Edger BRINKMAN

Judge, Court of Appeal

Some statistics

In the period June 2012-June 2014, Dutch courts handed down the following number of decisions:

• Supreme Court: 9 (7 more than in 2010-2012)
• Court of Appeal The Hague: 25 (same as 2010-2012)
• District Court The Hague: 60 on the merits, 31 kort geding (20 less than 2010-2012)

These statistics are based on contradictory and fully tried judgments only. No interim decisions or withdrawals, no judgments by default or settlements have been taken into consideration.

It should be noted that frequently more patents are tried in the same case. Also, in the Netherlands infringement and validity of the patent are virtually always reviewed together. There is no bifurcation.

Inventive step/novelty

The first important case to be discussed is the matter of Lundbeck's EP 0 347 066 for escitalopram (S-enantiomer of citalopram). This patent contains both process claims and product claims. The Court of Appeal in The Hague on 24 January 2012 re Lundbeck v Tiefenbacher et al. held the process to be novel and inventive, yet the product claim novel but not inventive. The Court of Appeal in The Hague reasoned that a strong incentive existed at the priority date to separate R- and S-enantiomers of citalopram to find which enantiomer worked. It also viewed Lundbeck's technical contribution to the art as being the process (for separating the enantiomers) and not the product (escitalopram). It further took into consideration that the product directly obtained by Lundbeck's process was protected (Article 64(2) EPC). Hence, Lundbeck was not entitled to the product claim.

The President of the District Court of The Hague on 14 August 2012 (in a case brought by Lundbeck against a different generic manufacturer Sandoz) viewed this reasoning of the Court of Appeal as unsound, as before Lundbeck's invention of the process nobody could obtain the S-enantiomer (escitalopram). This being so, the President reasoned that logically the product was also a technical contribution of the inventors. The Dutch Supreme Court concurred with the President on 7 June 2013 and held that an in itself obvious product could be inventive if there was no process known to obtain it. The Dutch Supreme Court regarded its decision as "in line with" (in Dutch: "in lijn met") EPO, English and German decisions. Further, the Supreme Court held that the burden of proof that there was a prior process to obtain the compound was on the challenger of the patent (contrary to what the Court of Appeal had held). It also deemed the problem-solution approach not to be required while assessing inventive step.

In the case of Teva v Sanofi the District Court of The Hague on 2 October 2013 held that if a claimed product is in fact no more than a mere alternative (no improvement is claimed), it is not necessary to demonstrate that a pointer to this alternative exists. All alternatives should be equally regarded as solutions to the problem of providing an alternative compound (irbesartan as alternative to DuP753). It therefore held that the irbesartan-patent and SPC was invalid (the Court of Appeal in The Hague had already earlier decided in summary proceedings that the SPC was invalid, as is now confirmed by the ECJ).

In Sandoz-Accord v Astra Zeneca, the Court of Appeal in The Hague rendered judgment on 10 June 2014. The case revolved around a slow-release formulation of quetiapine (antipsychotic). The Court of Appeal held the patent to be obvious (same as Arnold J., upheld in appeal, in UK), as there was a clear incentive to formulate a slow release formulation of quetiapine to improve inter alia patient convenience and compliance with reasonable expectation of success. The Court of Appeal in The Hague found that many problems indicated by Astra Zeneca were not mentioned in the patent and also not genuine problems.

Added matter

Added matter is still an important topic in litigation, especially intermediate generalisations (see i.a. Court of Appeal in The Hague Vermop v Rubbermaid 5.7). In its decision of 12 September 2012 re Occlutech v AGA (yet another divisional, EP 0 957 773, not EP 808 138 which revolved around interpretation of the plural "clamps"), the District Court applied the 3-step test frequently adopted by the EPO when deleting a feature. Incidentally, it should be noted that the applicability of that test was not disputed by the parties. According to this test, the feature to be deleted should:

(i) not be explained as essential in the disclosure;

(ii) not be indispensable for the functioning of the invention; and

(iii) require no real modification of other features.

Patentability exceptions

The Court of Appeal in The Hague decided a case on 25 June 2013 in re Rovi v Ziggo. It held that EP 1 244 300 for an electronic TV program guide does not infringe Article 52 EPC as long as the claims have technical features. Further, for novelty and inventive step, only technical features should be taken into account. Non-technical features that do not interact with technical subject-matter should be ignored. The Court of Appeal in The Hague shared the view of T 154/04 (Duns) and G 3/08. It held the patent not inventive.

Also the case of Taste of Nature v Cresco is of interest. It deals with EP 1 290 938 for the raphanus sativa plant in the name of Taste of Nature. Article 53(b) EPC provides that plant or animal varieties or essentially biological processes for the production of plants or animals (…) cannot be patented. The Enlarged Board of the EPO held in G 1/08 that the legislator's intention is to exclude conventional plant breeding processes (i.e. crossing and screening) from patentability. Even if a technical feature in such a process is introduced, that process is still excluded from patentability. The President of the District Court of The Hague held on 31 January 2012 that the exception under Article 53(b) EPC applies also to a plant-by-process claim, as otherwise G1/08 would have no effect: the breeder still cannot perform the conventional process which is intended to be non-patentable. However, the District Court of The Hague in proceedings on the merits took a different view on 8 May 2013. It held that the exception under Article 53(b) EPC does not apply to a plant-by-process claim as the wording of the provision clearly only refers to processes. It is therefore an apparent decision by the legislator to exclude a process but not a product claim. There is no undermining of Article 53(b) EPC as the process is still excluded and a product has to be new and inventive to be patentable. The Court of Appeal in The Hague on 28 May 2013 decided the same on the appeal in summary proceedings, as the decision on the merits takes precedence according to Dutch case law.

Scope of protection

Here a leading case was decided by the Dutch Supreme Court on 4 April 2014 re Medinol v Abbott. This is a case about EP 1 181 902 for a flexible expandable stent. The literal wording of the claim could cover both so-called in phase and out of phase meander patterns. The description and drawings however clearly address the problem of "foreshortening" which occurs only in out of phase meander patterns. According to the Supreme Court, the Court of Appeal in The Hague rightly limited the claim to out of phase meander patterns (reference to the protocol on Article 69 EPC). This means that the literal wording of a claim can be limited by the description and drawings.

Medinol also argued that at the date of infringement in phase meander patterns with foreshortening existed. The Dutch Supreme Court held that for infringement, two issues should be decided:

(i) interpretation of the patent to determine scope of protection

(ii) determination whether a product/process falls within that scope

Regarding (i) various viewpoints exist (inter alia essence of the invention: what is the contribution of the patent to the art) which are to be determined according to the time of the filing or priority date. The exception to this rule is the "file wrapper estoppel". Regarding (ii) the knowledge of the notional skilled person at the date of infringement is also to be taken into consideration, especially when determining equivalence (Article 2 of the protocol on Article 69 EPC). As Medinol's argument concerned question (i), the Court of Appeal in The Hague was right to use the knowledge at the priority date and to find no infringement.

The Court of Appeal in The Hague decided on 31 December 2013 the case of Bayer v Sandoz. In these process patents, a clear choice was made to claim a certain variant. In one patent, a ruthenium salt catalyst was claimed for the oxidation step, whereas the alleged infringer Sandoz used a TEMPO-catalyst. In the other patent, water elimination was performed using pTSA, i.e. an acid addition, whereas Sandoz used a pyridine base. Reasonable certainty for third parties means there can be no infringement with such different variants, even if it is not essential for the invention in the patent which variant is used. "What is disclosed but not claimed is disclaimed".

The Dutch Supreme Court handed down judgment on 13 September 2013 re Ajinomoto v Global. Articles 8 and 9 of the Bio-directive refer to biological material. Lysine produced by genetically modified E.Coli is not to be considered a biological material, therefore the ECJ Monsanto 6 July 2010 decision does not apply and there is no test whether genetic material still performs its function.