Pages 282-295

NATIONAL JUDGES' PRESENTATIONS

NL Netherlands

Robert VAN PEURSEM - Court of Appeal, The Hague - Some recent developments in Dutch patent law

Sept. 2010 – Sept. 2012

Statistics

Over the above period, the courts exclusively competent to hear patent litigation in the Netherlands dealt with the caseload below. These statistics are for fully-tried adversarial cases only – so interlocutory matters, withdrawals, default cases or settlements pending or after trial are not taken into account. Frequently more than one patent is at stake in a single case – two or three are no exception. Finally, in Dutch patent cases, both validity and infringement are typically tried together in the same proceedings – so no bifurcation:

District Court The Hague:

Scope of protection

- CoA 19 October 2010 and SC 25 May 2012 (confirming) AGA v Occlutech – occluder case

Well-known case: Claim was for a dumbbell shaped collapsible medical device characterised in that clamps are adapted to clamp the strands at the opposed ends of the device. Occlutech's dumbbell shaped device was for occluding septum defects. The District Court had found in favour of Occlutech's argument that the claims were limited to devices to be placed in a channel (so septum occluders would not infringe them), but the Court of Appeal rejected it since the description indicated that the medical devices might have a broader use – citing EBA decision G 2/88. But it upheld the main non-infringement argument: Occlutech's device only had a clamp at one end. No equivalence: analysing the description and the prosecution file, the Court found that clamping at opposed ends of the device was an essential element of the claim. Applying the function-way-result test, it ruled that Occlutech's 'way' was essentially different, so no infringement (like in the UK and before the BGH). Incidentally: the Supreme Court has not ruled that applying the function-way-result test is wrong – nor has it expressly endorsed it, but it is safe to infer that this test is an acceptable method for determining equivalence in the Netherlands.

The Supreme Court confirmed in the Occlutech case the Dutch position on Article 69 EPC and the Protocol taken since Impro v Liko (2004) and Lely v Delaval (2007) - and clarified the Dutch prosecution history estoppel rule established in Dijkstra v Saier (2006). It rejected Occlutech's view that the Protocol was on Article 69, not the scope of protection of patents, and that proper application of Article 69 automatically brought the result intended by Article 1 of the Protocol, because this would render the Protocol redundant. Furthermore, applying Article 69 as intended by Article 1 of the Protocol was closely related to the issue of determining the scope of protection. The Supreme Court ruled that the Protocol gives guidance on how to apply Article 69 and so determine the scope of protection. Other optional 'viewpoints' were the essence of the invention and the idea behind the wording of the claims as opposed to their literal meaning, but the claims are of course leading, and it has now been clarified that these other 'viewpoints' were far less important than under the pre-EPC rule whereby the scope of protection in the Netherlands amounted to the German Wesenslehre, and need not be taken into account in every case. The Supreme Court held that these other 'viewpoints' could still play a role, depending on the type of patent, the description and the parties' arguments, but it is rather unclear what it meant by this. In practice, it may not be very important. For instance, in its judgment, the Supreme Court ruled that the Court of Appeal had taken into account AGA's 'viewpoint' based on the idea behind the wording of the claims in so far as it had clearly rejected the 'viewpoint' suggested that devices with clamps on one side fell under the claim. An application of the 'viewpoint' 'essence of the invention' was seen in CoA 18 October 2011 Indorato v Balmain (hair extension).

Some interesting words from the Supreme Court on 'pioneer' inventions in point 4.2.6: broader scope of protection where the various possible applications cannot reasonably be foreseen, described and claimed. Not at issue in this case according to the Court of Appeal, and the Supreme Court endorsed this finding. The consequence for trivial claims can be a narrower scope of protection, as was seen in kort geding in Pres. DC 14 March 2012 Core v Lidl (collapsible ladder): no room for equivalence where a claimed trivial technical solution is implemented slightly differently. The Supreme Court observed obiter that, in cases of 'pioneer' inventions, a lack of clarity will not necessarily work to the patentee's detriment.

As a rule, third parties are not restricted in their use of the public part of the prosecution file to determine the scope of protection of the patent (unlike the patentee, who is). This has been clear since SC 2006 Dijkstra v Saier, as can be seen in e.g. CoA 1 November 2011 Sanofi-Aventis v Ratiopharm. Prosecution history can also be used to determine whether the patentee has willingly refrained from claiming certain embodiments it now seeks to include for the purpose of the infringement proceedings.

- CoA 24 January 2012 Lundbeck v Generics (cassation pending) – and Pres. DC 14 August 2012 Lundbeck v Sandoz – escitalopram case

The product claims for the active substance escitalopram (a blockbuster antidepressant) were revoked by the Court of Appeal on the ground of obviousness (the challenge to novelty was dismissed), whilst the method claims describing a specific procedure for the synthesis of escitalopram and the claim relating to an intermediate product were considered non-obvious. The SPC-specific nullity arguments were dismissed. Lundbeck's escitalopram patent had previously been revoked entirely by the District Court.

EP '066 claimed the pure enantiomere escitalopram (the S-enantiomere of the known racemic compound citalopram) and a method for its synthesis. The Court applied the problem-solution approach (PSA), taking US '193 disclosing racemic citalopram as the closest prior art (CPA) and dismissing Lundbeck's argument that the starting point should be a large group of antidepressant compounds. It established a strong incentive to separate and test the enantiomeres with a reasonable expectation of success and defined the objective technical problem as finding the new enantiomer of the known racemic compound that has an improved effect. Applying common general knowledge, the skilled person would immediately arrive at the S-enantiomer; the improved effect of the (+)-enantiomer with a factor 2 as compared to the racemate was considered not surprising. Exit product claims 1-5.

Method claim 6 described a stereoselective synthesis by taking a racemic precursor (the diol) known from the synthesis of citalopram, separating this diol into its enantiomers and subsequently converting the enantiomerically pure diol into escitalopram by means of a specific ring closure reaction. The Court found the CPA was not EP '943 (disclosing the racemic diol base) and also not a method claim for preparing escitalopram, but a document called Smith, i.e. a method for preparing escitalopram which did not mention the diol base. The very choice of the diol base as a starting point was considered non-obvious.

But since the compound escitalopram was considered obvious, it was up to Lundbeck to prove that no other methods were known at the priority date that could be used to obtain the optically pure enantiomer. Lundbeck failed to adduce such proof.

So the outcome before the Court of Appeal was no absolute substance protection, although the method of preparing the compound had been considered novel and non-obvious. This has been criticised – and cassation is pending. In the kort geding case of 14 August, Judge Edger Brinkman, in a preliminary ruling, said that Lundbeck had cast serious doubt on whether the Court of Appeal's reasoning would be upheld. According to him, logic dictated that once the skilled person had an inventive method to prepare a compound, the compound itself was inventive, even if the compound's existence as such had perhaps been to be expected. He said it seemed erroneous to state that a substance could only be patented if the substance itself was inventive and pointed out that this was also at odds with consistent TBA case law. He left it – of course – to the Supreme Court to give a final ruling on this and stated that the doubts about the Court of Appeal ruling were not so serious that claim 1 could be held provisionally valid in the preliminary injunction proceedings.

So, in two years, we will be able to tell you how our Supreme Court has ruled on this.

Inventive step – less dogmatic application of PSA?

- DC 27 Octctober 2010 and CoA 1 May 2012 (confirming) MSD v Sandoz (co-formulation dorzolamide & timolol – obvious)

- DC 26 January 2011 Sandoz v Glaxo (Seretide case: fluticason & salmeterol – obvious)

- DC 6 July 2011 Sandoz v Astra Zeneca (Nexium case – esomeprazol – isolating the enantiomer not obvious (unlike Lundbeck))

- DC 7 March 2012 Sandoz v Astra Zeneca (Seroquel XR – not obvious) 'reasonable' expectation of success depends on the level of motivation

Whilst in the first three cases a fairly classic PSA was applied, a possible move towards a more liberal attitude in this field was especially noticeable in the Seroquel case, in which the test applied to establish inventive step was as follows:

The first question to be answered when assessing inventive step, even if the PSA was applied, was whether the skilled person – assuming all the knowledge at his disposal on the priority date – was motivated to develop a sustained-release formulation of quetiapine and whether he would have a reasonable expectation of success, i.e. that this would solve the objective problem. Motivation and a reasonable expectation of success were interdependent ('communicating vessels') in that, if the skilled person had a strong incentive, a lower expectation of success would suffice, whereas he would need a high expectation of success if he had little incentive. In other words, what was a 'reasonable' expectation depended on the level of motivation.

Having found that motivation to make a sustained release formulation was fairly limited at the priority date and that the skilled person did not have a high expectation that he could successfully make a sufficiently efficacious sustained release formulation with success, the Court ruled that the invention was not obvious.

Another development in this area is the 'pointer' issue – what to do with 'negative' and 'positive' pointers in a certain direction when assessing inventive step. In the Seretide case it was held that the assessment of obviousness was not a question of the sum of 'positive' and 'negative' pointers, since the skilled person would follow a 'positive' pointer and not be stopped by a mere 'negative pointer', unless it amounted to a prejudice. In the Nexium case, however, a negative pointer was that previous research had shown that no enantiomer of Losec had any superior characteristics and this was one of the reasons given by the Court in support of its ruling of non-obvious in this case, although it did not explain whether or not this amounted to a prejudice.

Cross-border practice after Solvay v Honeywell

- DC 22 December 2010 Solvay v Honeywell – preliminary questions to CJEU

- CJEU 12 July 2012 Solvay v Honeywell, Case C-616/10

The Hague District Court sought CJEU clearance for its still current cross-border practice, albeit one applied, after GAT v LuK and Roche v Primus, in preliminary cases only. The CJEU endorsed the ongoing Dutch cross-border practice regarding provisional measures and (re)opened the door for cross-border injunctions in main proceedings under limited conditions. The Court seems to have limited the Roche v Primus rule.

Solvay sued one Dutch and two Belgian Honeywell companies, claiming all three had infringed with the same products in all designated countries. Solvay requested a provisional cross-border injunction for the duration of the main proceedings. The District Court referred questions on Articles 6(1), 22(4) and 31 of the Brussels Regulation (No. 44/2001).

'Irreconcilable judgments' within the meaning of Article 6(1) Brussels Regulation can arise in a situation like that in Solvay v Honeywell, i.e. one Dutch and two Belgian defendants allegedly infringing in other countries, where such defendants 'in proceedings pending before a court of one of those Member States, are each separately accused of committing an infringement of the same national part of a European patent which is in force in yet another Member State by virtue of their performance of reserved actions with regard to the same product'. The CJEU held that it was for the court ruling on the facts to assess whether such a risk of irreconcilable judgments existed, taking into account all the relevant information in the file. Therefore, it now seems largely up to the national courts to determine what constitutes 'the same situation in law and facts', depending on the specific circumstances of the case in hand.

The CJEU ruling also makes clear that the GAT v LuK rule does not apply to provisional measures: 'Article 22(4) (… ) must be interpreted as not precluding, in circumstances such as those at issue in the main proceedings, the application of Article 31 (…)'. Thus, the specific scope of Article 22(4) does not affect the application of Article 31 of the Brussels Regulation. The CJEU explained that the raison d'être of Article 22(4) – avoiding conflicting decisions – was not at stake where provisional decisions were taken by the court, since these preliminary measures would not in any way prejudice the decision to be taken by the court having jurisdiction under Article 22(4), which is precisely the reasoning applied by the Dutch patent courts since GAT v LuK.

First, the CJEU ruling seems to clearly endorse the Dutch cross-border practice concerning provisional measures developed since the GAT v LuK and Roche v Primus cases, as reported at the symposia in Thessaloniki (2006) and Bordeaux (2008). It is now extended to foreign defendants too. However, some uncertainty remains in this field since the CJEU rephrased main question 2 in a way probably not intended by the Hague District Court, given that it already had jurisdiction based on Articles 2 to 6 of the Brussels Regulation – not based on Article 31. But the reasoning seems equally valid for such jurisdiction as for that based on Article 31.

Second, the ruling on Article 6 seems to reopen the possibility of suing defendants from different countries together before a single national court in main proceedings concerning a typical factual situation like that in the case at issue, where this is necessary to avoid irreconcilable judgements in 'the same situation of law and fact', which is a matter to be determined by that national court. It does not seem too far-fetched to infer that the CJEU has now conferred on courts competence to rule in an infringement situation involving foreign subsidiaries as co-defendants where the company based in the country of the court has supplied infringing material to those subsidiaries, which then offer the material in their respective countries of origin, which seems to be a small step forward.

Dutch approach to standards – Sony v LG and Apple v Samsung cases

- Pres. DC 10 March 2011 Sony v LG

- DC 14 March 2012 Samsung v Apple

As reported at the Lisbon symposium (2010), the Dutch Orange Book decision (DC 17 March 2010 Philips v SK Kassetten) was the first case in which the right to enforce a standard essential patent was met by a FRAND defence.

In that case, it had been argued that the patentee could not invoke its patent as it was obliged to issue a licence under FRAND conditions. SK Kassetten had infringed several of Philips' essential patents in the field of CD and DVD technology which were included in the Orange Book standard. The District Court ruled that as long as no actual licence had been obtained, there was no legal basis permitting use of the patented technology and no legal basis for precluding enforcement of the patents at issue. SK Kassetten ought to have asked for a FRAND licence before starting to use the standard. If the request for such a licence was refused, there was still the option of asking for a compulsory licence in a kort geding procedure for the duration of the main proceedings. This decision differed from the BGH's Orange Book decision. The Dutch court had rejected the German approach as contrary to Dutch law on compulsory licences and on grounds of legal certainty. The Philips v SK Kassetten ruling made clear that the Court might rule differently in exceptional circumstances, so in special circumstances there is room for an exception to the general rule that there is no legal ground to deny the enforcement of a patent as long as no licence has been obtained.

In Pres. DC 10 March 2011 Sony v LG, concerning the Blue Ray standard, members Sony and LG litigated over whether Sony was prepared to enter into a FRAND licence – LG seizing Sony PS3 consoles in ex parte proceedings, invoking its essential patents. In the subsequent inter partes proceedings to get the seizure lifted, it transpired that they were still negotiating a FRAND licence. The DC President saw an exception to the general Dutch Orange Book rule, since both parties were members of the standard organisation and bound by its bylaws, which included the rule that an arbitrator ultimately decides if the parties fail to agree on FRAND terms. So, in the end, there would be a licence and, moreover, negotiations were pending. In those circumstances (during negotiations or arbitration), there can be no infringement.

In DC 14 March 2012 Samsung v Apple Samsung invoked four (out of 103) patents essential to the UMTS/3G standard, seeking an injunction against Apple's iPhone and iPad and compensation for past damages. The District Court's starting point in the case dealing with Apple's non-technical defence was again the Philips v SK Kassetten rule: the mere existence of a FRAND obligation does not mean that the patentee can not enforce its patents. However, this case likewise entailed an exception. The Court ruled that, given the pending negotiations between the parties on a FRAND licence, the request for an injunction constituted an abuse of right or violation of the pre-contractual obligation to negotiate in good faith. According to the Court, the threat of an injunction during negotiations in good faith puts unjustified pressure on the other side to accept non-FRAND conditions. Samsung's argument that it was entitled to an injunction since Apple had not negotiated in good faith was rejected. The fact that Apple already marketed products incorporating the 3G standard did not justify enforcement since Samsung had explicitly tolerated this and, once it had made clear it would cease to do so, Apple immediately requested a licence. Refraining from ruling on the FRAND character of Apple's counter-offer, the Court merely assessed whether, by making this counter-offer, Apple had acted contrary to its obligation to negotiate in good faith and held this was not the case in the specific circumstances.

So Apple's position thus far was evaluated as conduct in good faith, while Samsung's enforcement action amounted to an abuse of right. But if the circumstances changed, the entitlement to injunctive relief might be restored.

Summary: under Dutch law, enforcement of an essential patent may be abusive in two situations:

• - enforcement of essential patents during good-faith negotiations about a FRAND licence (unless and until there is lack of good faith or abuse of right by the alleged infringer)
• - non-compliance with FRAND obligations (insufficient opportunity provided to other side to conclude a FRAND licence, such as refusal to negotiate, unreasonably high offer or other extraordinary or unreasonable terms and conditions)

Incidentally, the technical issues were dealt with in three other judgments of the District Court handed down on 20 June 2012. This remained relevant for damages. The Court found no infringement in the multiplexer and UMTS happy bit cases, but established infringement in the multiplexer case.

Court of Appeal brings olanzapine case into line with mainstream (UK, Germany, US, Spain)

- CoA 27 September 2011 Lilly v Ratiopharm

Overruling the District Court's decision, the Court of Appeal held the olanzapine patent valid. According to the Court, the Schauzu publication did not disclose olanzapine. Even if, as the District Court had ruled, the skilled person would be tempted to correct an error in Schauzu, he would see that flumezapine, not olanzapine, was intended in Schauzu, and the Court therefore considered olanzapine novel. It further clarified that no specific rules on obviousness were valid in the field of selection inventions (as is the case with novelty of selection inventions), but did express a preference for applying the PSA 'in this field too'. The patent was held non-obvious over Chakrabarty 1980 and 1982 and GB '235 in the light of the common general knowledge of the skilled person. None of the documents relied on contained any pointers that olanzapine would have the desired combination of proper anti-psychotic activity in the absence of side-effects of EPS and agranulocytosis. As to the amount of evidence required in the patent application to substantiate the claimed technical effect of olanzapine, the Court ruled that, 'in general', in vitro experiments sufficed to demonstrate the plausibility of the claimed therapeutic effect or the absence of side-effects, observing that this was in line with the EPO approach and Dutch case law. Moreover, it held that the description went far beyond this minimum, since it contained comparable scientific research comparing olanzapine directly with flurnezapine and ethylolanzapine. Also, during the application phase, an SPC and marketing authorisations had been added to the file, which the Court regarded as further substantiation of the combination of therapeutic effect and absence of undesirable side-effects claimed in the application.

European Central Bank case: Court of Appeal revokes DSS patent

- CoA 21 December 2010 ECB v DSS – DSS patent held invalid for added matter

Yet another case in which the District Court was overruled. Revoking the patent on the grounds of added matter, the Court observed that there seemed to be broad consensus on the applicable test for added matter among the various European jurisdictions, i.e. UK High Court and Court of Appeal, the BGH, the French District Court and Court of Appeal, the Belgian District Court and the Austrian Patent Office.