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 —

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