Request for interim injunctive relief dismissed in view of nullity decisions in other European jurisdictions

Case No. S2014_001 ¦ Decision of 11 February 2015 ¦ “Vorsorgliche Massnahmen; Bedeutung ausländischer Nichtigkeitsurteile für die Glaubhaftmachung der Nichtigkeit des Streitpatents”

— THE DECISION IN A NUTSHELL —

AstraZeneca’s patent on an extended release formulation of quetiapine (Seroquel®) is heavily litigated in many countries. The FPC now dismissed AZ’s request for interim injunctive relief, essentially on the basis of parallel decisions in various European jurisdictions that held the patent invalid for lack of an inventive step.

— THE DECISION IN MORE DETAIL —

This case is all about 2-{2-[4-(Dibenzo[b,f][1,4]thiazepin-11-yl)-1-piperazinyl]ethoxy}ethanol.

Quetiapine

Getting confused? No worries.

This molecule is better known as quetiapine (international non-proprietary name, INN) or under the tradename Seroquel® of AstraZeneca. It is an atypical antipsychotic approved for the treatment of schizophrenia, bipolar disorder, and along with an antidepressant to treat major depressive disorder.

Seroquel is still a blockbuster drug, even though revenues have drastically declined since 2011 (see below). It was first approved by the FDA in 1997, and today generics are already available.

The plaintiff / patentee had requested interim injunctive relief about one year ago, based on EP 0 907 364 B1; the underlying PCT application is WO 97/45124 A1. The patent on quetiapine as such (EP 0 240 228 B1) has already lapsed. Note that EP 0 907 364 B1 only protects an extended release formulation thereof. Independent claim 1 at stake reads as follows:

A sustained release formulation comprising a gelling agent and [quetiapine] or a pharmaceutically acceptable salt thereof, together with one or more pharmaceutically acceptable excipients.

It was undisputed that the formulations marketed by the defendant contained — besides quetiapine — lactose and Viscarin GP 209. However, while the plaintiff / patentee argued that Viscarin GP 209 was a gelling agent, this was disputed by the defendant. Further, the defendant alleged that the patent-in-suit was invalid for various reasons: Insufficient disclosure of the invention; lack of novelty or, at least, lack of an inventive step.

In summary proceedings, the standard of proof is only prima facie evidence; see Art. 261(1) CPC, Art. 77 PatA. This also applies to a defendant’s plea in defense (see e.g. BGE 132 III 83, r. 3.2; BGE 103 II 287, r. 2; BGE 4P.228/1996). The national parts of EP 0 907 364 B1 had been revoked for lack of an inventive step in already five jurisdictions: Germany, the United Kingdom, the Netherlands, Spain and Italy. Only a decision of the Commercial Court of Vienna (Austria) held that the claimed subject matter involved an inventive step. I have collected copies of some of these decisions as follows: 3Ni 43/10 of the Federal Patent Court of Germany (also an inofficial EN translation is available) and the second instance decision X ZR 41/13 of the Federal Supreme Court of Germany; the decision of the High Court of Justice and the second instance decision of the Court of Appeal in the United Kingdom; the decision of the Appeal Court The Hague (Netherlands).

With reference to the decision 4P.89/2004 (r. 3.1-3.2) of the Supreme Court, the FPC unequivocally held that

[f]or the sole reason that the patent had been declared invalid by five European courts, the defendant’s plea for nullity is credible. […] Accordingly, the request for interim measures would have to be readily dismissed, […]. Nevertheless, in terms of a diligent assessement, an opinion of the reporting judge […] was obtained.

The FPC held that the alleged insufficiency of disclosure of the invention in the patent-in-suit was unfounded,

[…] at least to the extent of the specific embodiments disclosed in the patent-in-suit. However, this does not mean that the invention is workable over the whole scope of the claim, as required by Art. 83 EPC.

However, the FPC did not expand further on the alleged insufficiency of disclosure, but rather exhaustively discussed the parallel European decisions referred to above. The FPC held that the five decisions denying an inventive step were convincing, while the only dissenting decision of the Commercial Court of Vienna was held to be not conclusive.

In brief, the Federal Patent Court of Germany had found that the claimed subject matter did not involve an inventive step, starting from O. Gefvert et al.: “Time course for dopamine and serotonin receptor occupancy in the brain of schizophrenic patients following dosing with 150 mg Seroquel™ tid” (Abstract P-4-65 in European Neuropsychopharmacology 09/1995; 5(3):347) in combination with a press release of Eurand America, Inc. (“Eurand America, Inc. Signs Development Agreement with Zeneca Pharmaceuticals” (October 2, 1995)), in further view of Aulton, M.E.: “Pharmaceutics. The Science of Dosage Form Design” (1988) and US 4,389,393 A. This finding was confirmed by the Federal Supreme Court of Germany. The other courts apparently cited the same or similar prior art in support of their findings of lack of an inventive step; the Appeal Court The Hague further cited Hirsch, S.R.: “A new Atypical Antipsychotic Drug” (British Journal of Psychiatry (A22), May 1996). Only the Commercial Court Vienna apparently held that the “once-a-day” indication in the Eurand press release did not prompt the person of routine skill in the art towards an extended release formulation.

Be that as it may, the FPC held that the defendant had credibly established a lack of inventive step by prima facie evidence on the basis of the parallel European decisions.

The plaintiff had submitted amended / restricted sets of claims of the patent in suit, as auxiliary requests. However, the amendments did not revert the FPC’s findings re inventive step. The amendments related to the amount of the gelling agent to be added to the formulation, but no non-obvious effect of the amounts had been alleged by the plaintiff. The FPC could not spot any such effect, either. Therefore, the request for interim injunctive relief was dismissed.

Reported by Martin WILMING

— BIBLIOGRAPHY —

Case No. S2014_001 ¦ Decision of 11 February 2015 ¦ “Vorsorgliche Massnahmen; Bedeutung ausländischer Nichtigkeitsurteile für die Glaubhaftmachung der Nichtigkeit des Streitpatents”

AstraZeneca AB ./. (n/a)

Subject(s):

  • Infringement
  • Interim measures

Composition of the Board of the FPC:

  • Dr. Dieter BRÄNDLE (President)
  • Dr. Erich WÄCKERLIN (Reporting Judge)
  • Prisca von BALLMOOS (Judge)
  • Susanne ANDERHALDEN (First Court Clerk)

Representative(s) of Plaintiff:

  • Dr. Michael RITSCHER (MLL)
  • Dr. Mark SCHWEIZER (MLL)
  • Dr. Simon HOLZER (MLL)

Representative(s) of Defendant:

— FULL TEXT OF THE DECISION —

Download (PDF, 339KB)

Further insight into the requirements for an ex-parte interim injunction

Case No. S2015_001 ¦ Decision of 09 February 2015 ¦ “Abweisung superprovisorischer Massnahmen; Anforderung an Gesuch um superprovisorische Massnahmen bei negativem vorläufigen internationalen Prüfungsbericht”

— THE DECISION IN A NUTSHELL —

If an ex parte interim injunction is requested, the FPC will — to a certain extent — anticipate potential counter-arguments of the defendant ex officio, and evaluate their cogency. Novelty and involvement of an inventive step was not offhandedly assumed for a Swiss patent that is unexamined on the merits, since (i) the IPRP of the underlying PCT application denied novelty; and (ii) counter-arguments of the plaintiff / patentee re novelty and inventive step were not found convincing. Consequently, the interim injunction was not granted ex parte.

— THE DECISION IN MORE DETAIL —

As a general rule, Art. 261(1) CPC provides that a court shall order interim measures required provided the applicant shows credibly that: (a.) a right to which he or she is entitled has been violated or a violation is anticipated; and (b.) the violation threatens to cause not easily reparable harm to the applicant.

While interim measures are regularly dealt with in inter partes proceedings, ex parte interim measures may also be granted according to Art. 265 CPC: In cases of special urgency, and in particular where there is a risk that the enforcement of the measure will be frustrated, the court may order the interim measure immediately and without hearing the opposing party. This is frequently referred to as a super-provisional measure.

Thus, the law provides for such super-provisional measures. And the FPC has already granted a few of them. However, in none of these cases super-provisional injunctive relief was granted. And the present case it not (yet) the one that got away. But it provides further guidance on how the FPC actually deals with such requests.

It is common sense that the court has to examine a request for super-provisional measures circumspectly: The court must not offhandedly infer the credibility of the (qualified) endangering, but rather has to request proof, besides a plausible presentation of the facts (see p. 7536, penultimate para. of the dispatch of the Federal Council on the Civil Procedure Code).

However, what does this mean in patent litigation matters?

The FPC now took the opportunity to further shape the actual requirements in a hands-on example. Let’s have a brief look at the technical matter at stake. Even though it is not explicitly mentioned in the decision, it is clear that CH 708 247 B1 and WO 2013/174738 A1 are at stake. For further bibliographic details, please see Swissreg with regard to the Swiss patent and Patentscope with regard to the PCT application, respectively.

The PCT application had been nationalised in Switzerland and proceeded to grant, but without any examination on the merits (Art. 59(4) PatA). Therefore, the FPC must not offhandedly assume validity of the Swiss patent if ex parte interim measures are requested. Rather, further indication in support of the validity of the Swiss patent is necessary, such as e.g. an official search report or an international preliminary report on patentability (IPRP); see e.g. S2013_005, r. 3. Here, an IPRP was indeed available — but novelty was explicitly denied therein. Note that the claims of the Swiss patent and the PCT application are identical. Of course, the plaintiff did not agree with the findings of the IPRP and presented arguments in support of novelty over all documents cited in the IPRP. However, the FPC concluded that the findings of the IPRP re lack of novelty were prima facie not refuted. But even if the FPC would have followed the plaintiff’s reasoning re novelty, the plaintiff apparently failed to present convincing arguments re inventive step. In this regard, the FPC again reiterated that it is essential to define the person of skill in the art whenever inventive merit is being discussed. Moreover, it has to be shown why the person of skill in the art would not have arrived at the claimed solution, e.g. on the basis of the problem-and-solution approach established in EPO proceedings. The FPC briefly assessed the potential involvement of an inventive step and concluded that obviousness over D1 (EP 2 248 485 A1, in particular Fig. 5, 6 and 8) could not be ruled out by prima facie evidence, in further view of D3 (WO 2011/027229 A2).

My personal take-away message from the decision is the following:

To a certain extent, the court thus has to anticipate potential counter-arguments of the defendant ex officio, and to evaluate their cogency.

Evidently, the hurdle for an ex parte interim injunction is high — but not insurmountable. The FPC explicitly notes what has been missing here:

For an ex parte interim injunction to be granted, and if a negative IPRP has been issued, the FPC needs to be in a position to conclude prima facie and at least on the basis of the plaintiff’s submission that novelty and inventive step is nevertheless given.

This was not the case here. The request for ex parte interim injunctive relief was dismissed and the defendant was given the opportunity to reply.

— WHAT’S UP ON THE MARKET —

Patentees are Martin BÄCHLER and Jürg BÄCHLER, who are members of the board of directors of Valoc AG. In my perception, the retention inserts for the fixation of Valoc’s Novaloc™ matrices are products according to the patent in suit.

For more information on this system, please revert to the product brochure and the flyer. To better understand mounting and removal of the retention insert, the following video may help:

There is no indication at all in the decision as to the identity of the defendant.

Reported by Martin WILMING

— BIBLIOGRAPHY —

Case No. S2015_001 ¦ Decision of 09 February 2015 ¦ “Abweisung superprovisorischer Massnahmen; Anforderung an Gesuch um superprovisorische Massnahmen bei negativem vorläufigen internationalen Prüfungsbericht”

(not identified) ./. (not identified)

Subject(s):

  • Infringement
  • Interim measures without hearing the defendant
  • Dental retention insert

Composition of the Board of the FPC:

  • Dr. Dieter BRÄNDLE (President)
  • Dr. Tobias BREMI
  • Dr. Kurt SUTTER

Representative(s) of Plaintiff:

Representative(s) of Defendant:

  • (n/a)

— FULL TEXT OF THE DECISION —

Download (PDF, 824KB)

This milk frother won’t leave you cold

Case No. S2014_006 ¦ Decision of 06 October 2014 ¦ “Kaltmilchschäumer: Gutheissung vorsorglicher Massnahmen (Patentverletzung); Anforderungen Glaubhaftmachung offenkundige Vorbenutzung; Anforderungen Sicherheitsleistung”

— IN A NUTSHELL —

A prior use as prima facie evidence in a plea of nullity is frequently cumbersome — and was unsuccessful here. The prior use had allegedly occured already more than 10 years ago. The defendant did not provide a binding cease and desist declaration; preliminary injunctive relief was granted. It was not even made conditional on the payment of a security by the plaintiff since the defendant had repeatedly argued that the allegedly infringing machines were no longer marketed anyhow. Thus, the FPC did not anticipate that the measures may cause loss or damage to the defendant (Art. 264 CPC).

— IN MORE DETAIL —

Milk frothers are frequently litigated in Switzerland. You might perhaps recall the decisions Milchschäumer and Milchschäumer II a few years ago. The present case is apparently not related to the old ones, but again pertains to a milk frother. Fortunately, catchwords are not confusingly similar: This time, it’s a milk frother for cold milk (Kaltmilchschäumer).

i) BACKGROUND OF THE CASE

Latte macchiato, with milk froth toppingOne of the plaintiffs is the patentee of both patents in suit, i.e. a Swiss patent and a European patent. The other plaintiff is a member of the same group of companies. However, the parties are anonymized in the decision.

Nevertheless, from the wording of the requests and the technical details given in the decision, it is evident that CH 707 091 B1 and EP 2 120 656 B1 are the patents in suit. The patentee is Steiner AG Weggis. A connected undertaking of Steiner AG Weggis is Thermoplan AG — quite likely the second plaintiff. Never heard? Thermoplan manufactures the machines that Bloomberg recently referred to as Starbucks’ secret weapon.

Opposition/appeal proceedings are currently pending against EP 2 120 656 B1. The online file wrapper at the EPO is insightful: Franke Coffee Systems GmbH of Germany intervened as a party (under Art. 105 EPC), since proceedings for infringement of that patent had been instituted against them. In the intervention, it is referred to two summary proceedings at the regional court of Düsseldorf (Germany), i.e. 4a O 52/14 and 4a O 81/14 (the fulltext of the intervention is available here). No further details on these proceedings are available to date, but the present decision of the FPC also refers to two “corresponding decisions in summary proceedings” at the regional court of Düsseldorf on the German part the patent in suit. There are some further hints in the decision; in sum, it is abundantly clear to me that Franke Coffee Systems is involved as the defendant (i.e. the Swiss member of the Franke group of companies, Franke Kaffeemaschinen AG).

The European patent was maintained in slightly amended form by an Opposition Division (OD) of the EPO; see the Druckexemplar of the interlocutory decision of the OD. Appeal proceedings are still pending. The independent claims as maintained by the OD read as follows (markup vis-à-vis EP 2 120 656 B1 as granted:

1. A method for the production of milk foam or milk-based drinks, wherein milk is sucked with a pump (1) out of a container (3, 3′) and conveyed to an outlet (11′), air or a gas being added to the milk, whereby the milk/air mixture is processed in a cold or hot state into milk foam and conveyed as cold or hot milk foam to the outlet (11′), characterised in that
the milk or the milk/air mixture, which is sucked by the pump (1) und mixed with the air respectively the gas, is selectively conveyed via a throttle point (12) directly or via a flow heater (16) to the outlet (11′).

2. An apparatus for implementing the method according to claim 1, having a pump (1) sucking the milk from a container (3, 3′) via a suction line (2), having an outlet line (10) leading from the pump (1) to an outlet (11′), having an air supply line (5) opening out into the suction line (2), characterised in that the outlet line (10) has two parallel sections (10a, 10b), which can be enabled selectively by means of a valve (15) between the throttle point (12) and the outlet (11′), a flow heater (16) being assigned to one of these outlet line sections.

ii) WORDING OF THE REQUESTS

The proper wording of requests for injunctive relief is a matter of ongoing discussion amongst practitioners. Swiss case law strictly follows the rule that a request must be precise enough to allow enforcement of the prohibition by mere factual inspection; see e.g. this Blog here (with further reference). The present request for preliminary injunctive relief is quite lengthy. But it is a good example of a request that makes use of photographic illustrations of the infringing features to meet this goal (in German language, but you will get the idea):

Request for preliminary injunctive relief, with photographic illustration of features

Moreover, the request did not reach beyond the scope of the patents. Consequently, the FPC held that the wording of the requests was formally allowable.

iii) CLAIM CONSTRUCTION

Construction of the term “throttle point (12)” was under dispute. Clearly, this throttle point converts the milk/air mixture to a milk foam. In a function-oriented construction of the term, the FPC first clarified the terms “milk/air mixture” and “milk foam”. There is neither a precise definition in the patents nor have the parties provided any commonly accepted definition. A Ph.D. thesis of Katja BORCHERDING was not held sufficient since it only relied on a single reference for an amount of 0.5-0.97 vol.% of air in a milk foam. The term “milk/air mixture” was thus construed very broadly as “any mixture of air and milk”, thus also encompassing “milk foam”.

As to the contribution of the throttle point, the FPC held that this is any kind of bottleneck that at least contributes to the formation of a milk foam.

iv) ALLEGEDLY INFRINGING EMBODIMENT NO LONGER IN USE, PRELIMINARY INJUNCTION ISSUED ANYHOW: HOW COMES?

The defendant argued that the allegedly infringing machine had only been produced and sold from January 2013 to February 2014. It had then been replaced by a new machine with a different (allegedly non-infringing) milk frother. However, the defendant did not provide any arguments as to why the contested embodiment would not infringe the patents in suit. The FPC considered the legitimate interest of the plaintiff ex officio (Art. 59 CPC). A danger of repetition of the alleged and undisputed infrigement remained since the defendant did not declare to cease and desist; cf. BGE 124 III 72, r. 2a and BGE 128 III 96, r. 2e. Moreover, validity of the patents was still disputed, and even the allegedly non-infringing machine was illustrated with a diagram that still carried the name of the contested device. In sum, the FPC held that the legitimate interest in preliminary injunctive relief still remained.

A threat of a not easily reparable harm was acknowledged for the reason alone that it would be difficult for the plaintiff to later on prove the causality of the harm to have occured from the infringement. Urgency of the matter was not compromised by the fact that the plaintiff had awaited the outcome of the decision of the OD of the EPO; this was rather appreciated as prudent by the FPC.

v) PRIOR USE: REQUIREMENT OF PRIMA FACIE EVIDENCE

The defendant argued for nullity of the patents in suit. Besides some further prior art documents (see below), nullity was argued in view of a prior use “Esprè Magic”. This prior use had been documented in corresponding opposition proceedings before the EPO with the following documents:

  • B3 (invoice)
  • B4 (flyer)
  • B5 (technical assessment by patent attorney Philipp RÜFENACHT)
  • B6 (list of exhibitors)
  • B7 (exhibition flyer)

Note that the prior use had occured already more than ten years ago. Two affidavits in support of the prior use and the technical details thereof were put on file by the defendant when the plaintiff had disputed the public availability and the relevant technical details of “Esprè Magic”. These affidavits were not supported with further documentary material. Moreover, the affidavits were not free from inconsistencies. Thus, the FPC was reluctant in considering these declarations. Apparently, the Regional Court of Düsseldorf came to the same conclusion in parallel proceedings in Germany. Moreover, it was not only that the FPC had doubts as to whether a prior use had actually occured or not. Even the technical details of the alleged prior use were held to be not sufficiently clarified by prima facie evidence to be considered novelty-destroying for the patents in suit.

vi) FURTHER PRIOR ART DOCUMENTS

Novelty of claim 1 of CH 707 091 B1 over R4 (i.e. EP 0 485 350 A1) was disputed. The decision highlights two decisive issues: First, the term “throttle point (12)” was construed very broadly (cf. above), and thus the bottleneck in conduit 6 of R4 was identified as to fulfil this feature. Second, it was required that the milk foam be conveyed to the outlet in a cold state. R4 discloses that the conduits 3 and 6 can be held at room temperature, thus with inoperative heating elements 10. Accordingly, the FPC held that a prima facie lack of novelty of claim 1 of CH 707 091 B1 was given.

To the contrary, it was held that no prima facie case of lack of novelty or inventive step of claims 1 and 2 of EP 2 120 656 B1 had been established. The FPC essentially followed the reasoning of the OD of the EPO in consideration of R4 and R6 (i.e. US 6,192,785 B1).

vii) SECURITY

The FPC could have made the interim measure conditional on the payment of security by the plaintiff, but (only) if it had been anticipated that the measures may cause loss or damage to the defendant (Art. 264 CPC). The defendant requested a security of CHF 2’000’000,–, but the FPC stressed that the defendant had repeatedly argued that the allegedly infringing machines are no longer marketed anyhow. Therefore, one would not anticipate that the preliminary injunction could cause loss or damage to the defendant.

viii) WHAT’S UP ON THE MARKET

The allegedly infringing machines are not identified in the decision. But in the meantime it has become a rubber-stamping excercise for me to dig a bit deeper into what is actually happening on the market. I have learned from followers of this blog that this is highly appreciated. So, these are the snippets of information that I could gather from the internet:

The world premiere of the Franke FoamMaster™ FM800 (flyer dated 12/12; CH and DE) was in early 2013 in Switzerland (see gourmet 4/13). Consequently, this machine was also promoted on the Franke website back in 2013 as the new premium device:

Franke Website (CH): Screenshot of July 30, 2014
Franke Website (CH): Screenshot of July 30, 2013

However, the FM800 is no longer promoted on the Franke Website for Switzerland (see screenshot of August 13, 2014 below). The same holds true for the Website for Germany. No signs of the FM800 machine anymore. Seemingly, the FM800 has been replaced by a machine FM750 (flyer dated 07/14; CH):

Franke Website (CH): Screenshot of August 12, 2014
Franke Website (CH): Screenshot of August 13, 2014

Thus, the FM800 would perfectly match the bibliographic criteria of the allegedly infringing machine at stake in the present decision. I have found a detailed technical booklet on the FM800 machine on the internet, with a water flow diagram (Wasserlaufschema) on p. 320:

water flow diagram

This illustration looks strikingly similar to the one reproduced on p. 6 of the decision, but details are scarcely visible in the decision. Pump P100 and restrictor BL0.8 are referred to in the decision, and are also visible on the right side of the above water flow diagram. In my personal opinion, all these are strong technical indications towards the FM800 machine.

Reported by Martin WILMING

— BIBLIOGRAPHY —

Case No. S2014_006 ¦ Decision of 06 October 2014 ¦ “Kaltmilchschäumer: Gutheissung vorsorglicher Massnahmen (Patentverletzung); Anforderungen Glaubhaftmachung offenkundige Vorbenutzung; Anforderungen Sicherheitsleistung”

(not identified) ./. (not identified)

Subject(s):

  • Patent infringement
  • Preliminary measures

Composition of the Board of the FPC:

  • Dr. iur. Dieter BRÄNDLE (President)
  • Dr. Tobias BREMI (Judge)
  • Dr. Herbert LAEDERACH (Judge)
  • Lic. iur. Susanne ANDERHALDEN (First Court Clerk)

Representative(s) of Plaintiff:

Representative(s) of Defendant:

  • Dr. Lorenza FERRARI HOFER (Pestalozzi)
  • Dr. Michael REINLE (Pestalozzi)
  • Dr. Philipp RÜFENACHT (Keller), assisting in patent matters

— FULL TEXT OF THE DECISION —

Download (PDF, 309KB)

“HeatCut” technology of embroidery machines litigated again

Case No. S2014_004 ¦ Hearing of 05 June 2014

The parties know each other from an earlier case at the FPC: Lässer and Oerlikon Saurer Arbon were already litigating in the matter S2012_004; see a post commenting on that case here. From my understanding during the course of the hearing, EP 1 983 083 B1 might be at stake now (to be confirmed). Note that this is a patent within the patent family of EP 1 985 736 B1 that had been litigated before.

The claimant asked for interim injunctive relief. At the beginning of the hearing, the claimant had distributed a written statement and used this as the basis for his plea. But only selected parts of the written statement were orally presented. Consequently, it was not clear for the defendant what the basis for his reply should be. The defendant disputed any infringment and insisted on neither using the protected device nor the method according to the patent-in-suit.

In the claimant’s view, interim measures were justified since the (allegedly infringing) “HeatCut” system is excessively used in marketing activities by the defendant and can be used to upgrade existing machines (see e.g. brochure below). It was argued that this would constitute an irreparable harm for the claimant.

As outlined by the defendant, the allegedly infringing device is already on the market since 2011. In fact, it was argued that it is still the same device as in the matter S2012_004 (it was also referred to a parallel law suit in Taiwan). Thus, the defendant argued that no interim measures are to be granted for lack of urgency. 

Both parties agreed to enter into the non-public part of the hearing / settlement negotiations, but the defendant pointed out that taking a license is no option for him.

Reported by Susanna RUDER and Martin WILMING

— BIBLIOGRAPHY —

Case No. S2014_004 ¦ Hearing of 05 June 2014

Lässer AG Stickmaschinen ./. Oerlikon Saurer Arbon AG

Subject(s):

  • Infringement
  • Interim measures

Composition of the Board of the FPC:

  • Dr. iur. Dieter BRÄNDLE (President, Judge)
  • Dr. sc. nat. Tobias BREMI (Judge)
  • Frank SCHNYDER (Judge)
  • Lic. iur. Susanne ANDERHALDEN (Court Secretary)

Representative(s) of claimant:

Representative(s) of defendant:

  • Dr. Stefan KOHLER (Vischer AG)
  • Roland HÜTHER (TMP), assisting in patent matters

— TECHNICAL BACKGROUND —

A brochure on the “HeatCut” technology of the defendant, for ease of understanding of the general technology:

Download (PDF, 4.34MB)

Yet another request for preliminary injunctive relief based on AZ’s EP 1 020 461 (Esomeprazole with e.e. of ≥ 99.8%)

Case No. S2013_003 ¦ Decision of 12 May 2014 ¦ “Vorsorgliche Massnahme, Gegenstandslosigkeit, Abweisung”

Hepp Wenger Ryffel AG is involved in this case on behalf of the defendant. Thus, no detailed comments on the merits will be made here.

— THE DECISION IN A NUTSHELL —

The defendant had changed his product to a lower enantiomeric excess (e.e.), to get out of the scope of the patent. The product change was documented by an analysis report. In addition, the defendant submitted an unreserved declaration to cease and desist from marketing the former product (with the higher e.e.). Consequently, the request for preliminary injunctive relief had become groundless and was dismissed. Likewise, a callback of the former product was not ordered since the product had already been changed about a year ago. Nevertheless, the majority of the costs was imposed on the defendant, based on a prediction of the potential outcome on the merits. By prima facie evidence, the FPC was convinced that the patent was valid.

— THE DECISION IN MORE DETAIL —

The case pertains to the (S)-enantiomer of omeprazole; see structural formula below. For some general background information on omeprazole, please see an earlier post on a specific hydrate of (S)-omeprazole here.

Esomeprazole
(S)-omeprazole, so-called esomeprazole

The patent in suit is EP 1 020 461 of AstraZeneca, directed to the magnesium (Mg) salt of the (S)-enantiomer of omeprazole with an an optical purity of ≥ 99.8% enantiomeric excess (e.e.). The patent has lapsed in the meantime, on 27 May 2014. (Note that an SPC for yet another five years has been granted; however, not for Mg-esomeprazole as such, but rather only for a combination of naproxen and Mg-esomeprazole, marketed by AstraZeneca under the tradename Vimovo®. Such a combination was not at stake here.)

An opposition division had decided to revoke the patent-in-suit in 2011 (see the decision of the OD here), but a BoA set this decision aside in November 2012 and ordered to maintain the patent with only a minor amendment, according to the first auxiliary request (AR1); see the decision T1760/11 of the BoA 3.3.01. Only the appropriate adaptation of the decription in order to bring it in line with the amended claim is currently still outstanding. A petition for review of the Enlarged Board of Appeal has not been successful. Note that such a petition for review has no suspensive effect, anyhow (Art. 112a(3) EPC). For any further information on the patent-in-suit, please see the European Patent Register and the file wrapper at the EPO.

Products of the defendant had been seized at the customs on 13 November 2013, and the patent-in-suit was maintained by the BoA a few days later. In due consideration of the decision of the BoA, the defendant had changed his product to a lower enantiomeric excess (e.e.) of only 99.64%, to get out of the scope. The lower e.e. was documented by an analysis report. Since 01 March 2013 only these modified products had been imported to Switzerland and were put on the market as of 15 April 2013. When the defendant got aware of the present proceedings on 29 April 2013, sales of products imported before 01 March 2013 were immediately stopped on 02 May 2013. Moreover, the defendant provided an ureserved declaration to cease and desist from marketing the former product (with a higher e.e. of ≥ 99.8%). Thus, the FPC held that no risk of recurrent infringement remained and the request for preliminary injunctive relief was dismissed as groundless.

Likewise, in view of prima facie evidence on file that the product had been changed already more than a year ago, the request for a callback of the former product was dismissed. Such a callback would not have been conducive anymore and was thus held disproportional.

Costs were allocated at the discretion of the court (Art. 107(1) lit. e CPC), based on a prediction of the potential outcome on the merits with respect to the former product. As already outlined in an earlier post concerning the decision S2013_004 of same day issued by the same board of judges, the FPC was convinced by prima facie evidence that the patent as maintained was valid. The reporting judge essentially relied on the reasoning of T1760/11. In that decision, the BoA held that D1 (DE-A-40 35455) was not a realistic closest prior art; it was considered structurally close, but not functionally close. D2 (EP-A-0 124 495) was held to be a more realistic closest prior art. Anyhow, the reporting judge assessed the involvement of an inventive step according to the problem-and-solution approach starting from both D1 and D2 and concluded that the claimed subject-matter of the patent-in-suit was not obvious over both D1 and D2.

Interestingly, the decision also briefly touches the question whether an e.e. of 99.64% might constitute an infringement under the doctrine of equivalents. This was answered in the negative, beyond doubt (p. 12, first and second para. of the decision):

Daraus ergibt sich ein e.e.-Wert von 99.64%, das heisst ein Wert, der vom Massnahmepatent nicht umfasst wird. […] Der Vollständigkeit halber ist jedoch festzuhalten, dass das Merkmal der optischen Reinheit von 99.8% Enantiomerenüberschuss (e.e.) ein wesentliches technisches Merkmal ist, welches das Massnahmepatent von dem widerrufenen Stammpatent […] abgrenzt. Damit besteht kein Raum für eine Ausdehnung des Schutzbereichs der Ansprüche des Massnahmepatents auf Äquivalente mit geringerer optischer Reinheit.

Inofficially translated into English language:

This results in an e.e. value of 99.64%, i.e. a value that is not covered by the patent-in-suit. […] For the sake of completeness, it is to be noted that the feature of the optical purity of 99.8% enantiomeric excess (e.e.) is an essential feature that differentiates the patent-in-suit from the parent patent […] which had been revoked. Thus, there is no room for any extension of the scope of the claims of the patent-in-suit towards equivalents with reduced optical purity.

The parent patent is EP 0 652 872 B1, revoked by a BoA with decision T401/04. It will be interesting to see if / how the FPC is going to apply / further elaborate such a reasoning in the future.

Reported by Martin WILMING

— BIBLIOGRAPHY —

Case No. S2013_003 ¦ Decision of 12 May 2014 ¦ “Vorsorgliche Massnahme, Gegenstandslosigkeit, Abweisung”

(not identified) ./. (not identified)

Subject(s):

  • Infringement
  • Preliminary injunction

Composition of the Board of the FPC:

  • Dr. iur. Dieter BRÄNDLE (President)
  • Prisca von BALLMOS (Reporting judge)
  • Emmanuel JELSCH (Judge)
  • Lic. iur. Susanne ANDERHALDEN (Court Secretary)

Representative(s) of Plaintiff:

  • Dr. Michael RITSCHER (MLL)
  • Dr. Simon HOLZER (MLL)

Representative(s) of Defendant:

— FULL TEXT OF THE DECISION —

Download (PDF, 185KB)

Preliminary injunction issued based on AZ’s EP 1 020 461 (Esomeprazole with e.e. of ≥ 99.8%)

Case No. S2013_004 ¦ Decision of 12 May 2014 ¦ “Vorsorgliche Massnahme, Gutheissung”

Hepp Wenger Ryffel AG / Andreas WELCH is involved in the parallel case S2013_003, pertaining to the same patent-in-suit. Thus, no detailed comments on the merits will be made here.

— THE DECISION IN A NUTSHELL —

The defendant had apparently changed his product to a lower enantiomeric excess (e.e.), to get out of the scope of the patent. However, no declaration to cease and desist from marketing the former product (with the higher e.e.) was provided. By prima facie evidence, the FPC was convinced that the patent was valid. Consequently, preliminary injunctive relief was granted, and the defendant was obliged to arrange for a callback of the former product.

— THE DECISION IN MORE DETAIL —

The case pertains to the (S)-enantiomer of omeprazole; see structural formula below. For some general background information on omeprazole, please see an earlier post on a specific hydrate of (S)-omeprazole here.

Esomeprazole
(S)-omeprazole, so-called esomeprazole

The patent in suit is EP 1 020 461 of AstraZeneca, directed to the magnesium (Mg) salt of the (S)-enantiomer of omeprazole with an an optical purity of ≥ 99.8% enantiomeric excess (e.e.). The patent lapses 27 May 2014. (Note that an SPC for yet another five years has been granted; however, not for Mg-esomeprazole as such, but rather only for a combination of naproxen and Mg-esomeprazole, marketed by AstraZeneca under the tradename Vimovo®. Such a combination was apparently not at stake here.)

An opposition division had decided to revoke the patent-in-suit in 2011 (see the decision of the OD here), but a BoA set this decision aside in November 2012 and ordered to maintain the patent with only a minor amendment, according to the first auxiliary request (AR1); see the decision T1760/11 of the BoA 3.3.01. Only the appropriate adaptation of the decription in order to bring it in line with the amended claim is currently still outstanding. A petition for review of the Enlarged Board of Appeal has not been successful. Note that such a petition for review has no suspensive effect, anyhow (Art. 112a(3) EPC). For any further information on the patent-in-suit, please see the European Patent Register and the file wrapper at the EPO.

In due consideration of the decision of the BoA, the defendant had apparently changed his product to a lower enantiomeric excess (e.e.) of only 99.6 to 99.74%, to get out of the scope. However, the defendant neither provided a declaration to cease and desist from marketing the former product (with a higher e.e. of admittedly almost 100% ), nor was an analysis report of the currently marketed product submitted. Thus, the FPC held that a risk of recurrent infringement remained. Moreover, validity of the patent-in-suit was still disputed. However, the FPC was convinced by prima facie evidence that the patent as maintained was valid. The reporting judge essentially relied on the reasoning of T1760/11. In that decision, the BoA held that D1 (DE-A-40 35455) was not a realistic closest prior art; it was considered structurally close, but not functionally close. D2 (EP-A-0 124 495) was held to be a more realistic closest prior art. Anyhow, the reporting judge assessed the involvement of an inventive step according to the problem-and-solution approach starting from both D1 and D2 and concluded that the claimed subject-matter of the patent-in-suit was not obvious over both D1 and D2. Consequently, preliminary injunctive relief was granted.

With respect to the callback, the defendant argued that all former products would have an expiration date of November or December 2013. Thus, any callback would not only be meaningless but rather constitute black-marketing. However, in view of the still remaining risk of recurrent infringment (see above), the defendant was also obliged to arrange for a callback of the former product.

The plaintiff was ordered to initiate ordinary proceedings by 12 June 2014.

Reported by Martin WILMING

— BIBLIOGRAPHY—

Case No. S2013_004 ¦ Decision of 12 May 2014 ¦ “Vorsorgliche Massnahme, Gutheissung”

(not identified) ./. (not identified)

Subject(s):

  • Infringement
  • Preliminary injunction

Composition of the Board of the FPC:

  • Dr. iur. Dieter BRÄNDLE (President)
  • Prisca von BALLMOS (Reporting judge)
  • Emmanuel JELSCH (Judge)
  • Lic. iur. Susanne ANDERHALDEN (Court Secretary)

Representative(s) of Plaintiff:

  • Dr. Michael RITSCHER (MLL)
  • Dr. Simon HOLZER (MLL)

Representative(s) of Defendant:

  • Dr. Robert BRINER (CMS)
  • Dr. Cornelia HOFFMANN (SBMP), assisting in patent matters

— FULL TEXT OF THE DECISION —

Download (PDF, 158KB)

Déjà-vu: Advertising activities during the term of an SPC

Case No. S2014_003 (O2014_007) ¦ Decision of 31 March 2014 ¦ “Anbieten eines Arzneimittels (Generikum) während Laufzeit eines ESZ für die Lieferung danach; Gutheissung einer superprovisorischen Massnahme”

You might recall the case S2014_002 I have reported on in several earlier posts. The present matter is an astonishing blueprint. The FPC has again ordered a defendant to refrain from advertising activities during the term of an SPC — without hearing the defendant beforehand (Art. 77 PatA; Art. 261(1), Art. Art. 265(1) CPC). From the term of the SPC that is given in the decision, most likely the same SPC is concerned again.

There is not much to report on this decision in addition to what has been discussed already in the earlier posts. Again, the FPC had no doubt that an offer during the term of the SPC constituted an infringement (Art. 140d, Art. 8 PatA), even if delivery was only promised for the time when the SPC will have lapsed. In this respect, the FPC referred to the decision Simvastatin of the German Federal Supreme Court (X ZR 76/05); see #10, last sentence:

Eine funktionsbezogene Betrachtung des Verbots des Anbietens während der Schutzdauer dahin, ob sich das Angebot auf ein weiteres Verhalten bezieht, das für sich, etwa als Herstellen, Inverkehrbringen oder Einfuhr, unter den zeitlich begrenzten Schutz des Patents fällt, verbietet sich damit.

A highly complicated German sentence, put in simple English terms:

Offering is prohibited during the term of a patent, to whatever further action at whatever point of time this offer might relate to.

Oral proceedings in this matter were initially scheduled for April 07, but the hearing has been cancelled.

Reported by Martin WILMING

BIBLIOGRAPHY

Case No. S2014_003 (O2014_007) ¦ Decision of 31 March 2014 ¦ “Anbieten eines Arzneimittels (Generikum) während Laufzeit eines ESZ für die Lieferung danach; Gutheissung einer superprovisorischen Massnahme”

(not identified) ./. (not identified)

Subject(s):

  • Infringement of a SPC

Composition of the Board of the FPC:

  • Dr. iur. Dieter BRÄNDLE (President, Single Judge)
  • Lic. iur. Susanne ANDERHALDEN (Court Secretary)

Representative(s) of Plaintiff:

  • Dr. Michael RITSCHER (MLL)
  • Dr. Simon HOLZER (MLL)

Representative(s) of Defendant:

  • (not identified)

Full text of the decision right here:

Download (PDF, 70KB)

S2014_002: The final curtain

Case No. S2014_002 ¦ Decision of 27 February 2014 ¦ “Anbieten eines Arzneimittels (Generikum) während Laufzeit eines ESZ für die Lieferung danach; Gutheissung einer superprovisorischen Massnahme”

Recently, I have reported on the oral hearing and the settlement in this matter. As noted, the FPC had ordered the defendant to refrain from advertising activities — without hearing the defendant beforehand (Art. 77 PatA; Art. 261(1), Art. Art. 265(1) CPC). This decision has been published yesterday.

The wording of the inquiry of future demand can now be deducted from the decision as follows (non-official translation into English language):

Das Patent von […] wird am 31. Mai 2014 ablaufen. Sie, als wichtiger Kunde, können uns mit dieser Bedarfsanfrage helfen, unsere Lagermenge dem Bedarf anzupassen. Da dies bei grossen Produkten schwierig ist und wir eine kontinuierliche Lieferfähigkeit sicherstellen möchten, bedanken wir uns bei Ihnen für Ihre Unterstützung.

The patent of […] is about to lapse on May 31, 2014. You are an important custumer and could help us with the present inquiry of demand to adapt our stock to meet the demand. This is difficult for large products and we want to assure the continuous ability to deliver; thank you very much for your support.

The FPC had no doubt that this constituted an infringement (Art. 140d, Art. 8 PatA). However, the FPC expressed some doubts with respect to the imputability of this inquiry to the defendant. Nevertheless, the FPC ordered the interim measure without hearing the defendant beforehand. The FPC assessed the principle of proportionality in a second line of reasoning: If it turned out later that the inquiry had not been conducted by the defendant, the defendant would have been prohibited from (further) doing something that he had never done, anyhow. Thus, the defendant would not have been harmed by the order.

Reported by Martin WILMING

BIBLIOGRAPHY

Case No. S2014_002 ¦ Decision of 27 February 2014 ¦ “Anbieten eines Arzneimittels (Generikum) während Laufzeit eines ESZ für die Lieferung danach; Gutheissung einer superprovisorischen Massnahme”

Lundbeck (Schweiz) AG ./. Sandoz Pharmaceuticals AG

Subject(s):

  • Infringement of a SPC

Composition of the Board of the FPC:

  • Dr. iur. Dieter BRÄNDLE (President, Single Judge)
  • Lic. iur. Susanne ANDERHALDEN (Court Secretary)

Representative(s) of Plaintiff:

  • Dr. Michael RITSCHER (MLL)
  • Dr. Simon HOLZER (MLL)
  • Dr. Kilian SCHÄRLI (MLL)

Representative(s) of Defendant:

Full text of the decision right here:

Download (PDF, 103KB)

Lundbeck ./. Sandoz: Inquiry of (future) demand while the SPC on Escitalopram is still in force

Case No. S2014_002 ¦ Hearing of 06 March 2014

Today’s hearing was announced on the website of the FPC only on February 28, without any details on the merits of the case. In view of this very short notice, I felt that an interim measure without hearing of the defendant might be at stake. Indeed, it is. But let’s first have a look at the pharmaceutical and commercial background:

Escitalopram, the (S)-enantiomer of citalopram
Escitalopram

This case pertains to Lundbeck’s blockbuster drug escitalopram (also known under various trade names such as Lexapro® and Cipralex®). It is an antidepressant of the selective serotonin reuptake inhibitor (SSRI) class which is widely used for the treatment of adults and children over 12 years of age with major depressive disorder (MDD) and generalized anxiety disorder (GAD). Escitalopram is the (S)-enantiomer of citalopram; see the structural formula in the margin. Please revert to MedlinePlus for further information on this drug.

Escitalopram accounted for a (worldwide) revenue of DKKm 5,933 in 2013; see Lundbeck’s Annual Report 2013, p. 15 (approx. 1bn CHF).

Cipralex film-coated tablets
Cipralex® film-coated tablets

These are my personal conclusions and take-away messages from what has been argued by the parties earlier today:

Escitalopram is a mature drug. The corresponding patent EP 0 347 066 B1 was filed already back in 1989 (June 1), and even the SPC is about to lapse on May 30, 2014. According to PharmaWiki, various suppliers of generics have already obtained the market authorization in Switzerland. But, to date, Cipralex is the only available drug on the Swiss market comprising escitalopram (see the so-called Spezialitätenliste). And it is an important one for Lundbeck in Switzerland: It accounts for a turnover of CHF 3m per month which is about 80% of all sales of Lundbeck in Switzerland.

Similar to many other mature blockbuster drugs, there is a lot of litigation going on in many jurisdictions; see e.g. the EPLAW Patent Blog. But the present case is somewhat special. Apparently, sales representatives of the defendant had asked doctors for their (future) demand on escitalopram, well before the lapse of the SPC. The FPC had ordered the defendant to refrain from such activities — without hearing the defendant beforehand. Subsequently, the parties were summoned for today’s hearing.

From what has been discussed in the hearing, I understood that sales representatives of the defendant had used a kind of form for the inquiry. However, the defendant argued that this form had not been intended to be given away. Rather, it was meant as a tool for the sales representatives, i.e. for internal purposes only. Nevertheless, the plaintiff evidently got hold of a photography of such a form. The defendant neither denied authorship nor the actual use of the form. What was denied is that the inquiry of (future) demand could establish an infringement according to Art. 8 PatA. It had not been intended to enter the market before June 1, nor was this an offer. It was only aimed to streamline logistics upon market entry when the SPC will have lapsed on June 1. The defendant pointed out that this intention is underlined by the absence of any specific indication of the defendant’s (generic) product, its price and availability. Moreover, the defendant alleged that the plaintiff himself had notified the doctors of the forthcoming lapse of the SPC. This was disputed by the plaintiff.

The plaintiff argued that this inquiry was a “perfidious” marketing while the SPC is still in force: By asking the doctors for their future demand, they were made readily aware not only of the approaching lapse of the SPC, but also of the defendant as a potential future supplier of the generic version. From my understanding of what has been argued, the plaintiff had documented at least one case where a doctor refrained from immediate stock replenishing after such an inquiry and instead delayed it until the generic version(s) will be available.

Anyhow, the defendant declared to abstain from further use of the form (N.B., without acknowledging any legal obligation); all sales representatives had already been informed accordingly. Although these inquiries had triggered the dispute, a second request of the plaintiff might turn out to have severe implications: The plaintiff sought for an interim injunction being issued for a term of 2½ month after the lapse of the SPC.

The defendant essentially argued that injunctive relief would require the SPC to be still in force since this request relied on the PatA. To the contrary, the plaintiff argued that this request also relies on the law against unfair competition (UCL). Moreover, a prohibition of sales as an action for damages would not be uncommon, in connection with Art. 43 of the Code of Obligations. Inter alia, the plaintiff relied on C-316/95 of the EuC. In that case, samples of medicinal products manufactured in accordance with a patented process had been submitted to the authority competent for issuing marketing authorizations. It was held that a moratorium imposed by the court on the infringer of the patent right, in so far as it seeks to place the proprietor of the patent in the position in which it would, in principle, have been had its rights been respected, cannot in itself be held to be a disproportionate form of reparation.

The defendant emphasized that this case (and similar ones which would have to be decided differently nowadays, anyhow) were fundamentally different in that an infringing act had actually been carried out during the term of the patent or SPC.

Yet another point of discussion was the value in dispute for the moratorium. While the plaintiff argued for CHF 250’000,–, the defendant estimated the value in dispute to exceed CHF 1m.

The parties finally entered into non-public settlement negotiations.

Reported by Martin WILMING

BIBLIOGRAPHY

Case No. S2014_002 ¦ Hearing of 06 March 2014

Lundbeck (Schweiz) AG ./. Sandoz Pharmaceuticals AG

Subject(s):

  • Infringement

Composition of the Board of the FPC:

  • Dr. iur. Dieter BRÄNDLE (President, Single Judge)
  • Lic. iur. Susanne ANDERHALDEN (Court Secretary)

Representative(s) of Plaintiff:

  • Dr. Simon HOLZER (MLL)
  • Dr. Kilian SCHÄRLI (MLL)

Representative(s) of Defendant:

Drospirenone: A masterclass in equivalents

Case No. S2013_001 ¦ Decision of 21 March 2013 (excerpt) ¦ “Auszug aus dem Urteil Nachahmung (Äquivalenz)”

his post has been updated on 02/15/2016 with a more literal translation of the second question, in light of O2014_002.

HEADNOTE

Art. 109 PatA; Art. 69 EPC, Protocol on the Interpretation of Article 69 EPC; Art. 66(1) lit. a PatA:

When an allegedly infringing method or device does not literally fulfil one or more features of the claim but comprises replacing features instead, the following three questions need to be answered in the affirmative in order to conclude that the allegedly infringing method or device is within the scope of the claim:

(1.) Does the replacing feature objectively fulfil the same function? (“Gleichwirkung”)

(2.) Was the person skilled in the art enabled to find the replacing feature as having the same effect? Are the replaced features and their objectively same function rendered obvious by the teaching of the patent to the person of skill in the art? (“Auffindbarkeit”)

(3.) With due consideration of the claim wording in view of the description: Would the person skilled in the art have taken the replacing features into account as being an equivalent solution? (“Gleichwertigkeit”) (r. 17.2)

(Non-official translation from German into English language)

We already catched a glimpse of what was going on earlier this year; see the post on ex-parte injunctions of 26 May 2013. Now, we get some deeper insight into the subject-matter at stake. At first, I felt the take-away message is clear-cut: The FPC assess infringement under the doctrine of equivalents using essentially the Schneidmesser questionnaire established in Germany. That’s it. But this would have been too narrowly considered. On closer scrutiny, things are (much) more difficult. In fact, this case might turn out to be a masterclass in assessment of equivalents in various countries.

1.  Background of the case

Drospirenone
Drospirenone (DRSP; click to enlarge)

The plaintiff sought for preliminary injunctive relief and invoked two European patents: EP 0 918 791 B3 (hereinafter the ‘791 patent; see the European patent register for further details) and EP 1 149 840 B2 (which is a divisional of the ‘791 patent; hereinafter the ‘840 patent); see the European patent register for further details. Both patents relate to methods for the production of drospirenone (DRSP), a compound used in contraceptives (birth control pills).

Drospirenone closely resembles natural progesterone. Drospirenone-containing pills are presumably the most widely prescribed hormonal contraceptives in the world today. Proprietor of both European patents is Bayer Pharma AG, according to Swissreg (cf. here and here). Drospirenone-containing pills are one of the – if not the – best selling product of Bayer Pharma AG; see some further information directly on the website of Bayer Pharma AG. Thus, it’s reasonable to assume that Bayer Pharma AG or a connected undertaking is the plaintiff. The situation is not that clear to me with respect to the defendant(s), and I am not going to speculate.

2. The decision of the FPC

i)  Ex-parte interim measures

As already outlined in an earlier post, the ex-parte injunction in this case was not granted without any prior hearing of the defendant. In fact, the parties had already presented their case in writing, and a hearing with oral reply and rejoinder had already taken place on 31 January 2013. Moreover, the reporting judge had already presented his preliminary opinion on the merits of the case — presumably essentially in the sense of the present decision. Only shortly thereafter, on 7 February 2013, the plaintiff noticed that not all allegedly infringing products were withheld at the customs but that some appeared on the market in Switzerland. Under these circumstances, the FPC granted an ex-parte injunction.

ii)  Rectification of the record

The record of the hearing is quite lengthy (49 p.), and both parties requested rectifications of the record. The plaintiff did so within three days, pointed to five specific issues and indicated precisely what the correction should be. All these rectifications were accordingly made by the FPC.

The defendant filed his request for rectification only after seventeen days. The FPC held that this request was filed too late and thus already failed for this reason. Moreover, the defendant did not indicate what the correction should be, but rather requested the correction to be made on the basis of the tape. The FPC reminded the parties that the record is to contain the overall content of the submissions, but needs not to be a literal transcript (Art. 235(2) CPC; note that the non-official English translation of the CPC fails to properly recite the German wording “dem wesentlichen Inhalt nach“).

iii)  Value in dispute

The plaintiff had estimated the value in dispute to about CHF 500’000,– and indicated that this is a common value in summary proceedings pertaining to patents in the pharaceutical field. On the other hand, the defendant provided a reasoned estimation of the value in dispute to exceed CHF 1’000’000,– . The FPC agreed with the defendant. “Common values” are irrelevant. What counts is the individual assessment of each case.

iv)  Assessment of equivalents

Here we are at the very core of the dispute. A little bit of chemistry is no longer avoidable. Let’s have a look at the final steps in synthesis of drospirenone (DRSP; click to enlarge):

Final steps in synthesis of drospirenone (DRSP)

The starting molecule is the alkine ZK 34506 which is hydrated to form the compound ZK 92836 (step A). Next, ZK 92836 is oxidised to form the cyclic lactone ZK 90965 (step B). Finally, water is eliminated from ZK 90965 to form the enone DRSP (step C).

In simple terms, claim 1 of EP’791 protects the reaction scheme as outlined above, wherein step B is carried out in the presence of a ruthenium salt as a catalyst. Step C is not specified any further.

On the other hand, the only claim 1 of EP’840 specifically pertains to step C only and requires that dehydration is carried out through addition of p-toluenesulfonic acid.

Apparently, the plaintiff sought for injunctive relief with respect to two different methods. With respect to a “first method”, the FPC held that the plaintiff had not credibly shown that this method is effectively used by the (supplier of the) defendant, in particular in view of the injunction issued with decision 4a O 49/12 – Drospirenon of the Dusseldorf regional court; cf. r. 16. This Dusseldorf decision specifically pertains to the dehydration through addition of p-toluenesulfonic acid and refers to WO 2006/061309 A1 in this respect (more specifically to example 7, relating to a method of manufacturing DRSP that does not rely on a ruthenium salt as catalyst in step B, but still uses p-toluenesulfonic acid in step C). Even the plaintiff seemingly suspected that p-toluenesulfonic acid is not used by the defendant (anymore).

The “second method” is the more interesting one. The defendant did not dispute that the “second method” is used. Apparently, the following features were not literally fulfilled:

  • With respect to EP’791, step B is not carried out in the presence of a ruthenium salt as a catalyst, but rather in the presence of TEMPO in combination with Ca(OCl)2.
  • With respect to EP’840, dehydration is not carried out through addition of p-toluenesulfonic acid, but rather in the presence of pyridine/water.

Assessment of infringement of EP’791

The FPC concluded that both the ruthenium salt on the one hand and TEMPO in combination with Ca(OCl)2 on the other hand objectively fulfil the same function (catalysis), in the absence of any further limitation with respect to the specific mechanism of catalysis in the patent in suit (“Gleichwirkung”). The FPC then briefly discussed whether the person skilled in the art was enabled to find TEMPO in combination with Ca(OCl)2 as having the same effect, but finally left this undecided (“Auffindbarkeit”). Rather, the FPC held that the person skilled in the art would not have taken TEMPO in combination with Ca(OCl)2 into account as being an equivalent solution, with due consideration of the claim wording in view of the description (“Gleichwertigkeit”), for the following reasons: First, EP’791 explicitly aims to replace toxic chromium compounds with catalytic amounts of a metal compound. The ruthenium salt catalyis is said to be the key reaction in EP’791 (cf. para.  [0012]). The FPC thus held that this does not suggest the applicability of an organic radical like TEMPO, and EP’791 is not infringed (r. 17.4-17.8).

Apparently, courts in the Netherlands (Rechtsbank Den Haag, C/09/432919 / KG ZA 12-1391), Germany (Dusseldorf regional court, 4a O 190/12 and 4a O 192/12; both confirmed by the higher regional court with decisions 2 U 26/13 and 2 U 25/13, respectively) and Italy (Corto di Appello di Torino) have also issued decisions on this topic. Of course, the final outcome in main proceedings is to be awaited, but this is where we stand today, to the best of my knowledge:

TEMPO / Ca(OCl)2 replacing a ruthenium salt (EP’791) is held to be …
an infringement in … no infringement in …
IT* x
NL x
CH x
DE x
  • From what is discussed in the Dusseldorf decisions, I conclude that the Italian decision relies on an opinion of a court-appointed expert. Unfortunately, I could not yet retrieve a copy of this decision.

Assessment of infringement of EP’840

With p-toluenesulfonic acid, step C of the above reaction scheme is an acid-catalysed elimination of water. On the other hand, pyridine/water is a weakly basic system, relying on a different reaction mechanism. Nevertheless, the result (elimination of water) is the same. The FPC thus held that both reagents fulfill the same function (“Gleichwirkung”). Since both acid- and base-catalysed  elimination reactions are very basic reactions in organic chemistry, the FPC held that the person of skill in the art was enabled to find an appropriate base in general. Moreover, she/he would have also considered pyridine/water in particular since there is a pointer in the introductory part of the patent in suit, i.e. the discussion of the prior art. Therefore, the FPC held that the person of skill in the art was enabled to find pyridine/water as having the same effect (“Auffindbarkeit”). Finally, the FPC held that the person of skill in the art would also have taken pyridine/water into account as an equivalent means, since this reagent is known to her/him (as is evident from the discussion of the prior art in the patent in suit).

Concluding, the FPC held that EP’840 is infringed under the doctrine of equivalents and granted a preliminary injunction.

Again, what’s going on elsewhere? Note that the FPC was aware of the fact that the Rechtsbank Den Haag (C/09/432919 / KG ZA 12-1391) had decided the same question differently (r. 18.3, last para.). Later, the Dusseldorf court in the decisions 4a O 193/12 – Drospirenon II and 4a O 191/12 explicitly took the decision of the FPC into account — and decided for non-infringement. This was confirmed by the Dusseldorf higher regional court in decisions 2 U 23/13 and 2 U 24/13, respectively. To the contrary, the appelate court of Brussels (Belgium) decided for infringement (decision of March 25, 2013 — 2012/KR/127; unfortunately, I could not yet retrieve a copy of this decision). Of course, the final outcome in main proceedings is to be awaited, but this is where we stand today, to the best of my knowledge:

Pyridine/water replacing p-toluenesulfonic acid (EP’840) is held to be …
an infringement in … no infringement in …
NL x
BE x
CH x
DE x

3.  The decision of the Supreme Court

In summary proceedings, the Supreme Court does not examine the case on the merits again. Generally speaking, only violations of the law are reviewed, but not the discretionary adjudication of the first instance. The defendant referred to the decisions of the Dusseldorf regional court; see above. However, this was not considered by the Supreme Court for that it was only lately filed. It would have been interesting to learn more about the Supreme Court’s view on the merits of the case already now, but it’s not much of a surprise that the Supreme Court dismissed the appeal (4A_160/2013).

4.  Remarks

i)  What is not claimed, is disclaimed(?)

Perhaps the best-known statement of the status of the claims in UK law is by Lord Russell of Killowen in Electric and Musical Industries Ltd v Lissen Ltd (1938) 56 RPC 23, 39 (emphasis added):

The function of the claims is to define clearly and with precision the monopoly claimed, so that others may know the exact boundary of the area within which they will be trespassers. Their primary object is to limit and not to extend the monopoly. What is not claimed is disclaimed. The claims must undoubtedly be read as part of the entire document and not as a separate document; but the forbidden field must be found in the language of the claims and not elsewhere.

So, how to deal with the following situation:
The claim requires a feature (A). A variant (B) is outlined in the description of the patent, but not in the claims. Is there any room for equivalency, i.e. to cover embodiments with variant (B) under the doctrine of equivalents?

After the decision Okklusionsvorrichtung of the Federal Supreme Court in Germany, some practitioners feared (and some hoped) that the answer might be a clear “No”. In the meantime, the decision Diglycidylverbindung of the Federal Supreme Court provided some further guidance on the assessment in such cases. In a first step, the specific technical effect of the claimed feature (A) has to be determined in order to differentiate it from the alternative feature (B) mentioned in the description but not included in the claim. Second, it has to be established whether the allegedly infringing means provides for the specific technical effect of the claimed feature (A) and thus differs from the alternative feature (B) mentioned only in the description in the same way as the claimed feature (A).

It will be interesting to read a decision of the FPC in such a situation (in the present matter, the pointer to pyridine/water in the introductory part of EP’840 was apparently not held to preclude equivalency). In an obiter dictum, the FPC seemingly tends to assess such situations in line with the Federal Supreme Court in Germany: It is likely that variants explicitly outlined in the description but not in the claims cannot be considered to be covered under the doctrine of equivalents but rather are waived (r. 17.1, last para.).

Wäre das Mittel nämlich in der Beschreibung aufgeführt, aber nicht im Anspruch, müsste daraus voraussichtlich geschlossen werden, dass der Anmelder auf dessen Beanspruchung verzichtet hat und die betreffende Ausführungsart nicht unter Schutz stellen wollte.

ii)  Questionaires for assessement of equivalents – a broader European picture

In order to assess equivalency, the landmark decision in UK is Improver Corporation v Remington Consumer Products Limited (1990) FSR 181, 189. Questions to be answered in the assessement of equivalency are frequently referred to as Improver questions:

(1) Does the variant have a material effect upon the way the invention works? If yes, the variant is outside the claim. If no-

(2) Would this (i.e. that the variant had no material effect) have been obvious at the date of the publication of the patent to a reader skilled in the art. If no, the variant is outside the claim. If yes –

(3) Would the reader skilled in the art nevertheless have understood from the language of the claim that the patentee intended that strict compliance with the primary meaning was an essential requirement of the invention. If yes, the variant is outside the claim. On the other hand, a negative answer to the last question would lead to the conclusion that the patentee was intending the word or phrase to have not a literal but a figurative meaning (the figure being a form of synecdoche or metonymy) denoting a class of things which included the variant and the literal meaning, the latter meaning, the latter being perhaps the most perfect, best-known or striking example of the class.

In Germany, the Federal Supreme Court (BGH) took over a similar schedule of assessment in the decisions Schneidmesser I and Schneidmesser II:

(1) Does the modified embodiment solve the problem underlying the invention by means which have objectively the same technical effect?

(2) Was the person skilled in the art enabled by his expertise on the priority date to find the modified means as having the same effect?

(3) While answering question two, are the considerations that the person skilled in the art applies drawn from the technical teaching of the patent claim (so that the person skilled in the art took the modified embodiment into account as being an equivalent solution)?

And, finally, the test known from the Formstein decision (X ZR 28/85) of the German Federal Supreme Court (a kind of litmus test to preclude that a claim is construed overly broad, i.e. covering prior art):

(4) Is the modified embodiment anticipated or made obvious by the state of the art?

(A more detailed analysis of the doctrine of equivalents in various jurisdictions can be found in Yale Journal of Law and Technology.)

How was this dealt with in Switzerland by now? Well, questions (1) and (2) were already in use (BGE 97 II 85, r. 2; BGE 97 II 85, r. 1; BGE 125 III 29, r. 3b; BGE 115 II 490, r. 2a.), but a third question was missing — until now. However, the present case strikingly shows that similar questionnaires do not necessarily result in similar decisions. Hopefully, there is no revival of Epilady® or Spannschraube on the rise.

Reported by Martin WILMING


BIBLIOGRAPHY

Case No. S2013_001 ¦ Decision of 21 March 2013 (excerpt) ¦ “Auszug aus dem Urteil Nachahmung (Äquivalenz)”

(not identified) ./. (not identified)

Subject(s):

  • Infringement

Composition of the Board of the FPC:

  • (not identified)

Representative(s) of Plaintiff:

Representative(s) of Defendant:


Full text of the decision right here:

Download (PDF, 128KB)

Kitchen hood: Request for preliminary injunctive relief dismissed

Case No. S2013_006 ¦ Decision of 07 August 2013 ¦ “Abweisung vorsorglicher Massnahmen wegen fehlender Rechtsbeständigkeit bzw. Patentverletzung”

1.  Anonymisation

The parties and the patent in suit are not identified in the decision. However, there is enough information given to figure out the patent as well as the parties to the proceedings with relative ease. The patent in suit is EP 1 838 998 B1. According to the decision, the plaintiff is the proprietor of the patent (i.e. Wesco AG; cf. Swissreg).

Advertising material of the allegedly infringing devices is depicted in detail (cf. p. 6 of the decision). Apparently, this is taken from the video Die neue Premira-Linie von V-ZUG, available e.g. on Youtube or directly at the website of V-ZUG:

Youtube screenshot 1 (seen on 22 August 2013)
http://www.youtube.com/watch?v=EisQbI8YtCE (at 1:33)
(seen on 22 August 2013)
Youtube screenshot 2 (seen on 22 August 2013)
http://www.youtube.com/watch?v=EisQbI8YtCE (at 1:53)
(seen on 22 August 2013)
Youtube screenshot 3 (seen on 22 August 2013)
http://www.youtube.com/watch?v=EisQbI8YtCE (at 1:55)
(seen on 22 August 2013)

Therefore, it is more than reasonable to assume that the defendant is V-ZUG AG or a connected undertaking.

2.  Procedural aspects

The plaintiff had requested preliminary injunctive relief on 16 May 2013. Defendant filed his reply on 17 June 2013. The FPC served the plaintiff with this reply, but did not set a time limit for any further submission. In turn, the plaintiff requested to be given a formal opportunity to comment on the nullity arguments (based on 15 documents of prior art) presented by the defendant in case the FPC tended to rely on these facts and arguments.

Later on, the parties were given the opportunity to hand in the invoices for legal representation and assistance of a patent attorney, if any. Only the plaintiff submitted the respective invoices.

In summary proceedings, the standard of proof is reduced; only prima facie evidence needs to be presented (Art. 261(1) CPC; cf. also BGE 130 III 321 r. 3.3, BGE 132 III 83 r. 3.2 and BGE 103 II 287 r. 2). A reply and rejoinder is not mandatory in summary proceedings (cf. Art. 253 and 256 CPC). A party’s right to be heard would only be violated if a decision relied on facts and evidence presented by the other party without any opportunity to comment thereon. As discussed below, the decision in fact does not rely on such new facts but rather on a document already initially discussed by the plaintiff himself.

As a sidenote, the FPC again stressed that a time limit does not need to be formally set, anyhow. Instead, it is sufficient for the court to decide only after an adequate delay, in order to not contravene the other party’s mandatory right to comment on new facts and evidence (“unbedingtes Replikrecht”); cf. an earlier post in this respect.

Neither party had requested an expert opinion or a judge’s expert opinion (Art. 183(3) CPC, Art. 37(3) PatCA), and the FPC held that such an opinion indeed is not necessary. Instead, ordinary technical understanding was held sufficient (cf. BGE 4A.52/2008 r. 3.4).

3.  Facts of the case

Independent claim 1 of the patent in suit reads as follows:

A ventilator device with an inlet side (2), a suction motor (7) arranged in a suction chamber (6) and an exhaust path (9) connected to the suction chamber (6), characterised in that the suction motor (7) is enclosed on the suction side in the suction chamber (6) by an absorption filter performing on the one hand an air-purifying function and on the other hand a noise insulation function.

Fig. 1 of the patent in suit is given below:

Fig. 1 of EP 1 838 998 B1

First, the FPC held that the request for preliminary injunctive relief presented by the plaintiff fulfilled the (formal) requirements to precisely define the allegedly infringing device.

On the merits of the case, only the characterising part of the claim given above was under dispute, both with respect to the alleged infringement and its presence in the prior art. In this respect, the construction of the feature

[…] that the suction motor (7) is enclosed on the suction side […]

was at stake. Does this mean that the motor is fully enclosed, or is an at least partial enclosement by the absorption filter sufficient? It was beyond dispute that the motor of the allegedly infringing device was only partially enclosed (cf. screenshots above).

4.  The decision

Even though the FPC expressed some sympathy for a construction of the term enclosed in a sense of at least partially enclosed, depending on the respective installation situation and in view of the prior art document EP 1 134 501 A1 (p. 2, col. 1, l.  3-5 and 14-19), this issue was left undecided. It was beyond dispute that the allegedly infringing device did not comprise absorption filters on two vertical sidewalls (cf. screenshots above). The motor is thus clearly not fully enclosed by the absorption filter. Thus, on the one hand, with the term enclosed being construed in a sense of fully enclosed, the claim was not infringed. On the other hand, the FPC held that a respective device with a motor being at least partially enclosed by the absorption filter was known from prior art document EP 1 134 501 A1. Being construed this way, the claim would thus not be valid.

Noteworthy, the plaintiff had discussed EP 1 134 501 A1 already in his initial request for interim measures, but the FPC did not follow the plaintiff’s arguments in favour of novelty and inventive step of the claimed subject matter over EP 1 134 501 A1.

Consequently, the requests of the plaintiff were dismissed, and the costs were charged on the plaintiff (Art. 27 PatCA, Art. 106(1) CPC). In accordance with the (agreed) value of dispute of CHF 200’000,–, court fees were fixed to CHF 12’000,– (Art. 31 and 33 PatA, Art. 1 and 2 CostR-PatC) and the compensation for legal represenatation of the defendant to CHF 14’000,– (Art. 31 and 33 PatA, Art. 1 and 2 CostR-PatC). No compensation for involvement of a patent attorney was awarded, since no details on such costs were provided by the defendant.

5.  A personal remark on claim construction

Claim construction was a key issue in this case. In a nutshell, the pragmatic approach taken by the FPC was as follows:

If the feature […] was to be construed as X, the claim would not be infringed. If the feature […] was to be construed as Y, the claim would not be valid.

Concluding, the FPC held that the plaintiff had not credibly shown that a valid claim is infringed. This works well in summary proceedings: This way, it needs not to be decided on the construction of a specific term (here: enclosed) that is understood differently by the parties.

However, this must not be mixed up with the (frequently seen, but — in my personal opinion — plainly wrong) approach to construe a claim such that it is / remains valid (once called rechtserhaltende Auslegung):

The feature […] is to be construed as X, since otherwise — i.e., if construed as Y — the claim would not be valid.

Even though the prior art may well be used for the assessment of the general understanding of the person of routine skill in the art, one must not be led by an intention to construe the claim in a way that it remains valid.

Reported by Martin WILMING

BIBLIOGRAPHY

Case No. S2013_006 ¦ Decision of 07 August 2013 ¦ “Abweisung vorsorglicher Massnahmen wegen fehlender Rechtsbeständigkeit bzw. Patentverletzung”

Wesco AG ./. V-ZUG AG

Subject(s):

  • Patent infringement
  • Interim measure

Composition of the Board of the FPC:

  • Dr. iur. Dieter BRÄNDLE (President)
  • Dr. Tobias BREMI (Judge)
  • D. Herbert LAEDERACH (Judge)
  • Lic. iur. Susanne ANDERHALDEN (Court Secretary)

Representative(s) of Plaintiff:

Representative(s) of Defendant:

Full text of the decision right here:

Download (PDF, 523KB)

Ex parte interim measures: There’s life in the old dog yet

Zoll Douane Alt
Assistance by the Federal Customs Administration in patent matters proved helpful, indeed!

Requests for preliminary injunctions are mostly dealt with by a panel of three judges, since the understanding of a technical matter is of particular significance in patent cases (Art. 23(3) PatCA). However, formation of the panel takes at least a few days. As a rule, this timeframe is used by the FPC to provide the defendant with a possibility to be heard. I thus felt that the FPC might only refrain from hearing the defendant when an element of surprise is of the essence (e.g. in case of confiscation or description / precautionary taking of evidence); cf. this Blog here (item 2).

Well, exceptions prove the rule. In fact, the FPC apparently granted two(!) ex parte interim measures in case no. S2013_001. Unfortunately, these decisions are not published yet (on request of the defendant since details pertaining to a method of manufacturing in the field of pharmaceuticals are at stake). Thus, no information on the merits of the case was publicly available (except for a hearing being scheduled on January 31, 2013; cf. this Blog here) until Simon HOLZER provided some insight into this matter here.

i)  Interim measures to prevent the import of goods retained at the customs

The first ex parte interim measure in case no. S2013_001 relates to pharmaceuticals that were retained at the customs on request of the patentee. In such cases, the patentee is required to obtain an interim measure by the competent court within the very short term of only 10 days (an extension of yet further 10 days may be granted on request); otherwise, the goods are released by the customs (cf. Art. 86a-k of the Federal Act on Invention Patents). Evidently, it would almost never be possible for a patentee to get interim measures granted in inter partes proceedings at the FPC in this short time. These constraints being given: Is assistance by the Federal Customs Administration only a toothless tiger in patent matters? Not at all: The FPC now took a pragmatic approach and instructed the customs authorities to prolong the retention of the goods by an ex parte order without having examined the infringement and the validity of the patent in detail yet.

(A leaflet setting out the details of assistance from the Federal Customs Administration (FCA) can be found here; further information can be derived at the website of the FCA. Note, that the patentee is required to provide compensation for damages suffered due to the goods being retained should interim measures not be ordered or are revealed to be unfounded; a so-called Accountability Statement is to be signed.)

Subsequently, a hearing took place on January 31, 2013. At the occasion of this hearing, both parties had commented on the alleged infringement and the validity of the patent, and the preliminary assessment of the reporting judge tended to confirm infringement and validity of the patent in suit. The interim measure (prolongation of retention of the goods at the customs) was thus upheld.

ii)  Preliminary injunctive relief

Later on, a second ex parte interim measure was granted by the FPC, i.e. for injunctive relief. Even though the reporting judge had confirmed in the aforementioned hearing that the marketing of the pharmaceuticals in suit was infringing patentees’ patent rights, the defendant recognized after the hearing that the defendant had started distributing the pharmaceuticals in German-speaking Switzerland. The patentee immediately filed a request for a preliminary injunction. Since both parties were already given the opportunity to argue on the merits of the case in the prior hearing, the FPC was in a position to order preliminary injunctive relief ex parte. This ex parte injunction was replaced later by interim measures that were rendered by the FPC in the contradictory procedure. The defendant lodged an appeal with the Federal Supreme Court against the FPC’s interim measures. Note, that the appeal has no suspensive effect. This case is to be continued.

Revival of ex parte interim measures?

This case no. S2013_001 is special in that both parties have already had the chance to comment on infringement and validity of the patent in suit in FPC proceedings when the request for preliminary injunctive relief was filed. Most likely, such a situation will not occur soon again. There is no reason to assume that the practice of  the FPC will change in general; ex parte interim measures will only seldom be granted. But in addition to situations when an element of surprise is of the essence (e.g. in case of confiscation or description / precautionary taking of evidence), also in case of goods being retained by the customs.

Reported by Martin WILMING

(Many thanks to Simon HOLZER for a general discussion on procedural aspects of case no. S2013_001.)