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DISCLOSURE NOTICE: Hepp Wenger Ryffel is involved in this matter on behalf of the defendant, Mepha Pharma AG.

Case No. S2022_006 | Order of 12 October 2022 | ‘Fingolimod / Unfair competition’

WHAT YOU NEED TO KNOW

The FPC applies a broad understanding of its concurrent competency with cantonal courts. It suffices that patent law is touched as a preliminary question (‘vorfrageweise’).

Legal interest for a complaint based on the UCA requires a showing that one is actually better off when the complaint is allowed.

Novartis’ request for interim measures against Mepha’s mailing re fingolimod was not considered, for lack of legal interest. Main proceedings based on the UCA are stayed until an indication of validity of EP 894 is available; S2020_002.

Background

As mentioned earlier on this Blog here, Novartis is seeking injunctive relief for Mepha’s generic version of Gilenya®, i.e. Fingolimod Mepha®.

Fingolimod (aka FTY720) is an immunosuppressant for the treatment of relapsing multiple sclerosis (MS). It’s a structural analogue of sphingosine; grab/ rotate the molecule here or below to get a better idea:

Gilenya was Novartis’ third-best selling drug in 2021. It is still a blockbuster, but sales have been declining since 2018 when it was Novartis’ best selling drug (2021: USD 2.8m, -7%; 2020: USD 3.0m, -7%; 2019: USD 3.2m, -4%; 2018: USD 3.3, +5%).

The patent at stake

The patent at stake is EP 2 959 894 B1 (see EPO Register and Swissreg for bibliographic details), with a priority date of as early as 27 June 2006. It’s a grandchild patent: The grandparent application is EP 2 037 906 (regional phase of WO 2008/000419 A1 at the EPO, actively withdrawn in April 2015 after a negative office action), and the parent application is EP 2 698 154 (filed Sept 2013, notification of deemed withdrawal in May 2016 for failure to reply to an office action). Yet another divisional application is pending; EP 3 797 765 (filed Nov 2020).

EP 894 had initially been refused by the ED in November 2020. Novartis appealed in December 2020 and requested expedited processing since it intended to lodge infringement proceedings in Turkey; see the Notice of Appeal, p. 1 and 32 et seqq. The Board of Appeal indeed accelerated the case, overruled the ED and ordered in oral proceedings of 8 February 2022 that a patent be granted; T 0108/21. See also Novartis’ press release of 15 February 2022. Novartis subsequently filed an amended description, with some reservations (cf. p. 2), and withdrew the designation of the U.K. shortly before grant. EP 894 was issued on 12 October 2022, i.e. about 15.5y after the filing date and on the day of issuance of the FPC’s order.

Five oppositions have been filed with the EPO on the day of grant(!).

What happened?
Fingolimod-Mepha

It’s all about Mepha’s letter entitled «Wichtige Mitteilung zur Patentanmeldung von Novartis betreffend Fingolimod-Mepha® 0.5mg» dated 27 April 2022 that had been sent to customers; it had also been available on Mepha’s website until 15 June 2022.

Novartis asserted that the letter contained confusing / misleading information about the exemptions under Art. 9 para. 1 lit. g PatA. Novartis argued that Mepha encouraged physicists and pharmacists to stock-pile Fingolimod-Mepha® for use after the grant of EP 894 and/or when interim injunctive relief in parallel infringement proceedings has been granted. Mepha disagreed that the information was misleading.

Competency of the FPC

Novartis sought to obtain a list of all addressees of the letter, and requested that Mepha be obliged to send a follow-up letter correcting the allegedly confusing / misleading information. The patent had not yet been granted when Novartis brought the suit. Accordingly, Novartis invoked Art. 2 UCA only.

Now, is the FPC competent to hear such a case?

The FPC applied a broad understanding of its concurrent jurisdiction with cantonal courts under Art. 26(2) PatCA, i.e. that it is competent even if patent law is touched only as a preliminary question (‘vorfrageweise’), as it is the case here:

This concurrent competency also covers summary proceedings.

Lack of legal interest

Novartis had argued that the sales numbers of Gilenya and the generic Fingolimod-Mepha establish that Mepha’s letter of April 27 has actually raised Fingolimod-Mepha’s market share from about 17% to about 20-23%:

Monthly sales

Novartis further argued that physicists and pharmacists would docket the letter and consult it again when placing new orders of fingolimod. The President did not buy into this and notes that systematic docketing and re-assessment of such mailings contravenes experience of life. The increased market share of the generic can rather be attributed to the fact that physicists and pharmacists have been made aware or reminded of the mere existence of the generic. This effect, however, is to be accepted by Novartis, at least for the time being while infringement proceedings with the nullity plea in defense are pending.

The President held that Novartis lacks a legal interest because it would not actually be better off when it succeeded with the complaint. On the contrary, the requested follow-up correction letter would likely even worsen Novartis’ position because it would again remind customers of the existence of the generic; p. 9, first para.

What’s next?

Main proceedings in this matter are still pending; O2022_008. The President decided that these proceedings are stayed until a decision in co-pending summary proceedings re infringment / validity of EP 894 is available; S2022_002. If the patent is held presumably invalid, this would also impact the assessment of Mepha’s letter under the UCA:

Gilenya capsule

Oral proceedings in the case S2020_002 are scheduled for 9 November 2022. Stay tuned.

Btw, for the trademark aficionados: Novartis’ two stripes trademark application for the Gilenya capsule has been refused in 2016, for lack of distinctiveness.

✍ MW

BIBLIOGRAPHY

Case No. S2022_006 | Order of 12 October 2022 | ‘Fingolimod / Unfair competition’

Novartis AG
./.
Mepha Pharma AG

Single judge:

    • Dr. Mark SCHWEIZER

Court Clerk:

    • Sven BUCHER

Representative(s) of Plaintiff:

Representative(s) of Defendant:

ORDER

PATENT IN SUIT

T 0108/21 — 3.3.01

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