UPC_CFI_808/2025 – Guardant v Sophia

Expert Commentary

Condition for PI Facts 1. Guardant starts preliminary injunction (“PI”) proceedings on the basis of four European patents against four Sophia companies (French, Swiss, Italian and German) for the UPC and various non-UPC countries. 2. The oral hearing took place on 12 December 2025. 3. Guardant withdrew its claims with respect to one European patent. The Court 1. With respect to urgency (“any unreasonable delay in seeking provisional measures” under R. 211.4 RoP) the Court cited the Court of Appeal’s decision in Mammut v Ortovox of 25 September 2024. 2. Information about the infringement from before 27 May 2025 is either too general or relates to activities outside Europe. The manual was online as early as October 2024, but Guardant cannot be expected to monitor the internet for all competing products without having been alerted by Sophia’s activities in Europe. 3. The Court accepts urgency as a three months delay to prepare an action invoking several patents and complex technology is reasonable. 4. The Court deals with each of the patents separately. It establishes the skilled person and interprets the claims applying the Court of Appeal’s decision in Nanostring v 10x Genomics (UPC_CoA_335/2023). 5. A method which is mentioned in the description as other method, but is not mentioned in the claim, does not fall under the scope of protection. 6. With respect to added matter, the Court refers to the principles formulated by the Court of Appeal in the decision in expert klein v Seoul Viosys (UPC_CoA_764/2024). 7. The Court disagrees with the Opposition Division. It is insufficient to find all parts of the claim scattered over the whole PCT application. The question is if the claimed invention can be found in the document. 8. The Court concludes with respect to EP 3 591 073 that it is more likely than not that the patent is invalid and not more likely than not that it is infringed. 9. With respect to EP 3 766 986, basically for the same reason as cited under 7, the Court comes to the conclusion that the patent is more likely than not invalid for extension of subject matter. 10. With respect to the third patent, EP 3 443 066, the Court concludes that Guardant has not (sufficiently) proven the way Sophia’s software processes the information. The press release on which Guardant relies, gives insufficient details as to what is done and what information is stored in a database. 11. The Court rejects the application for a PI. The Court reduces the requested (interim) costs: € 400.000. Comment 1. The Division has a very realistic view on urgency. We have seen less realistic applications in for instance Brussels and Lisbon. 2. I wonder why the claimant chose to file PI proceedings on four patents in rather complicated proceedings without first properly establishing the facts (see for example above under 10). 3. I fully agree with the Court that there is extension of subject matter if the invention which is claimed is not disclosed in the application (which may be several hundred pages). The assessment is not limited to locating individual claim elements, potentially dispersed throughout the application, but also requires determining whether the skilled person, reading the application as a whole, would understand it to disclose an invention consisting of the specific combination of those elements.

Full Decision Text

1 Paris Local Division UPC CFI 808/ 2025 Final Order of the Court of First Instance of the Unified Patent Court delivered on 23/ 01/ 2026 HEADNOTES: 1) Unreasonable delay under R. 211.4 RoP: In t he present case, a t hree-mont h period const it ut es a reasonable delay t o prepare t he applicat ion for provisional measures by gat hering t he necessary evidence, given t hat t he case involves several pat ents and a complex and sophist icat ed t echnology. 2) Added mat t er (divisional pat ent ): It is decisive whet her all t he element s are direct ly and unambiguously derivable from t he pat ent as originally filed (in t he present case: t he PCT applicat ion) or w het her t he lat t er is used as som e kind of reservoir from w hich scat t ered fragment s can be combined, in w hich case t here is a w hole series of different ‘inventions’ included in t he PCT applicat ion. 3) Added mat t er: From t he select ions t hat have been made w it hout any clear indicat ion in t he earlier applicat ion, t he Court concludes t hat t he invent ion as now w orded in t he grant ed claim cannot direct ly and unambiguously be derived from t he pat ent as filed. 4) Demonst rat ion of an infringement w it h a sufficient degree of cert aint y (R. 211.2 RoP): The burden of proof for t he alleged infringement lies w it h t he part y invoking it . Applicant cannot rely solely on t he disput ed informat ion from a press release t o demonst rat e how Defendant s' soft w are processes dat a. Addit ional in-dept h invest igat ions int o how Defendant s’ plat form operat es or more t echnical document at ion on t he 'accused soft w are' w ould have been necessary. KEYWORDS: Provisional measures. Unreasonable delay. R. 211.4 RoP. Added mat t er. Sufficient degree of cert aint y-Infringement - Burden of proof. R. 211.2 RoP. 2 APPLICANT: Guardant Health, Inc. 3100 Hanover Street , 94304, Palo Alt o, CA, US represent ed by Agathe M ichel-de Cazotte, Avocat à la Cour, Rechtsanw aelt in, Cameron M arshall, European Patent At t orney, Annabel Strawson, European Patent At t orney, Caroline Horstmann, Rechtsanw aelt in, UPC represent atives. DEFENDANTS: 1) Sophia Genetics SA La Pièce 12, CH-1180, Rolle, CH 2) Sophia Genetics SAS Technopole Izarbel, 158 allée Faust e d’Elhuyar 64210, Bidart, FR 3) Sophia Genetics SRL Via M ichelangelo Buonarroti 39, 20145, M ilan , IT 4) Sophia Genetics GmbH Engelbergerstr. 19, 79106, Freiburg, DE Represent ed by Liz Cohen Part ner at Brist ow s (Ireland) LLP, Naoise Gaffney UPC Direct or at Brist ow s (Ireland) LLP, Rachael Cartwright Senior Associat e at Brist ow s (Ireland) LLP, Eden W inlow Associat e at Brist ow s (Ireland) LLP, Florence Plisner Associat e at Brist ow s (Ireland) LLP, UPC represent atives. PATENTSAT ISSUE Pat ent no. Proprietor EP 3470533 Guardant Healt h, Inc. EP 3591073 Guardant Healt h, Inc. EP 3443066 Guardant Healt h, Inc. EP 3766986 Guardant Healt h, Inc. 3 PANEL: Camille Lignières, Presiding judge and Judge Rapporteur Carine Gillet, Legally qualified judge M aximilian Haedicke, Legally qualified judge Cornelis Schüller, Technically qualified judge LANGUAGE OF PROCEEDINGS: English ORDER The part ies 1. The Applicant (hereinaft er “ GUARDANT HEALTH” ) is a US company founded in 2012, based in Palo Alt o (California) and incorporat ed in Delaw are, w hich is focused on cancer diagnosis t hrough genet ic t est ing and mut at ion det ect ion. It is specialised in t he “ liquid biopsy” approach, in w hich mut ant genet ic mat erial from t umours is isolat ed from a simple blood sample rat her t han requiring an invasive solid biopsy. It s market ed t ests include “ Guardant 360” , “ Guardant Reveal” , and “ SHIELD” . The Applicant is t he ow ner of several European pat ent s relat ing t o t he use of liquid biopsy for diagnost ic purposes. 2. The Defendant s are part of t he SOPHIA GENETICS group (hereinaft er “ SOPHIA GENETICS” ). Defendant 1 (Sophia Genet ics SA) is t he parent company set t led in Sw it zerland, Defendant s 2 (Sophia Genet ics SAS), 3 (Sophia Genet ics SRL), and 4 (Sophia Genet ics GmbH) are subsidiary companies based respect ively in France, It aly and Germany. SOPHIA GENETICS is a cloud-nat ive healt hcare t echnology company on a mission t o expand access t o dat a- driven medicine by using AI t o deliver w orld-class care t o pat ient s wit h cancer and rare disorders across t he globe. It is t he creat or of SOPHiA DDM ™, a plat form t hat analyses complex genomic and mult imodal dat a and generat es real-t ime, actionable insight s for a broad global net w ork of hospit als, laborat ories, and biopharma inst it ut ions. 3. According t o GUARDANT HEALTH, t he Defendant s offer and supply t he “ M SK-ACCESS® pow ered w it h SOPHiA DDM ” t est (hereinaft er “ M SK-DDM ” ) in t he Unified Pat ent Court (hereinaft er “ UPC” ) t errit ories, Spain, Swit zerland, t he Czech Republic, Poland and Norw ay. Summary of proceedings 4. On 29 August 2025, GUARDANT HEALTH lodged an applicat ion (hereinaft er “ t he Applicat ion” ) for provisional measures (pursuant t o Art . 62 UPCA and R. 206 RoP) before t he Paris Local Division, against SOPHIA GENETICS, for infringement of four of it s European Pat ent s: EP-3470533-B2 (“ EP’533” ) EP-3591073-B1 (“ EP’073” ) EP-3443066-B1 (“ EP’066” ), EP-3766986-B1 (“ EP’986” ). At t he st age of t he Reply t o Object ion, t he Applicant wit hdrew it s request w it h regard t o EP’533. 5. The Applicant is t he sole propriet or of t he t hree pat ent s in suit (Exhibit s GH 29, GH 34, and GH 37). 4 6. Jurisdict ion of t he UPC and t he int ernal compet ence of t he Paris Local Division w ere not cont est ed by t he Defendant s concerning t he UPC t errit ories (Cont ract ing M ember St at es: France, It aly and Germany). This case concerns a disput e relat ed t o t he market ing of M SK- DDM product , purport edly covered by t he above-m ent ioned European pat ent s, and one of t he Defendant s is a French company, t he ot her Defendant s are part of t he same group part icipat ing in t he commercialisat ion of t he accused product s. The Court confirms it s jurisdict ion t o hear t he disput e under Art . 32.1(a) and at least Art . 33.1(b) of t he UPCA. 7. The scope of t he jurisdict ion for t he non-UPC t errit ories Sw it zerland, Spain, Poland, t he Czech Republic and Norw ay, is cont est ed by t he Defendant s. 8. No prot ect ive let t er has been filed before t he filing of t he Applicat ion by SOPHIA GENETICS. 9. According t o a t imet able set by procedural order of 1st Oct ober 2025, SOPHIA GENETICS filed it s Object ion on 27 Oct ober 2025. GUARDANT HEALTH filed it s Reply t o t he Object ion on 10 November 2025, and SOPHIA GENETICS submit t ed it s Rejoinder on 24 November 2025. 10. Aft er t he oral hearing of 12 December 2025, SOPHIA GENETICS filed on 16 December 2025 an applicat ion under R. 336 RoP, request ing t hat t he preliminary opinion of t he Board of Appeal of t he European Pat ent Office issued on 15 December 2025 regarding EP’073 be admit t ed as evidence in t his case. By procedural order of 18 December 2025, t he Presiding Judge grant ed t his request . 11. A t echnically qualified judge has been allocat ed t o t he panel upon t he Judge Rapport eur's request at t he earliest st age of t he proceedings. 12. The value of t he case has been declared as amount ing t o 6 million euros, and t his amount is not cont est ed by t he Defendant . The accused product s 13. GUARDANT HEALTH accuses SOPHIA GENETICS of infringing it s pat ent s by offering and supplying t he product s called “ M SK-ACCESS® pow ered w it h SOPHiA DDM ” t est (hereinaft er “ M SK-DDM ” ) in t he UPC t errit ories, and Spain, Sw it zerland, t he Czech Republic, Poland and Norw ay. The accused product is a liquid biopsy t est . 14. The basic st eps in t he M SK-DDM t est are show n on t he Defendant ’s w ebsit e, as follow s (Exhibit GH 22, §88 of t he Applicat ion): 5 15. This t est t hus has six overall st eps: (i) DNA ext ract ion from blood, (ii) capt ure of DNA and preparat ion of a sequencing library, (iii) sequencing t he library, (iv) det ect ing and annot at ing sequence variant s w it hin t he DNA, (v) int erpret ing t he det ect ed sequence variant s, and (vi) report ing informat ion t o t he user. 16. In general t erms, t hese st eps can be classified as “ w et ” (st eps (i) t o (iii), w hich involve dealing w it h blood and DNA) and “ dry” (st eps (iv) t o (vi) w hich deal w it h dat a). The alleged infringing act ivit ies arise bot h from t he combined w et & dry st ages (EP’073, and EP’066), or from t he dry st age alone (EP’986). The w et st age relies on t he Defendant s’ kit know n as “ SOPHiA GENETICS™ Universal Library Prep for fragment ed DNA” (see page ii of GH 22, product 300232); t he dry st age relies on t he Defendant s’ SOPHIA DDM soft w are plat form. Part ies’ request s 17. In it s last submission (Reply dat ed 10 November 2025), GUARDANT HEALTH request s t hat t he Court grant t he follow ing provisional measures: Under EP’533: Request s A t o C in t he Applicat ion are w it hdraw n. Under EP’073: D. The Defendant s are ordered, in t he t errit ories of Aust ria, Belgium, Germany, France, It aly, t he Net herlands, and Sw eden, and t he Czech Republic, Sw it zerland, Spain, Poland and Norw ay, t o cease and desist from: I. using and/ or offering for use, 1. a met hod for processing at least one set of t agged parent polynucleot ides, comprising st eps of: a. convert ing initial st art ing genet ic mat erial int o the t agged parent polynucleot ides using non-unique barcode oligonucleot ides, w herein convert ing comprises enzymat ic ligat ion; b. amplifying t he t agged parent polynucleot ides in t he set t o produce a corresponding set of amplified progeny polynucleot ides; c. sequencing a subset of t he set of amplified progeny polynucleot ides, t o produce a set of sequencing reads; and d. collapsing t he set of sequencing reads t o generat e a set of consensus sequences, each consensus sequence corresponding t o a unique polynucleot ide among t he set of t agged parent polynucleot ides, w herein (i) t he init ial st art ing genet ic mat erial is cell-free DNA isolat ed from a body fluid, and comprises no more t han 100 ng of polynucleot ides, and (ii) det ect ion of t he non-unique barcodes in combinat ion w it h sequence dat a of beginning and end port ions of sequencing reads allow s assignment of a unique ident it y t o a parent polynucleot ide; (Direct infringement of Claim 1 as upheld) 6 2. in part icular, t he met hod of Claim 1, w herein t he barcodes comprise oligonucleot ides at least 3, 5, 10, 15, 20 25, 30, 35, 40, 45, or 50 base pairs in lengt h; (Direct infringement of Claim 2 as upheld) 3. in part icular, t he met hod of any one of t he preceding claims, w herein t he body fluid is blood; (Direct infringement of Claim 3 as upheld) 4. in part icular, t he met hod of any of t he preceding claims, comprising enriching t he set of amplified progeny polynucleot ides for polynucleot ides mapping t o one or m ore select ed mappable posit ions in a reference sequence by: (i) select ive amplificat ion of sequences from init ial st arting genet ic mat erial convert ed t o t agged parent polynucleot ides; (ii) select ive amplificat ion of t agged parent polynucleot ides; (iii) select ive sequence capt ure of amplified progeny polynucleot ides; or (iv) select ive sequence capt ure of init ial st art ing genet ic mat erial; (Direct infringement of Claim 4 as upheld) 5. in part icular, t he met hod of any one of t he preceding claims, furt her comprising: e. analyzing t he set of consensus sequences for t he set s of t agged parent polynucleot ides separat ely or in combinat ion; (Direct infringement of Claim 5 as upheld) 6. in part icular, t he met hod of Claim 5, w herein analyzing comprises det ect ing mut ations, rare mut at ions, indels, copy number variat ions, t ransversions, t ranslocat ions, inversion, delet ions, aneuploidy, part ial aneuploidy, polyploidy, chromosomal inst abilit y, chromosomal st ruct ure alt erat ions, gene fusions, chromosome fusions, gene t runcat ions, gene amplificat ion, gene duplicat ions, chromosomal lesions, DNA lesions, abnormal changes in nucleic acid chemical modificat ions, abnormal changes in epigenetic pat t erns, abnormal changes in nucleic acid met hylat ion infect ion or cancer; (Direct infringement of Claim 6 as upheld) 7. in part icular, t he met hod of Claim 5 or Claim 6, w herein analyzing comprises normalizing a measure t aken from a set of consensus sequences against a measure t aken from a set of consensus sequences from a cont rol sample; (Direct infringement of Claim 7 as upheld) 8. in part icular, t he met hod of any one of Claims 5 t o 7, w herein analysis furt her comprises det ect ion and monit oring of an abnormalit y or disease wit hin an individual, such as infect ion and/ or cancer; (Direct infringement of Claim 8 as upheld) 9. in part icular, t he met hod of any one of Claims 5 t o 8, comprising providing a pluralit y of set s of t agged parent polynucleot ides, w herein each set is mappable t o a different mappable posit ion in a reference sequence, opt ionally w herein t he mappable posit ion in 7 t he reference sequence is t he locus of a t umor m arker and analyzing comprises det ect ing t he t umor marker in t he set of consensus sequences; (Direct infringement of Claim 9 as upheld) 10. in part icular, t he met hod of any one of t he preceding claims, comprising filt ering out reads w it h an accuracy or qualit y score of less t han a t hreshold; (Direct infringement of Claim 10 as upheld) 11. in part icular, t he met hod of any one of t he preceding claims, w herein collapsing comprises det ect ing and/ or correct ing errors, nicks or lesions present in t he sense or ant isense st rand of t he t agged parent polynucleot ides or amplified progeny polynucleot ides; (Direct infringement of Claim 11 as upheld) 12. in part icular, t he met hod of any one of t he preceding claims, w herein collapsing comprises: a. grouping sequences reads sequenced from amplified progeny polynucleot ides int o families, each family amplified from t he same t agged parent polynucleot ide; and b. det ermining a consensus sequence based on sequence reads in a family; (Direct infringement of Claim 12 as upheld) 13. in part icular, t he met hod of any one of t he preceding claims, w here t he met hod is used: a. t o const ruct a genet ic profile of t he subject , from w hich t he body fluid derives, over t he course of a disease; or b. t o generat e a profile, fingerprint or set of dat a t hat is a summat ion of genet ic informat ion derived from different cells in a het erogeneous disease of t he subject from w hich t he bodily fluid derives; (Direct infringement of Claim 13 as upheld) 14. in part icular, t he met hod according t o Claim 13, w herein t he profile allow s t he subject or a pract it ioner t o adapt t reat ment opt ions in accord w it h t he progress of t he disease; (Direct infringement of Claim 14 as upheld) II. supplying and/ or offering t o supply for use means, w hich are suit able and int ended for use in, 1. a met hod for processing at least one set of t agged parent polynucleot ides, comprising st eps of: a. convert ing initial st art ing genet ic mat erial int o the t agged parent polynucleot ides using non-unique barcode oligonucleot ides, w herein convert ing comprises enzymat ic ligat ion; b. amplifying t he t agged parent polynucleot ides in t he set t o produce a corresponding set of amplified progeny polynucleot ides; c. sequencing a subset of t he set of amplified progeny polynucleot ides, t o produce a set of sequencing reads; and 8 d. collapsing t he set of sequencing reads t o generat e a set of consensus sequences, each consensus sequence corresponding t o a unique polynucleot ide among t he set of t agged parent polynucleot ides, w herein (i) t he init ial st art ing genet ic mat erial is cell-free DNA isolat ed from a body fluid, and comprises no more t han 100 ng of polynucleot ides, and (ii) det ect ion of t he non-unique barcodes in combinat ion w it h sequence dat a of beginning and end port ions of sequencing reads allow s assignment of a unique ident it y t o a parent polynucleot ide; specifically • t he soft w are for accessing t he ‘SOPHiA DDM ™’ plat form and • t he library preparat ion and hybridizat ion capt ure kit and component s t hereof, including but not limit ed t o t he ‘SOPHiA GENETICS CUM IN™’ adapt ers, ‘Probes by SOPHiA GENETICS’ and Inst ruct ions for Use, w it hout - in t he case of an offer, expressly and clearly indicat ing t hat t he means may not be used w it hout t he consent of t he Applicant as t he propriet or of t he European pat ent 3,591,073 for t he met hod of det ermining copy number variat ion according t o D.II., - in t he case of supply, imposing on t he purchasers, subject t o a cont ract ual penalt y payment t o t he Applicant of EUR 10,000 for each case of infringement , a w rit t en obligat ion not t o use t he means for t he met hod of det ermining copy number variat ion according t o D.II. wit hout t he prior consent of t he Applicant as t he pat ent propriet or of t he European pat ent 3,591,073; and • alternative to request D.I, t he M SK-ACCESS pow ered w it h SOPHiA DDM ™ t est ; (Indirect infringement of Claim 1 as upheld) 2. in part icular, t he met hod of Claim 1, w herein t he barcodes comprise oligonucleot ides at least 3, 5, 10, 15, 20 25, 30, 35, 40, 45, or 50 base pairs in lengt h; (Indirect infringement of Claim 2 as upheld) 3. in part icular, t he met hod of any one of t he preceding claims, w herein t he body fluid is blood; (Indirect infringement of Claim 3 as upheld) 4. in part icular, t he met hod of any of t he preceding claims, comprising enriching t he set of amplified progeny polynucleot ides for polynucleot ides mapping t o one or m ore select ed mappable posit ions in a reference sequence by: (i) selective amplificat ion of sequences from initial st art ing genet ic mat erial convert ed t o t agged parent polynucleot ides; (ii) select ive amplificat ion of t agged parent polynucleot ides; (iii) select ive sequence capt ure of amplified progeny polynucleot ides; or (iv) select ive sequence capt ure of init ial st art ing genet ic mat erial; (Indirect infringement of Claim 4 as upheld) 9 5. in part icular, t he met hod of any one of t he preceding claims, furt her comprising: e. analyzing t he set of consensus sequences for t he set s of t agged parent polynucleot ides separat ely or in combinat ion; (Indirect infringement of Claim 5 as upheld) 6. in part icular, t he met hod of Claim 5, w herein analyzing comprises det ect ing mut at ions, rare mut at ions, indels, copy number variat ions, t ransversions, t ranslocat ions, inversion, delet ions, aneuploidy, part ial aneuploidy, polyploidy, chromosomal inst abilit y, chromosomal st ruct ure alt erat ions, gene fusions, chromosome fusions, gene t runcat ions, gene amplificat ion, gene duplicat ions, chromosomal lesions, DNA lesions, abnormal changes in nucleic acid chemical modificat ions, abnormal changes in epigenet ic pat t erns, abnormal changes in nucleic acid met hylat ion infect ion or cancer; (Indirect infringement of Claim 6 as upheld) 7. in part icular, t he met hod of Claim 5 or Claim 6, w herein analyzing comprises normalizing a measure t aken from a set of consensus sequences against a measure t aken from a set of consensus sequences from a cont rol sample; (Indirect infringement of Claim 7 as upheld) 8. in part icular, t he met hod of any one of Claims 5 t o 7, w herein analysis furt her comprises det ect ion and monit oring of an abnormalit y or disease wit hin an individual, such as infect ion and/ or cancer; (Indirect infringement of Claim 8 as upheld) 9. in part icular, t he met hod of any one of Claims 5 t o 8, comprising providing a pluralit y of set s of t agged parent polynucleot ides, w herein each set is mappable t o a different mappable posit ion in a reference sequence, opt ionally w herein t he mappable posit ion in t he reference sequence is t he locus of a t umor m arker and analyzing comprises det ect ing t he t umor marker in t he set of consensus sequences; (Indirect infringement of Claim 9 as upheld) 10. in part icular, t he met hod of any one of t he preceding claims, comprising filt ering out reads w it h an accuracy or qualit y score of less t han a t hreshold; (Indirect infringement of Claim 10 as upheld) 11. in part icular, t he met hod of any one of t he preceding claims, w herein collapsing comprises det ect ing and/ or correct ing errors, nicks or lesions present in t he sense or ant isense st rand of t he t agged parent polynucleot ides or amplified progeny polynucleot ides; (Indirect infringement of Claim 11 as upheld) 12. in part icular, t he met hod of any one of t he preceding claims, w herein collapsing comprises: a. grouping sequences reads sequenced from amplified progeny polynucleot ides int o families, each family amplified from t he same t agged parent polynucleot ide; and 10 b. det ermining a consensus sequence based on sequence reads in a family; (Indirect infringement of Claim 12 as upheld) 13. in part icular, t he met hod of any one of t he preceding claims, w here t he met hod is used: a. t o const ruct a genet ic profile of t he subject , from w hich t he body fluid derives, over t he course of a disease; or b. t o generat e a profile, fingerprint or set of dat a t hat is a summat ion of genet ic informat ion derived from different cells in a het erogeneous disease of t he subject from w hich t he bodily fluid derives; (Indirect infringement of Claim 13 as upheld) 14. in part icular, t he met hod according t o Claim 13, w herein t he profile allow s t he subject or a pract it ioner t o adapt t reat ment opt ions in accord w it h t he progress of t he disease; (Indirect infringement of Claim 14 as upheld) E. The Defendant s are ordered t o deliver up t o a bailiff appoint ed by t he Applicant , at t heir ow n expense, any physical means referred t o under D. in st ock and/ or ot herw ise held, ow ned, or in t he direct or indirect possession of t he Defendant s in Aust ria, Belgium, Germany, France, It aly, t he Net herlands, and Sw eden, and t he Czech Republic, Sw itzerland, Spain, Poland and Norw ay, w it hin one w eek aft er service of t his order, and t o provide t he Applicant ’s counsel w it h proper evidence of t he full and t imely compliance w it h t his order w it hin 10 days aft er t he delivery t o t he bailiff. F. For each individual violat ion of t he orders under D. and E., t he respect ive Defendant shall pay t o t he court a penalt y payment of up t o EUR 10,000. Each infringing act in relat ion t o M SK-ACCESS pow ered w it h SOPHiA DDM ™ in respect of request D.I and/ or any means in respect of request D.II will be considered as a separat e violat ion. Furt her, in t he case of cont inuous non-compliance or cont inuous infringement such as t he offering of on t he int ernet or non-compliance w it h t he obligation under E., t he respect ive Defendant shall pay t o t he court a penalt y payment of up t o EUR 100,000 per day. Under EP’066: G. The Defendant s are ordered, in t he t errit ories of Aust ria, Belgium, Bulgaria, Denmark, Est onia, Finland, France, Germany, It aly, Lat via, Lit huania, Luxembourg, M alt a, t he Net herlands, Port ugal, Romania, Slovenia, Sw eden, Sw it zerland, and Spain, t o cease and desist from I. using and/ or offering 1. a met hod for det ect ing t he presence or absence of colorect al cancer, ovarian cancer, lung cancer or pancreat ic cancer in a subject comprising: sequencing circulat ing cfDNA from t he subject at a dept h of at least 50,000 reads per base t o det ect one or m ore genet ic variant s associat ed w it h cancer, w herein t he sequencing is performed on an enriched set of amplified cfDNA molecules w hich comprises a panel of genomic regions, w herein t he genomic regions in the panel comprise one or more loci from each of t he genes AKT1, ALK, APC, ATM , BRAF, CTNNB1, EGFR, ERBB2, ESR1, FGFR2, GATA3, GNAS, IDH1, IDH2, KIT, KRAS, M ET, NRAS, PDGFRA, PIK3CA, PTEN, RB1, SM AD4, STK11 and 11 TP53, and furt her comprising amplifying t he cfDNA prior t o sequencing, and det ermining a consensus sequence from sequence reads obt ained from t he sequencing t o reduce errors from amplificat ion or sequencing; (Direct infringement of Claim 1) 2. in part icular, t he met hod of Claim 1, w herein t he one or m ore genet ic variant s associat ed wit h cancer are select ed from t he group consist ing of an SNV, CNV, indel, fusion, or nucleosome binding pat t ern; (Direct infringement of Claim 2) 3. in part icular, t he met hod of Claim 2, w herein t he SNV is det ect ed in a gene select ed from t he group consist ing of AKT1, ALK, APC, ATM , BRAF, CTNNB1, EGFR, ERBB2, ESR1, FGFR2, GATA3, GNAS, IDH1, IDH2, KIT, KRAS, M ET, NRAS, PDGFRA, PIK3CA, PTEN, RB1, SM AD4, STK11, and TP53; (Direct infringement of Claim 3) 4. in part icular, t he met hod of any one of Claims 1 t o 5, w herein t he enriched set of cfDNA molecules comprises one or more enhancer sequences or prom ot er sequences; (Direct infringement of Claim 6) 5. in part icular, t he met hod of any one of Claims 1 t o 6, furt her comprising comparing sequence informat ion from t he cfDNA t o sequence informat ion obt ained from a cohort of healt hy individuals, a cohort of cancer pat ient s, or germline DNA from t he subject ; (Direct infringement of Claim 7) 6. in part icular, t he met hod of any one of Claims 1 t o 7, w herein t he germline DNA from t he subject is obt ained from leukocyt es from t he subject ; (Direct infringement of Claim 8) 7. in part icular, t he met hod of any one of Claims 1 t o 8, w herein det ermining t he consensus sequence is performed on a molecule-by-molecule basis or a base-by-base basis; (Direct infringement of Claim 9) 8. in part icular, t he met hod of any one of Claims 1 t o 9, w herein det ermining t he consensus sequence is performed using molecular barcodes t hat t ag individual cfDNA molecules derived from t he subject ; (Direct infringement of Claim 10) 9. in part icular, t he met hod of any one of Claims 1 t o 10, w herein det ermining t he consensus sequence is opt imized by comparing t he consensus sequence t o t hose obt ained from a cohort of healt hy individuals, a cohort of cancer pat ient s, or t he germline DNA from t he subject ; (Direct infringement of Claim 11) 10. in part icular, t he met hod of any one of Claims 1 t o 11, furt her comprising t agging t he cfDNA molecules w it h a barcode such t hat at least 20% of t he cfDNA in a sample derived from t he subject are t agged opt ionally w herein: 12 (a) t he t agging is performed by at t aching adapt ors comprising a barcode, opt ionally w herein t he adapt ors comprise any or all of blunt end adapt ors, rest rict ion enzyme overhang adapt ors, or adapt ors w it h a single nucleot ide overhang, opt ionally w herein t he adapt ors w it h a single nucleot ide overhang comprise C-t ail adapt ors, A-t ail adapt ors, T-t ail adapt ors, and/ or G-t ail adapt ors; (b) t he t agging is performed by PCR amplificat ion using primers w it h barcodes; (c) t he barcode is single st randed; or (d) t he barcode is double st randed; (Direct infringement of Claim 12) 11. in part icular, t he met hod of any one of Claims 1 t o 13, w herein t he cfDNA comprises at least 4000, at least 5000, at least 7,000, at least 10,000, or at least 15,000 unique molecules for every base t o be sequenced or analyzed. (Direct infringement of Claim 14) II. supplying and/ or offering t o supply for use means, w hich are suit able and int ended for use in, 1. a met hod for det ect ing t he presence or absence of colorect al cancer, ovarian cancer, lung cancer or pancreat ic cancer in a subject comprising: sequencing circulat ing cfDNA from t he subject at a dept h of at least 50,000 reads per base t o det ect one or m ore genet ic variant s associat ed w it h cancer, w herein t he sequencing is performed on an enriched set of amplified cfDNA molecules w hich comprises a panel of genomic regions, w herein t he genomic regions in the panel comprise one or more loci from each of t he genes AKT1, ALK, APC, ATM , BRAF, CTNNB1, EGFR, ERBB2, ESR1, FGFR2, GATA3, GNAS, IDH1, IDH2, KIT, KRAS, M ET, NRAS, PDGFRA, PIK3CA, PTEN, RB1, SM AD4, STK11 and TP53, and furt her comprising amplifying t he cfDNA prior t o sequencing, and det ermining a consensus sequence from sequence reads obt ained from t he sequencing t o reduce errors from amplificat ion or sequencing; specifically • t he soft w are for accessing t he ‘SOPHiA DDM ™’ plat form and • t he library preparat ion and hybridizat ion capt ure kit and component s t hereof, including but not limit ed t o t he ‘SOPHiA GENETICS CUM IN™’ adapt ers, ‘Probes by SOPHiA GENETICS’ and Inst ruct ion for Use, w it hout - in t he case of an offer, expressly and clearly indicat ing t hat t he means may not be used w it hout t he consent of t he Applicant as t he propriet or of t he European pat ent 3,443,066 for t he met hod of det ermining copy number variat ion according t o G.II., - in t he case of supply, imposing on t he purchasers, subject t o a cont ract ual penalt y payment t o t he Applicant of EUR 10,000 for each case of infringement , a w rit t en obligat ion not t o use t he means for t he met hod of det ermining copy number variat ion according t o G.II. w it hout t he prior consent of t he Applicant as t he pat ent propriet or of t he European pat ent 3,443,066; and 13 • alternative to request G.I, t he M SK-ACCESS pow ered w it h SOPHiA DDM ™ t est ; (Indirect infringement of Claim 1) 2. in part icular, t he met hod of Claim 1, w herein t he one or m ore genet ic variant s associat ed wit h cancer are select ed from t he group consist ing of an SNV, CNV, indel, fusion, or nucleosome binding pat t ern; (Indirect infringement of Claim 2) 3. in part icular, t he met hod of Claim 2, w herein t he SNV is det ect ed in a gene select ed from t he group consist ing of AKT1, ALK, APC, ATM , BRAF, CTNNB1, EGFR, ERBB2, ESR1, FGFR2, GATA3, GNAS, IDH1, IDH2, KIT, KRAS, M ET, NRAS, PDGFRA, PIK3CA, PTEN, RB1, SM AD4, STK11, and TP53; (Indirect infringement of Claim 3) 4. in part icular, t he met hod of any one of Claims 1 t o 5, w herein t he enriched set of cfDNA molecules comprises one or more enhancer sequences or prom ot er sequences; (Indirect infringement of Claim 6) 5. in part icular, t he met hod of any one of Claims 1 t o 6, furt her comprising comparing sequence informat ion from t he cfDNA t o sequence informat ion obt ained from a cohort of healt hy individuals, a cohort of cancer pat ient s, or germline DNA from t he subject ; (Indirect infringement of Claim 7) 6. in part icular, t he met hod of any one of Claims 1 t o 7, w herein t he germline DNA from t he subject is obt ained from leukocyt es from t he subject ; (Indirect infringement of Claim 8) 7. in part icular, t he met hod of any one of Claims 1 t o 8, w herein det ermining t he consensus sequence is performed on a molecule-by-molecule basis or a base-by-base basis; (Indirect infringement of Claim 9) 8. in part icular, t he met hod of any one of Claims 1 t o 9, w herein det ermining t he consensus sequence is performed using molecular barcodes t hat t ag individual cfDNA molecules derived from t he subject ; (Indirect infringement of Claim 10) 9. in part icular, t he met hod of any one of Claims 1 t o 10, w herein det ermining t he consensus sequence is opt imized by comparing t he consensus sequence t o t hose obt ained from a cohort of healt hy individuals, a cohort of cancer pat ient s, or t he germline DNA from t he subject ; (Indirect infringement of Claim 11) 10. in part icular, t he met hod of any one of Claims 1 t o 11, furt her comprising t agging t he cfDNA molecules w it h a barcode such t hat at least 20% of t he cfDNA in a sample derived from t he subject are t agged opt ionally w herein: 14 (a) t he t agging is performed by at t aching adapt ors comprising a barcode, opt ionally w herein t he adapt ors comprise any or all of blunt end adapt ors, rest rict ion enzyme overhang adapt ors, or adapt ors w it h a single nucleot ide overhang, opt ionally w herein t he adapt ors w it h a single nucleot ide overhang comprise C-t ail adapt ors, A-t ail adapt ors, T-t ail adapt ors, and/ or G-t ail adapt ors; (b) t he t agging is performed by PCR amplificat ion using primers w it h barcodes; (c) t he barcode is single st randed; or (d) t he barcode is double st randed; (Indirect infringement of Claim 12) 11. in part icular, t he met hod of any one of Claims 1 t o 13, w herein t he cfDNA comprises at least 4000, at least 5000, at least 7,000, at least 10,000, or at least 15,000 unique molecules for every base t o be sequenced or analyzed; (Indirect infringement of Claim 14) H. The Defendant s are ordered t o deliver up t o a bailiff appoint ed by t he Applicant , at t heir ow n expense, any physical means referred t o under G. in st ock and/ or ot herw ise held, ow ned, or in t he direct or indirect possession of t he Defendant s in Aust ria, Belgium, Bulgaria, Germany, Denmark, Est onia, Finland, France, It aly, Lat via, Lit huania, Luxembourg, M alt a, t he Net herlands, Port ugal, Romania, Slovenia, Sw eden, Sw it zerland, and Spain, w it hin one w eek aft er service of t his order, and t o provide t he Applicant ’s counsel w it h proper evidence of t he full and t imely compliance wit h t his order w it hin 10 days aft er t he delivery t o t he bailiff. I. For each individual violat ion of t he orders under G. and H., t he respect ive Defendant shall pay t o t he court a penalt y payment of up t o EUR 10,000. Each infringing act in relat ion t o M SK-ACCESS pow ered w it h SOPHiA DDM ™ in respect of request G.I and/ or any means in respect of request G.II w ill be considered as a separat e violat ion. Furt her, in t he case of cont inuous non-compliance or cont inuous infringement such as t he offering of as t he offering on t he int ernet or non-compliance w it h t he obligat ion under H., t he respect ive Defendant shall pay t o t he court a penalt y payment of up t o EUR 100,000 per day. Under EP 986: J. The Defendant s are ordered, in t he t errit ories of Belgium, Germany, France, It aly, t he Net herlands, Sw itzerland and Spain, t o cease and desist from I. using and/ or offering for use, 1. a comput er implement ed met hod comprising use of a comput er dat abase t o ident ify one or m ore effect ive t herapeut ic int ervent ions for a subject having cancer, w herein t he comput er dat abase includes, for each of a pluralit y of subject s having cancer: (i) t umor genomic t est ing dat a, including somat ic alt erat ions, collect ed at t w o or more t ime int ervals per subject via serial biopsy of cell-free DNA; (ii) one or m ore t herapeut ic int ervent ions administ ered t o each of t he subject s at one or more t imes; and (iii) efficacy of t he t herapeut ic int ervent ions; (Direct infringement of Claim 1) 15 2. in part icular, t he met hod of any one of Claims 1-4, w herein t he pluralit y of subject s is at least 50, at least 500 or at least 5000 subject s; (Direct infringement of Claim 5) 3. in part icular, t he met hods of any one of Claims 1-6, w herein w eight , adverse t reat ment effect s, hist ological t esting, blood t est ing, radiographic informat ion, prior t reat ment s, and/ or cancer t ype is used t o help classify t reat ment efficacy; (Direct infringement of Claim 7) 4. in part icular, t he met hod of any one of Claims 1-8, w herein t he met hod comprises classifying effect iveness of t reat ment using a classificat ion algorit hm, such as: (i) linear regression processes, such as mult iple linear regression, part ial least squares, regression and principal component s regression; (ii) binary decision t rees, such as recursive part it ioning processes such as classificat ion and regression t rees; (iii) art ificial neural net w orks such as back propagat ion net w orks; (iv) discriminant analyses such as Bayesian classifier or Fischer analysis; (v) logistic classifiers; and/ or (vi) support vect or classifiers, such as support vect or machines; (Direct infringement of Claim 9) 5. in part icular, t he met hod of any one of Claims 1-9, w herein bot h germline and somat ic alt erat ions are used for det ermining t reat ment efficacy; (Direct infringement of Claim 10) 6. in part icular, t he met hod of any one of Claims 1-12, w herein t he t um or genomic t est ing dat a is DNA sequencing dat a; (Direct infringement of Claim 13) 7. in part icular, t he met hod of Claim 13, w herein t he DNA sequencing dat a includes polynucleot ides mapping t o specific loci in t he genome t hat are t he subject of int erest , and have been isolat ed for sequencing by sequence capt ure or sit e-specific amplificat ion; (Direct infringement of Claim 14) 8. in part icular, t he met hod of any one of claims 1-14, w herein t he cell free DNA has been t agged or t racked in order t o permit subsequent ident ificat ion and origin of t he part icular polynucleot ide. (Direct infringement of Claim 15) II. supplying and/ or offering t o supply for use means, w hich are suit able and int ended for use in, 1. a comput er implement ed met hod comprising use of a comput er dat abase t o ident ify one or m ore effect ive t herapeut ic int ervent ions for a subject having cancer, w herein t he comput er dat abase includes, for each of a pluralit y of subject s having cancer: (i) t umor genomic t est ing dat a, including somat ic alt erat ions, collect ed at t w o or more t ime int ervals per subject via serial biopsy of cell-free DNA; 16 (ii) one or m ore t herapeut ic int ervent ions administ ered t o each of t he subject s at one or more t imes; and (iii) efficacy of t he t herapeut ic int ervent ions; specifically • t he soft w are for accessing t he ‘SOPHiA DDM ™’ plat form and • t he library preparat ion and hybridizat ion capt ure kit and component s t hereof, including but not limit ed t o t he ‘SOPHiA GENETICS CUM IN™’ adapt ers, ‘Probes by SOPHiA GENETICS’ and Inst ruct ions for Use, w it hout - in t he case of an offer, expressly and clearly indicat ing t hat t he means may not be used w it hout t he consent of t he Applicant as t he propriet or of t he European pat ent EP 3 766 986 for t he met hod of det ermining copy number variat ion according t o J.II., - in t he case of supply, imposing on t he purchasers, subject t o a cont ract ual penalt y payment t o t he Applicant of EUR 10,000 for each case of infringement , a w rit t en obligat ion not t o use t he means for t he met hod of det ermining copy number variat ion according t o J.II. w it hout t he prior consent of t he Applicant as t he pat ent propriet or of t he European pat ent EP 3 766 986; and • alternative to request J.I, t he M SK-ACCESS pow ered w it h SOPHiA DDM ™ t est ; (Indirect infringement of Claim 1) 2. in part icular, t he met hod of any one of Claim 1-4, w herein t he pluralit y of subject s is at least 50, at least 500 or at least 5000 subject s; (Indirect infringement of Claim 5) 3. in part icular, t he met hods of any one of Claims 1-6, w herein w eight , adverse t reat ment effect s, hist ological t esting, blood t est ing, radiographic informat ion, prior t reat ment s, and/ or cancer t ype is used t o help classify t reat ment efficacy; (Indirect infringement of Claim 7) 4. in part icular, t he met hod of any one of Claims 1-8, w herein t he met hod comprises classifying effect iveness of t reat ment using a classificat ion algorit hm, such as: (i) linear regression processes, such as mult iple linear regression, part ial least squares, regression and principal component s regression; (ii) binary decision t rees, such as recursive part it ioning processes such as classificat ion and regression t rees; (iii) art ificial neural net w orks such as back propagat ion net w orks; (iv) discriminant analyses such as Bayesian classifier or Fischer analysis; (v) logistic classifiers; and/ or (vi) support vect or classifiers, such as support vect or machines; (Indirect infringement of Claim 9) 17 5. in part icular, t he met hod of any one of Claims 1-9, w herein bot h germline and somat ic alt erat ions are used for det ermining t reat ment efficacy; (Indirect infringement of Claim 10) 6. in part icular, t he met hod of any one of Claims 1-12, w herein t he t um or genomic t est ing dat a is DNA sequencing dat a; (Indirect infringement of Claim 13) 7. in part icular, t he met hod of Claim 13, w herein t he DNA sequencing dat a includes polynucleot ides mapping t o specific loci in t he genome t hat are t he subject of int erest , and have been isolat ed for sequencing by sequence capt ure or sit e-specific amplificat ion; (Indirect infringement of Claim 14) 8. in part icular, t he met hod of any one of Claims 1-14, w herein t he cell free DNA has been t agged or t racked in order t o permit subsequent ident ificat ion and origin of t he part icular polynucleot ide. (Indirect infringement of Claim 15) K. The Defendant s are ordered t o deliver up t o a bailiff appoint ed by t he Applicant , at t heir ow n expense, any physical means referred t o under J. in st ock and/ or ot herw ise held, ow ned, or in t he direct or indirect possession of t he Defendant s in Belgium, Germany, France, It aly, t he Net herlands, Sw it zerland and Spain, w it hin one w eek aft er service of t his order, and t o provide t he Applicant ’s counsel w it h proper evidence of t he full and t imely compliance w it h t his order w it hin 10 days aft er t he delivery t o t he bailiff. L. For each individual violat ion of t he orders under J. and K., t he respect ive Defendant shall pay t o t he court a penalt y payment of up t o EUR 10,000. Each infringing act in relat ion t o M SK-ACCESS pow ered w it h SOPHiA DDM ™ in respect of request J.I and/ or any means in respect of request J.II w ill be considered as a separat e violat ion. Furt her, in t he case of cont inuous non-compliance or cont inuous infringement such as t he offering of on t he int ernet or non-compliance w it h t he obligat ion under K., t he respect ive Defendant shall pay t o t he court a penalt y payment of up t o EUR 100,000 per day. In addit ion: The Applicant also request s: M . Any orders shall be immediat ely enforceable. N. The Defendant s pay t he cost s of t he proceedings pursuant t o Art icle 69. O. An int erim aw ard of cost s under Rule 211.1(d). The Defendant s are ordered t o provisionally reimburse t he applicant for cost s in t he amount of EUR 600,000. Finally, t he Applicant request s t he allocat ion of a t echnically qualified judge under Rule 33 due t o t he complexity of t he field of t echnology. The relevant field of t echnology is generally DNA sequencing and sequence analysis, part icularly in t he field of cancer diagnosis. 18 18. In t heir Object ion and in t heir last submission (Rejoinder dat ed 24 November 2025), SOPHIA GENETICS ent it ies request : I. The Applicat ion for provisional measures dat ed 29 August 2025 is refused; II. The Applicant is ordered t o pay t he cost s of t he proceedings; and III. An int erim aw ard of cost s under R.211.1(d) RoP, for cost s in t he amount of EUR 600,000. IV. In t he alt ernat ive t o Request s I t o III, t he alleged infringement is allow ed t o cont inue subject t o t he provision of a securit y t he amount of w hich is left t o t he discret ion of t he Court (but w hich should not exceed t he value in disput e) by t he Defendant s wit hin tw o w eeks. The securit y can be provided in t he form of a bank guarant ee. V. In t he alt ernat ive t o Request s I t o IV, t he enforcement of t he order for provisional measures is dependent on t he provision of securit y by Applicant in t he amount of at least EUR 12 million, w hereby t he securit y can be provided in t he form of a bank guarant ee. VI. Wit h respect t o any order for provisional measures concerning indirect infringement , t he accused supply or offer of essent ial means be modified solely by applicat ion of t he w arning label request ed by t he Applicant (and not modified by cont ract ual penalt y). VII. Wit h respect t o any order for provisional measures, enforcement be st ayed for a period of t hree m ont hs, t o allow hospit als, labs and research inst it ut ions t o t ransit ion t o anot her liquid biopsy product so t hat pat ient s’ access t o crit ical healt hcare is not int errupt ed. VIII. Wit h respect t o any order for provisional measure concerning EP’073 or EP’533, enforcement is st ayed pending t he out come of t he EPO Technical Board of Appeal case T0717/ 24. The provisional measures are only t hen enforceable in t he event t he claims of EP’073 survive in t heir current form. IX. Wit h respect t o all request s, t he Applicant is ordered t o pay t he cost s of t he proceedings for all pat ent s and claims unsuccessfully assert ed. Wit h respect t o all alt ernat ive request s, any order for injunct ive relief is limit ed t o t he Cont ract ing M ember St at es w here t he pat ent s (respect ively) are in force, or in t he furt her alt ernat ive, is limit ed t o t he Cont ract ing M ember St at es and ot her EU st at es w here t he pat ent s (respect ively) are in force. GROUNDS FOR THE ORDER I. Requirements concerning all the patents in suit Ent it lement regarding all t he pat ent s in suit 19. It is undisput ed t hat t he Applicant is t he sole and regist ered propriet or of t he four pat ent s at hand, so it is ent it led t o file t he present Applicat ion. 20. It has already been ment ioned t hat , in t he course of t he proceedings, GUARDANT HEALTH w it hdrew all it s claims based on EP’533. 21. The t hree pat ent s in suit , respectively EP’073, EP’066, and EP’986, w ill be present ed furt her on in t he decision w hen examining t he respect ive requirement s under R. 211.2 RoP regarding “ sufficient degree of cert aint y” for validit y and for infringement . 22. The Court finds it opport une in t he present case t o address first ly t he requirement under R. 211. 4 RoP, w hich concerns t he w hole request regarding all t he pat ent s in suit . 19 On t he requirement of “ any unreasonable delay in seeking provisional m easures” under R. 211.4 RoP -legal framew ork 23. R. 211 RoP (Order on t he Applicat ion for provisional measures) foresees in it s point 4: “ The Court shall have regard t o any unreasonable delay in seeking provisional measures” . 24. The Order of 25 Sept ember 2024 (CoA, M am mut Sport v Ort ovox, UPC CoA ORD 44387/ 2024, Headnot es 5), st at es t hat : “ The delay w it hin t he meaning of R. 211.4 RoP shall be calculat ed from t he day on w hich t he applicant became aw are, or should have become aw are, of t he infringement t hat w ould enable him, in accordance wit h R. 206.2 RoP, t o file an application for provisional m easures w it h a reasonable prospect of success. Thus, t he decisive point in tim e is w hen t he applicant has, or should have had, aft er exercising due diligence, t he necessary fact s and evidence w ithin the meaning of R. 206.2(d) RoP.” (English t ranslat ion of t he Order issued in German). -part ies’ argument s 25. The Applicant cont ends t hat it w as informed of t he market ing in t he UK of t he allegedly infringing t est in M ay 2025, w hereupon it prompt ly conduct ed t he necessary invest igat ions int o M SK-DDM t est s and realised t hat t hese t est s infringed several of it s pat ent s. GUARDANT HEALTH t hen sent a let t er on 27 M ay 2025 t o SOPHIA GENETICS UK on t he basis of it s UK pat ent s (in part icular t he UK nat ional part s of EP’533 and EP’073). GUARDANT HEALTH explains t hat as SOPHIA GENETICS UK responded lat e and w it hout a sufficient ly clear explanat ion, it brought an infringement act ion on t he merit s before t he UK nat ional court on 14 July 2025. GUARDANT HEALTH t hen invest igat ed t he possible marketing of allegedly infringing product s t hroughout Europe and discovered t hat market ing had already begun in various European hospit als from M arch 2025 onw ards in France (Exhibit s GH 11 t o 14), It aly, Germany and Belgium (Exhibits GH 11 t o 14), and w as set t o expand t o ot her European count ries. GUARDANT HEALTH adds t hat it also became aw are of a w ebinar held on 27 August 2025 (present ed by a senior scient ist from SOPHIA GENETICS) relat ing t o t est s using “ clinical cfDNA mat erial” . 26. The Defendant argues t hat t he Applicant cannot provide a specific dat e on w hich it became aw are of t he alleged act s of infringement w it hin t he UPC t errit ory, nor t he specific circumst ances in w hich it became aw are of t hem. According t o SOPHIA GENETICS, t he first commercial use of t he allegedly infringing product s in France w as made public on 19 June 2024 (Exhibit SG 20). SOPHIA GENETICS adds t hat t he expansion of t he cust omer base invoked by t he claimant cannot const it ut e a revival of t he crit erion of urgency. SOPHIA GENETICS argues t hat t he dat e on w hich GUARDANT HEALTH became aw are of SOPHIA GENETICS’s act ivit ies must be set prior t o M ay 2025 given t hat a w ebinar present ed t he product s in quest ion on 25 February 2025, and it w as at t ended by one of GUARDANT HEALTH's employees (Exhibit s SG 42 and GH 33); t hat a second w ebinar on t he accused product s w as present ed on 25 M arch 2025 and w as at t ended by four GUARDANT HEALTH employees (Exhibit s GH 23 and SG 42); t hat t his w ebinar w as view ed on 20 M arch 2025 by t he ‘Vice President of Clinical Laborat ory Product ion at GUARDANT HEALTH’ (Exhibit SG 42) and by one of t he Applicant s in t he present act ion on 18 April 2025 (Exhibit SG 43); and t hat in August 2024, t w o GUARDANT HEALTH employees (a “ St aff Field Applicat ions Scient ist ” and an “ Associat e Direct or of Bioinformatics” ) request ed a demo from Sophia 20 DDM (Exhibit SG 44). Finally, SOPHIA GENETICS argues t hat on 11 July 2025, a w ebinar present ed t he allegedly infringing product s and t heir result s, and it w as at t ended by t hree GUARDANT HEALTH employees (Exhibit SG 45). SOPHIA GENETICS adds t hat bot h part ies belong t o t he same net w orks (not ably ELBS memberships) and have access t o t he same scient ific publicat ions, and t hat GUARDANT HEALTH monit ors or should monit or t he liquid biopsy market . SOPHIA GENETICS concludes t hat GUARDANT HEALTH w as or should have been aw are of t he accused product s prior t o receiving t he let t er of 20 June 2025, as t he only addit ional evidence t hey needed concerned t he existence of act ivity in Europe, w hich had been announced a year earlier, on 19 June 2024 (Exhibit s SG 20-21). -response t o t he argument s 27. The Applicant 's diligence must be assessed on a case-by-case basis. The Court shall t ake int o account , w hen st at ing t he st art ing point of t he reasonable delay, t hat t he Applicant had sufficient evidence at such t ime t o guarant ee a reasonable prospect of success of t heir case. 28. In t he present case, t he Court first not es t hat , cont rary t o SOPHIA GENETICS's assert ion, t he Applicant proposes t he st arting point as being 27 M ay 2025. This dat e refers t o t he let t er sent by GUARDANT HEALTH t o SOPHIA GENETICS concerning t he UK market , invoking several European pat ent s, including EP'533 and EP'073, in force in t he UK, as w ell as t w o UK pat ent s. It is clear from reading t his let t er t hat it was sent by GUARDANT HEALTH t o SOPHIA GENETICS at t he t ime of t he opening of a t ender by NHS England in relat ion t o t he supply of liquid biopsy t est ing services (Expressions of int erest from t he current seven genomic laborat ory hubs - Exhibit SG 049). In t his let t er, GUARDANT HEALTH drew up an init ial comparat ive t able bet w een Claim 1 of EP’533 and w hat GUARDANT HEALTH knew regarding t he allegedly infringing product , w hich w as available on SOPHIA GENETICS's w ebsit e (i.e. “ the fact sheet ” and “ t he user manual” ). Therefore, t he Court is sufficient ly informed concerning t he circumst ances in w hich t he Applicant claims t o have first become aw are of t he exist ence of an infringement or a risk of infringement in Europe. 29. Furt hermore, t he Defendant s’ argument s regarding t he fact t hat one of it s compet it ors had announced t he market ing of a t est in t he field of liquid biopsy as early as June 2024, and t he fact t hat GUARDANT HEALTH employees were at t ending online SOPHIA GENETICS seminars (w it hout est ablishing w het her t he aforement ioned employees have t he necessary IP knowledge and/ or a posit ion in t he management of t he group t o decide on a judicial action) prior t o M ay 2025 cannot be considered as sufficient , t aking int o account t he specificit y of such a highly complex t echnology. Accordingly, t he Court finds relevant t he Applicant ’s argument s put forw ard in §6 of t heir Reply, as follow s: “ Technical analysis of t he Defendant s’ t est bet w een M ay and July w as not st raight forw ard, and t his w ork t ook several w eeks due t o t he complexit y of t he pat ent s’ t echnology and t he lack of public t echnical informat ion on how M SK-DDM w orks. For example, it w as not readily apparent w het her M SK-DDM used non-unique t agging. Or, by w ay of anot her example, t he Applicant obt ained a copy of GH 22, t he user manual for M SK-DDM Capt ure Solut ions, w hich is crucial for show ing infringement , only on 11 July 2025.” 30. The Court not es t hat , t o est ablish t hat t he allegedly infringing product reproduces t he claims of t he pat ent s in quest ion, t he Applicant primarily relies on GH 21 and GH 22. 21 31. Regarding GH 21: even t hough SOPHIA GENETICS in it s Rejoinder §7 and 8 (Exhibit s SG 100 and 101 and GH 21) assert s and just ifies w it h a screenshot on Google t hat t he manual in GH 21 w as online as early as Oct ober 2024, GUARDANT HEALTH cannot be expect ed t o monit or t he Int ernet for all compet ing product s w hen it had not been alert ed by SOPHIA GENETICS's act ivit y concerning said product s in Europe (or at least in t he St at es w here t he European pat ent in quest ion are in force) before M ay 2025. 32. Regarding GH 22: t he fact t hat GUARDANT HEALTH only had access t o GH 22 in July 2025 is not disput ed by t he Defendant s; t he lat t er replies in it s Rejoinder t hat GUARDANT HEALTH could have est ablished it s case based solely on GH 21. How ever, t he demonst rat ion of t he infringement of pat ent s EP’073 and EP’066 is based on GH 22 regarding some key feat ures (see GUARDANT HEALTH Applicat ion: §187 for EP’073 and §205 for EP’066). 33. Concerning t he alleged infringement of EP’986, t he Applicant mainly relies on GH 21 as w ell as on Exhibit GH 39, and it is not cont est ed t hat t his lat est document w as post ed online in t he course of April 2025 (see §223 of GUARDANT HEALTH Applicat ion). 34. Finally, t he Court not es t hat t he ot her informat ion cit ed by t he Defendant s prior t o M ay 2025 is eit her t oo general in scope (i.e. commercial document s t hat do not cont ain t echnical informat ion) or relat es t o act ivit ies out side Europe (part icularly in t he USA). It has not been sufficient ly demonst rat ed by SOPHIA GENETICS t hat , on t he one hand, t he market ing of t he t est s in Europe w as obvious and know n and, on t he ot her hand, t hat t he t echnical specificat ions (i.e. t he charact erist ics and funct ionalit ies of t he t est accused of infringement ) w ere disclosed in sufficient det ail t o allow for an analysis of t he possible reproduct ion of t he pat ent s in suit . 35. Consequent ly, t he st arting point for t he reasonable delay in seeking provisional m easures required by R. 211.4 RoP, t hat is t o say t he dat e on w hich GUARDANT HEALTH became (or should have become) aw are of an infringement or risk of infringement of it s European pat ent s by t he SOPHIA GENETICS t est s in quest ion, is set by t he Court at 27 M ay 2025 (i.e. t he dat e on w hich a correspondence began bet w een t he part ies on t he subject of t he present disput e). 36. The Court considers t hat a t hree-mont h period (unt il t he applicat ion dat ed 29 August 2025) const it ut es a reasonable delay t o prepare it s act ion by gat hering t he necessary evidence, given t hat t he case involves several pat ent s and a complex and sophist icat ed t echnology. 37. Regarding t he Defendant 's argument t hat GUARDANT HEALTH was prepared t o init iat e provisional measures proceedings before t he UPC as early as 27 M ay 2025, t he dat e on w hich GUARDANT HEALTH sent a let t er relat ing t o proceedings in t he UK, t he Court considers t his irrelevant . In t he aforement ioned let t er, GUARDANT HEALTH refers t o financial report GH 49, st at ing: “ You are t argeting UK cust omers for t his t echnology” (SOPHIA GENETICS financial report for t he second quart er of 2024). Cont rary t o SOPHIA GENETICS's argument , t his document did not ment ion any cust omers in Europe out side t he UK for t he accused t est s. In part icular, it did not ment ion t he Universit y of Heidelberg in Germany. Furt hermore, GUARDANT HEALTH did not consider it self ready t o bring an act ion in t he UK on t he nat ional pat ent s and EP’533 and EP’073 unt il 14 July 2025, and it t ook several more w eeks before t aking act ion before t he UPC. This w as t o est ablish t he fact s of infringement in European count ries out side t he UK (i.e. t he M ember St at es of t he UPC) and 22 t o gat her sufficient evidence concerning t he four pat ent s it considered t o have been infringed, using t he public informat ion available at t hat t ime regarding t he accused t est s. This evidence had t o be sufficient from t he out set of t he provisional measures proceedings before t he UPC, w hich are charact erised by a “ summ ary procedure” and a “ front -loaded” syst em. 38. Consequent ly, SOPHIA GENETICS fails t o dem onst rat e t hat GUARDANT HEALTH sought provisional measures wit hin a delay t hat w as unreasonable under R. 211.4 RoP. II. Requests under EP’073 Present at ion of t he pat ent in suit 39. EP’073 is t it led “ M et hods t o det ect rare mut ations and copy number variat ion” . 40. The applicat ion w as filed on 4 Sept ember 2013. 41. The pat ent in suit claims priorit y of four US applicat ions: 4 Sept ember 2012 US 201261696734 P, 21 Sept ember 2012 US 201261704400 P, 15 M arch 2013 US 201361793997 P and 13 July 2013 US 201361845987 P. 42. EP’073 is a divisional applicat ion of EP’533 (t he pat ent for w hich t he request s have been w it hdraw n by t he applicant during t he present proceedings) w hich in t urn is a divisional applicat ion of EP 2893040 w hich has been revoked by t he EPO in appeal proceedings. 43. The not ice of pat ent grant w as published on 1 December 2021. Opposit ion has been filed at t he EPO, and t he opposit ion division upheld t he pat ent in slight ly amended form (i.e. by combining grant ed claims 1 and 3). An appeal against t his decision is pending, and oral proceedings are scheduled for 24 April 2026. 44. In it s preliminary opinion issued on 15 December 2025 regarding EP’073, admit t ed as new evidence in t he present case by procedural order of 18 December 2025, t he EPO Board of Appeal (BoA) holds t hat Claim 1 “ does not comply w it h requirement s of Art . 76(1) EPC” and is “ current ly of t he opinion t hat Claim 1 of each of t he auxiliary request s filed w it h t he respondent ’s reply to t he appeals fails t o comply w it h t he requirement s of Art icles 76(1) and 123(2) EPC” relat ing t o added subject -mat t er. In it s concluding remarks, t he BoA not es t hat “ it is likely t hat t he appeal w ill be allow ed and t he pat ent be revoked” . 45. The pat ent is current ly in force in Aust ria, Belgium, Germany, France, It aly, t he Net herlands and Sw eden. Out side t he UPC t errit ories, it is also in force in t he Czech Republic, Sw it zerland, Norw ay, Spain, Poland and t he UK. 46. EP’073 had been opt ed out of t he UPC’s jurisdict ion, but t he opt -out w as w it hdraw n on 28 August 2025. 47. The pat ent in suit comprises 14 claims. 48. Claim 1 reads as follow s: 1. A met hod for processing at least one set of t agged parent polynucleot ides, comprising st eps of: a. convert ing init ial st art ing genet ic mat erial into t he t agged parent polynucleot ides using non-unique barcode oligonucleot ides, w herein convert ing comprises enzymat ic ligat ion; 23 b. amplifying t he t agged parent polynucleot ides in t he set t o produce a corresponding set of amplified progeny polynucleotides; c. sequencing a subset of t he set of amplified progeny polynucleot ides, t o produce a set of sequencing reads; and d. collapsing t he set of sequencing reads t o generat e a set of consensus sequences, each consensus sequence corresponding t o a unique polynucleot ide among t he set of t agged parent polynucleot ides, w herein (i) t he init ial start ing genet ic mat erial is cell-free DNA isolat ed from a body fluid, and com prises no more t han 100 ng of polynucleot ides, and (ii) det ect ion of t he non-unique barcodes in com binat ion w it h sequence dat a of beginning and end port ions of sequencing reads allow s assignment of a unique ident it y t o a parent polynucleotide. -t he subject -mat t er of t he invent ion in EP’073 49. [001] and [002] of t he concerned pat ent provide t he background of t he invent ion: [0001] The det ect ion and quant ification of polynucleotides is import ant for molecular biology and medical applicat ions such as diagnostics. Genet ic t est ing is part icularly useful for a number of diagnost ic met hods. For example, disorders t hat are caused by rare genet ic alt erat ions (e.g., sequence variant s) or changes in epigenetic markers, such as cancer (…), may be det ect ed or more accurat ely charact erized w it h DNA sequence information. [0002] Early det ect ion and monit oring of genetic diseases, such as cancer is oft en useful and needed in t he successful t reat m ent or management of the disease. One approach may include t he monit oring of a sample derived from cell free nucleic acids, a population of polynucleot ides t hat can be found in different t ypes of bodily fluids. In some cases, disease may be charact erized or det ect ed based on det ect ion of genet ic aberrations, such as a change in copy num ber variat ion and/ or sequence variat ion of one or more nucleic acid sequences, or t he development of ot her certain rare genet ic alt erat ions. Cell free DNA (" cfDNA" ) has been know n in t he art for decades, and may cont ain genet ic aberrat ions associat ed wit h a part icular disease. With improvement s in sequencing and t echniques t o manipulat e nucleic acids, t here is a need in t he art for improved met hods and syst ems for using cell free DNA t o det ect and monit or disease. 50. EP’073 relat es t o met hods w hich t reat small quant it ies of cell-free DNA (hereinaft er “ cfDNA” ) (100 ng or less) in a w ay w hich allows t he sequence of individual cfDNA molecules t o be ident ified even aft er t he noisy st eps of amplificat ion and sequencing. The claimed met hod t ags cfDNA in a sample w it h barcodes, and t he t agged cfDNA is t hen amplified and sequenced t o produce sequence reads. (see §83 of t he Applicat ion). 51. The sequence reads are t hen arranged int o groups w hich correspond t o an original cfDNA molecule, and t he members of t his group are analysed t o provide a consensus sequence (see §71 of t he Applicat ion) for t he original cfDNA molecule: “ Where a DNA molecule has been sequenced mult iple times, the various sequence reads can be compared t o generat e ‘calls’ t hat represent t he best predict ion (or consensus) for t he t rue ident it y of t he nucleotide at each posit ion in t hat molecule. Differences bet w een sequence reads for t he same molecule (e.g. due t o experiment al noise) are t hus removed.” 24 52. An import ant aspect of Claim 1 is t hat it uses non-unique t agging, meaning t hat t he same t ag (barcode) is used for m ult iple cfDNA molecules. 53. Claim 1 of t he pat ent , as maint ained by t he EPO opposit ion division, reads as follow s (t he “ feat ure breakdow n” present ation by t he Applicant is not cont est ed by t he Respondent and adopt ed by t he Court ): Claim int erpret at ion regarding EP’073 -t he skilled person 54. Only t he Defendant s propose a definit ion of t he person skilled in t he art in t he present case: “ Like 533, 073 is addressed t o a skilled person w orking in t he genomic analysis of cfDNA” (§194 of t he Object ion). This definit ion w as not cont est ed by t he Applicant in it s Reply. 55. Provided t hat t he concerned met hod is a variat ion/ improvement of an exist ing sequencing t echnology as can be found in t he cit ed prior art , t he Court assert s t hat t he relevant skilled person in t he present case (under EP’073) is a molecular biologist , familiar w it h Next - generat ion sequencing t echnology (“ NGS” )1 and genet ic t est ing. -principles for claim int erpret at ion 56. In accordance w it h Art . 69 of t he European Pat ent Convent ion (EPC) and t he Prot ocol on it s Int erpret at ion, t he present panel adopt s t he st andard for t he int erpret at ion of pat ent 1 The NGS is used t o det ermine t he order of nucleot ides in ent ire genomes or t arget ed regions of DNA or RNA w herein a big number of fragment s are sequenced at t he same t ime. 25 claims set by t he UPC Court of Appeal in t w o recent orders (UPC CoA 335/ 2023 and UPC CoA 1/ 2024), as follow s: 1) The pat ent claim is not only t he st art ing point , but t he decisive basis for det ermining t he prot ect ive scope of t he European pat ent . 2) The int erpret at ion of a pat ent claim does not depend solely on t he st rict , lit eral meaning of t he w ording used. Rat her, t he descript ion and t he draw ings must alw ays be used as explanat ory aids for t he int erpret at ion of t he pat ent claim and not only t o resolve any ambiguit ies in t he pat ent claim. 57. How ever, t his does not mean t hat t he pat ent claim serves only as a guideline and t hat it s subject -mat t er may ext end t o w hat, from a considerat ion of t he descript ion and draw ings, t he pat ent propriet or has cont emplat ed. 58. The pat ent claim is t o be int erpret ed from t he point of view of a person skilled in t he art . 59. In applying t hese principles, t he aim is t o combine adequat e prot ect ion for t he pat ent propriet or w it h sufficient legal cert aint y for t hird part ies. 60. These principles for t he int erpret at ion of a pat ent claim apply equally t o t he assessment of t he infringement and validit y of a European pat ent . This follow s from t he funct ion of pat ent claims, w hich under t he EPC serve t o define t he scope of prot ect ion of t he pat ent under Art . 69 EPC and t hus t he right s of t he pat ent propriet or in t he designat ed Cont ract ing St at es under Art . 64 EPC, w hile considering t he condit ions for pat ent abilit y under Art . 52 t o 57 EPC. 61. In t he present case, t he Applicant present s Claim 1 of EP’073 w it h t he follow ing int erpret at ion: Feat ure 1.1: a met hod for dealing w it h t agged polynucleot ides in w hich: Feat ure 1.2: In st ep (a), enzymat ic ligat ion is used t o convert “ init ial starting genet ic mat erial” int o t agged mat erial. o The “ init ial st arting genet ic material” is defined in part (i) of t he final port ion of t he claim (Feat ure 1.6) as being “ cell-free DNA isolat ed from a body fluid” and includes “ no more t han 100 ng” of polynucleot ides. o The t agging uses “ non-unique barcode oligonucleot ides” . The reference t o “ non-uniquely tagging” in Claim 1 t hus means t hat a low number of different t ags is used in st ep (a), such t hat “ individual t arget polynucleot ides w ill receive t he same t ag oligonucleotide” Feat ure 1.3: In st ep (b), t he t agged cfDNA is amplified (e.g. using PCR) t o produce t he “ progeny polynucleot ides” . Tumor-derived cfDNA is present at very low levels, and so t he original molecules are amplified t o assist in sequencing. How ever, amplificat ion t echniques are inherent ly noisy and t here is t herefore a requirement t o remove t his noise. Feat ure 1.4: In st ep (c) a subset of t he progeny polynucleot ides is sequenced, w hich provides a set of sequencing reads. Feat ure 1.5: St ep (d) involves “ collapsing” t he set of sequencing reads “ t o generat e a set of consensus sequences” . The t agging in st ep (a) (Feat ure 1.2) means t hat sequence reads can be linked back t o individual st art ing cfDNA m olecules, and any noise added during st eps (b) & (c) (Feat ures 1.3 & 1.4) can be correct ed. The various sequencing reads w hich originat e 26 from t he same original cfDNA molecule are ‘collapsed’ t o generat e a ‘consensus sequence’ i.e. t hey are grouped t oget her and t racked back t o original cfDNA molecules (see [0084] of EP’073) and t hen t he m ost likely (i.e. consensus) t rue nucleot ide at each sequenced posit ion in t he original cfDNA molecules is ident ified, t hereby removing noise. Feat ure 1.7: Part (ii) in t he final port ion of t he claim provides more det ails on how t he ‘collapsing’ st ep (feat ure 1.5) operat es. Because non-unique t agging w as used in st ep (a) (Feat ure 1.2) it is not possible t o ident ify individual st art ing cfDNA molecules by using t he t ags alone. Rat her, t he claim st at es t hat t he link back t o st art ing molecules is made by det ect ing “ t he non-unique barcodes in combinat ion wit h sequence dat a of beginning and end portions of sequencing reads” , and t his combinat ion of informat ion provides “ a unique ident it y t o a parent polynucleot ide. 62. Regarding t he claims of EP’073, t he Defendant s accept t he Applicant ’s charact erisat ion of feat ures 1.2, 1.3 and 1.4 as set out in §173 of t he Applicat ion. The Defendant s agree w it h t he Applicant t hat t he only concept in Claim 1 of EP’073 not present in Claim 1 of t he parent pat ent EP’533 is t hat t he sequences are collapsed int o a consensus sequence (see feat ure 1.5 of EP’073). 63. The part ies disagree on t he int erpret at ion of t he t erms “ collapsing int o a consensus sequence” in feat ures 1.5 and 1.7. 64. The Defendant argues (§88, 196 t o 198 and 200 of t he Object ion) t hat collapsing sequences int o consensus sequences is a w ell-know n process. The pat ent describes t hat t here are t w o w ays t o do t his: 1) a st raight forw ard w ay w here sequences are aligned, and t he most frequent nu- cleot ide at a cert ain posit ion is t he consensus nucleot ide, as show n in t he fol- low ing scheme (§22 of t he Rejoinder) 2) probabilist ic met hods. 65. According t o SOPHIA GENETICS, in EP’073, claims only relat e t o t he first met hod since it ment ions only consensus sequences. Therefore, probabilist ic met hods w ould be excluded from t he scope of prot ect ion covered by t he pat ent as ment ioned in t he descript ion, but not being claim ed. 66. The Applicant st at es in it s Reply (§33 t o 40) t hat Claim 1 is not limit ed t o any part icular w ay of analysing t he consensus sequences or det ect ing variant s. According t o GUARDANT HEALTH, t he Defendant s read limit at ions int o t he claim t hat are not present . The claim encompasses t he approach described in [0124] as w ell as approaches t hat t ake int o account “ all of t he sequence reads in all of t he CUM IN families” w hen det ermining if a variant is present at a part icular frequency at a part icular posit ion (see §213 of t he SoD). The specificat ion of t he pat ent in [0078] ment ions t he use of ‘probabilit ies’ not as an alt ernat ive t o feat ure 1.5; rat her, t his subject mat t er falls w it hin t he scope of Claim 1. The last sent ence of [0078] st at es t hat “ Furt hermore, det ermining frequencies of base calls based on probabilit ies derived from family informat ion also reduces noise in t he received 27 message from an ensemble of molecules.” The w ord ‘furt hermore’ provides a cont inuat ion of t he preceding sent ence concerning ‘collapsing’. -Response t o t he part ies’ argument s 67. The Court not es t hat EP’073 ment ions in it s descript ion (§78, and §123 t o 175) t w o alt ernat ive met hods for analysing grouped amplified sequence reads in order t o reduce t he noise (effect of errors) caused by amplificat ion and sequencing. 68. As indicat ed by Defendant s, and t his point has not been cont est ed by GUARDANT HEALTH, t he probabilist ic met hod w as w ell-know n at t he t ime of t he grant of t he pat ent at hand, so t he skilled person w ill underst and t hat t he invent ion concerns t he ot her w ay, i.e., “ the base t o base met hod” as expressly ment ioned in Claim 1. 69. Therefore, t he Court is of t he opinion t hat in t he present case, EP’073 clearly t eaches t he person skilled in t he art t hat t he met hod based on probabilit ies is ment ioned in t he pat ent ’s specification as an illust rat ion of ot her met hods but is not ment ioned in t he claim, t hus it does not fall w it hin t he scope of t he prot ect ion of EP’073 (see CoA, 25 November 2025, M eril v Edw ards, UPC CoA 464/ 2024, Headnot es). On t he requirement t hat t he pat ent in quest ion is valid w it h a sufficient degree of cert aint y (R. 211.2 RoP) 70. SOPHIA GENETICS cont ends t hat provisional measures request ed by GUARDANT HEALTH on t he basis of EP’073 cannot be grant ed since t his pat ent is not valid on several grounds: added-mat t er and lack of invent ive st ep. -added-mat t er Legal framework 71. Art . 76 and 123(2) EPC 72. UPC caselaw : The UPC Court of Appeal has set out the follow ing principles regarding added- mat t er for divisional applicat ions (CoA, 2 Oct ober 2025, expert e-Commerce GmbH and expert Klein GmbH v. Seoul Viosys, UPC CoA 764/ 2024): « Headnot e - There is added-mat t er if the claim as grant ed contains subject -mat t er t hat ext ends beyond t he cont ent of t he applicat ion as filed. In order t o ascert ain w het her t here is added-mat t er, t he Court must t hus first ascert ain what the skilled person w ould derive direct ly and unambiguously using his common general know ledge and seen objectively and relative t o t he dat e of filing, from the w hole of t he applicat ion as filed, whereby implicit ly disclosed subject -mat t er, i.e. mat t er that is a clear and unambiguous consequence of what is explicit ly ment ioned, shall also be considered as part of it s cont ent . - Where, as here, t he pat ent result s from a divisional application, t his requirement applies t o each earlier application. The subject -matt er of t he grant ed claim 1 thus may not ext end beyond (1) t he disclosure of t he applicat ion as filed for t he pat ent in suit and (2) t he disclo- sure of t he original PCT applicat ion t hat ent ered t he regional phase and is t he parent appli- cat ion for t he divisional applicat ion.” 28 Parties’ arguments 73. SOPHIA GENETICS argues (§271 of t he Object ion) t hat Claim 1 comprises a combinat ion of feat ures t hat is not direct ly and unambiguously disclosed in t he applicat ion as filed. The Applicant has point ed t o embodiment 78 in t he original PCT applicat ion (Exhibit SG 91: applicat ion of WO 2014/ 034556) as t he st art ing point for t he combinat ion of feat ures in Claim 1. How ever, embodiment 78 does not cont ain (i) t he init ial st art ing mat erial being cell free DNA isolat ed from body fluid; (ii) comprising no more t han 100 ng of polynucleot ides; (iii) using non-unique barcode oligonucleot ides in combinat ion w it h t he st art and end port ions of t he parent polynucleot ides t o convert t he parent polynucleot ides int o uniquely ident ifiable molecules; and (iv) t hat t he conversion comprises enzymat ic ligat ion. Regarding feat ures (i), (iii) and (iv) above, t he EPO opposit ion division it self held at paragraph 45 of it s decision t hat t he “ embodiment s” on pages 85-113 of t he Applicat ion (including, t herefore, embodiment 78 on page 93) do not , on t heir ow n, provide a basis for all of t hese feat ures in combinat ion. Accordingly, t he opposit ion division should have held t hat Claim 1 adds mat t er. Whilst each of t hese addit ional feat ures may be disclosed elsew here in t he PCT applicat ion, t his is not in relat ion t o original embodiment 78 and t here is no t eaching t o suggest t o t he skilled person t hat all of t hese feat ures should be combined. SOPHIA GENETICS adds (§271 of t he Object ion) t hat each of dependent Claims 2-14 are invalid for added-mat t er. Again, w hilst t he addit ional feat ures in t hese claims may be disclosed somew here in t he applicat ion as filed, t hey are not disclosed in combinat ion w it h all of t he ot her feat ures in Claim 1. 74. GUARDANT HEALTH replies (§44 of t he Reply) t hat t he opposit ion division considered at lengt h t he not ion of basis in more t han 15 pages of it s decision (§16-111 of GH 31) and concluded t hat t he upheld claims find basis. In part icular, t he opposit ion division correct ly found t hat Claim 1 finds basis at embodiment 83 (w hich is dependent on embodiment s 78 and 82), and [00202], [00237], [00238], and [00243]; and t hat t he dependent claims also find basis. The opposit ion division also correct ly explained in §46-50 of GH 31 w here t he combinat ion of feat ures of Claim 1 find basis. Response to the parties’ arguments 75. The Applicant refers t o t he EPO opposit ion division decision t o defend against at t acks on t he validit y of it s pat ent , how ever t he Court not es t hat in t his decision under appeal, t he BoA, in it s recent preliminary opinion of 15 December 2025, considers revoking t he pat ent in suit on t he grounds of added-mat t er. 76. The Court also not es t hat t here are indeed scat t ered fragment s in t he original PCT applicat ion (Exhibit SG 91) w hich serve as t he basis for t he applicat ion, in part icular in t he embodiment 78, as suggest ed by SOPHIA GENETICS. How ever, t here are several element s missing from t his embodiment : i) t he init ial st art ing mat erial being cell free DNA isolat ed from body fluid; ii) comprising no more t han 100 ng of polynucleot ides; iii) using non-unique barcode oligonucleot ides in combinat ion w it h t he st art and end port ions of t he parent polynucleot ides t o convert t he parent polynucleot ides int o uniquely ident ifiable molecules; and iv) t hat t he conversion comprises enzymatic ligation 29 77. It is also clear t hat all t hese missing elements can be found in t he pat ent applicat ion as filed (Exhibit SG 91). The quest ion is w het her t hey are direct ly and unambiguously derivable from t he PCT applicat ion or w het her t he lat t er is used as some kind of reservoir from w hich scat t ered fragment s can be combined, in w hich case t here is a w hole series of different ‘invent ions’ included in t he PCT applicat ion. 78. Embodiment 78 in t he original PCT application reads as follow s: A met hod comprising: a. providing at least one set of t agged parent polynucleot ides, and for each set of t agged parent polynucleot ides, b. amplifying the t agged parent polynucleot ides in t he set t o produce a corresponding set of amplified progeny polynucleot ides; c. sequencing a subset (including a proper subset ) of t he set of amplified progeny polynucleot ides, t o produce a set of sequencing reads; and d. collapsing t he set of sequencing reads t o generat e a set of consensus sequences, each consensus sequence corresponding t o a unique polynucleot ide among t he set of t agged parent polynucleot ides. 79. The t agged parent polynucleot ides come from embodiment 82 w hich refers back t o embodiment 78: 82. The met hod of embodiment 78 furt her com prising convert ing init ial st arting genet ic mat erial int o t he t agged parent polynucleot ides. 80. The 100 ng st art ing mat erial is in embodiment 83, w hich refers back t o Claim 82. 83. The met hod of embodiment 82 w herein t he init ial starting genetic mat erial comprises no more t han 100 ng of polynucleotides. 81. The ot her element s come from different part s of t he descript ion i.e. cell-free DNA, enzymat ic ligat ion, bodily fluid such as blood, as follow s: [00237] The syst ems and met hods disclosed herein may be used in applicat ions t hat involve t he assignment of unique or non-unique ident ifiers, or molecular barcodes, t o cell free polynucleot ides. Oft en, t he ident ifier is a bar-code oligonucleot ide t hat is used t o t ag t he polynucleot ide [00238] Oft en, t he met hod comprises at t aching oligonucleotide barcodes t o nucleic acid analyt es t hrough an enzymat ic react ion including but not limit ed t o a ligat ion react ion. [00202] The syst ems and met hods may be part icularly useful in t he analysis of cell free DNAs. In some cases, cell free DNA are ext ract ed and isolat ed from a readily accessible bodily fluid such as blood. 82. It follow s from t hese mult iple element s from t he PCT applicat ion t hat t he det ect ion of non- unique barcodes in combinat ion w it h sequence dat a of beginning (st art ) and end (st op) port ions of sequence reads may allow for t he assignment of a unique ident it y t o a part icular molecule. The claims form a clear basis t o st art w it h, [237] show s unique and non-unique ident ifiers or molecular barcodes and t hey can oft en be oligonucleot ides. This means t here are already several alt ernat ives. [238] adds t hat oligonucleot ides can be added by enzymat ic react ions w hich can be lit igat ion but also ot her react ions, w hich const it ut e a choice of alt ernat ives. Finally, non-unique barcodes can be used combined w it h st art and st op port ions of sequences. 30 83. When examining t he alleged invalidit y of t he pat ent due t o an inadmissible ext ension of it s subject -mat t er, t he Court must ascert ain w hat t he skilled person w ould derive direct ly and unambiguously using t heir common general know ledge, as seen object ively wit h respect t o t he dat e of filing, from t he w hole PCT applicat ion as filed. On t he basis of t his, implicit ly disclosed subject -mat t er, i.e. element s t hat are a clear and unambiguous consequence of w hat is explicitly ment ioned, shall also be considered as part of it s cont ent . How ever, t he cont ent of an applicat ion must not be considered t o be a reservoir from w hich feat ures pert aining t o separat e embodiment s of t he applicat ion could be combined in order t o art ificially creat e a part icular embodiment . This concept applies w hen considering feat ures originally disclosed in separat e list s of alt ernat ives, except w hen t here is a point er t o combine t hese numerous specific feat ures, w hich encourages t he skilled person t o combine all t hese different element s in a part icular combinat ion. 84. In t he present case, GUARDANT HEALTH merely replied t o t he at t ack based on added- mat t er t hat t he EPO opposit ion division has t aken all t he various scat t ered elements found in t he PCT applicat ion t o conclude t hat t he invent ion derives direct ly and unambiguously from t hat docum ent . It does not provide any argument s t o convince t he Court t hat , among all t he element s mentioned in t he PCT applicat ion, t he person skilled in t he art w ould have been prompt ed t o choose from among t he alt ernat ives proposed, t hose leading t o t he invent ion disclosed in EP’073. 85. Consequent ly, Applicant fails t o demonst rat e t hat t he invent ion disclosed in t he pat ent in suit is a clear and unambiguous consequence of w hat is explicit ly ment ioned in t he earlier PCT applicat ion. Conclusion on the inadmissible extension 86. Against t his background, t he Court considers in t he cont ext of a preliminary injunct ion t hat it has not been dem onst rat ed w it h a sufficient degree of cert aint y t hat EP’073 meet s t he crit erion of Art icle 123 EPC. This pat ent is more likely t han not t o be invalid because of added-mat t er. 87. In view of t he above, dependent Claims 2 t o 14 of t he pat ent as maint ained aft er opposit ion are also more likely t han not t o be invalid for t he same reasons. 88. M oreover, t he Court not es t hat t he crit erion according t o w hich t he exist ence of infringement must be demonst rat ed w it h sufficient cert aint y (R. 211.2 RoP) has not been met eit her concerning t he infringement of EP’073 (Claim 1) by t he alleged infringing product , since feat ure 1.5, as explained in t he claim int erpret at ion, excludes t he met hod based on probabilit ies, and t hat it is not disput ed bet w een t he part ies t hat t he SOPHIA GENETICS t est accused of infringement uses only the met hod based on probabilit ies in t he accused t est and not t he met hod claimed in feat ure 1.5 w hich is t he w ay w here sequences are aligned and t he m ost frequent nucleot ide at a cert ain posit ion is t he consensus nucleot ide. 31 III. REQUESTS UNDER EP’066 Present at ion of t he pat ent in suit 89. EP’066 is t it led “ M et hods for early det ect ion of cancer” . 90. The applicat ion w as filed on 14 April 2017. 91. The pat ent in suit claims priorit y of 6 US applicat ions: 14 April 2016: 2016 US 201662322783 P, US 201662322773 P, US 201662322786 P, US 201662322784 P, US 201662322775 P, and 18 April 2016: US 201662324287 P. 92. The not ice of pat ent grant w as published on 2 Oct ober 2024. No opposit ion has been filed at t he EPO. 93. The pat ent is current ly in force in t he UPC t errit ories in Belgium, Germany, France, It aly, and t he Net herlands. Out side t he UPC t errit ories, it is also in force in Sw it zerland, Spain, and t he UK. The pat ent in suit comprises 14 claims. 94. Claim 1 reads as follow s: 1. A met hod for det ecting the presence or absence of colorect al cancer, ovarian cancer, lung cancer or pancreat ic cancer in a subject comprising: sequencing circulating cfDNA from the subject at a dept h of at least 50,000 reads per base t o det ect one or more genetic variant s associat ed w it h cancer, w herein t he sequencing is performed on an enriched set of amplified cfDNA molecules w hich comprises a panel of genomic regions, wherein the genomic regions in t he panel comprise one or more loci from each of t he genes AKT1, ALK, APC, ATM , BRAF, CTNNB1, EGFR, ERBB2, ESR1, FGFR2, GATA3, GNAS, IDH1, IDH2, KIT, KRAS, M ET, NRAS, PDGFRA, PIK3CA, PTEN, RB1, SM AD4, STK11 and TP53, and furt her comprising amplifying t he cfDNA prior to sequencing, and det ermining a consensus sequence from sequence reads obt ained from t he sequencing t o reduce errors from amplificat ion or sequencing. -t he subject -mat t er of t he invent ion in EP 066 95. The background of t he invent ion is provided as follow s in t he description of t he pat ent in suit : [0001] Cancer is a major cause of disease w orldw ide. Each year, t ens of millions of people are diagnosed w it h cancer around t he w orld, and more t han half of t he pat ient s event ually die from it . In many count ries, cancer ranks t he second most com mon cause of deat h follow ing cardiovascular diseases. Early det ect ion is associat ed wit h im proved out comes for many cancers. [0002] To det ect cancer, several screening t est s are available. A physical exam and hist ory survey general signs of healt h, including checking for signs of disease, such as lumps or ot her unusual physical sympt oms. A hist ory of a pat ient ’s healt h habit s and past illnesses and t reatment s w ill also be t aken. Laboratory t est s are anot her t ype of screening t est and may include medical procedures t o procure samples of t issue, blood, urine, or ot her subst ances in t he body before conduct ing laborat ory t est ing. Imaging procedures screen for cancer by generat ing visual represent at ions of areas inside t he body. Genet ic t est s det ect 32 cert ain gene delet erious mut ations linked t o some t ypes of cancer. Genetic t esting is part icularly useful for a number of diagnost ic met hods. 96. EP 066 relat es t o met hods for ident ifying four major t ypes of cancer (colorect al, ovarian, lung, pancreat ic) by using “ deep sequencing” of cfDNA. The concept of sequencing dept h w as explained in §70 of t he Applicat ion2, and t he claim uses a dept h of at least 50,000x for a panel of 25 specific genes t o improve t he det ect ion of rare variant s. Alt hough t his panel is relat ively small (t he human genome cont ains around 25,000 genes in t ot al), t he examples in t he pat ent show t hat focusing on t hese 25 genes permit s high sensit ivit y for det ect ing t he four list ed cancers. Like for EP’073, t he met hod includes a st ep in w hich errors from t he noisy processes of amplificat ion and sequencing are reduced. Claim int erpret at ion of Claim 1 EP’066 97. Reference shall be made t o t he principles of int erpret at ion set out by t he aforement ioned UPC CoA, and t he same definit ion of t he skilled person ment ioned for pat ent EP’073 shall be used since it concerns t he same t echnological field. 98. Grant ed Claim 1 of EP’066 reads as follow s (see §195 Applicat ion and Exhibit GH 35 for claim feat ure breakdow n): 2 §70 of GH Application: “ A sample w ill usually cont ain mult iple copies of DNA from a part icular region in t he genome (e.g. many millions of copies of a part icular gene even in 1 mL of blood). In a single experiment , any part icular nucleot ide in a genome can t hus be seen in mult iple different sequence reads. The number of t imes t hat a part icular nucleot ide is seen is referred t o as it s ‘sequencing dept h’. It is denot ed as a multiple e.g. a depth of 1,000x means t hat a part icular nucleot ide w as sequenced 1,000 t imes, and w as seen in 1,000 different sequence reads.” 33 99. The Applicant present s Claim 1 of EP’066 w it h t he follow ing element s (§196 of t he Applicat ion): Feat ure 1.1: A met hod w hich is used for det ect ing colorect al, ovarian, lung, or pancreat ic cancer. Feat ure 1.2: The met hod includes a st ep w here cfDNA t aken from a subject is subject ed t o a DNA sequencing react ion in order t o find variant s w hich are associat ed w it h cancer. Feat ure 1.3: This sequencing is performed “ at a dept h of at least 50,000 reads per base” . This means t hat any part icular nucleot ide posit ion of int erest has been seen in t he sequence reads at least 50,000 t imes (see above) Feat ure 1.4: Sequencing is “ performed on an enriched set of amplified cfDNA molecules” . Thus, t he cfDNA is subject ed t o bot h enrichment and amplificat ion prior t o sequencing. The pre-sequencing amplificat ion st ep is also ment ioned in t he final clause of t he claim. a) Enrichment focuses sequencing react ions on regions of int erest . The human genome cont ains around 25,000 genes, but Claim 1 specifies a panel of 25 different genes (0.1% of t he t ot al), and enrichment is used t o ensure t hat t hese 25 genes can be deeply sequenced. See [0187]-[0188] in t he descript ion for m ore det ails. b) Amplificat ion (also Feat ure 1.6) is used t o ensure t hat t here is enough DNA t o be det ect ed. Tumor-derived cfDNA is present at very low levels and so t he original molecules are amplified t o assist in sequencing. Various amplificat ion t echniques can be used (e.g. see [0181]-[186]), but PCR is most t ypical. How ever, as explained already, t hese amplificat ion t echniques are inherent ly noisy (see also [0207]) and so t here is a dow nst ream requirement t o remove t his noise. Feat ure 1.5: The enrichment and sequencing are performed for “ one or more loci” (i.e. at least one posit ion) in each of 25 named genes. These genes are ident ified by t heir st andard recognised names (“ AKT1, ALK, …” ), w hich t ypically represent an abbreviat ion of t he prot ein w hich t he gene encodes. Feat ure 1.7: Amplificat ion and sequencing bot h have an inherent noise level w hich can obscure t he det ect ion of variant s (see also [0207] of EP’066). To remove t his noise t he claim collat es t he various reads from t he sequencing st ep “ t o reduce errors from amplificat ion or sequencing” in order t o det ermine a consensus sequence. Overall, a st art ing cfDNA molecule is amplified (a noisy process) and sequenced (anot her noisy process), but t echniques are used t o remove t he noise and t hereby ident ify t he t rue nucleot ide at each posit ion in t he original cfDNA molecule. 100. The Defendant s do not disput e GUARDANT HEALTH's present at ion of each of t he feat ures, but t hey do disput e t he purpose of t he invent ion w it h regard t o t he det ect ion of t he presence or absence of cancer. Thus, SOPHIA GENETICS claims (§278 of it s Object ion) t hat t he purpose is t o det ermine w het her a pat ient has a specific t ype of cancer (e.g. colorect al cancer). In support of t his argument , SOPHIA GENETICS point s out t hat in several paragraphs of t he pat ent description [111], [112] and [114], explicit reference is made t o gene panels for each of t he four cancers list ed in Claim 1, and t hat [183] not es t hat w it hin regions of t he genome t hat are t arget ed for sequencing, t here are fact ors w hich infer t he presence or absence of a cert ain classificat ion of cancer cells or t ype of cancer. 34 101. According t o GUARDANT HEALTH, t he purpose of t he invent ion is t hat t he selection of t hese 25 genes is part icularly effect ive in det ect ing t he presence or absence of several t ypes of cancer, including t he four t ypes ment ioned in Claim 1 (feat ure 1.1). 102. For t he reasons put forw ard by GUARDANT HEALTH, t he Court considers t hat t he purpose of t he invent ion is t o det ect t he presence or absence of t he four t ypes of cancers ment ioned in 1.1 using a part icularly effect ive select ion of t hese 25 genes. On t he requirement t hat t he pat ent in quest ion is valid w it h a sufficient degree of cert aint y (R. 211.2 RoP) 103. SOPHIA GENETICS cont ends t hat provisional measures request ed by GUARDANT HEALTH on t he basis of EP’066 cannot be grant ed since t his pat ent is not valid on several grounds: added-mat t er and lack of invent ive st ep. -added-mat t er 104. The Court refers t o t he same legal framew ork as t hat indicat ed above for t he examination of EP’073, as EP’066 also relat es t o the same t echnological field. Parties’ arguments 105. In support of t he added-mat t er’s at t ack (§314 t o 315 of t he Object ion), SOPHIA GENETICS st art s from Claim 1 in t he original PCT applicat ion (Exhibit SG 94) and cont ends t hat on several point s a select ion from different list s of genes as can be found in t he descript ion has t o be made in order t o arrive at Claim 1 of t he pat ent in suit. SOPHIA GENETICS concludes t hat Claim 1 cannot be direct ly and unambiguously derived from t he applicat ion as filed. 106. In it s Reply, GUARDANT HEALTH (§70 of t he Reply) argues t hat t he st art from Claim 1 of t he original PCT applicat ion is not correct ; rat her, t he basis for t he current claim should be found in original PCT Claims 37/ 44/ 52/ 56 in combinat ion w it h [0145], [0155], and [0159] (Exhibit SG 94). 107. The element s invoked by GUARDANT HEALTH in t he parent applicat ion t o demonst rat e t he absence of ext ension of t he subject -mat t er by t he divisional pat ent EP’066 are as follow s: 108. Claims of t he earlier applicat ion: 35 109. In t he original PCT applicat ion’s descript ion, it is ment ioned: [0145] M et hods herein can be used t o det ect cancer in a subject . Cell free DNA can be sequenced in subject s not know n t o have cancer or suspect ed of having cancer to diagnose t he presence of absence of a cancer. Sequencing cell free DNA provides a non-invasive met hod for early det ect ion of cancer or for 'biopsy' of a know n cancer. Cell free DNA can be sequenced in subject s diagnosed w it h cancer t o provide information about t he cancer. Cell free DNA can be sequenced in subject s before and aft er t reat ment for cancer t o det ermine t he efficacy of t he t reat ment . [0155] To im prove t he likelihood of det ect ing t umor indicat ing mut at ions, t he region of DNA sequenced may comprise a panel of genes or genomic regions. Select ion of a limit ed region for sequencing (e.g., a limit ed panel) can reduce the t ot al sequencing needed (e.g., a tot al amount of nucleot ides sequenced. A sequencing panel can target a pluralit y of different genes or regions t o det ect a single cancer, a set of cancers, or all cancers. [0159] In some cases, t he one or more regions in t he panel can comprise one or more loci from one or a pluralit y of genes, including one or more of AKTl, ALK, APC, ATM , BRAF, CTNNBI, EGFR, ERBB2, ESRI, FGFR2, GATA3, GNAS, IDHI, IDH2, KIT, KRAS, M ET, NRAS, PDGFRA, PIK3CA, PTEN, RBI, SM AD4, STKI 1, and TP53. 110. In it s Rejoinder, SOPHIA GENETICS demonst rat es t hat w hat is t aught in EP’066 is not an unambiguous consequence of w hat is explicitly ment ioned in t he w hole original PCT applicat ion (Exhibit SG 94) t o w hich GUARDANT HEALTH refers (see §59 of t he Rejoinder). The Court’s opinion 111. It w as not ed above in t he sect ion on " claim int erpret at ion" t hat t he invent ion t aught by EP’066 discloses a specific met hod of sequencing cfDNA t hat aims t o det ect t he presence or absence of four t ypes of cancer by analysing 25 specifically select ed genes. The met hod t aught makes it possible t o det ermine w het her t he pat ient is a carrier of one of t he four cancers ment ioned in feat ure 1.1. The select ion of t his list of 25 genes and t he four t ypes of cancer t arget ed are essent ial feat ures of the invent ion in EP’066. How ever, claims 37, 44 and 52 of t he concerned earlier parent applicat ion do not disclose t hese feat ures. Even in t he descript ion of t his applicat ion, five and not four t ypes of cancer are ment ioned, and t here is not hing t o prom pt a person skilled in t he art t o select four out of t he five. Furt hermore, w it h regard t o t he 25 genes ment ioned in t he descript ion in §159, t here is no t eaching in t his paragraph regarding a panel comprising one or more loci from each and every one of t he 25 genes list ed in t he claim. On t he cont rary, t he grant ed claims ment ion one or more loci from each of t he genes. 112. Thus, t he Applicant fails t o demonst rat e t hat a skilled person w ould arrive at t he subject -mat t er of EP’066, as a clear and unambiguous consequence of w hat is explicit ly ment ioned in t he w hole applicat ion of t he original PCT applicat ion. 113. From t he select ions t hat have been made w it hout any clear indicat ion in t he earlier applicat ion, t he Court concludes t hat t he invent ion as now w orded in t he grant ed Claim 1 cannot direct ly and unambiguously be derived from t he pat ent as filed. 114. Consequent ly, EP’066 is more likely t han not t o be invalid on t he grounds of added-mat t er. The limit at ions in dependent claims 2-14 do not solve t hese issues; t hey are also more likely t han not t o be invalid for added-mat t er. 36 IV. Request under EP’986 Present at ion of t he pat ent in suit 115. EP’986 is t it led “ Det ect ion and t reat ment of disease exhibit ing disease cell het erogeneit y and syst ems and met hods for communicat ing test result s” (Exhibit GH 37). 116. The applicat ion w as filed on 28 December 2015 as a divisional applicat ion of EP 3 240 911. 117. The pat ent in suit claims priorit y of US 201462098426 P of 31 December 2014 and US 201562155763 P of 1 M ay 2015. 118. The not ice of pat ent grant w as published on 1 June 2022. No opposit ion has been filed at t he EPO. 119. The pat ent is in force in Belgium, Germany, France, It aly, and t he Net herlands. Out side t he UPC t errit ories it is also in force in Sw it zerland, Spain, and t he UK. 120. The pat ent in suit comprises 15 claim s. 121. Claim 1 reads as follow s: 1. A com put er implement ed met hod comprising use of a comput er dat abase t o ident ify one or more effect ive t herapeut ic int ervent ions for a subject having cancer, wherein t he com put er dat abase includes, for each of a plurality of subject s having cancer: (i) t um or genomic t est ing dat a, including somat ic alt erat ions, collect ed at t w o or more t ime int ervals per subject via serial biopsy of cell-free DNA; (ii) one or more therapeut ic int ervent ions administ ered t o each of t he subject s at one or more t imes; and (iii) efficacy of t he t herapeutic int erventions. -t he subject -mat t er of t he invent ion in EP’986 122. The background of t he invent ion is provided in [002] t o [005] of t he concerned pat ent : [0002] One of t he reasons cancer is difficult t o t reat is t hat current t est ing met hods may not help doctors mat ch specific cancers wit h effect ive drug t reat ment s. And it is a moving t arget - cancer cells are const ant ly changing and mut at ing. Cancers can accumulat e genet ic variant s (…) [0003] Cancers can evolve over t ime, becoming resist ant t o a t herapeut ic int ervent ion. Cert ain variant s are know n t o correlat e w it h responsiveness or resist ance t o specific t herapeut ic int ervent ions. M ore effect ive t reat ment s for cancers exhibit ing t umor het erogeneit y w ould be beneficial. Such cancers may be t reat ed wit h a second, different , t herapeut ic int ervent ion t o w hich t he cancer responds. 37 [0004] DNA sequencing met hods allow det ect ion of genetic variant s in DNA from t umor cells. Cancer t umors cont inually shed t heir unique genomic mat erial int o t he bloodst ream. Unfort unat ely, t hese t ellt ale genomic " signals" are so w eak t hat current genomic analysis t echnologies, including next -generat ion sequencing, may only det ect such signals spo- radically or in pat ient s w it h t erminally high t umor burden. The main reason for t his is t hat such t echnologies are plagued by error rat es and bias t hat can be orders of magnit ude higher t han w hat is required t o reliably det ect de novo genomic alt erat ions associat ed wit h cancer. [0005] In a parallel t rend, t o underst and t he clinical significance of a genet ic t est, t reating professionals must have a w orking know ledge of basic principles of genet ic inherit ance and reasonable facilit y w it h t he interpret at ion of probabilistic dat a. Some st udies suggest t hat many t reat ing professionals are not adequat ely prepared t o int erpret genetic t est s for disease suscept ibilit y. Some physicians have difficult y int erpret ing probabilist ic dat a relat ed t o t he clinical ut ilit y of diagnostic t est s, such as t he positive or negative predict ive value of a laborat ory t est . 123. To remedy t hese problems encount ered by t reat ing professionals in det ecting cancer and int erpret ing t est s, t he pat ent in quest ion proposes t he follow ing invent ion: [008] The invent ion provides a met hod comprising use of a comput er dat abase t o ident ify one or more effective t herapeut ic int ervent ions for a subject having cancer, w herein t he com put er dat abase includes, for each of a pluralit y of subject s having cancer: (i) t umor genomic t est ing dat a, including somat ic alt erat ions, collect ed at t w o or more t ime int ervals per subject via serial biopsy of cell-free DNA; (ii) one or more therapeut ic int ervent ions administ ered t o each of t he subject s at one or more t imes; and (iii) efficacy of t he t herapeut ic int ervent ions. 124. EP’986 relat es t o (see §213 and 214 of t he GUARDANT HEALTH Applicat ion) t he use of a dat abase t o make a link bet w een (i) cfDNA genomic t est ing dat a measured over t ime, w hich is used t o t rack a t umor, and (ii) t he efficacy of t herapeut ic int ervent ions. The descript ion explains how t he dat abase “ is useful t o infer efficacy of t he t herapeutic int ervent ions in subject s wit h a t umor” (see [0014]) and “ can be consult ed in det ermining a t herapeut ic int ervent ion for a disease w it h a part icular profile” ([0022]). The dat abase is part icularly useful w hen t he t umor is het erogeneous. [0019] not es t hat cfDNA is an ideal w ay of det ect ing such het erogeneit y, and [0020] report s t hat t his informat ion “ can be used by a healt h care provider, e.g., a physician, t o develop t herapeut ic intervent ions.” M oreover, [0021] st at es t hat “ M onit oring changes in t he profile of disease cell het erogeneit y over t ime allow s t herapeut ic int ervent ion t o be calibrat ed t o an evolving t umor.” Claim int erpret at ion of Claim 1 EP’986 125. Reference shall be made t o t he same principles of int erpret at ion set out by t he UPC CoA as aforement ioned. 126. Regarding t he relevant definit ion of t he skilled person, SOPHIA GENETICS proposes, given t he feat ures of EP’986’s claims w hich overlap mult iple fields, “ a t eam of expert s w it h an int erest in mult iple domains, including processing, analysing and st oring genomic sequencing dat a, t herapy select ion for cancer pat ient s, and t he design of relat ed decision 38 support t ools.” (§368 of t he Object ion). GUARDANT HEALTH does not raise any object ion regarding t his definit ion. 127. The Court adopt s t his definit ion, w hich is relevant for EP’986. 128. Claim 1 of t he pat ent reads as follow s (t he “ feat ure breakdow n” present ation by t he Applicant s is not cont est ed by t he Respondent and adopt ed by t he Court ) (§215 of t he Applicat ion and Exhibit GH 38): 129. The Applicant presents Claim 1 of EP’986 with the following interpretaƟon (see §215 of the GUARDANT HEALTH ApplicaƟon). Feat ures 1.1 & 1.2: The computer database includes at least three pieces of informaƟon from a number of cancer paƟents (“subject s” ): Feat ure 1.3: Genomic tesƟng data from their tumor (e.g. DNA sequencing dat a, as specified in claim 13), which includes data on somaƟc alteraƟons. This informaƟon can include single nucleoƟde variaƟons, indels, gene fusions, copy number variaƟons, et c. (see [0049]). This data is based on analysis of cfDNA. The informaƟon was collected from the paƟent in a series of two or more Ɵme points. Feat ure 1.4: At least one therapeuƟc intervenƟon was administered to the paƟent. Exam- ples of such intervenƟons are given in [0142] to [0152] of the patent. Feat ure 1.5: Details of whether the therapeuƟc intervenƟon(s) was/were efficacious. The dat abase is used (feat ure 1.1) to idenƟfy effecƟve therapeuƟc intervenƟons for a subject who has cancer. 130. SOPHIA GENETICS does not disput e t he present at ion of t he charact erist ics as described by GUARDANT HEALTH in it s Application, but provides more det ailed explanat ions on all t he feat ures of EP’986 (§370 t o 389 of t he Object ion). In view of t hese explanat ions, Defendant s conclude (§390 of t he object ion) t hat t he efficacy of t herapeut ic int ervent ions cont ained in t he dat abase must be based upon analysis of t he dat a out lined in feat ures 1.3 and 1.4 (serial genomic t est ing dat a of a specific pat ient in combinat ion w it h a know n t herapeut ic int ervent ion administ ered) and must result in a conclusion of efficacy of t he t herapeut ic int ervent ion based on t his. All three of t hese pieces of informat ion (1.3 t o 1.5) must t herefore be mat ched for each pat ient . 39 131. The Court agrees w it h SOPHIA GENETICS’s int erpret at ion of feat ures 1.3 and 1.4, w hich is in-line wit h w hat is disclosed in Claim 1 of EP’986 and t he specificat ion of t he pat ent in suit . On t he requirement t hat t he pat ent in quest ion is infringed w it h a sufficient degree of cert aint y (R. 211.2 RoP) 132. GUARDANT HEALTH accuses SOPHIA GENETICS of direct (and indirect ) infringement of Claim 1 and dependent Claims 1, 5, 7, 9, 10 and 13-15 of EP’986. 133. SOPHIA GENETICS cont ends t hat provisional measures request ed by GUARDANT HEALTH on t he basis of EP’986 cannot be grant ed since t his pat ent is not infringed by t he accused SOPHIA GENETICS’s t est , and since t his pat ent is more likely t han not t o be invalid (lack of invent ive st ep over prior art document s “ Elt on” and “ Forshew ” ). -GUARDANT HEALTH’s argum ent s 134. GUARDANT HEALTH provides a comparison bet w een t he feat ures of Claim 1 of t he pat ent in suit and t he accused product based on Exhibit GH 39, as follow s (§233 of t he Applicat ion): 135. GUARDANT HEALTH bases t heir infringement primarily on Exhibit GH 39. The Applicant explains t hat , w hen invest igating t he defendant s’ act ivit ies, t hey found a joint press release (Exhibit GH 39) t hat w as issued in collaborat ion w it h ‘Precision for M edicine’ and w hich explains, according t o GUARDANT HEALTH, t hat t hey are using t he M SK-DDM t est t o develop a dat abase and comput er-implem ent ed met hod precisely as defined in Claim 1 of EP’986: 40 1.1 A comput er-implement ed met hod comprising t he use of a comput er dat abase t o ident ify one or more effect ive t herapeut ic int ervent ions for a subject having cancer, w herein GH 39 refers t o t he generat ion of a collect ion of dat a (i.e. a com put er database) w hich w ill be used t o “ gain deeper insight s int o the efficacy of t herapies” . It also refers t o t he M SK- DDM liquid biopsy t est , w hich is used only for cancer pat ient s. 1.2 The comput er dat abase includes, for each of a pluralit y of subject s having cancer: GH 39 confirms t hat t he dat abase is built using dat a of “ how pat ient s responded to previous t reat ment s” . Indeed, it would be meaningless t o creat e a dat abase w it h dat a from only one pat ient . 1.3 (i) t umor genomic t est ing dat a, including somat ic alt erations, collect ed at t w o or more- t ime int ervals per subject via serial biopsy of cell-free DNA; GH 39 refers t o t he M SK-DDM t est , and fact sheet GH20 confirms t hat t his t est provides t um or genomic t esting dat a derived from cfDNA. To det ermine “ how pat ient s responded to previous t reat ment s” (as mentioned in GH39) based on t he output of t he t est , cfDNA from a patient must be analysed at m ore t han one t ime point . In t his regard: - Flyer GH19 highlight s t he use of t he t est for “ longit udinal monit oring” i.e. t o follow t heir cfDNA genomic t est ing dat a over t ime. - GH23 similarly st at es t hat t he M SK-DDM t est w ill be used for “ longit udinal t racking” of a pat ient. In part icular, it can “ use t hat information t o t rack disease over t ime. And t his is a feat ure w e’ve implement ed in bot h M SK ACCESS but also …” - Page 2 of GH21 st at es t hat t he t est considers if variant s w ere “ previously ident ified as somat ic variant s in M SK-ACCESS® pow ered w it h SOPHiA DDM ™ for t he same subject ” 1.4 (ii) one or m ore t herapeut ic int ervent ions administ ered t o each of t he subject s at one or more t imes; GH39 st at es t hat t he dat abase is built using dat a of “ how pat ient s responded t o previous t reat m ent s” , and also refers t o “ ret rospect ive clinical t rial dat a analysis” . 1.5 (iii) efficacy of t he t herapeut ic int ervent ions. GH 39 refers t o t he inclusion of “ ret rospect ive clinical t rial dat a” , t o “ underst anding how pat ient s responded t o previous t reat ment s” , and t o using information t o “ gain deeper insight s int o t he efficacy of t herapies” . 136. The Applicant affirms t hat (§122-126 of t he Applicat ion), t he Defendant s are already offering and dist ribut ing M SK-DDM in t he UPC t errit ory. This soft w are is already equipped t o t rack a user’s mut at ions over t ime. User manual (GH 21, page 20) explains t hat variant s det ect ed in M SK-DDM “ are st ored for future use as prior know ledge” and t hat t he soft w are st ores a “ prior knowledge variant s list ” . The bot t om of page 20 is unambiguous t hat dat a on somat ic variat ions are st ored and t hen subsequent ly used as “ prior knowledge” . 41 137. According t o GUARDANT HEALTH, at a w ebinar on 27 August 2025, a scient ist w orking for t he Defendant s w as asked about t he M SK-DDM t est and his answ er included t he follow ing st at ement (Exhibit GH 15): What is available right now for t he users at M SK-ACCESS as of t oday is t he abilit y t o ident ify previous variant s in t he same pat ient and revisit t his over longit udinal t imepoint s. 138. GUARDANT HEALTH concludes t hat t his already gives t he abilit y t o t rack or link variant s t o t herapeut ic int ervent ions. 139. The Applicant adds t hat M SK-DDM has already been dist ribut ed in t he UPC t errit ory and is already st oring detect ed variant s, t he defendant s have creat ed or are creat ing t he dat abase according t o Claim 1, and t hey have start ed or w ill st art imminently using and/ or offering t he met hod according t o Claim 1 (§226 of t he Applicat ion). 140. In support of it s object ion, SOPHIA GENETICS first not es t hat t he alleged infringing product (t he DDM t est it self) plays no role in t he exploit at ion of t he analyses and t hat w hat GUARDANT HEALTH alleges t o be infringement of t his pat ent is " t he soft ware for t he SOPHIA DDM platform as a w hole" (§364 of t he Object ion). Defendant s explain t hat t he only feat ure t hat could be reproduced by t heir plat form w ould be indirect ly feat ure 1.3 concerning t w o-st age informat ion collect ion, w hich t hey deny, and t hey allege t hat in any event , t he sole product ion of GH 39 (a press release), w hich is t he document on w hich GUARDANT HEALTH essent ially based it s comparison t able seeking t o demonst rat e t he reproduct ion of each of t he feat ures t aught in Claim 1, cannot be sufficient t o prove t he alleged infringement . 141. Furt hermore, SOPHIA GENETICS argues t hat t he Exhibit GH 39, w hich is a joint press release wit h Precision for M edicine announcing a part nership, is vague as t o what t he work of t he Precision for M edicine w ill ent ail in t he fut ure, and many of t he st at ement s made by Precision for M edicine are aspirat ional in nat ure, and not reflect ive of any w ork being done at present . Regardless, all of t he quot es t he Applicant point s t o in t his document are from a single paragraph focused on t he Product being provided t o Precision for M edicine’s cust omers rat her t han t he part nership more generally. This is no surprise given t hat t he Applicant seeks an injunct ion against only t he Defendant s in relat ion t o t he Product , rat her t han any ot her project associat ed w it h t his part nership (§400 of t he Object ion). 142. SOPHIA GENETICS crit icises GUARDANT HEALTH for const ruct ing an argument by ext rapolat ing from evidence t hat is insufficient t o prove t he alleged reproduct ion (§405 of t he Object ion). Thus, t he Defendant s not e t hat t he Applicant lift s a single quot e from t he passage above in GH 39 t o support t his argument (“ gain deeper insight s int o t he efficacies of t herapies” ). SOPHIA GENETICS argue t hat t his quot e is in relat ion t o w hat users can do w it h t he dat a generat ed using t he Product , and it is in t he cont ext of ret rospect ive clinical t rial dat a analysis. According t o SOPHIA GENETICS, t his is not relevant t o infringement for t hree reasons: (i) t he Product plays no part in such ret rospect ive analysis; (ii) t he Product does not collect any dat a on t herapies and t hus t he Defendant s cannot generat e a corresponding dat abase; and (iii) such analysis is performed aft er a t herapy has already been given t o pat ient s on a clinical t rial. 42 143. In it s Reply, Defendant s emphasise t hat GH 39 proves t hat SOPHIA GENETICS’s soft w are uses t he t w o st ages of informat ion (prior know ledge st ored, w hich is t hen used for a second know ledge) as t aught by t he met hod disclosed in EP’986 (Claim 1.3 t o 1.5). GUARDANT HEALTH subsequent ly responds t o t he Defendant s' argument t hat it is not SOPHIA GENETICS t hat implement s t he met hod t aught by EP’886 t hrough it s t est but rat her it s part ner or cust omers, by assert ing t hat even if t he condit ions for direct infringement w ere not met , t here w ould st ill be indirect infringement since SOPHIA GENETICS w hen offering t he accused t est w ould provide t heir part ner or t heir cust omers w it h t he means t o reproduce t he met hod t aught by EP’986 by offering t he accused t est . Response to the parties' arguments 144. First ly, it should be reminded t hat t he alleged infringement under EP’986 concerns only t he dry st age performed by “ SOPHIA DDM soft w are plat form” (see §16 in t he decision above on t he present ation of t he ACCUSED PRODUCT). 145. The Court not es, in line w it h SOPHIA GENETICS's argument on t his point (§183 and 185 of t he Object ion), t hat t he manner in w hich informat ion is processed in SOPHIA GENETICS's soft w are has not been sufficient ly proven. Indeed, t he Applicant primarily makes use of t he press release GH 39. From t his press release, it becomes t hat t he accused t est is deployed globally w it h t he support of Ast raZeneca. This press release gives no furt her det ails as t o w hat is done and w hat informat ion is st ored in a dat abase. 146. The accused t est is meant t o ret rospect ively analyse cancer t reat ment in clinical t rials and t o use t his informat ion t o refine and opt imise clinical t rial design and improve pat ient recruit ment for t rials. The refining and support ing of clinical t rial design is not t he same as t he ident ificat ion of one or m ore effect ive t herapeut ic int ervent ions. 147. From a Q& A of a w ebinar (Exhibit GH 15), it appears t hat at t he development level “ What is available right now for t he users at M SK-ACCESS as of t oday is t he abilit y t o ident ify previous variant s in t he same pat ient and revisit this over longit udinal tim epoint s. So this already gives t he abilit y t o t rack or link variant s to t herapeut ic int ervent ions.” This means t hat for individual pat ient s it becomes possible t o follow t he ‘fat e’ of t he variant s over t ime. 148. Against t his background, it follow s t hat t he Applicant has not demonst rat ed t hat t here is any act ual dat abase provided by SOPHIA GENETICS w hich uses t he met hod of Claim 1 t o ident ify one or m ore effect ive t herapeut ic int ervent ions, nor t hat such a dat abase is being developed. The burden of proof for t he alleged infringement lies w it h t he part y invoking it . It cannot rely solely on t he disput ed informat ion from GH 39 t o demonst rat e how SOPHIA GENETICS's soft w are processes dat a. Addit ional in-dept h invest igations int o how t he SOPHIA plat form operat es or more t echnical document at ion on t he 'accused soft w are' w ould have been necessary. It is not sufficient t o rely mainly on a press release such as Exhibit GH 39. This is t rue bot h for proving allegat ions of direct infringement (Art . 25 UPCA) and t hose of indirect infringement (Art . 26 UPCA). The Court concludes t hat t he allegat ions of infringement of GUARDANT HEALTH clearly suffer from a "lack of evidence" . 149. Therefore, t he Applicant has failed t o demonst rat e t he exist ence of an infringement of EP’986’s Claim 1, and subsequent ly of it s dependent claims, by " DDM access" w it h a sufficient degree of cert aint y as required by R. 211.2 RoP. 43 V. General conclusion 150. Consequent ly, GUARDANT HEALTH’s request s for provisional measures against SOPHIA GENETICS under t he t hree pat ent s in suit shall be reject ed, as w ell as all of it s subsequent request s. 151. As GUARDANT HEALTH’s claims have been reject ed, it is not necessary t o examine SOPHIA GENETICS’s subsidiary request s, not ably t he guarant ee. VI. Costs 152. The applicat ion for provisional measures is reject ed. The consequence of t his as regards t he cost s, is t hat GUARDANT HEALTH shall be ordered t o pay t he legal cost s of t he proceedings incurred by SOPHIA GENETICS. 153. R. 211.1(d) RoP provides t he opport unit y t o give an int erim aw ard of cost s in t hese proceedings. 154. In t his case, bot h part ies request ed reimbursement of t he cost s amount ing t o 600.000 euros t o be aw arded t o t he w inning part y. This amount corresponds t o t he ceiling set by t he decision of t he Administ rat ive Commit t ee of 24 April 2023 for a case w it h a value est imat ed at 6 million euros. 155. How ever, t he Court t akes int o account t hat t he present proceedings are a request for a provisional measure t hat only provides for a limit ed set of submissions in t he cont ext of a summary procedure. It furt her t akes int o account t he fact t hat t his disput e involves four different pat ent s. Even t hough t he applicant w it hdrew one of it s four pat ent s during t he proceedings, t he defendant had t o examine it s defence for t he four pat ent s t hat w ere opposed in it s Object ion of 27 Oct ober 2025, w hile t he w it hdraw al occurred lat er in GUARDANT HEALTH‘s reply t o t he Object ion, on 10 November 2025. 156. The Court considers t he am ount of 400.000 euros as reasonable and proport ionat e in t he present case. GUARDANT HEALTH w ill be ordered t o pay SOPHIA GENETICS t his amount as an “ int erim” aw ard of cost s. ORDER 1. The Court not es t he w it hdraw al of t he request s under EP 3 470 533. 2. The Applicat ion for provisional measures under EP 3 591 073, EP 3 443 066 and EP 3 766 986 is reject ed. 3. The Court orders t he Applicant t o pay t o t he Defendant s int erim cost s of t he proceedings amount ing t o 400.000 euros. An appeal against t his order may be brought in accordance w it h Art . 73 (2) (a) UPCA and R. 220.1 (c) and 224.1(b) RoP w it hin 15 calendar days of t he not ificat ion of t he order t o t he Applicant s. 44 Issued in Paris, on 23 January 2026. Camille Lignières, Presiding judge and Judge Rapport eur On behalf of Carine Gillet , Legally qualified judge Signed by Camille Lignières (due t o t echnical issues) On behalf of M aximilian Haedicke, Legally qualified judge Signed by Camille Lignières (due t o t echnical issues) On behalf of Cornelis Schüller, Technically qualified judge Signed by Camille Lignières (due t o t echnical issues) Charlot t e Ferhat , Clerk ORDER DETAILS UPC number: UPC CFI 808/ 2025 Dat e of issue: 23/ 01/ 2026 Applicat ion Type: Applicat ion for provisional measures (R. 205 et seq. RoP) Date : 2026.01.23 10:34:36 +01'00' Date : 2026.01.23 10:35:09 +01'00' Date : 2026.01.23 10:35:37 +01'00' Date : 2026.01.23 10:36:00 +01'00' CHARLOTTE CAMILLE CLAIRE FERHAT Signature numérique de CHARLOTTE CAMILLE CLAIRE FERHAT Date : 2026.01.23 11:56:30 +01'00'

Key Holdings

• A three-month delay to prepare a preliminary injunction action involving multiple patents and complex technology is considered reasonable for urgency.
• For added matter, it is insufficient to find claim elements scattered throughout an application; the claimed invention as a whole must be disclosed to the skilled person.
• Preliminary injunctions were denied as patents were deemed more likely than not invalid or infringement was not sufficiently proven.
• The Court applies established Court of Appeal principles for claim interpretation (Nanostring) and added matter (expert klein).
• Interim costs were significantly reduced by the Court.

Tags

• Added Matter
• Claim Construction
• Costs
• Infringement
• Patent Validity
• Preliminary Injunction
• Urgency

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