Waiting for a Fulvestrant judgment while the end of the 20y term approaches

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Case No. O2019_006 | Main hearing of 16 November 2020

Sandoz’s logo

AstraZeneca asserts 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).

AZ’s logo

Note that Sandoz’s generic has been on the market in Switzerland since 26 July 2016. AZ had asserted a different patent against the same generic already in summary proceedings S2016_007, i.e. EP 1 250 138 B2 (see this Blog here), but has apparently withdrawn that request later. Earlier this year, AZ’s complaint based on yet another patent, i.e. EP 1 272 195 B1, has failed, too (O2017_014); see this Blog here. Prior to the present main proceedings, AZ sought interim injunctive relief based on EP’573 (S2019_004), but could not establish urgency anymore; see this Blog here.

Meanwhile, EP’573 comes close to the end of its term, which is 8 January 2021. It will be interesting to see whether the judgment is handed down before the patent lapses.

Watches?!

Validity of EP’573 in view of Howell and McLeskey has already been dealt with by the FPC and the Supreme Court in proceedings between AZ and Actavis; see this Blog here. That’s an uphill fight for Sandoz.

But the case is not only about (in)validity of EP’573. Sandoz also disputes that its generic actually infringes EP’573. Note that the claim requires 10% (w/v) of ethanol. Sandoz argues 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. Sandoz argues that EP’573 itself puts emphasis on certain dilutions of EtOH, e.g. in [0031] and [0046]; and [0034] mentions «about 10%» of ethanol, but not the claim.

Yet another interesting discussion came up with respect to AZ’s expenses for the assisting patent attorneys. Sandoz 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.

Now, what will be first: The end of the 20y term of the patent, or the judgment? Holding a bet, anyone?

Reported by Martin WILMING

BIBLIOGRAPHY

Case No. O2019_006 | Main hearing of 16 November 2020

(1) AstraZeneca AB
(2) AstraZeneca AG
./.
Sandoz Pharmaceuticals AG

Panel of Judges:

    • Dr. Rudolf RENTSCH
    • Prisca VON BALLMOOS
    • Marco ZARDI

Court Clerk:

    • Susanne ANDERHALDEN

Representative(s) of AstraZeneca:

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

Representative(s) of Sandoz:

ANNOUNCEMENT

PATENT IN SUIT

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