FPC Review

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Case No. S2019_006 | Decision of 1 May 2019
Case No. S2019_006 | Decision of 21 March 2019

The SPC in suit is ICOS’ C00740668/01, the basic patent of which is EP 740 668 B1; see EPO Register and Swissreg for further information.

The SPC protects tadalafil (which is also referred to in claim 10 of the basic patent), a phosphodiesterase type 5 (PDE5) inhibitor. Lilly‘s products are Cialis® (for the treatment of erectile dysfunction) and Adcirca® (for the treatment of pulmonary arterial hypertension).

Lilly’s Cialis and its active ingredient tadalafil

The basic EP’668 had lapsed already back in 2015; and the SPC has also lapsed meanwhile, on 4 May 2019. But the present decisions relate to an apparent mishap shortly before the SPC finally lapsed.

Sandoz’s logo

Sandoz had Swissmedic’s market authorization for its generic ‘Tadalafil Sandoz’ since 7 November 2017, but did not yet put it on the market. Still, the plaintiffs came across database entries for ‘Tadalafil Sandoz’ in HCI Solutions‘ medINDEX (for physicists) and pharmINDEX (for pharmacists). These databases are used by practitioners to order pharmaceuticals. Even though ‘Tadalafil Sandoz’ could not be ordered at that time, the President held that the effect of the database entries was essentially comparable to an inquiry of future needs (see S2014_001). Potential customers are made aware that the launch of a generic is imminent. This may tempt them to postpone orders for the original product and to order the cheaper generic once it becomes available. The generic manufacturer benefits from this advertising effect to the detriment of the supplier of the original product. During the term of the SPC, such advertising constitutes a violation of the exclusive rights of the owner of the SPC.

At the face of it, the situation was apparently so clear that the President granted interim injunctive relief without hearing Sandoz beforehand, and obliged Sandoz to immediately request the database provider to delete the entries.

Decision of 21 March 2019 in case of ICOS Corp, Eli Lilly SA v. Sandoz Pharma AG re SPC for tadalafil: inclusion of product in database of available products infringes patentee’s exclusive rights even if the product cannot be ordered (ex parte injunction), https://t.co/5SLv4kFPKQ

— SwissPatentCourt (@PatentCourt) May 15, 2019

After hearing the defendant, it turned out that Sandoz’ had not made the entries in the databases. The entries had been made the database provider, an independent third party, without Sandoz’s knowledge and intervention. The database entries had meanwhile been deleted on Sandoz’s request, and thus there was no basis anymore for interim injunctive relief. The request was thus denied.

Now, what about the costs?

As a rule, the costs are clapped on the unsuccessful party; Art. 106(1) CPC. But the court may diverge from the general principles and allocate the costs at its own discretion when a party was caused to litigate in good faith; Art. 107(1) lit. b.

The President held that even though the plaintiff’s course of action may be understandable under the given circumstances, this still does not justify that the defendant bears the costs incurred in view of the unlawful conduct of an unrelated third party:

The plaintiffs have refrained from issuing a warning to the defendant before submitting the request for action. The applicants’ action may be understandable in the circumstances, but it does not justify the defendant having to bear the costs of the proceedings. As the defendant credibly demonstrates, it had nothing to do with the unlawful conduct of a third party; it is to be regarded neither as an instigator nor as an accomplice nor as a collaborator. Nor does it exercise any control over the third party. Since the defendant is not responsible for the unlawful conduct and has not created the appearance of being responsible for it, it cannot be ordered to pay the costs.

The court fee and a compensation for legal representation of the defendant are thus to be borne by the plaintiffs.

Reported by Martin WILMING

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BIBLIOGRAPHY

Case No. S2019_006 | Decision of 1 May 2019
Case No. S2019_006 | Decision of 21 March 2019