Posted: December 30th, 2021
AstraZeneca B.V. and AstraZeneca AB v. Menzis Zorgverzekeraar N.V. and Anderzorg N.V., Court of Appeal The Hague, The Netherlands, 28 December 2021, Case No. 200.286.638/0, with thanks to Willem Hoyng, HOYNG ROKH MONEGIER, for providing the judgment and the translation
“In 2014, the District Court invalidated a pharmaceutical patent of AstraZeneca AB for lack of inventive step. The invalidation has retroactive effect. Prior to the invalidation, AstraZeneca invoked the patent against one or more competitors. [Healthcare insurer] Menzis is of the opinion that AstraZeneca has acted unlawfully towards Menzis and that AstraZeneca has also been unjustly enriched to its detriment. Menzis points out that it has reimbursed the costs of the products purchased from AstraZeneca for its clients.
“The District Court held that AstraZeneca had been unjustly enriched from the moment that AstraZeneca had served a summary judgment on a competing drug manufacturer. The Court of Appeal rules in this judgment that there was no question of unlawful conduct or unjustified enrichment.
“5.1. The Court of Appeal rejects Menzis’ argument that AstraZeneca acted unlawfully versus Menzis by relying on the patent in the period from 24 March 2012 (date of expiry of the SPC protection) to June 2014 (date of the judgment declaring the Dutch part of the patent invalid), while this patent was retroactively invalidated for lack of inventive step. Menzis’ argument that the invalidation of the patent is at AstraZeneca’s risk is not supported by the law. The Court of Appeal will explain this below.
“5.2. It is not disputed that, in the relationship between a patent holder and his competitors, no strict liability applies to an invocation of a patent that is later invalidated. It follows from the CFS Bakel v. Stork judgment (1 HR 29 September 2006, ECLl:NL:HR:2006:AU6098) that Dutch law is directed at the – also in our neighbouring countries’ held view – that some degree of culpability on the part of the holder of the patent is required for the assumption of liability after the invalidation of a patent. That the proprietor of a patent who has invoked it is liable for the damage suffered by its competitors or others as a result of that conduct on the sole ground that a patent is subsequently invalidated is not accepted, according to that judgment.
“5.3. Contrary to what Menzis argues, there is no reason to assume strict liability in the relationship of the patentee with non-competitors such as Menzis. On the contrary, the fact that Menzis does not itself produce or market medicinal products and AstraZeneca has therefore never invoked the patent against Menzis argues against the application of strict liability in the relationship with Menzis. The fact that Menzis did not have the option of ‘ignoring’ the patent does not essentially distinguish its position from that of its competitor in the case that led to the CFS Bakel v. Stork judgment. In that case the patent holder CFS Bakels had invoked its patent in respect of (potential) customers of its competitor Stork. Stork could not prevent the ensuing damage by simply ignoring the patent claim of CFS Bakel patent claim.
“5.4. Nor does the fact that this case concerns a patent on a medicine compel the application of strict liability. In itself, Menzis rightly points out the general interest of good and affordable care. Strict liability may contribute to this in the sense that the prices of medicines will go down if patent holders do not invoke their patents anymore or damages are paid if those patent holders do and the patent is subsequently revoked. However, as the Supreme Court considered in the CFS Bakel v. Stork judgment, strict liability may also reduce the incentive to develop innovative medicines. The latter is also not in the interest of healthcare. The fact that in this case it was established that the drug claimed by AstraZeneca in the patent is not inventive does not make it any different. The acceptance of strict liability would also affect holders of valid patents. Strict liability implies that a patent holder may never rely on his assessment that the patent will survive invalidity proceedings.
“5.5. The fact that AstraZeneca has had protection for the active ingredient quetiapine for 25 years also does not compel the strict liability as pleaded by Menzis. Contrary to Menzis’ argument, AstraZeneca has not extended this market exclusivity by relying on the patent. The patent in question does not concern the active ingredient as such, but the sustained-release formulation of quetiapine. During the period to which Menzis’ claim relates, competitors were free to offer generic versions of Seroquel IR, and it is not disputed that competitors actually did so.”