The UPC does not merely apply rules of procedure: it decides questions of substance, on the basis of its own sources. In little more than two years, the Court of Appeal has laid down an analytical framework common to all divisions, which borrows as much from EPO practice as from national traditions.

Sources of law

The UPC bases its decisions, in this order, on Union law (including the regulations on the unitary patent), the Agreement, the EPC, other international agreements applicable to patents and binding on all the Contracting Member States, and national law (A24(1) UPCA). The applicable national law is determined by the rules of private international law (A24(2) UPCA).

Acts of infringement

Direct and indirect infringement

The patent confers the right to prevent any third party, without the proprietor’s consent (A25 UPCA), from:

  • making, offering, placing on the market or using the patented product, or importing or storing it for those purposes;
  • using the patented process or, where the third party knows or should have known that its use is prohibited, offering it for use;
  • offering, placing on the market, using, importing or storing a product obtained directly by the patented process.

It also confers the right to prevent the supply of means relating to an essential element of the invention, where the third party knows or should have known that those means are suitable and intended for putting the invention into effect, unless they are staple commercial products and there is no inducement (A26 UPCA).

Limitations, prior use and exhaustion

Excluded from the patent are, in particular, acts done privately and for non-commercial purposes, acts done for experimental purposes, and studies and trials with a view to obtaining a marketing authorisation for a medicinal product (the “Bolar” exemption) (A27 UPCA).

The right based on prior use (or prior possession) is not harmonised: any person who would have acquired it in a Contracting Member State in respect of a national patent enjoys the same rights, in that State, in respect of the European patent (A28 UPCA). A French exception therefore remains French. The defendant must raise it in its Statement of defence (R24(g) RoP UPC).

Finally, the rights are exhausted for products placed on the market in the Union by the proprietor or with its consent (A29 UPCA).

For the unitary patent, the same rules apply by reference from Regulation No 1257/2012: see “Rights conferred by a unitary patent”.

Claim interpretation

The principle: NanoString

The claim is not only the starting point but the decisive basis for determining the protective scope of a European patent (A69 EPC and its Protocol on Interpretation). Its interpretation does not depend solely on the strict, literal meaning of the wording: the description and the drawings must always be used to interpret it, and not only to resolve an ambiguity. This does not mean that the claim serves only as a guideline: its subject-matter also extends to what, after examination of the description and drawings, appears to be the subject-matter for which the proprietor seeks protection. The claim is interpreted from the point of view of the person skilled in the art, with the aim of combining adequate protection for the proprietor with sufficient legal certainty for third parties; these principles apply equally to infringement and to validity (UPC, Court of Appeal, 26 Feb. 2024, NanoString v. 10x Genomics, UPC_CoA_335/2023, headnote 2).

A single interpretation, then, for assessing both infringement and validity: the proprietor cannot argue for a broad claim to catch the infringer and a narrow one to escape the prior art.

Clarifications made since

The Court of Appeal has built on this foundation:

  • interpretation is a question of law: the Court cannot leave it to an expert, and the person skilled in the art is a theoretical figure whose knowledge is assessed by the judge and not by an expert (UPC, Court of Appeal, 30 Apr. 2025, Insulet v. EOFlow, UPC_CoA_768/2024, headnotes 1 and 2);
  • an embodiment presented as such in the patent is in principle covered by the claims, unless the patent clearly teaches the skilled person that it is not (UPC, Court of Appeal, 25 Nov. 2025, Meril v. Edwards, UPC_CoA_464/2024 and joined cases, headnote 3);
  • experimental data not contained in the patent are as a rule irrelevant to its interpretation (UPC, Court of Appeal, 7 Nov. 2025, OTEC v. Steros, UPC_CoA_579/2025, headnote);
  • a dependent claim that merely adds a feature, without specifying those of the main claim, hardly allows any inference as to the interpretation of the latter; and a claim drafted in the form of a medical use implies that the product is objectively suitable for the claimed use, that is, that it brings about a significant improvement in the patient’s condition (UPC, Court of Appeal, 25 Nov. 2025, Amgen v. Sanofi and Regeneron, UPC_CoA_528/2024 and UPC_CoA_529/2024, headnotes 1 to 3);
  • a “means for” feature covers any means suitable for performing the function (UPC, Court of Appeal, 14 Feb. 2025, Abbott v. Sibio, UPC_CoA_382/2024, headnote).

Validity

Grounds and burden of proof

The UPC may revoke a patent only on the grounds referred to in A138(1) EPC (A65(2) UPCA). The burden of proving the facts from which invalidity follows lies with the party seeking revocation; the assessment of those facts remains a question of law (UPC, Court of Appeal, 25 Nov. 2025, Meril v. Edwards, UPC_CoA_464/2024 and joined cases, headnote 6; A54 UPCA).

Inventive step: neither quite the EPO nor quite Karlsruhe

The Court of Appeal notes that national courts do not approach inventive step in the same way (the EPO’s problem-solution approach, also applied in France, Italy, the Netherlands and Sweden; more “holistic” approaches in Germany or the United Kingdom), all of them being merely guides that should lead to the same result. It sets out the UPC’s own method (UPC, Court of Appeal, 25 Nov. 2025, Meril v. Edwards, UPC_CoA_464/2024 and joined cases, headnotes 5 and 7 to 12; to the same effect, UPC, Court of Appeal, 25 Nov. 2025, Amgen v. Sanofi and Regeneron, UPC_CoA_528/2024, headnotes 10 et seq.):

  • first determine the objective problem, from the point of view of the skilled person at the filing or priority date, by comparing the claim as a whole, read in the light of the description, with the prior art, on the basis of the technical effects that the skilled person understands to be achieved; the problem must not contain pointers to the solution;
  • the solution is obvious if the skilled person, starting from a realistic starting point in the relevant field and wishing to solve the objective problem, would (and not merely could) have arrived at it;
  • a starting point is realistic if it would have been of interest to a skilled person wishing to solve that problem; there may be several, and the invention must involve an inventive step starting from each of them;
  • the skilled person has neither imagination nor inventive spirit: they need a pointer (“Anlass”) to take the next step towards the invention; the solution is obvious if they would have taken that step prompted by that pointer or as a matter of routine, in the expectation of a result.

EPO vocabulary (objective problem), a “realistic” starting point rather than the closest prior art, a German Anlass: the European synthesis has its charms.

Added matter

Extension beyond the content of the application as filed is a question of law, decided in the light of the claims and the application; the Court may examine the application as a whole (UPC, Court of Appeal, 25 Nov. 2025, Amgen v. Sanofi and Regeneron, UPC_CoA_528/2024, headnote 4).

Where the international application was not filed in an official language of the EPO, its content is assessed first of all through the translation filed by the applicant with the EPO: third parties and the Court may rely on it, and it is for the proprietor who claims that it is inaccurate to prove it (UPC, Court of Appeal, 5 Nov. 2025, Seoul Viosys v. expert e-Commerce, UPC_CoA_762/2024 and UPC_CoA_773/2024, headnote). Whoever mistranslates their application has only themselves to blame.

Sufficiency of disclosure

Sufficiency is assessed on the basis of the patent as a whole, from the point of view of the skilled person: they must be able to reproduce the invention without inventive skill or undue burden, one embodiment (or, for a functional feature, a technical concept) being sufficient; a reasonable amount of trial and error does not stand in the way (UPC, Court of Appeal, 25 Nov. 2025, Amgen v. Sanofi and Regeneron, UPC_CoA_528/2024, headnotes 5 to 8).

These criteria largely coincide with those of the EPO: see, for comparison, “The requirements for patentability”.