In the joined appeals
in Meril Italy Srl et al. v. Edwards Lifesciences Corp., UPC__CoA__A464/2024
et al. (Nov. 25, 2025), Panel 1 of the UPC Court of Appeals decided several
important issues, most notably relating to inventive step, in regard to a claim
of infringement of EP 3 646 825, for “a system comprising a prosthetic heart valve
and a delivery catheter” (p.6). For
present purposes and for brevity, I will focus exclusively on the (also very
important) remedy question presented, namely whether the hardship resulting
from a permanent injunction directed against certain infringing products would be disproportionate,
and therefore should be subject to a carve-out.
The Court concludes that the answer is yes.
To put the matter in perspective,
UPCA article 63(1) states that “Where a decision is taken finding an
infringement of a patent, the Court may grant an injunction against the
infringer aimed at prohibiting the continuation of the infringement,” and
article 64(1) states that the court “may order . . . that appropriate
[corrective] measures,” such as recall, removal, and destruction, be
taken. Article 64(4) further states that
“[i]n considering a request for corrective measures pursuant to this Article,
the Court shall take into account the need for proportionality between the
seriousness of the infringement and the remedies to be ordered, the willingness
of the infringer to convert the materials into a non-infringing state, as well
as the interests of third parties.”
There is no corresponding provision in article 63. The UPCA should be interpreted in conformity
with the Enforcement Directive, however, which states in article 3(2) that “remedies
shall . . . be effective, proportionate and dissuasive and shall be applied in
such a manner as to avoid the creation of barriers to legitimate trade and to
provide for safeguards against their abuse”—though as most readers probably are
aware, it has long been a matter of debate whether this provision requires
courts to consider the proportionality of injunctive relief in every case, or
only certain special cases, or (as some have argued) perhaps no cases at all,
as long as proportionality is guaranteed “from the functioning of the patent
system as a whole.” See, e.g.,
Lea Tochtermann, Injunctions in European Patent Law, 11 ZGE//IPJ
257, 265 (2019).
Anyway, in the
present matter, the Munich Local Division had concluded that one of Meril’s
product lines (the Meril XL devices), though infringing, should be subject to a
carve-out from permanent injunctive relief and corrective measures, because for
certain patients there are no good substitutes for a product of the same size; but
for Meril’s intermediate-size products, the evidence did not demonstrate any “notable
enhancement in patient care” (p.46 para. 192), and thus no carve-out would be appropriate. The Court of Appeal affirms, and in doing so actually
makes it a bit easier for Meril to keep the XL devices on the market.
The Court begins its discussion
of these matters by stating that “Art. 64 IPCA does not merely confer on the
Court the power to grant the measures requested. The Court has no discretion” (p.45, para.
187), and that “[t]he same applies to permanent injunctions” (p.46, para. 188). “Accordingly, where the proprietor files an infringement
action and the Court finds that an intellectual property right has been
infringed or is threatened to be infringed, it shall issue an order prohibiting
the continuation of the infringement unless there are special reasons for not
doing so” (p.46 para. 189). However—and this,
I think, is significant:
A special reason for denying an injunction may apply
if, in the circumstances of the particular case, granting an injunction does
not comply with the general obligations of Art. 3 of the Enforcement Directive,
in particular the obligation that the remedies shall be proportionate. In
addition, the Court must ensure that the application of its power under Art.
63(1) UPCA is not in conflict with fundamental rights protected by the European
Union legal order or with other general principles of EU law, such as the principle
of proportionality (CJEU, judgement of 29 January 2008, Promusicae, C-275/06, ECLI:EU:C:2008:54,
paragraph 68; judgement of 27 March 2014, UPC Telekabel Wien, C-314/12, ECLI:EU:C:2014:192,
paragraph 46; judgement of 16 July 2015, Coty Germany, C-580/13, ECLI:EU:2015:485,
paragraph 34).
When considering the proportionality of injunctive
relief and corrective measures, the Court may take into account not only the
interests of the parties to the litigation but also the interests of third
parties, such as patients. The Munich Local Division correctly held that the
interests of the patients justify an exception to the right to injunctive
relief and corrective measures if it is established that the infringing embodiment
is the sole available treatment method or represents an improvement upon the
available treatment methods, resulting in a notable enhancement of patient care
(id. paras. 190-91).
As noted, the Court
agrees that the XL devices may remain on the market, but disagrees with the Munich
Local Division in one respect:
As far as Meril’s XL devices are concerned, the Munich
Local Division acknowledged a legitimate interest in their availability. It
established that there may be patients who can only be adequately treated with Meril’s
XL devices, in view of inter alia the fact that Edwards’ products are not
recommended for native annulus sizes of more than 28 mm. It therefore exempted
XL devices that were scheduled for implementation in an individualized patient
by 15 November 2024 from the injunction and the corrective measures. This part
of the judgment is not challenged on appeal.
In respect of XL devices not scheduled for
implementation, the Munich Local Division held that the interest in their
availability is adequately addressed through Edwards’ Medical Request Portal.
Via this online portal, practitioners can upload relevant patient data. A team
of doctors at Edwards review the data and determine whether use of Edwards’
product is an option. If the doctors find that using Edwards’ products is not
an option, Edwards will grant an exception to the injunction.
The Court of Appeal agrees with Meril India and Meril
Germany that Edwards’ portal does not adequately address the legitimate
interest in the availability of Meril’s XL devices. The availability of these
products should not depend on the willingness of Edwards to maintain the portal
or on the assessment by Edwards’ team of doctors. A notification of an
intention to use Meril’s XL device by a physician confirming that such product
is the only available treatment option for a particular patient should be
sufficient. The Court of Appeal will therefore amend the injunction and orders
for corrective measures accordingly and maintain them on the basis of an
auxiliary request which the parties have drafted in common accord during the
oral hearing in the appeal proceedings.
Under the amended orders, the making, offering,
placing on the market and use of Meril’s XL devices, and the importing and
storing of the products for those purposes, are not covered by the injunction
and corrective measures, provided that a physician has submitted the required
notification. Contrary to the concerns put forward by Meril India and Meril
Germany, this implies that the injunction does not prohibit them from making
doctors aware of the availability of the XL devices where it is the only
treatment option for a particular patient (p.47, paras. 194-97).
The Court concludes
this section of the judgment by noting that, although the Munich Local Division
“regarded Meril India and Meril Germany as unwilling licensees,” its “findings
were not decisive for the Court’s decision to grant the injunction and the
corrective measures” with respect to the intermediate-sized products. The Court of Appeal therefore does not need
to review the “unwilling licensee” issue. It also permits Edwards to publish the
decision and amends the costs award.
