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 —

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