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20 January 2020
On 19 November 2019 the Barcelona Court of Appeal issued two decisions confirming the refusal of the preliminary injunctions that AstraZeneca had requested to prevent the commercialisation of fulvestrant generics by Teva and ratiopharm for alleged infringement of AstraZeneca's patents.
AstraZeneca is the holder of European Patents EP1250138 (EP'138) and EP2266573 (EP'573), which claim an intramuscular formulation of fulvestrant for the treatment of breast cancer. EP'573 is a divisional of EP'138 and both patents will expire on 8 January 2021.
AstraZeneca is also the holder of Patent EP1272195 (EP'195), which claims the use of fulvestrant for the treatment of a sub-type of breast cancer patients. This patent expires on 2 April 2021.
In July 2017 AstraZeneca sued Teva for alleged infringement of the formulation patents EP'138 and EP'573. It also requested and was granted an ex parte preliminary injunction. In January 2018 AstraZeneca sued ratiopharm for infringement of the same patents, plus use patent EP'195.
In parallel, in May 2017 the European Patent Office (EPO) Opposition Division revoked the divisional EP'573 due to lack of inventive step; AstraZeneca's subsequent appeal was pending.
Further, in a previous proceeding initiated by AstraZeneca against Sandoz for infringement of the formulation patents, the Barcelona Court of Appeal had revoked a preliminary injunction, which had been granted in first instance. In its decision, the court acknowledged that EP'573 had been revoked by the opposition division and concluded the prima facie invalidity of EP'138 due to lack of inventive step (Order of 27 December 2017).
With this background and by means of two orders of 18 July 2018, the Barcelona Commercial Court No 4 revoked the ex parte preliminary injunction previously granted against Teva and dismissed the request against ratiopharm. The court found EP'138 and EP'573 invalid due to lack of inventive step. As for EP'195, which AstraZeneca asserted against ratiopharm, the court found that it would be likely invalid due to lack of novelty.
While AstraZeneca's appeals against these orders were pending, the EPO Board of Appeal upheld EP'573 (decision of 24 January 2019), thus revoking the EPO Opposition Division's previous decision.(1)
Regarding the formulation patents (EP'138 and EP'573), the Barcelona Court of Appeal dismissed AstraZeneca's appeals and confirmed the refusal of the preliminary injunctions by concluding that there was not enough urgency, whereas serious doubt remained over the validity of the patents at stake.
As regards urgency, the court took into account that AstraZeneca no longer enjoyed a monopoly since there are other fulvestrant generics on the market besides those of Teva and ratiopharm and the regulatory price reduction systems are long being applied. The court further acknowledged that the risk of continued infringement is limited in time as the patents are close to expiring.
Regarding the doubtful validity of the patents, the court reiterated that it had already ruled on the matter when it revoked the preliminary injunction against Sandoz. In this regard, it explained that the fact that the EPO Board of Appeal subsequently found EP'573 valid did not preclude the court from maintaining its finding of lack of inventive step of the formulation patents.
The court also referred to the value of other European court decisions. In particular, it mentioned a German Supreme Court decision of 20 May 2019, which, being posterior to the EPO Board of Appeal decision, declared the invalidity of EP'138 due to lack of inventive step and thus confirmed its revocation.
With regard to use patent EP'195 asserted against ratiopharm, the Barcelona Court of Appeal found no urgency. The court upheld ratiopharm's argument that AstraZeneca had previously tolerated the alleged infringement of this patent by third parties, as it decided not to assert it in its previous infringement actions against other companies (eg, Sandoz and Teva).
The court also considered that the patent would not confer an absolute or broad protection, as it does not claim a drug or a formulation as such, but rather the use of fulvestrant for treating a certain sub-type of patients.
These decisions are final, as AstraZeneca cannot file any further appeals. Main proceedings on the merits are pending before Barcelona Commercial Court No 4.
For further information on this topic please contact Ignacio Pontijas at Grau & Angulo by telephone (+34 91 353 36 77) or email (email@example.com). The Grau & Angulo website can be accessed at www.ga-ip.com.
(1) A number of court decisions have been issued since these decisions in parallel litigations in other countries – including the Netherlands, Switzerland, Germany, Italy – over the same patents, but with different outcomes.
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