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 —

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