granted version) was considered to be presumptively capable of being maintained, that there are no far-reaching doubts as to the validity of the patent. However, the BPatG's statement is clearly to the effect that the patent in suit will not be maintained in its granted version, even if it can be maintained in an amended version. 38 The local division can leave open the fundamental question of whether a request under Art. 62 EPC on the basis of a patent claim that is even amendable from the patent proprietor's point of view can be successful. In the case under consideration here, there is another circumstance which represents a further factor of uncertainty for the validity of the patent: As already explained above in the context of the infringement examination, the applicants are of the opinion that the feature group ". .at least a portion of the plurality of predetermined subsequences forms an identifier of the at least one probe reagent...". must be interpreted as if it had been formulated as follows: "...at least a portion of the plurality of predetermined subsequences constitutes an identifier of the at least one analyte..." As outlined above, it cannot be ruled out that the view of the applicants can be followed in the main proceedings to define the term "applicant" as "applicant". Replace the term "probe reagent" with the term "analyte" by way of interpretation. However, such an interpretation raises further questions of disclosure of origin and/or a possible (inadmissible) extension of the scope of protection of the patent claim. This means additional factors of uncertainty for the legal status of the patent in suit. Despite the detailed discussion in the oral proceedings, the Local Chamber considers the legal situation to be insufficiently secured in the context of summary proceedings (Rule 205 of the Rules of Procedure), in any case due to the cumulative uncertainties from the amendment of the claim and the necessity of an interpretation deviating from the wording of the claim. 39 VI. There are also doubts regarding the necessity of ordering interim measures in terms of time. It follows from the requirement to state reasons for the provisional measure under Rule 206(2)(c) Verfo that there must be a necessity for ordering provisional measures. The mere finding of a (threatened) patent infringement, which is also a prerequisite for a final order under Article 63 EPC, cannot therefore be sufficient for ordering provisional measures. According to the Verfo, both temporal and factual circumstances are relevant for the necessity of ordering interim measures. The relevance of temporal circumstances results not only from Rule 209 no. 2 (b) Verfo ("urgency"), but also from Rule 211 no. 4 Verfo, according to which the court takes into account an unreasonable delay in applying for interim measures. The relevance of factual circumstances for the necessity of granting interim measures results, for example, from Rule 211 no. 3 of the Rules of Procedure, according to which, when deciding on the application for an injunction, the possible damage that the applicant may suffer must also be taken into account (while the possible damage to the defendant must be taken into account when weighing up the interests). In contrast to the proceedings UPC CFI 2/2023 before the local chamber, which dealt with a unitary patent, provisional measures were already possible in France and the Netherlands before 1 June 2023 with regard to the patent in suit asserted here. In doing so, the local division takes into account that, according to French legal practice, it could have been necessary to request a central limitation of the patent claim at the European Patent Office (Art. 105a EPC) before requesting provisional measures. There might already have been a reason for such a request for limitation on the basis of the BPatG's reference. The BPatG notice is dated 10 February 2023. 40 However, the applicants neither filed a request for limitation with the European Patent Office nor did they take legal measures to stop the defendants' bidding activities in France, as was done in Germany with main proceedings for the patent infringement asserted here. As a result, the same also applies to the legal practice in the Netherlands, although there does not seem to be any case law here that would prevent the assertion of the patent claim in a limited version. Also with regard to the Netherlands, there is no convincing answer to the question why no judicial measures were taken before 1 June 2023 to prohibit the defendants' bidding practices. VII. Finally, the order sought is not justified after weighing the interests (Art. 62(2) UPCA, Rule 211(3) IR). Pursuant to Art. 62(2) UPCA (Rule 211(3) IR), the court shall exercise its discretion to weigh the interests of the parties with a view to issuing the order or dismissing the application; in doing so, all relevant circumstances shall be taken into account, in particular the possible damage which the parties may suffer as a result of issuing the order or dismissing the application for an order. For the exercise of the discretion, the degree of probability to which the court is convinced of the existence of the individual circumstances to be included in the weighing is also decisive. The more certain the court is that the right holder is asserting the infringement of a valid patent, that there is a necessity to issue an injunction due to factual and temporal circumstances and that possible damages of the opponent or other justified objections are not opposed, the more likely it is that the issuance of an injunction is justified. The sooner, on the other hand, that there are relevant uncertainties with regard to individual circumstances relevant for the weighing of interests, which are detrimental to the conviction of the court, the court will, as a more lenient measure, grant the injunction subject to the provision of security. 41 have to consider continuation of the alleged violation or even dismissal of the application. On this basis, the local chamber comes to the following conclusion: In the case to be assessed here, there are doubts not only with regard to legal status and infringement, but also with regard to the question of whether measures could and should have been taken in the contracting states concerned before 1 June 2023 to prevent a (threatened) infringement of the patent in suit. In the overall view, these doubts also lead to the rejection of the request with regard to the threatened damages to the applicants. B. The applicants, having been unsuccessful, are ordered to pay the costs pursuant to Article 69(1) and (2) UPCA. C. The local chamber sees reason to clarify the following with regard to the applicable time limits for appeal (Art. 73 UPCA): According to Rule 211(6) of the RP, the order for provisional measures must contain the indication that an appeal may be lodged under Article 73 UPCA and Rule 220(1) of the RP. Rule 211(6) of the Rules of Procedure does not expressly provide for the dismissal of the application for provisional measures. Strictly speaking, however, the dismissal of a request under Art. 62 UPCA is not an order under Art. 62 UPCA, but a dismissal decision. The Rules of Procedure also assess measures of the court elsewhere (Rule 21) either as orders or as decisions, depending on the success of the application. However, the rule of Art. 73(2) UPCA, which has a higher priority than the provisions of the Rules of Procedure and is therefore decisive, appears to provide for a uniform time limit for consideration of orders under Art. 62 UPCA and the (full or partial) deviation from requests for orders under Art. 62 UPCA. Accordingly, the 42 dismissal of a request for an order under Art. 62 UPCA must be treated as an order and not as a decision. As a precautionary measure, the Local Division therefore points out that an appeal against the rejection of the request for an order may be lodged within 15 calendar days of the notification of the (rejection) order to the applicants, pursuant to Article 73(2) UPCA and Rule 220(1) IR. For these reasons, the Munich Local Chamber of the EPG, composed of the presiding judge Dr. Zigann, the legally qualified judges Kupecz and Pichlmaier, and the technically qualified judge Enderlin, hereby rules as follows Arrangement A. The application for interim measures is dismissed. B. Order the applicants to pay the costs of the proceedings. C. The amount in dispute is set at€ 3 million. 43 INFORMATION ON THE V O C A T I O N An appeal against the present decision may be lodged with the Court of Appeal by any party who has been unsuccessful in whole or in part with his claims within 15 calendar days from the date of notification of the decision (Art. 73 (2) a) EPCÜ, R. 220.1 (c), 224.1 (b) Verfo). INFORMATION ON ENFORCEMENT (ART. 82 EPGÜ. ART. ART. 37(2) EPGS. R 118.8. 158.2. 354. 355 4 VERFO): A certified copy of the enforceable decision shall be issued by the Deputy Registrar at the request of the enforcing party, Rule 69 RegR. INFORMATION ON A R R A N G E M E N T S Procedure number: UPC CFI 17/2023 Number of the related application: ACT 459996/2023 Type of application: Application for interim measures Dr Zigann Presiding Judge Matthias ZIGANN Digitally signed by Matthias ZIGANN Date: 2023.10.10 11:19:40 +02'00' Pichlmaier Rapporteur Tobias Günther Pichlmaier Digitally signed by Tobias Günther Pichlmaier Date: 2023.10.10 11:14:59 +02'00' Kupecz legally qualified judge András Ferenc Kupecz Digitally signed by András Ferenc Kupecz Date: 2023.10.J 0 12:58:52 +02'00' Enderlin technically qualified judge Eric, André Enderlin Signature numér!que de Eric, André Enderlin Date: 2023.10.10 12:54:45 +02'00' Ruisinger Clerk Veronika Ruisinger Digitally signed by Veronika Ruisinger Date: 2023.J0.J 0 13:45:39 +02'00' 42

Key Holdings

  • The application for interim measures is dismissed.
  • The Local Board is not convinced with sufficient certainty that the respondents infringe the patent in suit.
  • The Local Board is also not convinced with the certainty required to order provisional measures that the patent in suit is legally valid.
  • There are also doubts regarding the necessity of ordering interim measures in terms of time.
  • Finally, the order sought is not justified after weighing the interests (Art. 62(2) UPCA, Rule 211(3) IR).

Tags

  • Admissibility
  • Balance of Interests
  • Bayh-Dole Act
  • Claim Construction
  • Costs
  • Infringement
  • Jurisdiction
  • Licensing
  • Patent Validity
  • Preliminary Injunction
  • Urgency

Related Rules

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