Wrongful reinstatement is no ground for nullity of an SPC

Case No. S2016_009 ¦ Decision of 04 July 2017 ¦ “ESZ / Nichtigkeitsgründe”

The decision grants interim injunctive relief in summary proceedings based on an SPC.

Notably, the defendant neither disputed validity of the basic patent, nor that the subject-matter of the SPC is covered by the basic patent or that the attacked embodiment is covered by the SPC. Rather, the defendant (only) alleged that the SPC is invalid because the office wrongfully granted re-establishment of rights (Art. 47 PatA) with respect to the time limit for filing the SPC application under Art. 140f PatA.

Publications in the Patent Bulletin and Swissreg as to the actual filing date of the SPC application are indeed confusing, to say the least. The (belated) filing date of 13 December 2014 has not been published at all, nor has the re-establishment of rights. Anyway, the FPC holds that in view of the apparent inconsistency between a belated filing date and the fact that the SPC had been granted anyway should have prompted a check of the dossier. The defendant would then have noticed the re-establishment of rights.

The FPC notes that the defendant could have appealed the decision of reinstatement (Art. 48 ff APA in the version of 09 December 2003), together with the decision of grant of the SPC – but failed to do so. The decision is thus formally final, and the defendant has to live with it.

The FPC further holds that the list of grounds for nullity of an SPC as set forth in Art. 140k PatA is exhaustive. The alleged wrongful reinstatement is thus no valid ground of nullity.

It was undisputed that the defendant had advertised the attacked embodiment at a congress in December 2016, and had actually sold products already in September 2016. However, the defendant argued that there was no threat of any further infringing acts: The defandant would stick to his affirmation to give notice to the patentee a month before commercialising the product again (the patentee demanded for an advance notice of at least 6 months). The FPC held that an advance notice of 1 month clearly is insufficient: One cannot expect injunctive relief to be granted within a month; the advance notice (at least this short one) does not preclude the threat of a further infringement.

The FPC also confirmed the threat of an irreparable harm, with a straight-forward reasoning. Interim injunctive relief was thus granted.

FROM A MARKET PERSPECTIVE

Infringement of the Swiss SPC C00716606/01 concerning sevelamer is at stake; the basic patent is EP 0 716 606 B1 of Genzyme Corporation.

Sevelamer is a phosphate binding drug used to treat hyperphosphatemia in patients with chronic kidney disease; it binds to dietary phosphate and prevents its absorption. Sevelamer is legally marketed in Switzerland under the trade names Renagel® (sevelamer hydrochloride) and Renvela® (sevelamer carbonate).

Sevelamer consists of polyallylamine that is crosslinked with epichlorohydrin. Sevelamer carbonate is a partial carbonate salt. The amine groups of sevelamer become partially protonated in the intestine and interact with phosphate ions through ionic and hydrogen bonding.

Structural formula of sevelamer carbonate
Structural formula of sevelamer carbonate

The confusing publications in the Swiss Patent Bulletin are +pat+ 08/2005, p 1317-1318 and 06/2006, p 1058. The publication in Swissreg is not of much help, either; it rather adds to the confusion:

Dass das IGE schliesslich am 8. Dezember 2016 noch zu guter Letzt als neues – nicht erklärbares – Datum der Berichtigung den 7. April 2005 einführte, komplettierte den Zahlensalat.

The market authorisations for the active ingredient sevelamer are listed in Compendium and the ‘Spezialitätenliste‘; this reveals the parties involved: Genzyme Corporation (SPC holder) and Sanofi-Aventis (Suisse) SA (exclusive licensee and market authorisation holder) as the plaintiffs. The defendant apparently is Salmon Pharma GmbH since it is the only other holder of a market authorisation for a product containing sevelamer, ie the product Sevelamercarbonate Salmon Pharma.

Reported by Martin WILMING

BIBLIOGRAPHY

Case No. S2016_009 ¦ Decision of 04 July 2017 ¦ “ESZ / Nichtigkeitsgründe”

  1. Genzyme Corporation
  2. Sanofi-Aventis (Suisse) SA

./.

Salmon Pharma GmbH

Composition of the Board of the FPC:

  • Dr. Dieter BRÄNDLE
  • Dr. Andreas SCHÖLLHORN SAVARY
  • Dr. Ralph SCHLOSSER

Court Clerk:

  • Susanne ANDERHALDEN

Representative(s) of Requester:

Representative(s) of Respondent:

  • Dr. Robert BRINER (CMS)

DECISION IN FULL

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BASIC PATENT

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BREAKING: FPC to assess SPC granting practice

Case No. O2017_001 ¦ Main hearing of 21 August 2017 @ 10am

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

The FPC published a leaflet earlier today with key bibliographic details of a hearing in the matter O2017_001 (watch out for a link ‘weitere Informationen’ on the list of public hearings):

Further information on the hearing

Such a leaflet has been published for the very first time; it is only available in German language, at least for the time being.

Gilead's Truvada
Truvada®

Nullity of the SPC C00915894 is at stake. The basic patent is EP 0 915 894 B1; see EPO Register and Swissreg.

The pharmaceutical is Gilead‘s Truvada®, a combination of tenofovir disoproxil fumarate and emtricitabine. The medication is used to treat and prevent HIV/AIDS.

Emtricitabine
Emtricitabine
Tenofovir disoproxil fumarate
Tenofovir disoproxil fumarate

The question of whether or not a product is protected by a basic patent is decisive for an SPC both in the European Community (Regulation (EC) No. 469/2009, Art. 3 lit. a) and Switzerland (Art. 140b(1) lit. a PatA).

This appears to be an easy decision at first glance, but the devil is in the detail:

(C) The Court of Justice of the European Union
(C) The Court of Justice of the European Union

Thus, the latest judgements of the CJEU and the Swiss Supreme Court are not in line anymore. The key issue in this matter is whether the Swiss SPC granting practice is to be brought in line with the case law of the CJEU.

When it got public in 2015 that the Swiss Federal Institute of Intellectual Property (FIIP) intended to change its practice to bring it in line with the CJEU case law, some commentators felt that this would draw Switzerland’s SPC granting practice into a future mess. However, this obviously also depends on whose side you’re on. We’ll see …

Reported by Martin WILMING

BIBLIOGRAPHY

Case No. O2017_001 ¦ Main hearing of 21 August 2017 @ 10am

Mepha Pharma AG ./. Gilead Sciences Inc.

BASIC PATENT

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SUMMARY

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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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