The decision is Edwards Lifesciences Corp. v. Meril GmbH, UPC_CFI_1160/2026 (Oct. 28, 2026). I blogged about an earlier order in this matter here. Prior to that, in an earlier proceeding, Meril was found to have infringed Edwards’ patent (EP 3 699 828 B2) for a prosthetic heart valve. Edwards thereafter “filed an application for the determination of damages, which includes a request for an order to lay open books” (para. 2). Specifically, Edwards claims that it is entitled to discovery pertaining to damages not only for the infringing products themselves, but also for (1) “related accessory products” (“convoyed goods”); and (2) damages relating to other noninfringing products which, according to Edwards, Meril would not have sold but for the foothold that the infringing products provided (referred to here as “springboard damages”). From the decision:
4. Edwards argues that as a result of the infringement of EP 828, Meril has also sold related accessory products, including the Navigator delivery apparatuses, crimping devices, delivery sheaths, and balloon catheters. Such accessory products constitute “convoyed” goods, namely products that would not have been sold but for the underlying infringement. Further, as a result of the infringement of EP 828, Meril has established (a) relationships with clinicians responsible for the implantation of THV devices; (b) a distribution network for THV devices; (c) a clinical evidence base which it uses to market the “Myval Series”, including devices other than the Infringing Products, i.e., the Octacor THV / System, Octapro THV / System, and Octapro+ THV / System (together, the “Other Relevant Devices”; and (d) other relationships and knowledge regarding the THV market within the Territory for Relief. Edwards understands that the CE marks granted in respect of the “Other Relevant Devices” have been granted on the basis that no “significant changes” have been made to their design and intended purpose as compared to the “legacy device”, being the Myval System (per Medical Device Regulation 2017/745, Art. 120.324). As a consequence, these devices have essentially been able to “ride on the back” of the approval given for the Myval System, a device which infringes EP 828. Consequently, but for the infringement of EP 828, Meril would not have been able to obtain approval for these other devices in Europe or at least would not have been able to avoid undergoing a full MDR certification process –i.e., submitting an MDR application, undergoing assessment of the technical documentation demonstrating conformity with MDR requirements and obtaining approval of the MDR evaluation package - which would have delayed approval by several years. Edwards also understands that Meril has “substituted” one THV device for another in the context of national approvals, tenders, etcetera where a particular THV device has ceased to be available due to the grant of an injunction. As a result, Meril has been able to use an infringing device to establish a foothold in the market, and then substitute a different device when that device ceased to be available as a result of activities which have been found by a court to infringe Edwards’ patent rights. . . .
26. . . . as any order pursuant to Rule 141RoP must be proportionate, the possibility of ordering access to information is limited, particularly with regard to information relating to non-infringing activities.
27. The need to take the principle of proportionality (and fairness/equity) into account follows from Art. 42 UPCA, the Preamble to the RoP (2-6) and Art. 10.3 and Art. 13.1 of the Enforcement Directive. The latter demands that damages awarded to the patent owner are proportionate to the actual prejudice suffered as a result of the infringement. By virtue of Art. 20 UPCA, the Unified Patent Court shall apply Union law in its entirety and respect its primacy.
28. One aspect of proportionality is necessity. . . .
34. The extent to which the profits realised are attributable to the infringement of the intellectual property right cannot usually be determined precisely but only estimated. The necessary causal link between the infringement of the intellectual property right and the profit realised must not be understood solely in terms of adequate causality. Even in the case of profits derived from the marketing of devices manufactured in accordance with a patent, it must rather be determined, on a discretionary basis, whether and to what extent the profit realised is reasonably attributable to the characteristics of the sold item associated with the infringed intellectual property right or to other factors. Profits that are causally related but too far removed should not be attributed as having no sufficient connection with the infringement.
35. On this basis, the claim for the surrender of the infringer’s profits also encompasses ancillary transactions which, whilst not constituting an act of use within the meaning of Art. 25, 26 UPCA, are nevertheless concluded in a causal connection with acts of infringement and have a sufficient link to the infringing subject-matter.
36. Such a sufficient connection exists, in any event, in the case of profits from transactions involving consumables or reusable devices intended for use with a patent-infringing device. However, this only applies when those transactions are causally linked to the patent infringement. As with the profit derived from placing the infringing article on the market, the profit derived from the sale of consumables in such scenarios will, as a rule, not be based solely on the infringement, but on other factors that were decisive for the customer’s purchasing decision. However, this does not alter the fact that the profit is in any event also based on the patent infringement, because the distribution of consumables or any other related accessory devices, respectively, would not have been possible, or not to the same extent, without the placing on the market of the patent-infringing device. This is particularly evident in situations where the consumable or any other related accessory devices, respectively, is, by its very nature, tailored to the protected device, or where sourcing from a single supplier offers advantages for other reasons. A defining feature of the distribution of consumables or any other related accessory devices, respectively, is precisely the close link to the infringing business, which quite naturally paves the way for further revenue from the supply of consumables or any other related accessory devices, respectively, as these are necessary to put the infringing product into proper operation or to continue using it. This almost inevitable connection necessitates the extension of liability for damages to include such subsequent transactions as well.
37. Therefore, when calculating the damage caused by a patent-infringing offer, also profits derived from the performance of a contract causally linked to that offer must not be disregarded merely because the acts carried out in performance of the contract were carried out with non-infringing devices. . . .
42. Meril did not object to (information regarding) profits made from the sale of 'related accessory devices' being considered alongside those from infringing devices. This is because devices such as the crimping device are tailored to the properties of the infringing Myval THV device and designed to be used together. . . .
43. It cannot be ruled out at this point that profits earned with 'other relevant devices' and related accessory devices' along with them are to be taken into account if Meril participated in a tender offering at least one infringing device. This applies, as explained above, even if the tender offer has been amended subsequently and the infringing device was replaced with a non-infringing 'other relevant device'. This is because the infringing activity is participating in the tender with an infringing device. Participation in a tender constitutes an offer in the sense of Art. 25(a) UPCA and therefore constitutes an infringing activity. Even if the infringing device is replaced with a non-infringing device later on, any profits earned thereafter are causally linked to the infringing offer that secured the tender. Therefore, these profits might be considered as unfair as these profits would not otherwise have been possible. They are also directly linked to the patented invention, since the invention was incorporated into the device used to win the tender. Profits from 'related accessory devices' might also be attributed to the participation in this tender, even if the sales were made after the infringing product was replaced by a non-infringing one.
44. Profits made by Meril from sales of 'other relevant devices' and 'related accessory devices' outside of this scenario and/or without any close connection to infringing activities, are clearly not to be considered.
45. Edwards is arguing that Meril used the infringing devices to enrol patients in the LANDMARK and COMPARE clinic trials, build a distribution network and establish and deepen relationships with interventional cardiologists. Thus, according to Edwards, Meril used the infringing products as a springboard to launch the “other relevant devices” thereby securing an unlawful start in their development, validation, customer adoption and market positioning. Edwards argues e.g. that the CE marks granted in respect of the “other relevant devices” have been granted on the basis that no signification changes to the infringing Myval THV are present.
46. This is not convincing. The sales of the non-infringing 'other relevant devices', as outlined by Edwards, do not have sufficient (causal) connection with the infringing acts and are not sufficiently linked to the infringing subject matter, unlike sales of non-infringing devices following an offer of an infringing device. Edwards has not established that these activities, particularly the use of infringing devices in clinical trials or in the administrative process for acquiring CE marks, constitute a use under Article 25 and 26 of the UPCA or the relevant national law in the protected territories. Even if that were the case, subsequent sales of non-infringing products would no longer be sufficiently linked to the use of the invention. The invention relates to the folding of tabs 112, 116 within a leaflet structure within an implantable prosthetic heart valve . . . . Non-infringing devices use a different leaflet structure. The benefits described by Edwards, such as the distribution network and relationships with cardiologists, must be considered as independent of this limited contribution to the state of the art provided by the invention protected by the patent in suit. None of these benefits have been achieved because of the specific leaflet properties.
The court also notes that "[f]or periods prior to the coming into force of the Agreement on a Unified Patent Court, the calculation of damages must be based on the national law of the relevant member states in which the infringing activities took place" (para. 39), but concludes that no other result is mandated under German or French law (paras. 60-66).
Overall, this seems like a pretty reasonable approach to me. The court’s position on convoyed goods appears to be slightly more favorable to the patentee than the corresponding rule in the United States. As I explained in my August post, under Rite-Hite Co. v. Kelley Corp., 56 F.3d 1538 (Fed. Cir. 1995) (en banc), although infringers can be liable for lost profits on sales of noninfringing goods that compete with infringing products, they are not liable for lost profits on sales of noninfringing complementary products that the patent owner ordinarily sells along with the patented article, unless those complementary products “function together with the patented component in some manner so as to produce a desired end product or result” and are therefore “analogous to components of a single assembly or be parts of a complete machine, or . . . constitute a functional unit.” The U.S. rule can be defended on various grounds, but I am inclined to think it is too formalistic and that normal proximate causation principles should apply. Applying those principles to a case like Meril arguably would result in an outcome similar to that which the LD Munich reached, which may result in recovery for damages on convoyed goods (para. 36) but not for the more remotely-caused benefits or harms based on the development of customer relationships and such.
Edwards and/or Meril may appeal, and the extent of any damages eventually to be awarded remains to be seen.
For discussion elsewhere, see the write-ups on ip fray, EPLaw, and Kluwer.
