Samsung Bioepis NL B.V. v. Regeneron Pharmaceuticals Inc., District Court The Hague, The Netherlands, 1 Oktober 2025, Case no. ECLI:NL:RBDHA:2025:18108
The District Court of The Hague upheld Regeneron’s aflibercept patents and found Samsung’s biosimilar Opuviz to infringe; an injunction was issued.
Samsung is a subsidiary of the Korean company Samsung Bioepis Co. Ltd., and part of the Samsung Bioepis group. The company focuses on the development of biosimilar medicines.
Regeneron is a biotechnology company that develops medicines and is the inventor of the substance aflibercept. Regeneron is the holder (among others) of patents EP 691 and EP 306. These patents claim formulations and a pre-filled syringe containing an aflibercept formulation. For ophthalmic (eye) applications, Regeneron (in Europe, via Bayer) markets aflibercept formulations under the brand name Eylea. This medicine is used for eye conditions such as wet age-related macular degeneration (wAMD) and is suitable for intravitreous administration (meaning that the formulation is suitable for use in the eye).
Samsung’s claims (main proceedings)
Samsung seeks the revocation of EP 691 (case 24-972) and EP 306 (case 24-974). In addition, in both cases, it requests a declaration of non-infringement (a so-called Gillette/Arrow declaration) that the formulation shown below was obvious at the priority date, or at least the filing date, of the Patents.
Samsung argues that the patents are invalid due to added subject matter, lack of novelty compared to WO 852, WO 650, and Fraser, and lack of inventive step compared to US 234 and Fraser, and to WO 852 and WO 650 if those documents represent the full state of the art. The patents cannot validly claim priority from US 484. In any case, Samsung argues that Opuviz falls outside the scope of protection of the patents because it represents a non-inventive variant of the prior art at the priority and filing dates.
Regeneron’s defense and counterclaims
Regeneron defends EP 306 only in accordance with the main request it maintained in the EPO proceedings (appeal pending). In its counterclaim, Regeneron seeks, as far as possible enforceable provisionally (among other things): a declaration that Opuviz falls within the scope of claims 5 and 6 of EP 691 (NL), an injunction prohibiting Samsung from infringing EP 691 (NL).
The skilled person
The Court holds that the relevant skilled person has expertise in formulation science and protein chemistry.
Added matter and priority
The Court finds that the combination of a VEGF antagonist with the other components of the formulation is directly and unambiguously disclosed in US 484 and in the applications, as are the sodium phosphate buffer and the pre-filled syringe. Therefore, there is no invalid claim to priority within the meaning of Article 87 in conjunction with 123(2) EPC, nor added matter within the meaning of Article 76 in conjunction with 123(2) EPC. Samsung’s invalidity arguments on these grounds fail.
Novelty
The cited documents do not destroy novelty.
Inventive step
The Court holds that, contrary to Samsung’s argument, the skilled person -starting from US 234 in combination with common general knowledge- would not routinely arrive at the formulation claimed in EP 691 with a reasonable expectation of success.
“The skilled person would realize that it was not self-evident that a formulation could be found meeting all the conditions for intravitreal administration, because the necessary balance was delicate. Reading US 234 as a whole, the skilled person would also see that the document did not encourage making an aflibercept formulation, but rather one with a mini-trap. Under these circumstances, there was no ‘try-and-see’ situation as Samsung suggests.”
Moreover, Fraser does not provide a realistic starting point for the skilled person, as it concerns intravenous administration of aflibercept to regulate fertility in macaques, a completely different problem. Thus, the Court rejects Samsung’s request to revoke EP 691, and limits EP 306 in line with the main request defended by Regeneron in these proceedings.
Samsung’s request for a Gillette/Arrow declaration is also denied, since it is based on the assertion that the patents lack novelty and inventive step.
Counterclaim – Infringement of Claim 6 of EP 691
Regeneron argues that Opuviz meets the features of claim 6 of EP 691 (NL).
Samsung disputes that Opuviz meets the requirements of being suitable for lyophilization (freeze-drying) and reconstitution, such that it is suitable for intravitreal administration. Samsung claims it does not know whether its product has these properties.
Regeneron refers to the Cepter report, which states that an aflibercept formulation matching Opuviz’s composition remained 99% in native conformation after freeze-drying and reconstitution, indicating suitability for lyophilization and reconstitution.
Samsung’s expert, Dr. Yaman, argued that it was unclear whether the Cepter simulation accurately represented Opuviz, that the test methods could not be reproduced, and that the results suggested instability.
However, the Court rejects this defense.
“Samsung has not provided any of its own data on Opuviz’s lyophilization suitability, merely disputing Regeneron’s assertion without proper reasoning. From the time Samsung began preparing its defense in the counterclaim, it could have performed its own tests, especially since it refused Regeneron’s request to provide samples. The Court also notes that Samsung could have eliminated the reproducibility objections raised by Yaman by providing Regeneron with Opuviz samples, as Regeneron requested.”
“Furthermore, Samsung seeks a Gillette/Arrow declaration for a formulation with the same two characteristics discussed above, and did not limit that request even when disputing Opuviz’s lyophilization suitability. Samsung claims to need the declaration in view of possible future Regeneron divisionals containing those features, but that alleged threat does not explain why it seeks such a declaration if its own product lacks those properties.”
Scope of protection – Claim 6
Samsung argued, for the first time in its closing statement, that Opuviz falls outside the scope of claim 6, because that claim is based on a different inventive concept than the preceding claims. According to Samsung, claim 6 concerns only the idea of a formulation that can be lyophilized and reconstituted, while the earlier claims concern a stable ophthalmic formulation for intravitreal administration. Since Opuviz is not intended to be lyophilized and reconstituted, it would fall outside the contextual scope of claim 6.
The Court finds this argument untimely. Moreover, a contextual interpretation of claim 6 does not exclude protection for ophthalmic products suitable for intravitreal administration that are not intended to be lyophilized but are capable of being so.
“The skilled person, reading EP 691 as a whole, will understand that claim 6 is directed to a lyophilizable formulation that, like claims 1–5, is stable and intended for intravitreal use, not to a different inventive concept. Multiple paragraphs, including [0027], make clear that the lyophilizable formulation is intended for ophthalmic use. Paragraphs [0052] and [0053] show that reconstitution restores the formulation for intravitreal use. The skilled person will therefore interpret claim 6 as not limited to formulations intended for lyophilization and reconstitution, but as covering all ophthalmic formulations suitable for lyophilization and reconstitution before intravitreal administration.”
Decision
The Court: rejects Samsung’s invalidity actions, upholds EP 691, maintains EP 306 in its limited form (main request), finds that Opuviz infringes claim 6 of EP 691 (NL), and grants an injunction against Samsung.
The decision (in Dutch) can be read here.
