Time flies: MSD’s SPC on Cerazette® lapsed before it was held invalid

Case No. O2013_011 ¦ Order of 27 May 2015 ¦ “Gegenstandslosigkeit (Art. 242 ZPO) infolge Ablaufs des ESZ; Kostenfolgen” 

Note that Hepp Wenger Ryffel is involved in this case on behalf of the plaintiff.

This nullity suit pertains to Merck Sharp & Dohme’s patent und relating SPC on the the contraceptive Cerazette®.

Cerazette® (active ingredient: Desogestrelum)
Cerazette® (active ingredient: desogestrelum)

Generally speaking, there are two main kinds of hormone contraceptives: On the one hand, the combined pill, commonloy referred to as ‘the pill’, which contains two types of female sex hormone (an oestrogen and a progestogen). On the other hand, the progestogen-only pill, sometimes referred to as ‘POP’ or ‘mini-pill’, which does not contain an oestrogen. Cerazette®  is such a ‘mini-pill’, marketed in Switzerland by MSD Merck Sharp & Dohme; see compendium.ch for details.

Desogestrel
Desogestrel

Most POPs work primarily by preventing the sperm cells from entering the womb but they do not always prevent the egg cell from ripening, which is the main way that combined pills work. According to the manufacturer, Cerazette® is different from most POPs in having a dose that in most cases prevents the egg cell from ripening, making it a highly effective contraceptive.

In contrast to the combined pill, Cerazette can be used by women who do not tolerate oestrogens and by women who are breast feeding.

The progestogen contained in Cerazette® as the active ingredient is desogestrel. This compound as such was already known at the filing date of the patent in suit. The invention of EP  491 443 B1 pertains to the use of 70 to 80 micrograms of e.g. desogestrel as sole contraceptive. The independent claims cover this concept in different categories and read as follows:

1. A combination and contraceptive kit comprising sequential daily dosage units for oral administration each containing as the sole contraceptively effective ingredient from 70 to 80 micrograms of desogestrel, 3-ketodesogestrel, or mixtures thereof.

5. The use of an oral daily dosage unit consisting essentially of 70 to 80 micrograms of a progestogen selected from the group of progestogens consisting of desogestrel, 3-ketodesogestrel, or mixtures thereof, in the preparation of a drug delivery system, said drug delivery system characterized by consisting of daily dosage units containing only a progestogenic compound as sole therapeutically effective ingredient.

6. A drug delivery system comprising a package containing 26 to 30 daily sequential dosage units consisting essentially of from 70 to 80 micrograms of a compound selected from the group consisting of desogestrel, 3-ketodesogestrel, and mixtures thereof.

7. A contraceptive kit of the type containing progestogen-only daily dosage units, wherein the improvement comprises using from 70 to 80 micrograms of 3-ketodesogestrel, desogestrel, or mixtures thereof as the progestogen in said daily dosage units.

8. A process of manufacturing a drug delivery system comprising:
mixing predetermined quantities of a progestogen selected from the group consisting of desogestrel, 3-ketodesogestrel, and mixtures thereof, with predetermined quantities of excipients and converting the mixture into dosage units each containing 70 to 80 µg of desogestrel, 3-ketodesogestrel, or mixtures thereof, and packaging a plurality of said dosage units into a kit.

The nullity suit had been lodged already on July 12, 2013. The defendant answered on March 6, 2014. A first hearing was held on June 4, 2014; no settlement could be reached. Reply and rejoinder followed on September 2, 2014 and October 22, 2014, respectively. With his rejoinder, the defendant indicated to limit the patent to embodiments with 28 daily doses, as an auxiliary measure. Various submissions of both parties followed, and the parties were then summoned to the main hearing on June 2, 2015.

But the main hearing did not take place anymore, since neither party was interested in it. The reporting judge had provided her assessment on February 6, 2015, and both parties had commented on that assessment in writing. The SPC C00491443/01 (based on EP  491 443 B1 and the market authorization of Cerazette®) finally lapsed on March 27, and the President asked both parties on March 31, 2015 to comment on their remaining legal interest.

Cevanel
Cevanel

The defendant declared that no monetary claims will be raised against the plaintiff for marketing a generic version — Cevanel® — before the SPC had lapsed. Thus, both parties agreed that no legal interest in a decision on nullity remained. Proceedings had become groundless and the case was dismissed; Art. 242 CPC.

As a general principle, the unsucessful party has to bear the costs; Art. 106(1) CPC. However, someone has to pay the bills even if no decision is being taken. According to Art. 107(1) lit e CPC, the FPC may allocate the costs at its own discretion if proceedings are dismissed as groundless. Towards this end, the FPC had nevertheless to assess the probable outcome of the case, in order to allocate the costs.

Novelty was undisputed, but the plaintiff argued for lack of an inventive step essentially over three prior art documents:

In a nutshell, desogestrel had already been used in combined pills. Moreover, it had also been known that desogestrel completely prevents ovulation when given at a dosage of more than 60 microgram/day, and it had been suggested to further pursue desogestrel to be administered as sole contraceptive. And, finally, it had been known that dosages of 125 and 150 microgram/day of desogestrel were well tolerated. The reporting judge thus held that determination of a beneficial dosage of desogestrel within the aforementioned boundaries was just a matter of routine experimentation. Limitation of the claims to embodiments with 28 daily doses did not help, either: POPs with this dosage regime had also been known before.

The defendant objected that the reporting judge had chosen the wrong closest prior art in her assessment of inventive step according to the problem-and-solution approach. Starting from prior art POPs, inventive merit should be acknowledged. However, anything that is obvious having regard to the [whole] state of the art is not patentable as an invention; see Art. 1(2) PatA. With reference to T 967/97 (hn I and II) and BGE 138 III 111 (r 2.2), the FPC emphasized that it is sufficient to show that the person of skill in the art would have arrived at the alleged invention without inventive activity in at least one way.

The finding of lack of an inventive step is in line with a decision on the same European patent and corresponding SPC in Germany; see decision 3 Ni 21/12 of the Federal Patent Court in Germany of May 6, 2014. The Dusseldorf Regional Court had issued a preliminary injunction on November 15, 2012 (4bO 123/12), but the Dusseldorf Higher Regional Court lifted that decision on November 7, 2013, since validity of the patent was doubtful (I-2 U 94/12).

Likewise, the Tribunal de Grande Instance de Paris had also held that the basic patent was invalid inter alia for lack of an inventive step (decision of December 5, 2014).

The FPC thus concluded that the plaintiff would presumably have entirely succeeded and allocated the whole costs on the defendant (party compensation of CHF 114’080,– and court fee of CHF 30’000,–, based on a value in dispute of CHF 500’000,–).

Reported by Martin WILMING

— BIBLIOGRAPHY —

Case No. O2013_011 ¦ Order of 27 May 2015 ¦ “Gegenstandslosigkeit (Art. 242 ZPO) infolge Ablaufs des ESZ; Kostenfolgen” 

Mepha Pharma AG ./. Merck Sharp & Dohme B.V.

Subject(s):

  • Inventive step
  • Assessment of the reporting judge
  • Court costs
  • Party compensation

Composition of the Board of the FPC:

  • Dr. iur. Dieter BRÄNDLE (President)
  • Lic. iur. Susanne ANDERHALDEN (First Court Secretary)

Reporting judge:

  • Dr. Hanny KJELLSAA-BERGER

Representative(s) of Plaintiff:

Representative(s) of Defendant:

— DECISION IN FULL —

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