Gilead Sciences vs Sandoz - Round One
In one of many parallel cases regarding an SPC owned by Gilead, the Danish Maritime and Commercial Court on 24 April 2018 ruled in a PI-case against Sandoz A/S, prohibiting Sandoz from producing and selling the drug “Padviram” in Denmark. The Danish Maritime and Commercial Court placed great emphasis on an earlier decision from the High Court when granting the PI against Sandoz, referring also to the existing interpretive uncertainty of article 3(a) of the SPC Regulation 469/2009. Sandoz appealed the case.
Preliminary ruling from the ECJ
On 25 July 2018, the ECJ gave a preliminary ruling on the construction of article 3(a) of the SPC Regulation based on a request for a preliminary ruling in UK proceedings regarding Gilead's SPC.
The ECJ ruled that the combination of several active ingredients with a combined effect is 'protected by a basic patent in force' within the meaning of article 3(a), even if the combination is not expressly mentioned in the claims of the basic patent, provided that those claims relate necessarily and specifically to the combination in question.
Gilead Sciences vs Mylan
Following the ECJ decision, the Danish Maritime and Commercial Court concluded on 15 October 2018 in PI proceedings against Mylan S.A.S, that Gilead’s SPC should be held invalid as the claimed product did not fulfil the dual test worded by the ECJ.
The ruling created an asymmetric situation where Mylan could freely sell its generic product, whereas other companies, including Sandoz, were enjoined from selling their generic product due to the preliminary injunctions against them.
Gilead Sciences vs Sandoz - Round Two
Since the appeal hearing of the Sandoz-PI was scheduled for late January 2019, Sandoz brought a new case to the Danish Maritime and Commercial Court requesting a repeal of the PI. Repeals of PI's are extremely rare in Danish patent case law – only one prior decision exists.
On 20 December 2018, the Danish Maritime and Commercial Court repealed the preliminary injunction from 24 April 2018 against Sandoz after a 1-day hearing.
Two judges held that Gilead's SPC did not fulfil the EJC-test and, thus, that the preliminary injunction against Sandoz should be repealed.
One dissenting judge, however, held that Sandoz should wait for the appeal case to be heard in late January 2019. The reasoning from the dissenting judge is very surprising, given that the law is clear with respect to repeal of preliminary injunctions; If the conditions for granting a preliminary injunction are no longer satisfied, the preliminary injunction must be repealed.
The case shows that under certain circumstances it is possible to repeal a PI and that a repeal could be considered even though a main case or appeal already is pending.
Sandoz was represented by Horten during the whole process.