BI’s uphill fight re validity of EP 1 379 220

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Case No. O2018_008 | Hearing of 10 December 2020

BI’s logo

The main hearing in this matter had initially been scheduled and announced for 24 September 2020, but was cancelled on short notice.

Finally, the main hearing took place earlier this week, on 10 December 2020.

Tiotropium bromide

Glenmark challenges validity of Boehringer Ingelheim’s EP(CH) 1 379 220 H1, which is the Swiss part of EP 1 379 220 B1 after a partial waiver. The patent is about tiotropium capsules for inhalation and relates to BI’s Spiriva® Handihaler® for the management of chronic obstructive pulmonary disease (COPD).

There is big business behind; Spiriva® is still a blockbuster with € 2.3 bn of sales in 2019, but generic competition is on the rise. And it is an uphill fight for BI in view of what courts have already decided elsewhere concerning the very same patent (or a closely related one, such as in Norway). Just to name a few decisions that I could readily spot:

Germany

The Netherlands

United Kingdom

Norway

On the other hand, the High Court of Ireland held that EP 220 is valid; see [2017] IEHC 495.

UPDATE 18 December 2020:

Thanks to Simon HOLZER for bringing the Irish decision to my attention.

Now, which claims are still at stake in the Swiss proceedings? As a quick recap, claim 1 as initially granted reads as follows:

Capsules for inhalation which contain as the inhalable powder tiotropium in admixture with a physiologically acceptable excipient, characterised in that the capsule material has a reduced moisture content as a TEWS or halogen drier moisture content of less than 15%.

With the partial waiver, BI split the independent claim into two alternatives (amendments marked-up in bold; only available in German, for the time being); see the claims in mark-up and BI’s request below:

Claim 1 after waiver

Inhalationskapseln, die als Inhalationspulver Tiotropium im Gemisch mit einem physiologisch unbedenklichen Hilfsstoff enthalten, dadurch gekennzeichnet, dass als Kapselmaterial Gelatine im Gemisch mit dem Zusatz Polyethylenglycol (PEG) in einem Anteil von 1–10 Gew-%, bevorzugt 3–8 %, verwendet wird und dass das Kapselmaterial einen reduzierten Feuchtegehalt als TEWS- oder Halogentrockner-Feuchte von ≤ 10% aufweist und dass der physiologisch unbedenkliche Hilfsstoff Lactose ist.

Claim 3 after waiver

Inhalationskapseln, die als Inhalationspulver Tiotropium im Gemisch mit einem physiologisch unbedenklichen Hilfsstoff enthalten, dadurch gekennzeichnet, dass das Kapselmaterial Hydroxypropylmethylcellulose ist und einen reduzierten Feuchtegehalt als TEWS- oder Halogentrockner-Feuchte von ≤ 5% aufweist und dass der physiologisch unbedenkliche Hilfsstoff Lactose ist.
Glenmark’s logo

I understood from the pleadings that the judge-rapporteur’s expert opinion held that both claims 1 and 3 had been obvious in view of the prior art.

Both parties essentially only argued re (in)validity of claim 3, i.e. inhalation capsules based on hydroxypropyl methylcellulose (hypromellose; HPMC). In particular, the parties apparently dissent on whether claim 3 of EP 220 H1 provides for an (unexpected) advantage over the prior art, or merely an alternative.

I could not stay until the very end of the hearing, but I do not assume that I missed an essential twist of things after the lunch break. Assuming that the parties have not settled, a judgment can be expected early next year.

Reported by Martin WILMING

BIBLIOGRAPHY

Case No. O2018_008 | Hearing of 10 December 2020

Glenmark Pharmaceuticals Europe Ltd
./.
Boehringer Ingelheim Pharma GmbH & Co. KG

Panel of Judges:

    • Dr. Daniel ALDER
    • Dr. Tobias BREMI
    • Marco ZARDI

Judge-rapporteur:

    • Dr. Tobias BREMI

Court Clerk:

    • Susanne ANDERHALDEN

Representative(s) of Plaintiff:

    • Dr. Markus WANG (Bär & Karrer)
    • Dr. Christoph FRAEFEL (SBMP), assisting in patent matters

Representative(s) of Defendant:

    • Dr. Simon HOLZER (MLL)
    • Dr. Ulrike CIESLA (MLL), assisting in patent matters

ANNOUNCEMENT

PATENT IN SUIT

EP 1 379 220 B1 (as granted):

EP(CH) 1 379 220 H1 (after partial waiver):

Claims after partial waiver, mark-up:

Request of partial waiver:

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