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NL – Novartis v. Mylan / Appeal – fingolimod

01 Nov 2022

Novartis AG v. Mylan B.V. and Mylan Ireland Limited, Court of Appeal The Hague, The Netherlands, 18 October 2022, Case no. ECLI:NL:GHDHA:2022:2079

The Novartis-group produces and markets amongst others a medical substance with fingolimod (also named FTY720) as active ingredient for the treatment of relapsing-remitting multiple sclerose (hereafter: RRMS). Novartis holds related EP 2 959 894 of which claim 1 reads: “A S1P receptor modulator for use in the treatment of relapsing-remitting multiple sclerosis, at a daily dosage of 0.5 mg p.o., wherein said S1P receptor modulator is 2-amino-2-[2-(4-octylphenyl)ethyl]propane-1,3-diol in free form or in a pharmaceutically acceptable salt form.”

Novartis alleged Mylan infringed its Patent. In first instance PI proceedings, the preliminary relief Judge ruled that there was a serious, non negligible chance that the patent would be found to be invalid in proceedings on the merits due to lack of inventive step and denied the injunction.

In this appeal, the Court of Appeal comes to the same conclusion, albeit on different grounds, namely added matter:

“Since the functional technical feature of claim 1 that the clinical benefit will arise is not disclosed directly and unambiguously in the application, claim 1 provides the average skilled person with new technical information relative to the application. The application merely proposes to investigate whether the treatment of RRMS with an oral daily dose of 0.5 mg fingolimod provides clinical benefit. Even if paragraphs 31 and 32 of the application make it plausible that this will be the case, the average skilled person at most derives from this a certain expectation that this will be the case. However, he will see that it is also possible that the clinical trial will show that the clinical benefit will not materialize. Claim 1 teaches the average skilled person more, namely that that treatment will yield therapeutic benefit (cf. par. 50/51 of T2842/18). Therefore, the Court of Appeal is of the preliminary opinion that there is added matter.

“The Court notes that during the granting procedure the Examiner ruled that claim 1 did not provide added matter, because the choice for 0.5 mg fingolimod was a choice from a list of only three doses as disclosed in paragraph 33. In the preliminary view of the Court of Appeal, the Examiner has wrongly ignored that claim 1 concerns a medical indication claim of which, according to settled case law of the TBA, the achievement of clinical benefit is a functional characteristic and/or insufficiently recognized that paragraph 33 of the application only describes a prophetic study which, as contemplated above, does not directly and unambiguously disclose that the 0.5 mg/d dose provides clinical benefit.

“In its decision of 8 February 2022, the TBA did not devote any considerations to the requirements of Article 123(2) EPC. If this is raised during an opposition procedure – already announced by Mylan – it must be expected that the TKB will revoke EP 894, in view of the TBA’s opinion on novelty and the considerations in T 2842/18. [NOTE editor: meanwhile, opposition has been filed]

“In view of the foregoing – albeit on a different ground – the Court of Appeal, like the preliminary relief judge in the District Court, is of the opinion that there is a serious, not negligible chance that EP 894 will not survive an opposition or invalidity procedure. For that reason, there is no reason to align this decision with that of the TBA of 8 February 2022 as advocated by Novartis.”

A copy of the decision (in Dutch) can be read here.