Novartis v Mylan (Gerechtshof Den Haag, 200.313.064/01, 2022)

Dhenne Avocats · 11 October 2026

Our analysis

Summary

The Hague Court of Appeal upheld the refusal, in interim proceedings, to restrain Mylan from marketing fingolimod on the basis of EP 2 959 894, whose single claim covers fingolimod at a daily oral dose of 0.5 mg for relapsing-remitting multiple sclerosis (paras 2.3 and 6.1). On a different ground from the first instance judge, it found a serious risk that the patent would not survive opposition or invalidity proceedings because of added matter (paras 5.21 and 5.24). The therapeutic effect, a functional technical feature of a medical use claim, must be directly and unambiguously disclosed in the application as filed: a proposed clinical study without results does not disclose it, and a disclosure that might make the effect plausible is not enough (paras 5.11, 5.19 and 5.20).

Facts and procedure

The Novartis group markets a fingolimod (FTY720) medicine for relapsing-remitting multiple sclerosis (para 2.1). Divisional application EP 894, filed on 16 July 2015, derives from a 2007 application claiming priority from 27 June 2006 (para 2.2). On 8 February 2022 an EPO Technical Board of Appeal decided that a patent would be granted on the claim at issue (para 2.3) and found it novel over a 2006 Novartis press release (D10) announcing a phase III study testing, among others, 0.5 mg daily, because therapeutic efficacy was not disclosed (paras 2.6 and 5.10). Novartis sought an injunction from grant; Mylan relied on added matter, insufficiency, lack of novelty and lack of inventive step (para 3.1). The interim relief judge dismissed the claims on the basis of a serious risk of invalidity for lack of inventive step (para 3.2).

The applicable law

Article 123(2) EPC, mirrored for Dutch patents by Section 75 of the Dutch Patents Act 1995 (ROW 1995), allows amendments only within what the skilled person can derive directly and unambiguously from the application as filed (para 5.2). Under the settled case law of the Boards of Appeal, achieving the therapeutic effect is a functional technical feature of a medical use claim (paras 5.4 and 5.5). Article 123(2) and Article 83 EPC serve different purposes (para 5.16).

Question

Does the description in the original application of a proposed clinical study including the 0.5 mg dose directly and unambiguously disclose the therapeutic effect of that dose, and is plausibility of the effect enough for Article 123(2) EPC?

Decision

Paragraph 33 of the application describes a prophetic study, not yet carried out, giving 0.5, 1.25 or 2.5 mg daily, with no results (para 5.7). Novartis, which had argued that the announcement of the phase III study in D10 did not disclose efficacy, failed to explain why paragraph 33 disclosed more (paras 5.8, 5.9 and 5.11). The court relied on T 2842/18, where the description of a proposed trial merely expressed an expectation about its outcome (para 5.12). Neither other passages of the application nor the rat study disclose the effect of the claimed dose (paras 5.13 and 5.14). For Article 123(2), a bare statement of the effect suffices, without any need to make it plausible; conversely, plausibility is not a direct and unambiguous disclosure, since the skilled person knows that the expected effect may not materialise (paras 5.18 to 5.20). The claim therefore adds new technical information (para 5.21). The examiner, who treated the dose as a mere selection from three, overlooked the functional nature of the effect (para 5.22); the Board of Appeal did not address Article 123(2), and the court expected it to revoke the patent if the point were raised in opposition (para 5.23). Novelty, plausibility and inventive step were not examined (para 5.25). Novartis was ordered to pay the costs of the appeal (para 6.2).

Key points for practice

• In a medical use claim, the therapeutic effect itself must be directly and unambiguously disclosed in the application as filed (paras 5.4 and 5.5).
• A prophetic clinical study expresses an expectation, not a disclosure of the effect (paras 5.11 and 5.12).
• Plausibility and direct and unambiguous disclosure are separate tests, belonging respectively to Article 83 and Article 123(2) EPC (paras 5.16 to 5.20).
• Practical point: a position taken before the EPO to defend novelty may be turned against the patentee on added matter; consistency of arguments across fora should be checked in advance (paras 5.8 to 5.11).

Provisions applied

European Patent Convention

Art. 54(5); Art. 83; Art. 123(2)

National law

Section 75 ROW 1995; Article 1019h Rv

Case law cited

EPO, Technical Board of Appeal, decision of 8 February 2022 on application EP 2 959 894; EPO, T 2842/18; EPO, T 2593/11

Prepared by Dhenne Avocats from the text of the decision (rechtspraak.nl, Dutch text), consulted on 11 October 2026. Only the official text is authoritative.