Lundbeck ./. Sandoz: Inquiry of (future) demand while the SPC on Escitalopram is still in force

Case No. S2014_002 ¦ Hearing of 06 March 2014

Today’s hearing was announced on the website of the FPC only on February 28, without any details on the merits of the case. In view of this very short notice, I felt that an interim measure without hearing of the defendant might be at stake. Indeed, it is. But let’s first have a look at the pharmaceutical and commercial background:

Escitalopram, the (S)-enantiomer of citalopram
Escitalopram

This case pertains to Lundbeck’s blockbuster drug escitalopram (also known under various trade names such as Lexapro® and Cipralex®). It is an antidepressant of the selective serotonin reuptake inhibitor (SSRI) class which is widely used for the treatment of adults and children over 12 years of age with major depressive disorder (MDD) and generalized anxiety disorder (GAD). Escitalopram is the (S)-enantiomer of citalopram; see the structural formula in the margin. Please revert to MedlinePlus for further information on this drug.

Escitalopram accounted for a (worldwide) revenue of DKKm 5,933 in 2013; see Lundbeck’s Annual Report 2013, p. 15 (approx. 1bn CHF).

Cipralex film-coated tablets
Cipralex® film-coated tablets

These are my personal conclusions and take-away messages from what has been argued by the parties earlier today:

Escitalopram is a mature drug. The corresponding patent EP 0 347 066 B1 was filed already back in 1989 (June 1), and even the SPC is about to lapse on May 30, 2014. According to PharmaWiki, various suppliers of generics have already obtained the market authorization in Switzerland. But, to date, Cipralex is the only available drug on the Swiss market comprising escitalopram (see the so-called Spezialitätenliste). And it is an important one for Lundbeck in Switzerland: It accounts for a turnover of CHF 3m per month which is about 80% of all sales of Lundbeck in Switzerland.

Similar to many other mature blockbuster drugs, there is a lot of litigation going on in many jurisdictions; see e.g. the EPLAW Patent Blog. But the present case is somewhat special. Apparently, sales representatives of the defendant had asked doctors for their (future) demand on escitalopram, well before the lapse of the SPC. The FPC had ordered the defendant to refrain from such activities — without hearing the defendant beforehand. Subsequently, the parties were summoned for today’s hearing.

From what has been discussed in the hearing, I understood that sales representatives of the defendant had used a kind of form for the inquiry. However, the defendant argued that this form had not been intended to be given away. Rather, it was meant as a tool for the sales representatives, i.e. for internal purposes only. Nevertheless, the plaintiff evidently got hold of a photography of such a form. The defendant neither denied authorship nor the actual use of the form. What was denied is that the inquiry of (future) demand could establish an infringement according to Art. 8 PatA. It had not been intended to enter the market before June 1, nor was this an offer. It was only aimed to streamline logistics upon market entry when the SPC will have lapsed on June 1. The defendant pointed out that this intention is underlined by the absence of any specific indication of the defendant’s (generic) product, its price and availability. Moreover, the defendant alleged that the plaintiff himself had notified the doctors of the forthcoming lapse of the SPC. This was disputed by the plaintiff.

The plaintiff argued that this inquiry was a “perfidious” marketing while the SPC is still in force: By asking the doctors for their future demand, they were made readily aware not only of the approaching lapse of the SPC, but also of the defendant as a potential future supplier of the generic version. From my understanding of what has been argued, the plaintiff had documented at least one case where a doctor refrained from immediate stock replenishing after such an inquiry and instead delayed it until the generic version(s) will be available.

Anyhow, the defendant declared to abstain from further use of the form (N.B., without acknowledging any legal obligation); all sales representatives had already been informed accordingly. Although these inquiries had triggered the dispute, a second request of the plaintiff might turn out to have severe implications: The plaintiff sought for an interim injunction being issued for a term of 2½ month after the lapse of the SPC.

The defendant essentially argued that injunctive relief would require the SPC to be still in force since this request relied on the PatA. To the contrary, the plaintiff argued that this request also relies on the law against unfair competition (UCL). Moreover, a prohibition of sales as an action for damages would not be uncommon, in connection with Art. 43 of the Code of Obligations. Inter alia, the plaintiff relied on C-316/95 of the EuC. In that case, samples of medicinal products manufactured in accordance with a patented process had been submitted to the authority competent for issuing marketing authorizations. It was held that a moratorium imposed by the court on the infringer of the patent right, in so far as it seeks to place the proprietor of the patent in the position in which it would, in principle, have been had its rights been respected, cannot in itself be held to be a disproportionate form of reparation.

The defendant emphasized that this case (and similar ones which would have to be decided differently nowadays, anyhow) were fundamentally different in that an infringing act had actually been carried out during the term of the patent or SPC.

Yet another point of discussion was the value in dispute for the moratorium. While the plaintiff argued for CHF 250’000,–, the defendant estimated the value in dispute to exceed CHF 1m.

The parties finally entered into non-public settlement negotiations.

Reported by Martin WILMING

BIBLIOGRAPHY

Case No. S2014_002 ¦ Hearing of 06 March 2014

Lundbeck (Schweiz) AG ./. Sandoz Pharmaceuticals AG

Subject(s):

  • Infringement

Composition of the Board of the FPC:

  • Dr. iur. Dieter BRÄNDLE (President, Single Judge)
  • Lic. iur. Susanne ANDERHALDEN (Court Secretary)

Representative(s) of Plaintiff:

  • Dr. Simon HOLZER (MLL)
  • Dr. Kilian SCHÄRLI (MLL)

Representative(s) of Defendant:

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3 Replies to “Lundbeck ./. Sandoz: Inquiry of (future) demand while the SPC on Escitalopram is still in force”

  1. In an earlier version of this post, a package of Cipralex® Meltz was depicted for illustrative purposes. In the meantime, I have been informed that this orodispersible dosage form of Cipralex® is separately patented, but this patent was not at stake here. I have thus replaced the former illustrative image with an image of Cipralex® film-coated tablets.

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