Suffering from COPD

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Case No. O2018_008 | Decision of 2 February 2021

We have reported about the main hearing in this matter on this Blog here.

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.
the outcome in a nutshell

As to the common general knowledge (CGK) of the skilled person, the decision holds, with reference to Aulton (a textbook which at the face of it is not prior art but has still been referred to by both parties) and Voigt/Fahr, that the skilled person knew that gelatine as a capsule material was an established material that is suitable for dose inhalation. The skilled person further knew that hydroxypropyl methylcellulose (HPMC) can also be used as a capsule material in general, and in particular in connection with inhalation. The landmark article Ogura et al., which is referred to in Aulton, would probably be consulted by the skilled person without further ado in connection with the selection of a material for such a capsule, even if the content per se was not part of the CGK.

On the merits, the decision holds that the invention had been obvious over Maessen et al. in further view of JP 502 (JP 2000-143502, available as machine translation). Undisputed between the parties, the distinguishing features of claim 1 over Maessen et al. are that the capsule material

    1. is gelatine, admixed with 1-10% of PEG; and
    2. has a moisture content of less than 10%.

JP 502 discloses a broader range of PEG (0.4-33%) and an upper limit of 14% for the moisture content, with 8-12% being preferred. Cutting a long(er) story short, the decision holds that the selected sub-ranges are just an arbitrary selection from JP 502, without any apparent / surprising effect. Accordingly, being a mere alternative to what had already been more broadly suggested in JP 502, the subject-matter of the partially waived patent was held obvious. Experimental evidence submitted by the patentee were of no avail since they did show a comparison with the compositions taught by Maessen et al. and/or JP 502.

Essentially the same reasoning is applied in the decision with respect to claim 3, which is held obvious over Maessen et al. and Ogura et al. (or vice versa).

The German Federal Supreme Court had revoked the German part of EP 220 already back in 2016 with a similar reasoning; X ZR 38/14.

The ‘closest prior art’, revisited

The decision holds that it is not possible in civil proceedings to disregard a certain piece of prior art as the ‘closest prior art’ in the problem-solution approach when a party to the proceedings referred to it as such; ¶ 36. At least at first glance, this appears to be indeed settled case-law of the FPC; see e.g. O2013_011, ¶ 5.6 and S2017_001, ¶ 4.6. Note that Dieter BRÄNDLE, the former President of the FPC, has recently contributed an article on this issue to the Festschrift for Peter Meier-Beck; see p. 147 et seqq.

What is interesting, though, is fn 10:

This footnote refers to a different opinion in the commentary Patentgesetz (PatG), Art. 1 N 70,  There, it is held that certain pieces of prior art are unsuitable as a starting point for assessing inventive step and should not be taken into account:

Nach hier vertretener Auffassung gibt es Entgegenhaltungen, die als Ausgangspunkt für die Beurteilung der erfinderischen Tätigkeit ungeeignet und nicht zu berücksichtigen sind.

This different opinion has weight: The co-author of this chapter is Mark SCHWEIZER, the current president of the FPC — who has not been on the panel in the present matter. It will be interesting to once see a case where this is the potentially decisive issue. Maybe, the case-law of the FPC is not as settled as it might appear at first glance: Mark SCHWEIZER had not been on the panel in the two cases O2013_011 and S2017_001.

Does the ‘technical contribution’ test survive?

The EPO is renowned for a rather strict approach to allowability of amendments. Just by way of example, selection and combination of elements from two lists of certain lenghts is typically held to contravene Art. 123(2) EPC in EPO proceedings. In my view, the ‘two lists’ approach took a life of its own and is frequently applied as a mere formalism, without actually looking into what really matters, i.e. what the skilled person would really have understood from the lists, with the whole content of the application as filed in mind.

‘Two lists’, uh?

Getting straight to the point, an esteemed colleague recently referred to the ‘two lists’ approach simply as «garbage» in an official meeting. That’s a pretty harsh statement, and I guess only a Brit can make it sound serious. But to the extent that a formalism must not replace the gist of the law, I do agree with it.

Now, what about selections from converging lists?

The present decision of the FPC makes an interesting reference in ¶ 26 to the hn of a recent decision of a Board of Appeal of the EPO, i.e. T 1621/16, as follows:

1) When fall-back positions for a feature are described in terms of a list of converging alternatives, the choice of a more or less preferred element from such a list should not be treated as an arbitrary selection, because this choice does not lead to a singling out of an invention from among a plurality of distinct options, but simply to a subject-matter based on a more or less restricted version of said feature.

2) A claim amended on the basis of multiple selections from lists of converging alternatives might be considered to meet the requirements of Article 123(2) EPC if:

i)  the subject-matter resulting from the multiple selections is not associated with an undisclosed technical contribution, and

ii)  the application as filed includes a pointer to the combination of features resulting from the multiple selections.

I very much appreciate any attempt to overcome the mere formalism of the ‘two lists’ approach. However, I wonder whether reference and early adoption of T 1621/16 might be premature. 

First, T 1621/16 is not case law of the Boards of Appeal yet (as it is referred to in ¶ 26 of the decision). Actually, it is the very first decision of its kind, and it remains to be seen whether this will be sth that other Boards adopt — or not. It may well be that this decision turns out to be an outlier, for reasons outlined below.

Second, not even T 1621/16 itself says that the two criteria in hn 2 are the only ones to take into account. On the contrary, hn 2 holds that Art. 123(2) EPC «might be considered to be met» when these two criteria are fulfilled. Yet more criteria might apply, as is expressly held in ¶ 1.7.3: «For the board, at least the following two conditions should be met: […].» To me, T 1621/16 is more aiming to trigger a discussion and further evolvement of the case-law of the Boards rather than to carve a new test in stone. Whether this will end up in a new test (and if so, which one) remains to be seen.

Third, I don’t feel comfortable at all with the reference to the (lack of an) «undisclosed technical contribution» in hn2, item i).

For novelty and basis in the application as filed, the same «gold standard» is applied at the EPO, asking for «what a skilled person would derive directly and unambiguously, using common general knowledge,» from a certain piece of prior art or the application as filed; see Case Law of the BoA, E 1.1, fourth but last paragraph.

For the assessment of novelty, however, the majority of the Boards appear to have moved away from asking whether a certain selection of a sub-range from a broader range in the prior art is associated with a new technical teaching / previously undisclosed effect. For good reason. Arguably, the assessment of effects is indeed more related to obviousness rather than to novelty. Even the EPO Guidelines had been amended in November 2019: The third criterion that asked for a purposive selection or new technical teaching was deleted.

EPO Guidelines Nov 2019 (mark-up over 2018 edition)

epi had sent a letter to the President of the EPO in October 2019, asking to refer this issue to the Enlarged Board of Appeal because there was not (yet) consensus across the Boards. I fully share epi’s concerns. But the EPO replied that this was just regular evolvement of case law, and that the time was right to amend the Guidelines accordingly. Both letters are available here.

Now, what? I cannot really see how a check for a previouly undisclosed technical contribution might become part of the test for allowability of selections from converging list, while at the same time we don’t care anymore about the technical contribution in the test for novelty of sub-ranges. I may well be wrong, but this is why I do not yet see that the approach taken in T 1621/16 will be broadly adopted by the Boards.

Interestingly, the decision of the FPC also discusses a report of the Comptroller on proposed amendments in corresponding proceedings in the UK; see ¶ 27. The Comptroller had held in a report of 17 June 2015 with respect to a certain amendment that no «special advantage» of the selected features was apparent, and that the amendement therefore added matter:

The present decision holds that such considerations were alien to the assessment of the admissibility of amendments; they would rather have to be dealt with under obviousness:

Suffering from COPD

Don’t get me wrong, I do agree that such considerations relate more to obviousness than to added matter. But still, I don’t feel that the Comptroller can be blamed for confusing concepts when T 1621/16 does exactly that: Applying concepts of obviousness in the assessment of added matter.

Oh man, sometimes it feels like I am suffering from a very special form of COPD, i.e. a Chronic Obviousness and Pointer Disorder.

UPDATE 10 March 2021:

An appeal is pending at the Supreme Court.

Reported by Martin WILMING

Header image courtesy of Vecteezy

BIBLIOGRAPHY

Case No. O2018_008 | Decision of 2 February 2021

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

DECISION IN FULL

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:

BE ON THE KNOW

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

Reading time: 5 minutes

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:

BE ON THE KNOW

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