UPC_CFI_613/2024 – Pari v Philips

Expert Commentary

Revocation action Facts 1. The revocation action was started on 23 October 2024 against a Unitary Patent for “Air-flow in a nebulizer head”. 2. The claimant argued: a. lack of novelty; b. lack of inventive step; c. of independent as well as of dependent claims. 3. The patentee filed two auxiliary requests. 4. As per the first auxiliary request “the patent shall be partially upheld by maintaining the claims that the Court believes to be valid while only revoking the claim the Court believes to be invalid”. The Court 1. The claimant can rectify its name. 2. The claimant has standing: “concerned by the patent” (within the meaning of R. 47(6) RoP) does not require the claimant to show a specific legal or economic interest in the patent. Everybody potentially operating in the field of the patent can bring a revocation action – this criterion mainly excludes strawmen. 3. The Court breaks down the claim as agreed by the parties and start with interpreting the claim in accordance with the Court of Appeal’s decision in Nanostring v 10x Genomics (UPC_CoA_335/2023). 4. With respect to novelty, the Court remarks: when it comes to “purpose” characteristics, if the prior art discloses a device with physical characteristics as disclosed in the patent, it is novelty-destroying irrespective of the intended use, except where the disclosed device is not suitable or needs to be amended to be suitable for the intended use as claimed by the patent. 5. D1 (constituting prior art under Art. 54(3) EPC) takes away novelty. 6. Auxiliary request 1 is inadmissible. 7. Auxiliary request 2 is admissible. 8. Inventive step analysis: the Court refers to Art. 56 EPC and to the decisions of the Court of Appeal of 25 November 2025 (in Meril v Edwards, UPC_CoA 457/2024, and in Amgen v Sanofi, UPC_CoA 528/2024, 529/2024). 9. The Court takes a product which was put on the market before the priority date as a realistic starting point and finds, on an hypothetical basis, that some elements of the claim are present in the prior art product, but the Court eventually sees no incentive to arrive at the product claimed in the patent. Comment 1. The novelty-destroying Art. 54 (3) EPC prior art could not be invoked to argue the lack of inventive step of the new auxiliary request 2. The Court in my opinion correctly applies the criterion of the Court of Appeal with respect to inventive step. 2. It is somewhat strange that the applicant did not establish common general knowledge (as pointed out by the court). One would expect that this could have provided some good lack of inventive step arguments against this type of generally known products.

Full Decision Text

UPC_CFI_613/2024 DECISION of the Court of First Instance of the Unified Patent Court Central Division Milan issued on 27 November 2025 concerning EP3397329 HEADNOTES 1. Any person or entity potentially trying to ascertain their “freedom to operate”, therefore any party (potentially) operating in the technical field of the patent are “concerned” by a party and have a standing to sue under Art. 47(6) UPCA. 2. The skilled person will generally not (directly and unambiguously) deduce dimensions from schematic figures. CLAIMANT Pari Pharma GmbH Represented by Holger Stratmann Moosstr. 3 82319 Starnberg – Germany DEFENDANT Koninklijke Philips N.V. Represented by Michael Ras High Tech Campus 52 5656AG - Eindhoven - Netherlands 1 PATENT AT ISSUE Patent no. Proprietor(s) EP3397329 Koninklijke Philips N.V. DECIDING JUDGE: Full Panel COMPOSITION OF THE FULL PANEL: Presiding judge Andrea Postiglione Legally qualified judge and judge rapporteur Anna-Lena Klein Technically qualified judge Koen Callewaert A. Summary of the facts and requests I. Procedural background and the proceedings before the Central Division 1. On 23 October 2024, Pari Pharma GmbH (“the Claimant”) brought the present Revocation action in the Central Division (Section Milan) against Koninklijke Philips N.V. (“the Defendant”). 2. The defendant filed an application to amend the patent. 3. An online interim conference was held on 16 September 2025 by the Central Division. The outcome of the interim conference is laid down in the procedural order issued on 26 September 2025. 4. The oral hearing was held in person in Milan on 7 October 2025. II. The patent at issue 5. European patent No. 3 397 329 entitled “Air-flow in a nebulizer head” (“the patent” or “the patent in suit”) was filed on 21 December 2016 and claims priority of US patent application US 201562271387 P of 28 December 2015. The claimant did not challenge the validity of the priority date. 6. Grant of the patent was published on 8 March 2023. The defendant is the only registered proprietor of the patent. The patent is registered with unitary effect. 2 7. The patent is in force in the UPC Contracting Member States Germany (DE) and France (FR) (as well as in the non-EU country GB). 8. The patent in suit relates to the air-flow in a nebulizer head, in particular to a nebulizer head and to a nebulizer system for providing a substance in an aerosolized form using a nebulizer, [0001]. Its independent claim 1 reads as follows: A nebulizer head (10), comprising: - a housing structure (12) providing a bidirectional air-flow path (16) between two opposite air- flow openings (18a, 18b), wherein one of the air-flow openings is provided as a mouth-piece opening and another one of the air-flow openings is provided as a backside opening, and wherein a flow direction from the backside opening to the mouth-piece opening is a first air-flow direction for inhaling and a vice versa flow direction is a second air-flow direction for exhaling; - a fluid reservoir (14) provided to accommodate a liquid from which small droplets are to be generated in order to form an aerosol; - an aerosol generator (20) with an aperture member (22) that comprises an aperture surface (24) with a plurality of apertures to provide the small droplets from the liquid; wherein the fluid reservoir is arranged adjacent the aerosol generator such that the aperture member is in contact with the fluid, wherein the aperture member (22) is mounted substantially vertically in the nebulizer head (10) in relation to the air-flow path (16) which is, in normal use of the nebulizer head (10), arranged horizontally; wherein the aerosol generator is arranged within the air-flow path; wherein at least one by-pass flow path (26) is provided between the aerosol generator and the housing structure, wherein the by-pass flow path (26) is arranged around the aerosol generator (20), and wherein a flow direction of the by-pass flow path (26) is the same as the second air- flow direction; wherein the air enters the air-flow path and leaves the air-flow path via the air-flow openings; wherein the aperture surface is arranged transverse to the first and second air-flow direction; and wherein the air-flow is manually activatable by the user breathing in and out respectively; and wherein the air-flow is non-supported by ventilation means. III. Requests of the parties 9. The claimant argues that the patent is invalid because claim 1 lacks novelty (Art. 54 EPC) in view of the allegedly priorly used “Pari eMotion” and in view of WO 2017/102308 A1 (D1). Claimant further argues that claim 1 is not inventive (Art. 56 EPC) over WO 2011/089485 A1 (D2) as closest prior art in combination with US 2011/0146670 A1 (D5), EP 1 927 373 A1 (D3) as closest prior art in combination with US 2005/0011514 A1 (D7) or the Pari eMotion, and US 2005/0011514 A1 (D7) as closest prior art in combination with any of WO 2014/082818 A1 (D8), US 2012/0085344 A1 3  (D9), US 2011/0146670 A1 (D5), EP 1 927 373 A1 (D3), WO 2004/052436 A1 (D4) and US 2003/0072717 (D6). Claimant further submits that the challenged dependent claims 2 to 11 also lack novelty or inventive step. 10. The claimant requests that the Court I. entirely revokes the Patent in Suit, as per Art. 65 UPCA and R. 118.3 RoP, in the territory of Germany (DE) and France (FR); and II. orders that the Defendant pays all costs incurred by the Claimant in the revocation action as per Art. 69 UPCA. 11. On 21 January 2025, defendant lodged the defence to revocation, which included an application to amend the patent as auxiliary request 2. 12. The defendant requests the Court I. to dismiss the action for revocation and to maintain EP 3 397 329 B1 (“the patent”) as granted; II. auxiliarily, in case the Court decides that the patent cannot be maintained as granted, to partially maintain the patent according to auxiliary request 1, and if auxiliary request 1 cannot be allowed, to partially maintain the patent according to auxiliary request 2 and to dismiss the action for revocation to the corresponding extent; III. to order that the claimant pays all costs incurred by the defendant in the revocation action as per Art 69 UPCA; 13. As a first auxiliary request, the defendant requests that the patent be partially maintained by maintaining all claims that the Court believes to be valid, while only revoking the claims the Court believes to be invalid. 14. Auxiliary request 2 reads as follows, with claims 4 and 5 being incorporated into claim 1 as amended (see HE 3a, and HE3b in correction mode): 1. A nebulizer head (10), comprising: - a housing structure (12) providing a bidirectional air-flow path (16) between two opposite air-flow openings (18a, 18b), wherein one of the air-flow openings is provided as a mouth-piece opening and another one of the air-flow openings is provided as a backside opening, and wherein a flow direction from the backside opening to the mouth-piece opening is a first air-flow direction for inhaling and a vice versa flow direction is a second air-flow direction for exhaling; - a fluid reservoir (14) provided to accommodate a liquid from which small droplets are to be generated in order to form an aerosol; - an aerosol generator (20) with an aperture member (22) that comprises an aperture surface (24) with a plurality of apertures to provide the small droplets from the liquid; wherein the fluid reservoir is arranged adjacent the aerosol generator such that the aperture member is in contact with the fluid, wherein the aperture member (22) is mounted substantially vertically in the nebulizer head 4 (10) in relation to the air-flow path (16) which is, in normal use of the nebulizer head (10), arranged horizontally; wherein the aerosol generator is arranged within the air-flow path; wherein at least one by-pass flow path (26) is provided between the aerosol generator and the housing structure, wherein the by-pass flow path (26) is arranged around the aerosol generator (20), and wherein a flow direction of the by-pass flow path (26) is the same as the second air-flow direction; wherein the air enters the air-flow path and leaves the air-flow path via the air-flow openings; wherein the aperture surface is arranged transverse to the first and second air-flow direction; and wherein the air-flow is manually activatable by the user breathing in and out respectively; and wherein the air-flow is non-supported by ventilation means wherein one of the air-flow openings is provided as a mouth-piece opening (46) and the other one of the air-flow openings is provided as a backside opening (48); and a flow direction from the backside opening to the mouth-piece opening is the first air-flow direction and the vice versa flow direction is the second air-flow direction; and wherein, preferably, the aerosol generator provides the small droplets in the inhaling direction; and wherein during inhaling a flow of air flowing around the aerosol generator is provided at a rear side of the aperture surface. wherein a portion of the air-flow path between the aerosol generator and the mouth-piece opening is a front air channel (50) and a portion between the aerosol generator and the backside opening is a rear air channel (52); and wherein the rear air channel and preferably the by-pass sections are equal or larger in clear cross- section than the mouth-piece opening. 2. Nebulizer head according to claim 1, wherein the rear air channel is angled upward in the exhaling direction. 3. Nebulizer head according to claim 1 or 2, wherein the mouth-piece is provided as a fixedly mounted mouth-piece. 4. Nebulizer head according to one of the claims 1 to 3, wherein the mouth-piece provides the front air channel having a length (L) between the mouth-piece opening and the aperture member, which length is larger than 5 cm; and wherein, preferably, the mouth-piece opening is oval in shape. 5. Nebulizer head according to one of the claims 1 to 4, wherein the longitudinal axis of the mouthpiece makes an angle greater than five degrees with respect to an horizontal axis. 5  6. Nebulizer head according to one of the preceding claims, wherein the aperture member is provided as one of the group of a mesh or membrane with a plurality of holes or apertures, and a plate with a plurality of droplet outlets. 7. A nebulizer system (100), with: - a nebulizer head (102) according to one of the preceding claims; and - a base structure (104) comprising a power supply and a control and operating element for operating the aerosol generator; wherein the nebulizer head is at least temporarily mounted to the base structure. 15. In response to Defendant’s Statement of Defence, the claimant, in addition, requests that the Court I. dismisses Defendant’s alternative requests to maintain the Patent in suit based on any of Defendant’s proposed amendments of the claims of the Patent in suit, including all of Defendant’s auxiliary requests; II. orders the Defendant to bear the legal costs of the proceedings. 16. The parties have agreed before the interim conference that recoverable legal costs for the prevailing party shall be 30.000 €, as set out in the order by the Judge Rapporteur from 26 September 2025. 17. The grounds and defences brought forward by the parties will, to the extent relevant for this decision, be discussed in detail below. Grounds for the decision I. Summary of the outcome 18. The CD Milan concludes that the action for revocation is admissible. Claim 1 of the patent in suit as granted lacks novelty over D1, because the subject matter of the claim is directly and unambiguously disclosed in the prior art document D1. The first auxiliary request is inadmissible. The second auxiliary request is admissible and leads to the patent being revoked only in part. II. Admissibility 19. The revocation action is admissible. 1. The claimant is named correctly as PARI Pharma GmbH and is clearly identifiable 20. According to R. 44.1, 13.1.a RoP, the Statement of claim shall contain the name of the claimant. The correct name and identification of the claimant is important for the defendant so that the defendant can assess if the claimant has a right to sue and if there is a need to request a security according to R. 158 RoP, since the correct identification of the claimant might be important to assess, e.g., if the claimant is bound by any contract not allowing them to sue the defendant. 6  Additionally, knowing the correct claimant might prove important in later recourse and reimbursement of cost proceedings, as the defendant points out. 21. The Court of Appeal has clarified that if a defendant has been incorrectly named in the statement initiating the proceedings, the Court may allow the claimant to correct the error, if the incorrect statement and the correction do not unreasonably prejudice the defendant. In this regard, the CoA stated that there will generally be no unreasonable prejudice if, despite the incorrect statement of the name, it must have been clear to the defendant and to the Court, based on the circumstances of the case, that the claimant intended the statement for revocation to be directed against the defendant (CoA, APL_588420/2023, UPC_CoA_433/2023, APL_588422/2023, UPC_CoA_435/2023, APL_588423/2023, UPC_CoA_436/2023, APL_588425/2023, UPC_CoA_437/2023, APL_588426/2023, UPC_CoA_438/2023, order issued on 3 April 2024, para. 13 – NJOY v Juul). 22. The same principle may generally apply with regard to an incorrect naming of the claimant. In this Court’s view, an incorrect statement of the claimant’s name and a subsequent correction will generally not unreasonably prejudice the defendant, if an uncertainty about the identity of the claimant has no immediate and direct effect on the legal issues mentioned in margin 20. If the claimant is named incorrectly or in a misleading way, the defendant’s side knows that they are being sued and need to take action to defend themselves in legal proceedings. In such a case, the Court may allow the claimant to correct a name during the written phase. 23. The claimant was named in the heading of the Statement for revocation as “PARI Pharma GmbH” as the company actually bringing the lawsuit. On page 2 of the Statement for revocation, however, the company “PARI GmbH Spezialisten für effektive Inhalation” which exists under registration number 66609 at the Munich companies’ registry (“Handelsregister”) with the same registered address as PARI Pharma GmbH (see defendant’s Exhibits 1 and 2) was named under the heading “Information pursuant to R. 44 RoP”. 24. Nevertheless, the claimant clarified that PARI Pharma GmbH is the correct claimant in the reply, thus preventing any doubt on the company bringing the lawsuit. 25. The defendant’s procedural rights are not prejudiced by treating PARI Pharma GmbH as the claimant. Any doubts were dispelled in the first phase of the proceedings. The defendant does not point out any additional difficulties in its defence because of any doubts about the claimant’s identity before it was clarified in the reply. 26. The claimant has legally permissibly corrected the incorrect naming of the claimant in the reply. The correction is allowed by this Court. 2. The claimant has a standing to sue, Art. 47(6) UPCA 27. According to Art. 47(6) UPCA, any other natural or legal person, or any body entitled to bring actions in accordance with its national law, who is concerned by a patent, may bring actions in accordance with the Rules of Procedure. 28. The Agreement does not clarify what the phrase “concerned by a patent” means with regard to revocation actions. However, it is clear both from the systematic approach of the UPCA and from 7  the RoP that the phrase “concerned by a patent” does not require the claimant to show a specific legal or economic interest in the patent. 29. One of the explicit goals of the UPCA is to provide legal certainty, as can be seen from paragraph 5 of the preamble. By providing the possibility of a standalone revocation action beside the possibility of a counterclaim for revocation in infringement proceedings and actions for declarations of non-infringement, the UPCA clarifies that the validity of a patent may be challenged in front of the Court outside of an infringement dispute. This allows for an early judicial assessment of validity issues and is therefore one way to achieve the UPCA’s goal to provide legal certainty, especially (but not exclusively) with regard to entities who want to develop and invest in the technical field of the patent concerned. 30. Since the patent grants an exclusive right to the patentee which has an effect on the (whole) public, any member of the public who is either a natural or legal person or a body entitled to bring actions in accordance with its national law are concerned by the patent and may therefore lodge a revocation action (Bopp/Kircher EurPatentprozess-HdB/Burrichter/Kirchhofer § 14 para. 133). 31. In relation to revocation actions, Art. 47(6) UPCA therefore excludes, at most, the lodging of revocation actions by straw men (see, in this regard, Tilmann/Plassmann/Fähndrich/Klicznik/M. Tilmann EPGÜ Art. 65 Rn. 17; dissenting – even straw men are allowed to lodge a revocation action – Bopp/Kircher EurPatentprozess-HdB/Burrichter/Kirchhofer § 14 para. 133). 32. This broad approach is supported by the requirements set out in the Rules of Procedure. With regard to infringement actions, R. 13.1(f) RoP provides that, where the claimant is not the proprietor of the patent concerned, or not the only proprietor, the statement of claim shall contain evidence to show the claimant is entitled to commence proceedings [Article 47(2) and (3) of the Agreement]. R. 44 RoP relating to revocation actions, on the other hand, does not require the claimant’s side to explain their “concern” by the patent. This shows that the “concern” is not regarded as an additional requirement to be explained and/ or proven by the claimant. 33. In any case, however, any person or entity potentially trying to ascertain their “freedom to operate”, therefore any party (potentially) operating in the technical field of the patent are “concerned” by a party and have a standing to sue under Art. 47(6) UPCA. The legal certainty aimed at by allowing a standalone revocation action is especially important for competitors of the patentee who may want to make sure they have “freedom to operate” in a certain field and therefore safety with regard to developments and investments. 34. Therefore, while a person or entity who was notified of a possible infringement by a patentee, received a warning letter, or is sued, is certainly concerned by a patent in the sense of Art. 47(6) UPCA, such an action by the patentee is – contrary to the defendant’s argument – not required for the claimant to show concern in this sense. 35. Undisputedly, in the case at hand, the claimant is a competitor of the defendant. Thus, the claimant has a standing to sue under Art. 47(6) UPCA. III. On the merits 1. Technical background of the patent in suit 8 36. The patent relates to a nebulizer head and a nebulizer system, [0001]. 37. According to the description of the patent, for inhalation purposes – e.g. for inhalation therapy – a liquid may be used to generate a plurality of small droplets (also called atomization of the liquid) and to generate a mist or aerosol that can be inhaled by the patient. Compressed air, ultrasonic or mesh droplet generators are provided, as explains [0002]. 38. The patent in suit cites several documents as prior art: US 2008/0000470 A1 [0002], US2008/000470A1 [0003], US2005/166912A1 [0004], EP 1882487A1 [0005]. With regard to US 2008/0000470 A1, the patent in suit underlines that care must be taken that the drug medication – at least for certain drug medication – does not get on the face of the patient, for example into the eyes, [0002]. 39. Against this background, the patent in suit states in [0006], that there may be a need to provide a nebulizer head with an improved air-flow guidance. To achieve this aim, the patent teaches to provide a device as specified by the patent claims, where air exits at the rear side when the user breathes out, and which provides an improved mixture and reduces the re-deposition of drugs onto the aperture surface, [0009]. 40. The objective problem can therefore be phrased as providing a nebulizer head with an improved air-flow guidance, where care is taken that the drug medication does not get on the face of a patient, an improved mixture is provided and re-deposition of drugs onto the aperture surface is reduced. 41. According to claim 1 of the patent at issue, this problem is to be solved by the device according to claim 1. 2. Feature analysis of claim 1 42. Claim 1 (as granted) can be broken down as follows, as agreed upon by the parties and adopted by the Court: Title A nebulizer head (10), comprising: Feature 1 a housing structure (12) providing a bidirectional air-flow path (16) between two opposite air-flow openings (18a, 18b), Feature 1.1 wherein one of the air-flow openings is provided as a mouthpiece opening Feature 1.2 and another one of the air-flow openings is provided as a backside opening, and Feature 1.3 wherein a flow direction from the backside opening to the mouthpiece opening is a first air-flow direction for inhaling and a vice versa flow direction is a second air- flow direction for exhaling; Feature 2 a fluid reservoir (14) provided to accommodate a liquid from which small droplets are to be generated in order to form an aerosol; Feature 3 an aerosol generator (20) with an aperture member (22) that comprises an aperture surface (24) with a plurality of apertures to provide the small droplets 9  from the liquid; wherein the fluid reservoir is arranged adjacent the aerosol generator such that the aperture member is in contact with the fluid, Feature 3.1 wherein the aperture member (22) is mounted substantially vertically in the nebulizer head (10) in relation to the air-flow path (16) which is, in normal use of the nebulizer head (10), arranged horizontally; Feature 3.2 wherein the aerosol generator is arranged within the air-flow path; Feature 4 wherein at least one by-pass flow path (26) is provided between the aerosol generator and the housing structure, Feature 4.1 wherein the by-pass flow path (26) is arranged around the aerosol generator (20), and Feature 4.2 wherein a flow direction of the by-pass flow path (26) is the same as the second air-flow direction; Feature 5 wherein the air enters the air-flow path and leaves the air-flow path via the air-flow openings; Feature 6 wherein the aperture surface is arranged transverse to the first and second air-flow direction; and Feature 7 wherein the air-flow is manually activatable by the user breathing in and out respectively; and Feature 8 wherein the air-flow is non-supported by ventilation means. 3. Claim interpretation 43. In view of the discussion between the parties, several features of claim 1 of the patent in suit need to be examined further. a) Legal Standard 44. As the Court of Appeal has made clear (CoA, UPC_CoA_335/2023 App_576355/2023, order of 26 February 2024, as rectified by UPC_CoA_335/2023, APL_576355/2023, Order of 11 March 2024 – NanoString v 10x Genomics), the patent claim is not only the starting point, but the decisive basis for determining the protective scope of a European patent under Art. 69 EPC in conjunction with the Protocol on the Interpretation of Art. 69 EPC. The interpretation of a patent claim does not depend solely on the strict, literal meaning of the wording used. Rather, the description and the drawings must always be used as explanatory aids for the interpretation of the patent claim and not only to resolve any ambiguities in the patent claim. However, this does not mean that the patent claim merely serves as a guideline and that its subject-matter also extends to what, after examination of the description and drawings, appears to be the subject-matter for which the patent proprietor seeks protection. The patent claim is to be interpreted from the point of view of a person skilled in the art. In applying these principles, the aim is to combine adequate protection for the patent proprietor with sufficient legal certainty for third parties. These principles for the interpretation of a patent claim apply equally to the assessment of the infringement and the validity of a European patent. 10 45. This means that a person skilled in the art will not only consider the literal meaning of a certain word used in the patent claim but will also consider the technical function of a certain part addressed in the patent claim (LD Dϋsseldorf, ACT 58084/2023, decision of 31 October 2024). However, in the view of this Court, a function-oriented claim interpretation may not change the scope of the patent claim. Features described defined by physical characteristics may not be reduced to their function alone. 46. A feature in a patent claim must be interpreted in light of the claim as a whole (CoA, APL_8/2024 UPC_CoA_1/2024, Order issued on 13 May 2024, para. 29). This means that the patent claim as a whole must be examined to deduce which technical function specific features have and provide, individually and as a whole (CD Munich, UPC_CFI_252/2023, decision issued on 17 October 2024, para. 8.4). The description and the drawings may show that the patent specification defines terms independently and, in this respect, may represent a patent’s “own lexicon” (see, e.g., CD Munich, UPC_CFI_252/2023, decision issued on 17 October 2024, para. 8.4). Embodiments explained in the description shall generally not limit the patent claim (see, e.g., LD Munich, UPC_CFI_248/2024, decision issued on 22 August 2025, para. 94). 47. The skilled person will try to arrive at an interpretation of the claim which is technically sensible and takes into account the whole disclosure of the Patent. The Patent must be construed by a ‘mind willing to understand, not a mind desirous of misunderstanding’ (see, e.g., CD Milan, UPC_CFI_497/2024, UPC_CFI_571/2024, decision issued on 23 October 2025, para. 2.2). 48. Claim construction is a matter of law (CoA, UPC_CoA 768/2024, decision issued on 20 April 2025, para. 37 - Insulet v EOFlow). 49. Optional features, indicated by the use of words like “for example” or “preferably”, do generally not limit the scope of a patent claim. b) The skilled person 50. The skilled person is a mechanical engineer with several years of professional experience in the field of developing medical nebulization devices. c) Claim interpretation from the point of view of the person skilled in the art as defined above 51. aa) The nebulizer head has a housing structure that provides a bi-directional air-flow path between two opposite openings (Feature 1). One of the openings is a mouthpiece opening, the other one is a backside opening (Features 1.1 and 1.2). There exist two air-flow directions, from the backside opening to the mouthpiece and vice versa, for inhaling (“first air-flow direction”) and exhaling (“second air-flow direction”) (Feature 1.3). 52. Figures 1a and 1b show schematic cross-sections through a nebulizer head and the air-flow and aerosol generation during inhalation (Figure 1a) and exhalation (Figure 1b): 11 53. The dotted arrows 30 and 38 in both figures show the air-flows, [0014] and [0015]. The user of the nebulizer head would be placed on the right side of the figures. 54. The nebulizer head further comprises a fluid reservoir (Feature 2). The reservoir is depicted in Figure 1a above as number 14. It is provided to accommodate a liquid. From the liquid, small droplets are to be generated in order to form an aerosol. This is shown in Figure 1a by dotted arrows 32. 55. The nebulizer head further comprises an aerosol generator, with an aperture member, which comprises an aperture surface with a plurality of apertures (Feature 3). This can be achieved by a mesh or a plate with multiple holes, e.g. (see [0039]). Feature 3 clarifies that the fluid reservoir is positioned adjacent the aerosol generator in a way that the aperture member is in contact with the fluid. Thus, the member draws liquid from the adjacent fluid reservoir. The aperture member is depicted in Figure 1a as component 22. 56. The aperture member is mounted substantially vertically in relation to the air flow path. The air- flow path is in normal use of the nebulizer head arranged horizontally (Feature 3.1). The aerosol generator is also arranged within the air-flow path (Feature 3.2). [0021] describes the arrangement as advantageous because the droplets have a similar direction and the aerosol can thus be well distributed. 57. Feature group 4 deals with the by-pass flow path. At least one by-pass flow path (26) is provided between the aerosol generator and the housing structure, Feature 4. This by-pass flow path is shown in Figure 1b as number 26. According to Feature 4.1, the by-pass flow path is arranged around the aerosol generator (20), as can be seen from Figure 1 b. Feature 4.2 provides that a flow direction of the by-pass flow path (26) is the same as the second air-flow direction, the latter addressed in feature 1.3. As can be seen from Figure 1b, the by-pass flow path is part of the air- flow path. 58. Thus, during inhalation, aerosol droplets mix effectively with the inhaled air (feature group 3); during exhalation, exhaled air bypasses the aerosol generator, reducing the likelihood of droplet re-deposition and preventing unwanted exposure of the face to drug medication (feature group 4). 59. The air enters the air-flow path and leaves the air-flow path via the air-flow openings (Features 1, 1.1 and 1.2), see Feature 5. The aperture surface is arranged transverse to the first and second air- 12  flow direction (Feature 1.3), Feature 6. The air-flow is manually activatable by the user breathing in and out respectively, Feature 7, and non-supported by ventilation means, Feature 8. 60. bb) Some features need further explanation. 61. (1) Claim 1 relates to a (non-specific) device realizing all the features of claim 1. The nebulizer head in the sense of the Title of claim 1 may thus be a so-called MDI (metered dose inhaler). 62. (2) The housing structure of Feature 1 provides a bidirectional air-flow path between two opposite openings. Whereas the housing structure and the two opposite openings are physical features of the claimed device, the sub-feature “provides a bidirectional air-flow path” is a purpose characteristic. Purpose characteristics clarify that the device they relate to must provide certain physical characteristics so that the device is objectively suitable to achieve the purpose (see, e.g., LD Munich, UPC_CFI_248/2024, decision issued on 22 August 2025, para. 102 - Brita vs. Aquashield; LD Mannheim, UPC_CFI_340/2023, decision issued on 31 January 2025 – Rematec v Europe Forestry; LD Düsseldorf, UPC_CFI_462/2023, decision issued on 30 March 2024). Any housing structure that allows a bidirectional air-flow path is thus a housing structure in the sense of Feature 1. 63. The defendant’s argument that the claim not only requires that the housing be suitable for providing the bidirectional air-flow path but must instead actually provide the bidirectional air- flow path, is not shared by the Court. Any housing that allows a bidirectional air-flow path provides such a path in the sense of claim 1 of the patent in suit. Only where a one-way valve is introduced into the air-flow path is the housing neither suitable for providing a bidirectional air-flow path, nor does it actually provide a bidirectional air-flow path. 64. (3) The backside opening (Feature 1.2) must be an air-flow opening. It shall provide a possibility for the user of the device to exhale without the exhaled air (comprising medicaments) getting on the face of the user, see [0002]. To achieve that goal, the patent describes that the air exits at the rear side, opposite to the face side, [0009]. It is thus physically led away from the patient. The opening allows the air to exit into the atmosphere. 65. It is clear from feature 1 that the two openings lie opposite each other, so that the backside opening is opposite to the mouthpiece. Accordingly, figure 1a and figure 1b show the openings 18a, 18b as being opposite, see [0012]. The same can be inferred from Figure 4, see [0031]. 66. The patent description provides in [0033], that as an option, the backside opening is arranged behind the aperture surface 24. [0034] specifies that the backside opening is arranged downstream the aperture surface in the exhaling air-flow direction, and upstream in the inhaling air-flow direction. The backside opening is arranged at a distal end when the user is breathing through the mouthpiece. 67. While the function of the sub-feature “backside opening” is to make sure that exhaled air (comprising medicaments) shall not get on the face of the patient and may not require that the backside opening is located at the part of the device facing away from the patient when in use (the “back” of the device), the sub-feature “backside opening” encompasses physical requirements, and may not be reduced to its function. Rather, as the claim clearly requires the opening to be a 13  backside opening and to be opposite to the mouthpiece, the wording requires a physical arrangement of the opening opposite to the mouthpiece and on the backside. 68. This understanding is not changed by the fact that [0033] addresses the backside opening being arranged behind the aperture surface 24. This part of the description may, with regard to the patent claim, not be understood as to mean that any opening should be seen as a backside opening as long as it is arranged “behind” the aperture surface, notwithstanding the fact that the description of the patent in suit does not disclose any embodiments where the backside opening is not arranged behind the aperture surface 24. This understanding would disregard the physical requirements claim 1 imposes on this sub-feature. Therefore, it is irrelevant if [0033] relates to a claim that was deleted during prosecution, as the defendant explained during the oral hearing, and if the litigation history may generally be used in litigation proceedings. 69. For clarification, since claim construction is a matter of law, as discussed above, it is irrelevant that the defendant only explicitly presented a narrower interpretation of the sub-feature “backside opening” during the oral hearing. The Court is not bound by the parties’ claim construction. Furthermore, while the defendant stated in their Statement of defence that the backside opening is behind the aperture surface (“This bidirectional approach allows air to exit passed the plane of aerosol generation. As a result, the backside opening corresponding to the exhalation exit is behind the aperture surface generating the liquid droplets.”), they also pointed out that the air exits at the rear side, opposite to the face side, when the patient breathes out (see Statement of Defence, page 12). Therefore, it was clear from the statement of defence that they would not accept any opening behind the aperture surface as a backside opening. In reaction to the claimant’s explanation of their understanding of the defendant’s claim construction (Reply page 11, margins 36, 37), the defendant stated that they disagree. While it is not stated explicitly if the defendant disagrees with claimant’s explanation of defendant’s claim construction or the disclosure of D1, based on the wording of the submission there was no basis for the claimant to assume that the defendant agreed to an understanding of a backside opening being located anywhere behind the aperture surface, especially with regard to the fact that this broad interpretation was not even provided by the claimant in their revocation action (see page 9, margin 15). 70. (4) Feature 3.1 (“wherein the aperture member (22) is mounted substantially vertically in the nebulizer head (10) in relation to the air-flow path (16) which is, in normal use of the nebulizer head (10), arranged horizontally;”) addresses the physical positioning of the aperture member in relation to the air-flow path. The aperture member is arranged transversely or perpendicular to the airflow, so that the direction of the airflow aligns with the direction of the droplets generated by the aperture member, to obtain an improved mixture. The feature does not address the positioning of the aperture member in relation to gravity. 71. Feature 3.1 may not require that the air-flow path is arranged horizontally (in normal use) throughout the whole device. However, the skilled person will understand that the horizontally arranged flow path implies that the airflow at the level of the aperture member is horizontal, and that the dominant direction of the airflow transporting drug droplets from the aperture member to the mouthpiece is likewise horizontal. 14 72. Feature 3.1 provides a technical effect. As the skilled person understands from [0009] and [0021], the technical effect of the vertical orientation of the aperture member in relation to the airflow path, as indicated in the patent, is that an improved mixture and well distributed aerosol is provided for inhalation by the patient. 73. (5) Feature 4 (“wherein at least one by-pass flow path (26) is provided between the aerosol generator and the housing structure,”) does not require the by-pass flow path to be positioned along the whole perimeter of the aerosol generator. 74. (6) Claim 4 provides that one of the air-flow openings is provided as a mouth-piece opening (46) and the other one of the air-flow openings is provided as a backside opening (48); and a flow direction from the backside opening to the mouth-piece opening is the first air-flow direction and the vice versa flow direction is the second air-flow direction; and wherein, preferably, the aerosol generator provides the small droplets in the inhaling direction; and wherein during inhaling a flow of air flowing around the aerosol generator is provided at a rear side of the aperture surface. 75. The first part of claim 4 is redundant with regard to features 1.1, 1.2 and 1.3 of claim 1. 76. The word “preferably” in the second part of claim 4 only refers to the phrase “the aerosol generator provides the small droplets in the inhaling direction;”. This is clear from the claim language of claim 4 as a whole: first, a semicolon is used, indicating the addressing of a new aspect. Secondly, after the semicolon, a second “wherein” is used. This further shows that the semicolon introduces a break or separation between the two half sentences. 77. (7) Claim 5 provides that a portion of the air-flow path between the aerosol generator and the mouth-piece opening is a front air channel (50) and a portion between the aerosol generator and the backside opening is a rear air channel (52); and wherein the rear air channel and preferably the bypass sections are equal or larger in clear cross-section than the mouth-piece opening. 78. The skilled person will understand that the use of the word “preferably” does not limit the claim, because it is an optional feature, thus this part of claim 5 can be read as “wherein the rear air channel is equal or larger in clear cross-section than the mouth-piece opening”. The skilled person will understand that the technical effect of the rear air channel being equal or larger than the mouth-piece opening might be achieved even if the bypass section has a smaller passage, because even then a rear canal with a larger diameter can still provide better flow. 4. Novelty of claim 1 as granted a) Legal standard 79. For the purposes of Art. 54 EPC, an invention shall be considered new if it does not form part of the state of the art. The state of the art, in accordance with Art. 54.2 EPC, shall be held to comprise everything made available to the public by means of a written or oral description, by use, or in any other way, before the date of filing of the European patent application. 80. The CoA has clarified that it is decisive if the subject-matter of the claim with all its features is directly and unambiguously disclosed in the prior art (UPC_CoA_182/2024, App 21143/2024, Order of 25 September 2024, para. 123 – Mammut v Ortovox). 15 81. With regard to purpose characteristics, the assessment of novelty only requires an assessment if prior art discloses a device with physical characteristics as disclosed in the patent in suit. If prior art discloses such a device, the device as such is disclosed, irrespective of the specific intended use. An exception can only be made where the disclosed device is not suitable or needs to be amended to be suitable for the intended use as foreseen by the patent in suit (LD Munich, UPC_CFI_248/2024, decision issued on 22 August 2025, para. 144 - Brita vs. Aquashield). 82. The skilled person will generally not (directly and unambiguously) deduce dimensions from schematic figures. b) Lack of novelty over D1 83. The CD Milan concludes that the subject matter of claim 1 of the patent as granted lacks novelty over D1 (WO 2016/102308 A1). It is thus not decisive if claim 1 (also) lacks novelty over the Pari eMotion device. 84. aa) D1 was filed on 17 December 2015, claiming the priority of DE 14200105.6 filed on 23 December 2014. The application was published on 30 June 2016, under publication number WO 2016/102308 A1. D1 constitutes prior art according to Article 54.3 EPC. 85. D1 relates to an aerosol delivery device and an operating method for the aerosol delivery device. Figure 1 shows a schematic cross-sectional view of an aerosol delivery device according to an embodiment of the invention of D1: 86. Number 16 is a nosepiece. It is clear from the teaching of D1 on page 25, second paragraph, that the adaptation element 14 may also be equipped with a mouthpiece: 87. Figure 1 shows a gas compressor (depicted as number 1) connected to the air inlet 12. However, D1 teaches on page 25, third paragraph, that the gas compressor may be omitted: 16 88. bb) D1 discloses all features of claim 1 of the patent in suit directly and unambiguously. 89. The parties differ (only) on the disclosure of a bidirectional air-flow path with regard to feature 1 (and, in this context, the second airflow direction for exhaling of feature 1.3, the flow direction being the same as the second airflow direction of feature 4.2, that the air enters and leaves the air-flow path via the airflow openings of feature 5, and the aperture surface being arranged transverse to the second airflow direction of feature 6), as well as the disclosure of features 1.2 and 3.1 by D1. The Court therefore only establishes in the following that these features are disclosed. 90. (1) Feature 1 (“a housing structure providing a bidirectional air-flow path between two opposite air-flow openings”) is directly and unambiguously disclosed. 91. D1 discloses that the aerosol delivery device has a body, which is to be seen as the housing structure in the sense of Feature 1. D1 teaches that the housing structure provides two air flow openings. One is the mouthpiece 16, the other is the air inlet 12. 92. D1 also directly and unambiguously discloses that the body of the aerosol device in D1 provides a bi-directional air-flow path between the two openings. 93. Since this sub-feature is a purpose characteristic, as explained above, the assessment of novelty only requires an assessment if prior art discloses a device with physical characteristics as disclosed in the patent in suit. 94. In this regard, D 1 discloses (in the alternative embodiment without the gas container) a housing structure that provides a bi-directional air-flow path between the two openings. The skilled person understands that the alternative embodiment of D1 allows for the user to inhale and exhale from the inlet 12 to the mouthpiece 16. There is no indication that the air-flow would be blocked by any specific physical characteristic of the device (i.e. a one way valve). 95. Contrary to defendant’s argument (referring to page 28, 4th paragraph of D1), D1 does not only disclose an exhalation airflow through the adaption element 14. It is correct that there is no explicit mentioning in the description that the exhalation airflow flows to the air inlet 12. However, the disclosure of D1 is to be seen as a whole, from the perspective of the person skilled in the art. Figure 1 shows a schematic drawing of an embodiment of the claimed invention, with an air inlet 12 and the mouth- or nosepiece 16. The skilled person will directly and unambiguously deduce from this figure, that the device depicted in figure 1 allows for the user to inhale and exhale through the device, using the air inlet 12 and the nose-/ mouthpiece 16, as no physical characteristic is shown that could prohibit the air to be breathed out through the device. Thus, the requirement of disclosure of Feature 1 is met. 96. The same can be said for the defendant’s referral to pages 4/5 of D1 (Statement of Defence, page 16), where it is said: 17 97. It is correct that D1 states that the patient respires “partly” through the device. If this “partly” refers to the timely use of the device or entails that the respiration air flow might not go all the way through the device, is irrelevant here. In any case, the paragraph cited above clearly states that the user respires at least partly through the device. Taking this into account, the person skilled in the art will still find as a direct and unambiguous disclosure that the device may be used to inhale and exhale through the device from air inlet 12 to nose-/ mouthpiece 16. 98. As far as the defendant argues against this assessment because figure 1 of D1 shows a device with an air compressor and skilled person understands that the exhalation airflow cannot flow from the adaption element 14 to the air inlet 12 because of the gas compressor 1, D1 explicitly allows for an alternative embodiment without the gas compressor 1, as explained above. It is correct that D1 does not mention any changes to the delivery device with regard to the alternative embodiment without the gas compressor. However, the skilled person understands that by omitting the gas compressor, the air inlet would be an open and free air inlet. No (further) changes to the device depicted in figure 1 are needed. It follows that it can be used for exhalation as well. 99. Notwithstanding that Figure 1 is only schematic, this does not mean that the skilled person would not arrive at the conclusion that the air must take the same path during exhalation. There is no reason for the skilled person to assume that additional openings would be present in the device as depicted by figure 1. Rather, a person skilled in the art would have no reason to suspect that any other airflow path or opening would be required for the working of the device of D1, as shown with a gas compressor and nosepiece or in the alternative without a gas compressor and with a mouthpiece. At the least, the device is suited for a bidirectional airflow. The same can be said for the fact that air inlet 12 is only referred to as an inlet (not an outlet). This finding is also valid with regard to defendant’s argument during the oral hearing that there could be device like a rotating sensor in the device 10, because sensor 5 shall detect a flow, so there must be another opening. There is no incentive for the skilled person to look for sensors who would need a deviation from the device depicted in Figure 1. 100. (2) Features 1.3, 4.2, 5 and 6, which defendant challenges with regard to the bidirectional air-flow path are disclosed for the same reasons. 101. (3) D1 directly and unambiguously discloses a backside opening in the sense of Feature 1.2 of the patent in suit. The person skilled in the art, faced with the described alternative of having a device 18  without a gas compressor 1, will immediately understand that the inlet 12 can serve as the outlet of exhaled air. In this regard, it is irrelevant that Figure 1 is schematic. The person skilled in the art will clearly see from the figure that the inlet 12 and the nose- or mouthpiece 16 are on opposite sides of the device. For that reason, it is irrelevant that there is no textual description in D1 regarding the location of the inlet 12 and the nose-/mouthpiece 16 relative to each other. The positioning of the backside opening can be deduced directly and unambiguously from Figure 1. It is also irrelevant that the air inlet 12 is denoted “inlet” and that there is no textual description of it being an outlet. It is clear for the skilled person that, if the gas compressor 1 is omitted, the air inlet will function as a free and open inlet and is thus suitable to function also as an outlet. 102. (4) D1 directly and unambiguously discloses feature 3.1 (“wherein the aperture member (22) is mounted substantially vertically in the nebulizer head (10) in relation to the air-flow path (16) which is, in normal use of the nebulizer head (10), arranged horizontally”). 103. The skilled person will deduce this feature from Figure 1. The airflow would lead from inlet 12 to mouthpiece 16 and vice versa, so it would be horizontal. Figure 1 shows an aperture member – membrane 30 – in a prima facie vertical orientation in relation to the air-flow path between the inlet 12 and the mouthpiece 16. Notwithstanding that dimensions shall generally not be disclosed by figures (see above), a relatively simple orientation (versus a specific dimension) may be deduced from a figure. Moreover, the feature only calls for a substantially vertical positioning, no exact vertical positioning, which can be clearly deduced from Figure 1. 104. The fact that the device depicted in Figure 1 could possibly also be used in a different positioning does not change the findings above. There is no indication that a user would position the device in use like mentioned by the defendant (see the following picture, statement of Defence, p 17), especially since there is no need to do so. The skilled person will understand that Figure 1 shows the device as it would be oriented in normal use. Additionally, the skilled person understands that the device depicted in Figure 1 can be used in the orientation as depicted in that figure, so the device is at least suitable to fulfil the requirements of feature 3.1. The device of Figure 1 has a nosepiece 16. D1 does not disclose a particular design of a mouthpiece, however there is no reason to assume that the orientation or the functioning of the device would be different when using it with a mouthpiece. 19 105. (5) Feature 4 (“wherein at least one by-pass flow path (26) is provided between the aerosol generator and the housing structure,”) is disclosed as well. On page 27, D1 specifies “A flow passage 36 is formed between the membrane 30 and the body of the aerosol delivery device 10 which allows for the passage of gas, i.e. air in the present embodiment, (…).” The flow passage is depicted in Figure 1 with dotted lines. The by-pass flow-path is a portion of this flow path. It is irrelevant here that the membrane 30 corresponds to the aperture member, not the (whole) aerosol generator. The aperture member is part of the aerosol generator, as can be seen from feature 3. Since D1 discloses a flow path between the aperture member and the housing structure, it therefore and accordingly also discloses a flow path between the aerosol generator and the housing structure. 106. Since the disclosure of the other features is not disputed, it follows that claim 1 of the patent in suit is not novel over D1. 107. Since claim 1 as granted cannot be maintained, the requirements of the auxiliary requests (“in case the Court decides that the patent cannot be maintained as granted”) are met. 5. Auxiliary request 1 is inadmissible 108. Auxiliary request 1 is inadmissible. a) Legal standard 109. According to Art. 65.2 and Art. 65.3 UPCA, the Court may revoke the patent entirely or partly if the respective requirements are met. If the grounds for revocation affect the patent only in part, the patent shall be limited by a corresponding amendment of the claims and revoked in part, without prejudice to Art. 138.3 EPC, Art. 65.3 UPCA. Art. 138.3 EPC provides that in proceedings before the competent court or authority relating to the validity of the European patent, the proprietor of the patent shall have the right to limit the patent by amending the claims. The patent thus limited shall form the basis for the proceedings. 110. Art. 76.1 UPCA provides that the Court shall decide in accordance with the requests submitted by the parties and shall not award more than is requested. 111. It follows that the patentee needs to amend the patent claims and lodge a specific amended version of a claim or several claims if the patentee wants to defend the patent “in part”. Dependent claims cannot be upheld individually. Their scope would be unclear. It is furthermore not the Court’s task to uphold the patent partially by adding features from dependent claims into an independent claim, should this be the defendant’s request. Since the Court decides in accordance with the parties’ requests, Art. 76.1 UPCA, it is the patentee’s responsibility to lodge amended claims stating the exact wording in which a patent shall be upheld. This is in line with the requirements of the Rules of Procedure. If the patentee wants to defend the patent in an amended form, the patentee must file an application to amend the patent containing the proposed amendments of the claims of the patent in suit, see R. 50.2, R. 30.1(a) RoP. It is thus clearly the obligation of the patentee to phrase and state amendments. The patentee may not leave the amendment to the discretion of the Court (see also LD Mannheim, UPC_CFI_359/2025, decision of 2 April 2025 – Fujifilm - Kodak, para 160 et sequi.). 20  b) Decision in casu 112. Auxiliary request 1, which leaves the amendment of the patent to the discretion of the Court, is therefore inadmissible. 113. Furthermore, auxiliary request 1 is perplex and therefore inadmissible: If the Court finds that claim 1 cannot be upheld as granted, and therefore only upholds dependent claims, the limitation goes beyond the possible limitation requested by the auxiliary request 2. Since auxiliary request 2 shall only be decided if the Court deems auxiliary request 1 inadmissible but could have a broader scope than auxiliary request 1, auxiliary request 1 is illogical, thus perplex and inadmissible. 6. Auxiliary request 2 is admissible and well-founded 114. Since auxiliary request 1 is inadmissible, the requirements to assesses subordinate auxiliary request 2 are met. It leads to the patent being upheld in amended form, since auxiliary request 2 is admissible and claim 1 as amended is novel and inventive. a) Feature analysis of claim 1 as amended by auxiliary request 2 115. New claim 1 of the second auxiliary request corresponds to the combination of claim 1 as granted with claim 4 and claim 5 as granted. The feature analysis of claim 1 as amended can be provided as follows. The Court does not follow the feature analysis presented by the defendant (Statement of defence page 31), since the features from the former dependent claim 4 integrated into claim 1 as amended must be considered as well. Title A nebulizer head (10), comprising: Feature 1 a housing structure (12) providing a bidirectional air-flow path (16) between two opposite air-flow openings (18a, 18b), Feature 1.1 wherein one of the air-flow openings is provided as a mouthpiece opening Feature 1.2 and another one of the air-flow openings is provided as a backside opening, and Feature 1.3 wherein a flow direction from the backside opening to the mouthpiece opening is a first air-flow direction for inhaling and a vice versa flow direction is a second air- flow direction for exhaling; Feature 2 a fluid reservoir (14) provided to accommodate a liquid from which small droplets are to be generated in order to form an aerosol; Feature 3 an aerosol generator (20) with an aperture member (22) that comprises an aperture surface (24) with a plurality of apertures to provide the small droplets from the liquid; wherein the fluid reservoir is arranged adjacent the aerosol generator such that the aperture member is in contact with the fluid, Feature 3.1 wherein the aperture member (22) is mounted substantially vertically in the nebulizer head (10) in relation to the air-flow path (16) which is, in normal use of the nebulizer head (10), arranged horizontally; Feature 3.2 wherein the aerosol generator is arranged within the air-flow path; 21  Feature 4 wherein at least one by-pass flow path (26) is provided between the aerosol generator and the housing structure, Feature 4.1 wherein the by-pass flow path (26) is arranged around the aerosol generator (20), and Feature 4.2 wherein a flow direction of the by-pass flow path (26) is the same as the second air-flow direction; Feature 5 wherein the air enters the air-flow path and leaves the air-flow path via the air-flow openings; Feature 6 wherein the aperture surface is arranged transverse to the first and second air-flow direction; and Feature 7 wherein the air-flow is manually activatable by the user breathing in and out respectively; and Feature 8 wherein the air-flow is non-supported by ventilation means. Feature 9 wherein one of the air-flow openings is provided as a mouth-piece opening (46) and the other one of the air-flow openings is provided as a backside opening (48); and a flow direction from the backside opening to the mouth-piece opening is the first air-flow direction and the vice versa flow direction is the second air-flow direction; and Feature 10 wherein, preferably, the aerosol generator provides the small droplets in the inhaling direction; and wherein during inhaling a flow of air flowing around the aerosol generator is provided at a rear side of the aperture surface. Feature 11 wherein a portion of the air-flow path between the aerosol generator and the mouth-piece opening is a front air channel (50) and a portion between the aerosol generator and the backside opening is a rear air channel (52); and Feature 12 wherein the rear air channel and preferably the by-pass sections are equal or larger in clear cross-section than the mouth-piece opening. b) Auxiliary request 2 is admissible 116. Auxiliary request 2 is admissible. 117. aa) According to R. 30.1(b) RoP, the application to amend the patent shall contain an explanation as to why, i.a., the amendments satisfy the requirements of Art. 84 and Art. 123.2, 123.3 EPC. 118. bb) The defendant addressed why claim 1 as amended satisfies the requirements of Art 84 and 123.2, 123.3 EPC. Therefore, auxiliary request 2 is admissible. c) Auxiliary request 2 is clear in the sense of Art. 84 EPC 119. aa) As stated above, Art. 84 EPC provides that the claims shall define the matter for which protection is sought. They shall be clear and concise and be supported by the description. 120. The Court may only assess if the amendments meet the above-mentioned requirements. It may not assess clarity and conciseness issues, if they stem from unclarity issues already present in 22  granted dependent claims (see LD Düsseldorf, UPC_CFI_355/2023, decision dated 28 January 2025, Fujifilm v Kodak, referring to G3/14). 121. bb) Auxiliary request 2 is clear. 122. As pointed out by the claimant, Feature 9 (claim 4 as granted, lines 2 to 8) is redundant, because its subject matter is part of features 1.1 to 1.3. However, since the clarity issues presented by the claimant were all present in the dependent claims 4 and 5, they are not relevant in these proceedings. 123. The same is to be said with regard to the phrasing “preferably” in Feature 10 (claim 4 as granted, lines 9 to 13). The Court does not agree with claimant’s finding that the word “preferably” could also refer to the second half-sentence, starting in line 10 (“(…); and wherein (…)”). It is clear from the use of a semicolon and the repeating of the words “and wherein” that the preferential character is not attached to the second half-sentence starting in line 10, as stated above. It does not agree with claimant’s findings, either, that optional features should, for clarity reasons, remain in a dependent claim (Reply to the Statement of Defence, page 38). They are allowed into claims as long as no clarity issues arise (see i.e. Guidelines for Examination, F.IV.4.9 “Optional Features”). As discussed earlier, any clarity issue arising from the use of the word “preferably” was already present in claim 4 as granted. 124. The same can be said for the use of the word “preferably” in Feature 12 (claim 5 as granted, lines 7 to 9). d) Novelty of claim 1 as amended by auxiliary request 2 125. Claim 1 as amended by auxiliary request 2 is novel. Not even the claimant does dispute this. Claimant has never introduced an argument claiming that claim 5 was not novel. Thus, claim 1 as amended (which incorporates claims 4 and 5) is novel. e) Claim 1 as amended by auxiliary request 2 is also inventive 126. Claim 1 as amended by auxiliary request 2 is inventive. 127. aa) The assessment of inventive step must be carried out in accordance with Art. 56 EPC, which states that “[a]n invention shall be considered as involving an inventive step if, having regard to the state of the art, it is not obvious to a person skilled in the art”. An objective approach must be taken to the assessment of inventive step. The subjective ideas of the applicant or inventor are irrelevant. Inventive step is to be assessed from the point of view of the skilled person on the basis of the state of the art as a whole, including the skilled person’s common general knowledge. The skilled person is assumed to have had access to the entire publicly available art on the relevant date. The decisive factor is whether the claimed subject matter follows from the prior art in such a way that the skilled person would have found it on the basis of that person’s knowledge and skills, for example by obvious modifications of what was already known. 128. The Court of Appeal has clarified that the UPC’s approach to assess inventive step is as follows (see UPC_CoA 457/2024 et alii, decision of 25 November 2025, margins 128 et sequi – Meril v 23  Edwards; UPC_CoA 528/2024, 529/224, decision of 25 November 2025, margin 127 et sequi - Amgen v Sanofi): 129. It first has to be established what the object of the invention is, i.e. the objective problem. This must be assessed from the perspective of the person skilled in the art, with their common general knowledge, as at the application or priority date (also referred to as the effective date) of the patent. This must be done by establishing what the invention adds to the state of the art, not by looking at the individual features of the claim, but by comparing the claim as a whole in the context of the specification and the drawings, thus also considering the inventive concept underlying the invention (the technical teaching), which must be based on the technical effect(s) that the person skilled in the art, on the basis of the application, understands is (are) achieved with the claimed invention. 130. In order to avoid hindsight, the objective problem should not contain pointers to the claimed solution. 131. The claimed solution is obvious when at the effective date the person skilled in the art, starting from a realistic starting point in the state of the art in the relevant field of technology and wishing to solve the objective problem, would (and not only “could”) have arrived at the claimed solution. 132. The relevant field of technology is the specific field relevant to the objective problem to be solved as well as any field in which the same or similar problem arises and of which the person skilled in the art of the specific field must be expected to be aware. 133. A starting point is realistic if the teaching thereof would have been of interest to a person skilled in the art who, at the effective date, wishes to solve the objective problem. This may for instance be the case if the relevant piece of prior art already discloses several features similar to those relevant to the invention as claimed and/or addresses the same or a similar underlying problem as that of the claimed invention. There can be more than one realistic starting point, and the claimed invention must be inventive starting from each of them. 134. The person skilled in the art has no inventive skills and no imagination and requires a pointer or motivation (in German: “Anlass”) that, starting from a realistic starting point, directs them to implement a next step in the direction of the claimed invention. As a general rule, a claimed solution must be considered not inventive/obvious when the person skilled in the art would take the next step, prompted by the pointer or as a matter of routine, and arrive at the claimed invention. 135. A claimed solution is obvious if the skilled person would have taken the next step in expectation of finding an envisaged solution of his technical problem. This is generally the case when results of the next step were clearly predictable, or where there was a reasonable expectation of success. 136. bb) Claim 1 as amended is inventive over the Pari eMotion as a starting point in combination with D5. 137. (1) The Court can for the sake of assessing inventive step assume hypothetically that the Pari eMotion is construed as follows (see Statement of Claim p. 16 et sequi). The nebulizer head comprises a “Verneblerkammer” (which unofficially translates as “nebulizer chamber”; denoted 24  with number 40 and annotated in blue by the claimant in the following images), a “Mundstueck” (which unofficially translates as “mouthpiece”; denoted with number 30 and annotated in red by the claimant in the following images), a “Einatemventil Grundkoerper” (which unofficially translates as “inhalation valve basic body”; denoted with number 20 and annotated in light blue in the following images), “a “Fluessigkeitszufuehrung” (which unofficially translates as “liquid supply”; denoted as number 10 and annotated in yellow and purple in the following images). The Fluessigkeitszufuehrung comprises a “Medikamentenbehaelter” (which unofficially translates as “medicine container” and is shown in yellow) and a “Deckel” (which unofficially translates as “lid” and is shown in purple). 138. The Court hypothetically assumes, as stipulated by the claimant, that the “Medikamentenbehälter”/ medicine container has two openings (green below) at the top. It can also assume that air enters through these openings into the nebulizer during inhalation and air exits the nebulizer through these openings during exhalation. The two openings communicate 25  with the four openings of the “Einatemventil Grundkoerper”/ inhalation valve basic body (see below, image from Revocation action page 17): 139. The Court hypothetically assumes that the Einatemventil Grundkörper/ inhalation valve basic body has four openings (green below) arranged around a central hole for sealing against the aperture surface of the aerosol generator (Aerosolerzeuger eMotion) (see Statement of Claim page 19): 140. The Court may also for the sake of assessing inventive step assume that the Pari eMotion has openings behind the aperture surface (downstream in the exhaling direction), as shown below (see Statement of Claim, page 23, with annotations from claimant): 26 141. For the sake of assessing inventive step, the Court may also assume hypothetically, that the Pari eMotion has been publicly used prior to the priority date, although this is in dispute between the parties (see, in this regard, Revocation action pages 13 et sequi, Statement of Defence, pages 8 et sequi, Reply to the Statement of Defence, pages 24 et sequi, Rejoinder in Revocation action, pages 18 et sequi). As will be shown below, there is in any case inventive step over the Pari eMotion. 142. (2) For the sake of assessment of inventive step, the Court may consider the Pari eMotion as a starting point. Public prior use may generally be the starting point for the assessment of inventive step. The Pari eMotion as a hand held nebulizing device can be a realistic starting point. 143. (3) The Pari eMotion as a realistic starting point does not disclose a backside opening in the sense of feature 1.2 of claim 1, and it therefore does not disclose feature 1, feature 9 (dependent claim 4) and feature 12 (dependent claim 5) either. 144. (a) Feature 1.2 (backside opening) is not disclosed. As discussed above, a backside opening in this sense requires an opening physically arranged at the backside of the device, opposite to the mouthpiece. This is not disclosed by the Pari eMotion. Claimant refers to openings positioned laterally on top of the device, not in the rear of the device. They are not backside openings in the sense of feature 1.2 as interpreted by this Court. 145. (b) Feature 1 is therefore not disclosed, either. Admittedly, notwithstanding that the Pari eMotion is named an “inhaler”, it is suitable for a bidirectional airflow. Nothing in the drawings of the Pari eMotion device permits to conclude that it has only a one-directional airflow path and that it can only be used as an inhaler. There are no indications that it is not possible to use the Pari eMotion device with a bi-directional airflow path. As long as there are no means that would restrict airflow in one direction, airflow will be possible in both directions. The skilled person would not arrive at a different conclusion because of the name “Einatemventil”. Although a one-way valve would prohibit the air from flowing in both directions, there is nothing in the drawings to let the skilled person arrive at the conclusion that the name “Einatemventil” refers to a one-way valve. However, the Pari eMotion does not disclose a bidirectional air-flow path in the sense of claim 1, meaning a bidirectional air-flow path between two opposite openings, whereof one is a backside opening in the sense of feature 1.2, as explained above. 146. (c) Feature 9 (as part of former dependent claim 4, now integrated into claim 1 as amended) (“wherein a portion of the air-flow path between the aerosol generator and the mouth-piece opening is a front air channel (50) and a portion between the aerosol generator and the backside opening is a rear air channel (52); and”), is not disclosed by the technical drawings relating to the Pari eMotion. As discussed above, the Pari eMotion does not disclose a backside opening, therefore, it does not disclose a rear air channel in the sense of dependent claim 4 as integrated into claim 1 as amended. 147. (d) Features 11 and 12 (former dependent claim 5, now integrated into claim 1 as amended) (“wherein a portion of the air-flow path between the aerosol generator and the mouth-piece opening is a front air channel (50) and a portion between the aerosol generator and the backside opening is a rear air channel (52); and wherein the rear air channel and preferably the bypass sections are equal or larger in clear cross-section than the mouth-piece opening”), are not 27  disclosed, because the Pari eMotion does not show a backside opening in the sense of claim 1 as amended. 148. Even if the component addressed by the claimant as a backside opening was seen as a backside opening, the skilled person would deduce from the figures referred to by the claimant that these components are smaller than the mouthpiece opening. There is no way to deduce from the images presented by the claimant if the clear cross-section of the rear air channel (thus the portion between the aerosol generator and the backside opening) is larger than the clear cross- section of the backside opening. Anyway, the clear cross-section is determined by the smallest portion. Thus, the rear air channel is not equal or larger in clear cross-section than the mouthpiece opening, thus feature 12 is not disclosed. 149. (4) The skilled person, starting from the Pari eMotion, would not arrive at the subject-matter of the invention of claim 1 as amended, in the Court’s opinion. 150. (a) There is no reason to believe that the skilled person, starting from the Pari eMotion, would arrive at the subject matter of claim 1 of the patent in suit by using their common general knowledge. The common general knowledge (CKG) at the priority date of the patent in suit has not been explicitly addressed by the claimant. The ‘CGK’ is, just like the other elements of the lawsuit, subject to evidence and pursuant to Art. 54 of the UPCA, the burden of proving the existence of the ‘CGK’ lies with the party invoking it (UPC_CFI 307/2023, decision issued on 29 November 2024, para. 3 – NJOY v. VMR). The Court may therefore assume that it is well-known to the skilled person only that the smallest cross-section in a flow path governs the pressure resistance, as the claimant points out and the defendant does not dispute. However, the Court does not agree with claimant’s argument that the skilled person will inadvertently arrive at the subject matter of granted claim 5/ feature 12 without the need for inventive activity, if one intends to govern the pressure resistance exclusively by the mouthpiece opening. There is no evidence of an incentive for the skilled person to govern the pressure resistance exclusively by the mouthpiece opening. This is not the technical problem solved by the patent. The problem thus formulated by the claimant contains a pointer to the solution, which is to be avoided, as explained above. 151. Additionally, and conclusively, this argument by the claimant is based on the assumption that the Pari eMotion discloses a backside opening in the sense of claim 1 of the patent. As discussed above, this is not correct. 152. (b) The skilled person would not arrive at the subject matter of claim 1 as amended of the patent in suit by combining the Pari eMotion with the teaching of D5. 153. (aa) D5 (US 2011/0146670 A1) relates to a nebulizer for ventilation machines and a ventilation machine comprising such a nebulizer. In relation to nebulizers for ventilation machines known in the art, D5 states that non-return valves allow a flow solely in the direction of the patient. It is coupled perpendicularly to a first flow channel, with the aerosol being supplied in a direction perpendicular to the direction of flow in a first flow channel, [0003]. D5 establishes that this design entailing a non-return valve might have serious consequences in case of malfunction, [0004]. Owing to the perpendicular introduction of the aerosol, there is a high deposition of the aerosol on the surface, [0005]. Thus, the object of the invention of D5 is to create a nebulizer for ventilation machines, wherein the deposition of aerosol on the surfaces of the flow channel and 28  the losses associated therewith are reduced and failures of vulnerable elements can be avoided, [0007]. D5 also addresses that no flow resistance may be generated, the nebulizer must be airtight at a certain positive pressure, filling of the nebulizer must be possible during operation of the device without loss in pressure in the system, [0007]. According to [0009], the idea forming the basis for the invention of D5 is to reposition the nebulising device in the flow channel such that the aerosol generation occurs by nebulising the fluid parallel to the direction of flow in the flow channel, instead of coupling the nebulising device perpendicular to the direction of flow. 154. D5 thus teaches how to place a vibrating-mesh aerosolizer in a ventilator flow channel so that the nebulization is parallel to the ventilator flow. It also discloses flow-around clearances around the membrane to avoid ventilator flow resistance. 155. Figure 4 of D5 shows a device according to the invention of D5, with the membrane 37 of the aerosol generator disposed in the flow channel from connection 10 to the second connection 31, arranged vertically transverse to the flow direction. 156. (bb) The skilled person would not arrive at the subject matter of the invention of the patent in suit by combining the teaching of the Pari eMotion device with the teaching of D5. 157. The skilled person at the time of priority of the patent in suit looking to solve its objective technical problem did not have any reason to combine the teaching of the Pari eMotion with the teaching of D5, so this was not obvious to the skilled person. The skilled person might have been aware of prior art in the field of nebulizers for ventilation machines, but will have acknowledged that hand held nebulizers and nebulizers for ventilation machines have different requirements. While the air flow in a nebulizer for a ventilation machine and a hand held nebulizer might be the same, the nebulizer for a ventilation machine does not have to meet requirements to ensure that no medication gets on the face of a patient. The exhaled air is led away from the patient by a line. Therefore, notwithstanding the fact that the Pari eMotion and D5 might fall under the same IPC classification, the skilled person will not consider nebulizers for ventilation machines as a 29  relevant field of technology, as they are not relevant to the objective problem of the patent in suit, trying to ensure that medication does not get on the face of the patient. 158. Additionally, the claimant does not provide any argument why the skilled person would modify the Pari eMotion in order to have a backside opening. The Court does not see any incentive for the skilled person to provide this modification when combining the Pari eMotion with the teaching of D5, either. D5 does not disclose a backside opening in the sense of the patent in suit, allowing air to exit into the atmosphere. Connection 10, that claimant refers to as a “backside opening”, does not allow the air to exit into the atmosphere. 159. cc) Claim 1 as amended is inventive over D2 (WO 2011/089485 A1) as realistic starting point, in combination with D5. 160. (1) D2 relates to a nebulizing drug delivery device having an improved user interface and a method of manufacturing the same. It could therefore be a realistic starting point for the skilled person. 161. D2 discloses a nebulizing drug delivery device 10, configured to nebulize a liquid drug solution for inhalation by a subject. It comprises, inter alia, a housing 12 and a drug nebulization module 16 ([0018]). The housing 12 may be formed from a set of different parts that are selectively detachable and/or replaceable, [0019]. As shown in figure 1, this may include a lower base portion and an upper portion comprising the nebulization module 16. The housing includes a mouthpiece 20 and a body 22, [0019]. The mouthpiece 20 may be removable from the rest of body 22, [0020]. In figure 1, it is shown integrally formed with the housing 12. 162. The drug nebulization module 16 includes a medication chamber 32 and a mesh 36. The mesh 36 is vibrated by a piezoelectric element (not shown) to generate an aerosol that is communicated to the subject through body 22 ([0023]). 163. Figure 1 of D2 (with annotations from the claimant, see page 36 of the Statement of claim) shows a sectional view of a nebulizing drug delivery device, according to one or more embodiments of the invention ([0008], [0018]): 30 164. (2) D2 does not disclose Features 1.2, 3.1, 4, 4.1 and 4.2. 165. (a) As explained by the claimant and agreed on by the defendant, D2 does not disclose features 3.1, 4, 4.1 and 4.2. The Court agrees. 166. (b) Additionally, D2 does not disclose a backside opening in the sense of the patent in suit. While the device in Figure 1 seems to show an opening in the back, as annotated by the claimant, the skilled person cannot deduce from this figure that there is an airflow path between the opening 24 of the mouthpiece and the annotated backside opening. Figure 1 does not permit to recognize an airflow path between the annotated backside opening and the mouthpiece 20. The description of D2 is silent on airflow paths and the existence of a backside opening. It also does not disclose that the user of the device depicted in Figure 1 would exhale through the device. Based on the single view of Fig. 1 it is not possible for the skilled person to determine whether there is an airflow path between the annotated backside opening and the mouthpiece. Neither can the skilled person determine if the backside opening of the device depicted in figure 1 of D2 can be used as an air-flow opening, because a possible air-flow cannot be deduced from the figure. Fig. 2 and 3 of D2, which illustrate perspective views of the device (see [0024]), do not show any backside opening. 167. (3) The skilled person, starting from D2, would not arrive at the subject matter of claim 1 as amended of the patent in suit by combining the teaching of the D2 device with the teaching of D5. First, for the reasons stated above, the skilled person would not consider D5 when looking to improve the device of D2. Additionally, the claimant does not provide any argument why the skilled person would modify the device of D2 in order to have a backside opening. The Court does not see any incentive for the skilled person to provide this modification when combining with D5, either, as explained above. 168. dd) Claim 1 as amended is inventive over D7 as realistic starting point, in combination with D5. 31 169. (1) D7 (US 2005/0011514 A1) discloses a nebulizer having a body 19 and an aerosol generator 7. It could therefore be a realistic starting point for the skilled person. The aerosol generator 7 comprises a vibratable member 40 and a piezoelectric element 41 ([0049]). The vibratable member 40 is oriented horizontally (see figure 5, below). The aerosol generator 7 is mounted at the outlet of a medication cup 2 to aerosolise the liquid medicament ([0044]). 170. The body 19 has an outlet port 21 having a connector piece (outlet 22) to which a mouthpiece part 24 is connected. The connector piece is inclined upward relative to the horizontal axis ([0045]). 171. As [0045] provides, aerosol generated by the aerosol generator 7 is delivered into a vented aerosol passage 20 defined by the nebulizer body 19. Air passes into the passage 20 through air inlets 21. The air entrains the aerosolised medicament, and the entrained aerosolised medicament is delivered from the nebulizer through the outlet port 22 from the passage 20. In this case, the inlets 21 are formed by air vents which are located above the aerosol generator 7. 172. The arrangement of the inlet 21 on one side of the nebulizer housing, the outlet 22 on a generally opposite side of the housing and the baffle 25 (which directs air and entrained aerosolised medicament to the outlet 22) optimises the flow of air and entrained aerosolised medicament to the outlet 22 ([0046]). 173. During inhalation, the aerosolised medicament passes from the aerosol generator 7 into the passage 20 of the housing 19. The aerosolised medicament is entrained with a gas, such as air, which passes into the passage 20 through the inlet 21. The entrained mixture of the aerosolised medicament and the gas then pass out through the outlet 22 and onto the respiratory system of the patient ([0086]). 174. [0087] describes that the user breathes in and out slowly. On the exhale cycle, exhaled gas flows back along the mouthpiece 24 and into the passage 20. Exhaust may pass through the gas inlets 21. 175. Figure 5 (as annotated by the claimant, see page 46 of the Statement of claim) is a cut-away view of the nebulizer of Figure 4, which is a perspective view of a nebulizer according to an embodiment of the invention with a mouth piece fitted, see [0033], [0032]: 32 176. (2) D7 does not disclose feature 3.1. 177. (a) This is undisputed by the claimant. The Court agrees: During normal use, the membrane 40 (part of the aerosol generator 7, shown above) is arranged horizontally. At the level of the membrane, the orientation of the membrane is perpendicular to the air flow, but the airflow is vertical, not horizontal. As the claimant acknowledges, the fact that the air flow (as annotated by the claimant in Figure 5 in the image above) has different orientations is not enough to disclose a horizontally arranged air-flow path in normal use. In the device of D7, the airflow at the level of the membrane is vertical, while the dominant direction of the airflow transporting drug droplets to the mouthpiece is not horizontal. 178. (b) Contrary to the defendant’s arguments, features 4.1 and 4.2 as well as a bidirectional air-flow path in the sense of the patent are disclosed. 179. (aa) A bidirectional air flow path in the sense of the patent is disclosed. The defendant does not explain their argument that D7 uses a blower to generate the air flow (see Statement of Defence, page 25). D7 does not explicitly address a blower, and the Cort does not see where a blower could be implicitly disclosed or addressed, either. The sketch on page 25 of the Statement of Dfeence does not correspond to the device in figure 5 of D7. The claimant disputes the defendant’s technical understanding of D7 in this regard. The defendant seems to agree in their Rejoinder in the revocation action and reply re the application to amend (page 14). They do not further explain their argument, referring to figure 1b of the patent in suit, that the air-flow in D7 is fully different from the air-flow in the patent in suit. A specific orientation of the air-flow path is only addressed in feature 3.1. 33 180. (bb) Feature 4.1 (“wherein the by-pass flow path (26) is arranged around the aerosol generator (20), and”) is dislosed by D7. As is illustrated by figure 5 of D7, the air inlet 21 is situated above the aerosol generator 7 and a ring-shaped space extending around the aerosol generator 7 connects to the air inlet 21 opening and to the aerosol passage 20. The ring-shaped space constitutes a by- pass flow path. 181. (cc) Feature 4.2 (“wherein a flow direction of the by-pass flow path (26) is the same as the second air-flow direction”) is disclosed as well. D7 explains [0086] and [0087]) that during inhalation, the aerosolized medicament is entrained with air passing into the passage 20 through the inlet 21 and the entrained mixture of aerosolized medicament and the air passes out through the outlet 22 and further on to the respiratory system of the patient; and during exhalation, exhaled gas flows back along the mouthpiece and into the passage 22 subsequently passed through the gas inlet 21. 182. (3) The skilled person would not arrive at the claimed invention by combining the teachings of D7 and D5. 183. For the reasons stated above, the skilled person would not consider D5 when assessing possible improvements of D7. 184. Additionally, in order to arrive at the claimed invention, the skilled person does not only need to modify the position of the aperture member but also needs to modify the shape and orientation of the housing 19, as well as the orientation of the connecting piece 22 and the mouthpiece 24 in order to obtain an airflow that is, in normal use of the nebulizer head, arranged horizontally. 185. Such an adjustment would require a thorough modification of the device of D7. The claimant does not provide any reason why a skilled person would modify the orientation of the airflow in normal use based on the teaching of D5. 186. As the claimant states correctly (Statement of Defence, page 28) in this context, there is already a bidirectional (vertical) flow path in D7 as shown in the above figure, and the skilled person would have no reason to modify such a structure, especially since in D7 the aperture member is oriented substantially perpendicular in relation to the air-flow path such that the aerosol generation occurs by nebulizing the fluid parallel to the direction of the airflow. The generated droplets are thus provided in the inhalation air-flow direction in the device of D7. 187. ee) The same can be said for the attack on inventive step based on D7 as closest prior art in combination with D6 and D5. 188. ff) Claim 1 as amended by auxiliary request 2 is inventive over D3 as realistic starting point in combination with D7 and D5. 189. (1) D3 (EP 1927373A1) discloses an inhalation nebulizer. It provides an inhalation nebulizer presenting a flow path (9) from openings in a lid to the mouthpiece opening for inhaling air. A fluid reservoir (“liquid storage container 4”) is arranged adjacent an aerosol generator 2 for forming an aerosol, [0025], [0026]. When a patient exhales into the opening of the mouthpiece, an exhalation valve (322) is opened so that the exhaled air of the patient is discharged into the surroundings without passing along the aerosol generator, [0032]. An inhalation valve (20,21a) prevents exhaled 34  air from entering the mixing chamber and reversely passing the aerosol generator in exhalation phase, [0031]. 190. D3 explains in [0012] that “[t]he present invention takes special account of the fact that in the above mentioned cases patients show a specific breathing pattern that consists of a relatively short inhalation phase followed by a prolonged exhalation phase.” 191. [0014] provides: “While the patient exhales into the inhalation therapy device, the generated aerosol is collected in the mixing chamber. (…) the continuously generated aerosol can accumulate therein without losses even when the exhalation phase is longer than the inhalation phase like in the case of emphysema.” 192. “Since aerosol is accumulated in the mixing chamber during exhalation (…), not only the amount of aerosol generated due to the continuous production is available for the inhalation, but at the beginning of the inhalation phase an aerosol bolus can be inhaled, (…)” ([0016], see also [0033]). 193. Figure 1 shows a sectional view of an embodiment of an inhalation therapy device according to the invention ([0023]), shown below with annotations from the Court in green, red and violet: 194. (2) Undisputedly, D3 does not disclose features 1, 1.3, 4.2 and 6. The Court agrees. 195. (3) The skilled person would not, in the Court’s opinion, arrive at the subject matter of claim 1 as amended by combining the teaching of D7 and D5 with the teaching of D3. The skilled person would not without taking an inventive step combine D3 with D7 and D5. As explained above, D7 does provide a bidirectional airflow. This solution is however inconsistent with the objectives of the device of D3. The presence of the inhalation valve 20, together with the exhalation valve 33, is an essential feature of the device of D3. 196. The above-mentioned objectives, set out in [0012], [0014] and [0016] of D3, are reached by the presence of the inhalation valve 21 that is open to allow an inflow of ambient air into the mixing chamber 3 during an inhalation phase and is closed to prevent escape of the aerosol from the mixing chamber 3 during an exhalation phase. This inhalation valve is combined with an exhalation valve 322 that is opened to allow the discharge of the respiratory air of a patient into 35  the surroundings during the exhalation phase and is closed to prevent the inflow of ambient air during the inhalation phase ([0031] and [0032], claim 1). 197. This makes the inhalation valve an essential feature of the device of D3. There is no hint to remove the valves. Therefore, D3 teaches away from omitting the inhalation valve 20. 198. As D3 relates to a device that permits to accumulate aerosol during an exhalation phase in order to release at the beginning of the inhalation phase an aerosol bolus, a person skilled in the art will not combine the D3 with D7 and D5 to solve the objective technical problem. 199. Even if the person skilled in the art would combine D3 with D7 and D5, they would not arrive at the claimed invention as they would not find any suggestion in D7 or D5 to solve the objective problem while maintaining the objectives of D3. 200. gg) For the sake of completeness, claimant has not raised an attack against claim 1 as amended based on the Pari eMotion as closest prior art in combination with D2/ D7 and D5. In any event, any attack against claim 1 as amended on the basis of the Pari eMotion as closest prior art in combination with D2 or D7, and D5 is precluded due to the front-loaded nature of the UPC proceedings. 201. (1) During the oral hearing, the claimant presented an attack based on the Pari eMotion plus D2 or D7 in relation to claim 1 as granted. They did not present an attack based on the Pari eMotion plus D2 or D7 plus D5 against claim 1 as amended by auxiliary request 2. The Court does not assess possible attacks ex officio. 202. (2) If this attack should have been presented implicitly, it is precluded due to the front-loaded nature of the UPC proceedings. While the claimant explained that this attack was first raised during the oral hearing in reaction to the defendant’s claim construction, which was narrower than understood by the claimant from the submissions, for the reasons set out above, there was no reason to assume that the defendant would accept any opening situated behind the aperture surface as a backside opening, so there was reason for the claimant to present this attack earlier. Conclusion 203. Claim 1 of the patent as granted is not novel over D1. Auxiliary request 1 is inadmissible. Claim 1 of auxiliary request 2 is inventive and valid. The dependent claims of auxiliary request 2 share the same fate as claim 1 and are considered valid. Costs 204. The parties agree that the recoverable amount of attorney fees shall be 30.000 €, if necessary, split depending on the outcome of the case. This means that by implicit mutual agreement the value of the case is set, according to the ceilings for recoverable costs, to 250.000 €. 205. Art. 69(1) UPCA provides that costs are generally to be borne by the unsuccessful party. Where a party exceeds only in part, the Court may order that the parties bear their own costs, Art. 69(2) UPCA. 36 206. Both parties are equally successful and unsuccessful. The claimant is successful on the main attack because the patent is only upheld in an amended version, but it is not entirely invalidated. Thus, the Court deems it appropriate to let the parties bear their own costs. Decision 1. The revocation action concerning European Patent 3 397 329 B1 is rejected, insofar as the patent is maintained as amended by Auxiliary Request 2 for France and Germany. 2. The value of the proceeding is set to 250.000 €. 3. The parties shall bear their own costs. 4. The Registry shall send a copy of this decision to the European Patent Office and to the national patent office of any Contracting Member States concerned, after the deadline for appeal has passed. Issued on 27 November 2025 Firmato digitalmente Presiding Judge da ANDREA POSTIGLIONE Andrea Postiglione Data: 2025.11.27 13:59:16 +01'00' Legally qualified judge and judge-rapporteur Firmato digitalmente da ANNA- ANNA-LENA KLEIN LENA KLEIN Anna-Lena Klein Data: 2025.11.27 09:56:40 +01'00' Technically qualified judge Koen Digitally signed by Koen Callewaert Koen Callewaert Callewaert Date: 2025.11.27 10:48:47 +01'00' Deputy-Registrar Firmato VALERIA digitalmente da VALERIA MOLINARI MOLINARI Data: 2025.11.27 14:03:36 +01'00' 37 Information about appeal An appeal against the present Decision may be lodged at the Court of Appeal, by any party which has been unsuccessful, in whole or in part, in its submissions, within two months of the date of its notification (Art. 73(1) UPCA, R. 220.1(a), 224.1(a) RoP). Information about enforcement (Art. 82 UPCA, Art. Art. 37(2) UPCS, R. 118.8, 158.2, 354, 355.4 RoP) An authentic copy of the enforceable decision will be issued by the Deputy-Registrar upon request of the enforcing party, R. 69 RegR. 38

Key Holdings

• The claimant's standing for a revocation action was affirmed, clarifying that 'concerned by the patent' (R. 47(6) RoP) does not require a specific legal or economic interest.
• Claim interpretation was conducted in accordance with the Court of Appeal's decision in Nanostring v 10x Genomics.
• The Court found a lack of novelty based on prior art D1 (Art. 54(3) EPC), emphasizing that a device with disclosed physical characteristics is novelty-destroying regardless of intended use, unless unsuitable.
• Auxiliary request 1 was deemed inadmissible, while auxiliary request 2 was admissible.
• Applying Art. 56 EPC and recent CoA decisions, the Court found no inventive step incentive from a prior art product, leading to the patent being partially upheld on auxiliary request 2.

Tags

• Auxiliary Requests
• Claim Construction
• Inventive Step
• Novelty
• Patent Validity
• Revocation

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