Source: https://www.patentlitigation.ch/tag/preliminary-injunction/
Timestamp: 2020-04-04 14:12:45
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Preliminary injunction Archives | FPC Review
Case No. S2014_001 ¦ Decision of 11 February 2015 ¦ “Vorsorgliche Massnahmen; Bedeutung ausländischer Nichtigkeitsurteile für die Glaubhaftmachung der Nichtigkeit des Streitpatents”
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.
This case is all about 2-{2-[4-(Dibenzo[b,f][1,4]thiazepin-11-yl)-1-piperazinyl]ethoxy}ethanol.
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.
Seroquel XR by AstraZeneca
Revenues generated with Seroquel
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:
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 The national parts of EP 0 907 364 B1 had been revoked for lack of an inventive step in already five jurisdictions: Germany, the United Kingdom, the Netherlands, Spain and Italy.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.
AstraZeneca AB ./. (n/a)
Dr. Erich WÄCKERLIN (Reporting Judge)
Prisca von BALLMOOS (Judge)
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 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 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.)
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.
Raphael MEIER (Schellenberg Wittmer)
Posted on August 23, 2013 March 14, 2015
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”
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:
http://www.youtube.com/watch?v=EisQbI8YtCE (at 1:33)
(seen on 22 August 2013)
http://www.youtube.com/watch?v=EisQbI8YtCE (at 1:53)
http://www.youtube.com/watch?v=EisQbI8YtCE (at 1:55)
Therefore, it is more than reasonable to assume that the defendant is V-ZUG AG or a connected undertaking.
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).
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:
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).
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.
Wesco AG ./. V-ZUG AG
D. Herbert LAEDERACH (Judge)
Dr. Reinhard OERTLI (Meyerlustenberger Lachenal)
Dr. Simon HOLZER (Meyerlustenberger Lachenal)
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