This was another decision in the pan-European pemetrexed battle, in which the Court of Appeal found Eli Lilly’s patent valid and infringed. The patent claims an anticancer agent, pemetrexed disodium, in combination treatment. The main question was whether a different salt form of pemetrexed would constitute infringement by equivalence.
Whilst the Dutch courts have not always followed a two-step test for determining the scope of a claim, the Court of Appeal in this decision chose to do so. The court laid down four requirements for protecting equivalents:
The Court of Appeal also gave further guidance on relevant factors to consider when assessing these questions. The equivalent itself does not need to have basis in the application, and hence limitations for added matter are not relevant. Furthermore, even where the patent application could have been drafted more clearly, this does not rule out protection of equivalents. This decision suggests that the Dutch courts are now more likely to follow the two-step test in the future.
This judgment marks the first time that the court has held a pharmaceutical company (AstraZeneca) liable to a health insurance company (Menzis) for higher reimbursement costs in The Netherlands caused by the enforcement of a patent that was later declared invalid.
Sandoz and other generic manufacturers started a nullity action against AstraZeneca’s patent EP 0 907 364 for a formulation of quetiapine, but the action was unsuccessful and the patent was held valid by the District Court of The Hague. Shortly afterwards the UK part of the patent was held invalid by the High Court in London, which was confirmed by the Court of Appeal. Several months later the District Court of The Hague issued a preliminary injunction against Sandoz for infringement.
AstraZeneca then served the judgment on Sandoz, acquiring a compensation liability to Sandoz if the preliminary injunction would later be overturned. Therefore, Menzis had to reimburse the originator, as the less expensive generic could not enter the market. On appeal in the Dutch nullity action, the patent was declared invalid.
The court confirmed that patentees are not liable merely for maintaining a patent that is later revoked despite the risk that this approach could hinder technological investments. Nevertheless, enforcement, such as serving the injunction for infringement while validity is still at issue, could give rise to liability for consequential damages suffered by third parties. The court ruled that Menzis’ damages resulted from AstraZeneca’s market exclusivity, which in turn resulted from wrongful enforcement of the patent. Therefore, AstraZeneca was unjustifiably enriched to the detriment of Menzis and liable for damages to Menzis. One factor in this ruling was that enforcement of the preliminary injunction occurred after the Court of Appeal in London had declared the UK counterpart of the patent invalid.
The Court of Appeal dismissed Asus’ invalidity challenge and found the patent essential to the UMTS-standard and thus infringed by Asus. The court applied the CJEU’s Huawei v ZTE framework in assessing the compliance of the parties with their FRAND obligations and considered that the Huawei v ZTE steps should be treated as guidelines for bona fide negotiations between parties.
The court concluded that Philips had properly notified the patent to Asus. It dismissed Asus’ FRAND defence, holding that Asus was an unwilling licensee because of its delaying tactics. According to the court, it is a prerequisite for the FRAND obligation to arise that the SEP holder submits its FRAND offer and that the implementer shows its willingness to conclude a licence under FRAND conditions.
Moreover, Asus did not promptly submit its counteroffer after Philips sent its standard licence agreement. Under those circumstances, even if it would have been for Philips to submit a FRAND offer, the implementer could not successfully rely on a FRAND defence. Asus’ counteroffer, submitted after Philips rightfully initiated injunction proceedings, could not render the initiating of those proceedings a breach of the FRAND obligations by Philips. The court commented that it did not follow from the CJEU ruling that the SEP holder needed to explain why its licence offer was FRAND. The same would hold for the counteroffer by the implementer.
The District Court of The Hague had found High Point’s European patent invalid and rejected its infringement claims. On appeal, High Point relied on its patent being voluntarily centrally limited at the EPO, after auxiliary requests were denied by the Court of Appeal. The requests were refused based on the so-called “two-statement rule” which provides that reliance on auxiliary requests needs to be included in the grounds of appeal.
According to the Supreme Court, the right of the patentee to limit its patent at the EPO as laid down in the EPC does not prevent a court from refusing to admit it into the proceedings as contrary to the requirement of due process, stressing that the case at hand was extraordinary. It accepted the decision of the Court of Appeal to this effect. The Court of Appeal was entitled to take into account that the patent in limited form was virtually identical to High Point’s auxiliary requests, which the Court of Appeal already refused in its earlier interlocutory judgment and against which High Point had unsuccessfully appealed to the Supreme Court.
The judgment of the Supreme Court appears to leave open the possibility of invoking the limited patent in new proceedings, even after the invalidation of the patent as granted. The outcome may also be different if the patent claims are limited in opposition instead of through a voluntary limitation.
Biogen claimed the Dutch part of Richter’s patent was invalid for lack of novelty, obviousness, and insufficiency. During opposition at the EPO, Richter had relied on five auxiliary requests (I-V). In the Dutch proceedings, Richter relied on auxiliary requests IV and V as a fallback position if the court held the granted claims invalid. However, during the oral hearing Richter stated that it would limit the dispute in The Netherlands to defending auxiliary requests IV and V only, accepting at least limitation of the claims as granted.
According to the court, this had to be equated to the partial surrender of the Dutch part of the patent as granted. This would imply that the debate on the patent in the broader form in which it was granted was superseded in the light of the fallback to the auxiliary requests. Therefore, according to the court, Richter had effectively acknowledged that the attacks against the claims as granted were well founded, and hence these claims were not novel over the cited prior art. The court then ruled that the additional features in the auxiliary requests did not establish novelty or inventive step over the prior art which was cited against the original claims (which were invalid over this prior art as they were no longer defended). Therefore, the patent was invalid even as proposed to be amended.
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