Case No. O2019_006 | Decision of 22 December 2020
We have reported about the main hearing of 16 November2020 on this Blog here. In brief, 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 / 5 ml (Swissmedic approval no. 56778).
And, indeed, the FPC holds that Fulvestrant Sandoz 250 mg / 5 ml infringes EP’573.
A somewhat strange timeline
EP’573 had already been close to the end of its 20y term (8 January 2021) when the main hearing took place, and I wondered whether the judgment would be handed down before the patent lapses. But I did not anticipate an outcome where the decision actually dates before the patent lapsed (see the date on the title page: 22 December 2020), but apparently has only been sent out to the parties well after the patent lapsed (see the footer on the last page: 20 January 2021).
From the reasons of the decision, I get the impression that it has been written before the patent has lapsed. The lapse of the patent is referred to as a point of time in the future:
What is more, the decision comprises an injunction in item 2 of its operative part (which, in light of the reasons, is surely not meant to be a spring-board injunction).
But why then hasn’t it been sent out earlier, i.e. before the patent lapsed? Maybe, the reasons of the decision had not yet been fully reviewed / agreed on by the whole panel of judges. But even in that case, at least the operative part of the decision could have been sent out earlier, in accordance with Art. 239(1) lit. b CPC.
I don’t really get it; the timeline is a bit strange to me.
Obviousness / The objective technical problem
Validity of EP’573 in view of Howell and McLeskey had already been dealt with — and approved — by the FPC in proceedings between AZ and Actavis; see this Blog here.
Likewise, EP’573 had also been maintained by a Board of Appeal with decision T 1680/17 of 24 January 2019. Thus, the outcome in the present matter that EP’573 is non-obvious over the same prior art does not come as a huge surprise. It also is in line with proceedings in The Netherlands (Gerechtshof Den Haag, 200.237.828/01), but contrary to what has been held by the German Federal Supreme Court (X ZR 59/17).
Infringement
Sandoz had disputed that its generic actually infringes EP’573 because the claim requires 10% (w/v) of ethanol. Sandoz had argued that ethanol refers to the substance EtOH, not to the various degrees of purity of EtOH that are available on the market. Apparently, Sandoz uses 10% EtOH with a purity of 96%, i.e. only 9.6% of the substance EtOH.
However, the decision holds that ethanol is to be construed, in view of the specification, as ethanol according to the Pharmacopeia standard, i.e. with a purity of 94.9 to 96%.
Expenses for patent attorneys in mixed firms
Sandoz had questioned whether costs incurred by a patent attorney who is a partner of the same law firm that does the legal representation are actually refundable as «necessary expenses» in accordance with Art. 3 lit. a CostR.
Good new for mixed firms: The decision holds that this is not an issue.
Miscellaneous
The decision holds that AstraZeneca AG’s standing to sue had not been proven; a distribution agreement between AstraZeneca AB and AstraZeneca AG was not sufficient in this respect.
Reported by Martin WILMING
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BIBLIOGRAPHY
Case No. O2019_006 | Decision of 22 December 2020
| (1) AstraZeneca AB (2) AstraZeneca AG |
| ./. |
| Sandoz Pharmaceuticals AG |
Panel of Judges:
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- Dr. Rudolf RENTSCH
- Prisca VON BALLMOOS
- Marco ZARDI
Court Clerk:
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- Susanne ANDERHALDEN
Representative(s) of AstraZeneca:
Representative(s) of Sandoz:
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DECISION
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PATENT IN SUIT
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BE ON THE KNOW
As to your question why the operative part of the decision has not been sent out before the patent lapse, I think that the FPC is required to always issue its decision with reasons, as its decisions are subject to an appeal to the FSC (see art. 112(1)(b) BGG; art. 239(3) CPC). It would not have been possible to issue the decision without reasons (or such decision would at least not have been enforceable).
Thanks for the great blog!
Ah, you´re right. I had the PI without hearing the defendant in mind, but that one couldn’t be appealed to the Supreme Court, i.e. it could be handed down without reasons. Thanks for clarification.