Fulvestrant, revisited: Is it still urgent? Views are divergent …

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Case No. S2019_004 | Decision of 9 April 2019
Case No. S2019_004 | Decision of 20 February 2019

Sandoz’s logo

With request of 12 February 2019, AstraZeneca asserted EP(CH) 2 266 573 B1 (see EPO Register and Swissreg for further information) against Sandoz’s generic version of AZ’s Faslodex®, i.e. Fulvestrant Sandoz 250 mg/5ml (Swissmedic approval no. 56778). Note that Sandoz’s generic has been on the market in Switzerland since 26 July 2016.

AZ’s request for interim injunctive relief w/o hearing the defendant beforehand was dismissed with decision of 20 February 2019. Hearing the defendant didn’t change the outcome; the request was also dismissed with decision of 9 April 2019. Both requests failed for lack of urgency, given the fact that Sandoz’s generic has been on the market since 2.5 years.

At the face of it, this appears to be pretty straight forward, in particular in view of the most recent decisions S2018_006 (¶13) and S2019_001 (¶6) emphasizing the 14 months time bar in no uncertain terms.

But the devil is in the detail. Maybe.

AZ’s logo

This is not the first time that the FPC had to deal with EP’573. The patent had been revoked for lack of inventive step over Howell in view of McLeskey; see this Blog here. But AZ appealed and essentially argued that the FPC erroneously assumed a (concrete) pharmaceutical formulation in Howell, thus incorrectly defined the distinguishing features and the (objective) technical problem, and then wrongly concluded for lack of inventive step.

Fulvestrant (aka ICI 182,780), the active ingredient of AZ's Faslodex®
Fulvestrant (aka ICI 182,780), the active ingredient of AZ’s Faslodex® and Sandoz’s generic

And, indeed, the Supreme Court agreed and remitted the case for re-assessment of inventive step; see this Blog here. From the reasons of the present decisions, we can now catch a glimpse of what is currently going on in the remitted proceedings (formerly O2015_011, now O2018_009): The judge-rapporteur held on 23 November 2018 that the patent was valid. But it is not only that the wind has changed at the FPC. The Gerechtshof Den Haag also held that the patent was valid, in second instance proceedings. Likewise, a Board of Appeal at the EPO overruled the first instance revocation of an opposition division and finally ruled on 24 January 2019 that the patent was valid.

On the other hand, this is also not the first time that AZ sought injunctive relief for Sandoz’s generic. AZ had asserted a different patent against the same generic already in summary proceedings S2016_007, i.e. EP'138. It becomes clear from the present decisions that these earlier proceedings had been terminated because AZ had withdrawn the requests.

Now, here is a timeline events which is colored to reflect my very personal view on the prima facie validity of EP’573 over time:

17 Jun 2015 Grant of EP’573
29 Oct 2015 1st opposition filed (Hexal)
16 Feb 2016 2nd opposition filed (Actavis)
8 Mar 2016 3rd opposition filed (Fresenius Kabi)
16 Mar 2016 4th opposition filed (Intas)
17 Mar 2016 5th opposition filed (Teva)
17 Mar 2016 End of EPO opposition period
21 Mar 2016 Acceleration request by FPC in opposition proceedings
26 Jul 2016 Sandoz’s market entry
3 Aug 2016 AZ seeks interim injunctive relief based on another patent, i.e. EP'138; S2016_007, see this Blog here
30 Nov 2016 Summons (EPO) issued with ED’s preliminary opinion that patent is invalid
… Mar 2017 Request for interim injunctive relief in case S2016_007 withdrawn
8 May 2017 EPO first instance decision to revoke EP’573
29 Aug 2017 FPC’s first instance decision to revoke EP(CH)’573; O2015_011, see this Blog here
8 May 2018 On appeal re O2015_011, Supreme Court remits the case for re-assessment of obviousness; 4A_541/2017, see this Blog here
15 Oct 2018 Preparatory notes of EPO BoA indicating that obviousness is tbd in the hearing
23 Nov 2018 Judge-rapporteur’s expert opinion in O2018_009 (which is the remitted case O2015_011) that EP(CH)’573 is valid
27 Nov 2018 Gerechtsbank Den Haag holds that EP(NL)'573 is valid and infringed
24 Jan 2019 EPO BoA pronounces the decision to reject the oppositions / maintain EP’573 at the end of the hearing
12 Feb 2019 AZ files requests for interim injunctive relief in the present proceedings
15 Mar 2019 EPO BoA issues reasoned decision

One may conclude from the above timeline that there had been some red(-ish) flags concerning the validity of EP’573 for quite a long time.

The decisions note in passing that main infringement proceedings with case no. O2017_004 concerning Sandoz’s generic are pending in parallel, but based on a different patent (EP'195); from the case no. it is clear that this suit has been brought in 2017, but no further information is available to date.

Further, the decision indicates that in some proceedings with case no. O2018_010 the very same EP’573 is at stake as in the present matter, but the defendant is not revealed.

AZ essentially argued that it had been prevented from bringing the request for interim injunctive relief earlier because of the previously negative assessment of validity EP’573 by the EPO, the FPC (O2015_011) and the district court of The Hague (NL), and that the wind has changed only very recently; see timeline above.

The single judge did not buy into that and emphasized that AZ had undoubtedly been aware of Sandoz’s generic since 26 July 2016; AZ could have lodged main proceedings at any time since then. The decision further holds (¶22; inofficial translation):

[T]he decision of the Board of Appeal of the EPO of 24 January 2019 […] may substantiate the claim to which the plaintiff is entitled with regard to the validity of the patent in suit, but in no way justifies urgency. […]

Ultimately, however, all parallel proceedings have no influence on the purely procedural question of urgency in the present summary proceedings. […]

The tactical awaiting of a foreign parallel decision on the patent in suit before an action is lodged does not belong to the subjective but rather to the subjective circumstances.

It surely is a tough exercise to fit the gist of a decision in a single tweet; but the FPC’s tweet on the decision is straight to the point:

A decision of a Board of Appeal of the EPO does not give rise to urgency where the contested product has been on the market for 30 months.


The approach taken in the present decisions in my understanding focuses much more on the total time than on the apparent change of prima facie validity of the patent in suit over time. While the 14 months time bar is comparably generous (German courts typically deny urgency after 1-2 months, in my experience), it seems to be a pretty rigid time bar nowadays.

In an earlier case at the FPC, urgency had still been acknowledged for a request that had been filed five months after a BoA of the EPO had maintained the patent in suit which had been revoked in first instance by an opposition division (S2013_004, decision of 12 May 2014, ¶4.8).

It will be interesting to see how the FPC’s approach in the assessment of urgency will develop.

Reported by Martin WILMING

BIBLIOGRAPHY

Case No. S2019_004 | Decision of 9 April 2019
Case No. S2019_004 | Decision of 20 February 2019

AstraZeneca AB
./.
Sandoz Pharmaceuticals AG

Single judge:

  • Dr. Rudolf RENTSCH

Court Clerk:

  • Susanne ANDERHALDEN

Representative(s) of AstraZeneca:

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

Representative(s) of Sandoz:

FIRST DECISION OF THE FPC
→ no injunctive relief without hearing the defendant
Case no.: S2019_004
Decision of: 20 February 2019
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SECOND DECISION OF THE FPC
→ no injunctive relief at all, after hearing the defendant
Case no.: S2019_004
Decision of: 9 April 2019
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PATENT IN SUIT

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T 1680/17 – Decision of EPO BoA 3.3.01

Chairman: A. Lindner
Member: M. Pregetter
M. Blasi

Decision of 24 January 2019:

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