Irides: Weekly patent litigation update

The Irides Weekly Update is our round-up of patent litigation news highlights from around the world. Taking its name from the plural of “iris” - a nod to the ability of Irides to see what’s happening around the world.

Our latest edition - 7 February 2025 - is below:

BRAZIL

Court refuses PI request to suspend tender process.

By decision dated 13 November 2024, the Court of Justice of the State of São Paulo has dismissed Sun Farmacêutica’s request for a preliminary injunction against the São Paulo State Department of Health. The purpose of Sun’s request was to suspend the public tender for the purchase of the drug nintedanib esylate (Nintedanib), the active ingredient in Boehringer Ingelheim’s Ofev and Vargatef products. 

Nintedanib is used for the treatment of various lung conditions. However, the public tender notice required that the drug’s package leaflet contain a specific reference to the fact that it is also indicated for the treatment of Idiopathic Pulmonary Fibrosis (IPF). Sun alleged that this requirement was anti-competitive, as the IPF indication is subject to patent protection and therefore the tender process was unfairly directed to benefit the patent proprietor.  The effect of this requirement was that Sun, which had carved out the IPF indication from its label, was not permitted to participate in the tender.

In dismissing Sun’s request for a preliminary injunction, the Court noted that the requirement that the package leaflet contain a reference to IPF was, in principle, both legitimate and prudent and that it was not right that the Department of Health should assume the health risks and responsibilities associated with the possibility of off-label use. The Court also rejected Sun’s claim that the requirement was anti-competitive on the basis that any manufacturer which obtains regulatory approval for the IPF indication could take part in the tender.

Sun filed an appeal against the decision which was also dismissed. The appeal decision upheld the first instance decision in full, emphasising that the requirement that the package insert contain a reference to IPF was legitimate and that it did not unduly restrict competition.

UPC

Munich Local Division grants ex-parte Order for preserving and inspecting evidence necessary to prove infringement
(UPC_CFI_63/2025).

On 3 February 2025, the Munich Local Division handed down an Order in a dispute between Nanoval GmbH & Co. KG (Nanoval) and ALD Vacuum Technologies GmbH (ALD). Nanoval had made an application requesting measures to preserve evidence and an inspection pursuant to r. 192 RoP, in order to support its infringement claim against ALD. 

Nanoval’s patent relates to a device and method for crucible-free melting of a material and for atomising the molten material for the production of powder, in particular metal or ceramic powder.  From the parameters of the metal powder described in ALD’s product brochure, Nanoval submitted that this new system must implement the features of claim 1 of the patent in suit.  The systems at issue are relatively large and only manufactured to order and therefore not available for purchase and/or inspection by everyone.

The Munich Local Division granted the Order, which was immediately enforceable, and included securing evidence and inspecting premises, photographing or filming for documentation purposes, and retrieving copies of relevant files and documents. In making its decision, the Court considered that the validity of the patent was sufficiently secured.  In considering possible infringement, the Court reviewed technical information from both parties (ALD had provided such information in protective documents and the EPO opposition proceedings) and considered there was a sufficient indication of infringement.  Account was also taken of the fact that ALD had challenged the patent in opposition proceedings at the EPO and, following the Board of Appeal’s decision to uphold the patent, requested a cross-licence. This gave rise to considerable suspicion.

The Court dealt with the application on pursuant to Art. 60(5) UPCA.  Nanoval had convinced the Court of the risk that the evidence to be secured would no longer be fully available in the event of a prior hearing.  Further, ALD’s conduct prior to the application had not been cooperative and it had not provided sufficiently concrete information on the design of the product in its protective letters or responses to Nanoval’s requests.  The Court concluded that Nanoval would suffer irreparable damage if it were not possible fully to  secure the evidence. The Munich Local Division  ordered Nanoval to provide security in the amount of €30,000, with the decision on costs to be made at a later date.

UPC

Munich Local Division Dismisses Second Counterclaim for Revocation in Patent Dispute
(UPC_CFI_740/2024).

The Munich Local Division has upheld a preliminary objection raised by the patentee under r. 19 RoP against a second counterclaim for revocation of European patent EP 3 780 758, which was already the subject of earlier pending proceedings between the same parties in the same Local Division.

The second counterclaim was filed after the patentee sought to amend their initial infringement action (UPC_CFI_41/2024) to include additional requests for injunctive relief, recall, and destruction. A first counterclaim for revocation was filed in this action. When the Court rejected this amendment request, the patentee filed a second infringement action seeking the additional remedies. In response, the defendant submitted the second counterclaim for revocation, challenging the patent’s validity once again.

The patentee argued that the Court lacked jurisdiction for the second counterclaim due to the principle of lis pendens (pending litigation on the same issue), as the patent’s validity had already been challenged in the earlier action between the same parties. The Court agreed, interpreting Art. 33(2) UPCA to apply not only when the same case is brought before different divisions, but also when the same case is filed twice within the same division. The Court ruled that this second challenge was inadmissible, as the validity of the patent was already being addressed in the earlier proceedings.  In doing so, the Court also held that the jurisdiction for preliminary objections under r. 19 RoP extends to counterclaims for revocation, not just infringement actions.

The Court also clarified that no separate decision would be made on costs at this stage. Costs incurred in relation to the preliminary objection would instead be addressed at the conclusion of the ongoing second infringement proceedings.