Fulvestrant, reloaded (and still to be continued)

Case Nos. O2105_011 and O2015_012 ¦ Main hearing of 13 June 2017

A first glimpse of these disputes could be catched in parallel proceedings O2015_010 concerning nullity of AstraZeneca’s CH 696 260 A5 (commented on this Blog here). From r 4 of this decision, it has been evident that nullity proceedings are pending at the FPC for the two corresponding European patents in the same patent family:

The only independent claim 1 of EP’573 reads as follows (emphasis added):

A pharmaceutical formulation for use in the treatment of breast cancer by intra-muscular injection, wherein the pharmaceutical formulation comprises fulvestrant, a pharmaceutically-acceptable alcohol being a mixture of 10 % weight of ethanol per volume of formulation and 10 % weight of benzyl alcohol per volume of formulation, and the formulation contains 15 % weight of benzyl benzoate per volume of formulation and a sufficient amount of a ricinoleate vehicle so as to prepare a formulation of at least 45 mgml-1 of fulvestrant, wherein the ricinoleate vehicle is castor oil, and wherein the total volume of the formulation is 6 ml or less.

EP’138 B2 comprises various independent claims; only claim 1 is given below for illustrative purposes:

Use of fulvestrant in the preparation of a pharmaceutical formulation for the treatment of a benign or malignant disease of the breast or reproductive tract by intra-muscular administration, wherein the formulation comprises fulvestrant in a ricinoleate vehicle, a pharmaceutically acceptable non-aqueous ester solvent, and a pharmaceutically acceptable alcohol, and wherein the formulation is adapted for attaining a therapeutically significant blood plasma fulvestrant concentration for at least 2 weeks.

 

The main hearing covered both cases. We concluded from what has been discussed that  the assessment of inventive step in view of McLeskey and Howell will be key. It would be inappropriate for us to judge on the prospects based on the limited information at hand. But from the pleadings, it became clear that the expert opinion of the judge-rapporteur must have been disadvantageous for the patentee / defendant.

EP’573 has been fully revoked by an OD of the EPO in a hearing of May 8, 2017. The reasoned decision is not yet available, but the President of the FPC pushes for it, repeatedly.

UPDATE Sep 4, 2017:

The OD’s decision is published meanwhile. Appeal proceedings are pending.

Likewise, EP’138 has been fully revoked in Germany, in line with the interim assessment of the German FPC. But the reasoned decision had not been available until Friday before the hearing (Tuesday). The FPC was informed therof by the defendant / patentee in the hearing, and it turned out that the plaintiff’s representatives had not been aware of this at all. The parties will be given the opportunity to comment on this decision in writing.

The patentee / defendant also requested during the hearing that one of his auxiliary requests be amended by addition of yet another feature. The parties disagreed on whether this was admissible at this stage of the proceedings. The President noted that an order or a decision will be issued on this aspect.

If you are interested in what has happened elsewhere, these are corresponding decisions we got get a hand on from public files:

This list surely is incomplete. If you have further references to be included here, please send them in and we will accordingly update the list.

Reported by Ingo LUMMER and Martin WILMING

BIBLIOGRAPHY

Case Nos. O2105_011 and O2015_012 ¦ Main hearing of 13 June 2017

Actavis Switzerland AG ./. AstraZeneca AB

Composition of the Board of the FPC:

  • Dr. Dieter BRÄNDLE
  • Dr. Hanny KJELLSAA-BERGER
  • Dr. Prisca VON BALLMOOS
  • Dr. Hannes SPILLMANN
  • Dr. Daniel ALDER

Judge-rapporteur:

  • n/a
    (most likely Dr. Hannes SPILLMANN since the judge-rapporteur has always been referred to by the parties in the male form)

Court Clerk:

  • Susanne ANDERHALDEN

Representative(s) of Plaintiff:

Representative(s) of Defendant:

  • Dr. Michael RITSCHER (MLL)
  • Dr. Mark SCHWEIZER (MLL)
  • Dr. Thorsten BAUSCH (Hoffmann Eitle), assisting in patent matters
  • Dr. Ulrike CIESLA (Hoffmann Eitle), assisting in patent matters

THE ‘138 PATENT IN SUIT

Download (PDF, 1.04MB)

THE ‘573 PATENT IN SUIT

Download (PDF, 674KB)

PREPARATORY NOTES BEFORE THE HEARING

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