Does the Supreme Court assess the skilled person’s understanding of a piece of prior art?

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Case No. 4A_149/2021 (Supreme Court) | Judgment of 24 June 2021 on appeal against O2018_008 (Patent Court) | Judgment of 2 February 2021 to revoke EP(CH) 1 379 220 H1

Tiotropium bromide

Glenmark had challenged the 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).

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 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.

We have reported about the FPC’s decision on this Blog here. In a nutshell, the FPC had held that the subject-matter of claim 1 (gelatine with PEG as capsule material) was obvious over Maessen et al. in further view of JP 502 (JP 2000-143502, available as machine translation). Essentially the same reasoning applied to the subject-matter of claim 3 (HPMC as capsule material; the FPC had held that claim 3 was obvious over Maessen et al. and Ogura et al. (or vice versa).

And the Supreme court?

Only the finding of obviousness of claim 3 (HPMC capsule material) was challenged by BI in the appeal proceedings. BI’s arguments essenitally hinged on the formulation of the ‘objective technical problem’ in the problem-solution approach of the FPC; ¶ 5. The FPC had held that it was only the provision of an alternative (which in by far the most cases results in a finding of obviousness), while BI argued that it should be an improvement over the prior art; ¶ 5.1 (i.e. the improved physical stability of the encapsulated active agent, and thereby improved inhalability.)

The Supreme Court did not buy into that and held (with reference to the case law of the Boards of Appeal of the EPO) that a specific technical effect can only be considered in the formulation of the ‘objective technical problem’ (and supported by subsequent experimental evidence) when it is at least foreshadowed in the application as filed:

See Case Law of the Boards of Appeal, I.D.4.2.2 for further information; in particular, see e.g. T 321/16, ¶ 1.3.1, in German («[…] wenn diese Wirkung in den ursprünglich eingereichten Unterlagen nicht wenigstens angedeutet wird.»), with reference to T 344/89, ¶ 5.3.1, in English language («[…] if the new problem were foreshadowed in the originally filed application.»).

The Supreme Court noted that BI failed to establish in first instance proceedings that there was any effect foreshadowed in the application as filed that would go beyond the provision of a mere alternative to gelatine, as exemplified e.g. by Maessen et al.

Stepping back, I feel that this is not out of the ordinary. The patent as granted outlines the invention as to provide a capsule material with a reduced moisture content of less than 15% (¶ [0008] and claim 1), and mentions as the (subjective) technical problem to achieve a sufficient stability of the active agent (¶ [0006]). Notably, irrespective of the actual capsule material — and even though some preferred upper limits below 15% are mentioned, the patent is silent about why they are preferred. What is more, both gelatine and HPMC are actually described exchangeably in the specification; no indication whatsoever that there was any advantage of HPMC over gelatine. (The outcome might well have been different if the patent had indicated any preference of HPMC over gelatine, maybe.)

Further, the FPC had held that Voigt/Fahr was sufficient evidence of the skilled person’s knowledge that a more dry capsule material was preferred; and that Zeng et al. had been appropriately considered by the FPC (even though not expressly mentioned again in the context of claim 3, but rather only in the assessment of claim 1).

Does the Supreme Court assess the skilled person’s understanding of prior art documents?

There is one paragraph in the Supreme Court’s judgment that might suggest otherwise:

The Supreme Court held, losely translated, that it assesses violations of Federal Law, and that it does not assess the skilled person’s technical understanding of prior art documents. This paragraph already gave rise to a critical comment on Kluwer Patent Blog and Lexology.

I don’t see much of an issue here. In my reading in context, it appears that the Appellant had argued in appeal proceedings that Ogura et al. only pertained to the moisture content of empty capsules. The Supreme Court refers to this argument as an interpretation which had not been at stake in the underlying decision of the FPC — and which Respondent disputed.

With this in mind, I feel what the Supreme Court meant to say when it later again refered to an interpretation of a prior art document is that it does not assess the skilled person’s technical understanding of such a document from scratch again on appeal, when a new interpretation is brought forward only in the appeal stage. But there may well be situations where the FPC’s finding of the skilled person’s understanding of a certain piece of prior art could be reviewed by the Supreme Court, e.g. when the finding is just arbitrary.

BI’s appeal was dismissed; EP(CH) 1 379 220 H1 is finally revoked.

Reported by Martin WILMING

BIBLIOGRAPHY

Case No. 4A_149/2021 (Supreme Court) | Judgment of 24 June 2021 on appeal against O2018_008 (Patent Court) | Judgment of 2 February 2021 to revoke EP(CH) 1 379 220 H1

Glenmark Pharmaceuticals Europe Ltd
(Appellant / Defendant)
./.
Boehringer Ingelheim Pharma GmbH & Co. KG
(Respondent / Plaintiff)

Panel of Judges:

    • Dr. Christina KISS
      • Dr. Yves RÜEDI
      • Marie-Chantal MAY-CANNELLAS

Court Clerk:

    • Dr. Matthias LEEMANN

Representative(s) of Appellant / Defendant:

    • Dr. Simon HOLZER (MLL)
    • Louisa GALBRAITH (MLL)

Representative(s) of Respondent / Plaintiff:

SUPREME COURT DECISION

PATENT COURT DECISION

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:

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