No cherry-picking: Supreme Court endorses EPO case-law re singling out

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Case No. 4A_613/2019 (Supreme Court) | Decision of 11 May 2020 on appeal against O2017_009 (FPC) | Decision of 7 November 2019

MundiPharma’s EP(CH) 2 425 821 B1 and EP(CH) 2 425 824 B1 had been revoked by the FPC with decision of 7 November 2019; O2017_009. Accordingly, MundiPharma’s counterclaim for infringement failed. A detailed comment on that decision is available on this Blog here.

MundiPharma had appealed the decision, but only with respect to EP(CH) 821:

The decision of the Supreme Court gives an overview of some relevant decisions of the Boards of Appeal of the EPO concerning Art. 123(2) EPC in ¶ 3.2, which the Supreme Court apparently endorses without hesitation. As to the matter at hand, the Supreme Court confirms that the FPC had correctly applied these principles and that the subject-matter of EP(CH) 821 is the result of an unallowable singling out of at least two features from different lists. The resulting combination of features, i.e. the weight ratio of oxycodone to naloxone of 2:1 in combination with the reduction of obstipation, is not directly and unambiguously disclosed in the application as originally filed; see ¶¶ 3.3 and 3.4. In particular, MundiPharma could not establish how the skilled person would have derived the specific weight ratio and the reduction of obstipation in combination from the application as filed:

Further, the Supreme Court did not spot a violation of MundiPharma’s right to be heard because the FPC allegedly did not take the skilled person’s knowledge into account. The Supreme Court holds that the FPC in fact did take it into account, and that MundiPharma essentially only argues that it had a different opinion of how the law and case-law should be applied to the case at hand:

Finally, the Supreme Court dealt with MundiPharma’s objection concerning the apportionment of costs. It may well be that in a nullity case the necessary expenses incurred by the assisting patent attorney exceeds the amount that can be refunded for legal representation according to the tariff:

Oral proceedings before a Board of Appeal in co-pending proceedings at the EPO are scheduled for 23 September 2021, to be continued on 24 September 2021 if necessary. No preliminary opinion of the Board is available yet.

Reported by Martin WILMING

BIBLIOGRAPHY

Case No. 4A_613/2019 (Supreme Court) | Decision of 11 May 2020 on appeal against O2017_009 (FPC) | Decision of 7 November 2019

MundiPharma Medical Company (Appellant / Defendant)
./.
Develco Pharma Schweiz AG (Respondent / Plaintiff)

Panel of Judges:

    • Dr. Christina KISS
      • Dr. Fabienne HOHL
      • Dr. Martha NIQUILLE
      • Dr. Yves RÜEDI
      • Marie-Chantal MAY-CANNELLAS

Court Clerk:

    • Christian STÄHLE

Representative(s) of Appellant / Defendant:

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

Representative(s) of Respondent / Plaintiff:

DECISION OF THE SUPREME COURT
→ appeal against FPC decision to revoke EP(CH) 2 425 821 B1
Case no.: 4A_613/2019
Decision of: 11 May 2020
The unredacted decision had been submitted by the Respondent / Plaintiff in the co-pending opposition / appeal proceedings at the EPO:

DECISION OF THE FPC
→ Revocation of EP(CH) 2 425 821 B1
Case no.: O2017_009
Decision of: 7 November 2020

PATENT IN SUIT

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Oxycodone / Naloxone II, III, … and counting(?)

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Case No. O2017_009 | Decision of 7 November 2019 | ‘Oxycodon und Naloxon II und III’

The patents at stake in this nullity case are MundiPharma‘s EP 2 425 821 B1 (see EPO Register and Swissreg) and EP 2 425 824 B1 (see EPO Register and Swissreg). The same parties have already litigated over EP 2 425 825 B9 in separate proceedings O2016_016; see this Blog here — and so did yet another plaintiff in O2016_017; see this Blog here.

Wondering about the color code? It is adopted from the decision itself (¶ 16), to help getting the ducks (pardon me, divisional applications) in line:

Patents in suit: EP’821 and EP’824

Yet again, it’s all about a combination of oxycodone hydrochloride and naloxone hydrochloride, in a weight ratio of 2:1.

This combination is an analgesic drug that is available as modified-release tablets under the trade name Targin® by MundiPharma.

Develco sought annulment of both EP(CH)’821 and EP(CH)’824 inter alia for undue extension of subject-matter, in violation of Art. 76 and Art. 123 EPC. Note that both patents had been filed as divisional applications, without any claims in first place. However, the claims of WO’520 had been recited in the specification in ¶ [0127] of EP 821 A1 and ¶ [0131] of EP 824 A1, respectively.

As to EP 824, the decision holds that claim 1 as granted does not comply with Art. 76 and Art. 123 EPC; see the following mark-up over the first claim-like clause  in ¶ [0131] of EP 824 A1:

EP 824 as granted; mark-up over ¶ [0131] of EP 824 A1
Likewise, the first auxiliary request (AR 1) — wherein only feature 1.7 had been amended over the claims as granted — failed  for essentially the same reasons:

AR 1, mark-up over the claims as granted

Both claim 1 as granted and claim 1 of the AR 1 had also been held by an Opposition Division of the EPO to not comply with Art. 123 EPC; see the decision of 11 September 2019, ¶¶ 2.4-2.9, 6 and 8.

Finally, also AR 2 failed for essentially (some of) the same reasons as the claims as granted, and in line with the ratio decidendi of the EPO’s Opposition Division:

AR 2, mark-up over the claims as granted

As to EP 821, the decision is pretty straight forward because the specification is the same as in EP 824. Claim 1 as granted does not comply with Art. 123 EPC:

EP 821 as granted; mark-up over ¶ [0127] of EP 821 A1
The FPC comes to the same conclusion for claim 1 of AR 1:

AR 1, mark-up over the claims as granted

This finding of the FPC is in line with the decision of an Opposition Division in parallel proceedings at the EPO; see the decision of 11 September 2019 (AR 1 corresponds to AR IX in EPO opposition proceedings).

On the merits, I feel that this case is nothing out of the ordinary in terms of assessment of undue extension of subject-matter. Still, there are two statements that I find noteworthy.

First, the decision holds in ¶ 25 that, as a rule, when reading a patent application or a patent, the person skilled in the art assumes that features, if they are expressly mentioned in an independent claim, are important and not just superfluous — unless there are clear indications to the contrary. Thus, for a feature to be omitted, it is therefore not sufficient to show that it is not highlighted anywhere as important. Rather, it must be shown that the skilled person recognizes that the feature does not make a technical contribution or can be omitted. It must therefore be established that the skilled person, using common general knowledge, would regard the claimed subject-matter even without the specific feature  as — explicitly or implicitly — directly and unambiguously disclosed in the application as filed.

Grundsätzlich geht der Fachmann beim Lesen einer Patentanmeldung oder einer Patentschrift a priori zunächst einmal davon aus, dass Merkmale, wenn sie ausdrücklich in unabhängigen Patentansprüchen genannt werden, auch wichtig und nicht einfach überflüssig sind, sofern es nicht klare Hinweise für das Gegenteil gibt.

Damit ein Merkmal weggelassen werden kann, genügt es also nicht, zu zeigen, dass es nirgends als wichtig hervorgehoben wird, sondern es muss gezeigt werden, dass für den Fachmann zweifelsfrei erkennbar ist, dass das Merkmal keinen technischen Beitrag leistet oder auch weggelassen werden kann. Mithin muss gezeigt werden, dass der Fachmann unter Heranziehung des allgemeinen Fachwissens den beanspruchten Gegenstand auch ohne das Merkmal als – explizit oder implizit – unmittelbar und eindeutig in der ursprünglichen Fassung der Anmeldung offenbart ansehen würde.

In my perception, this is essentially the approach of the EPO, even though the decision does not make any reference to the EPO Guidelines or case-law of the Boards of Appeal in this respect.

Second, the decision makes a clear distinction in ¶ 44, with extensive reference to case-law of the Boards of Appeal, between mere deletion of some elements from lists of a certain length on the one hand (which may well be admissible), and so-called singling out of specific elements from a lists (which is typically not permissible).

Reported by Martin WILMING

BIBLIOGRAPHY

Case No. O2017_009 | Decision of 7 November 2019 | ‘Oxycodon und Naloxon II und III’

Develco Pharma Schweiz AG
./.
MundiPharma Medical Company

Panel of Judges:

    • Dr. Daniel M. ALDER
    • Dr. Tobias BREMI
    • Dr. Hannes SPILLMANN

Judge-rapporteur:

    • Dr. Tobias BREMI

Court Clerk:

    • Susanne ANDERHALDEN

Representative(s) of Develco:

    • Andrea MONDINI (TIMES)
    • Dr. Cornelia HOFFMANN (SBMP), assisting in patent matters

Representative(s) of Mundipharma:

    • Dr. Simon HOLZER (MLL)
    • Renato BUCHER (MLL)
    • Dr. Dirk BÜHLER (Maiwald), assisting in patent matters
    • Dr. Andreas LEDL (Maiwald), assisting in patent matters

DECISION IN FULL

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A Swiss approach to the EPO’s gold standard

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Case No. O2016_016 | Decision of 6 June 2019

The patent at stake is MundiPharma‘s EP 2 425 825 B9; see EPO Register and Swissreg. EP’825 pertains to a combination of oxycodone hydrochloride (in an amount of 10 to 150g) and naloxone hydrochloride (in an amount of 1 to 50g), in a weight ratio of 2:1.

This combination is an analgesic drug that is available as modified-release tablets under the trade name Targin® by MundiPharma.

Develco’s logo

Develco sought annulment of EP(CH)’825 for various reasons, i.e. undue extension of subject-matter, non-enablement and invalidity of the priority claim. Please see this Blog here for a brief summary of the main hearing in this matter, and some relevant prior art Develco has asserted against patentability of the claimed subject-matter.

MundiPharma’s logo

Defendant / patentee MundiPharma countersued for infringement. MundiPharma not only countersued the plaintiff, but rather also attempted to involve the German branch of Develco as well as Konapharma. This attempt failed.

It was evident from the pleadings at the main hearing that the expert opinion of the judge-rapporteur had held that the patent was invalid for undue extension of subject-matter. Thus, it does not come as a big surprise in the decision that EP(CH)’825 is held invalid for undue extension of subject-matter. Consequently, the decision does not address the other grounds of invalidity asserted by Develco; and the counterclaim for infringement is moot, too.

In my perception, the detailed assessment of undue extension of subject-matter is nothing out of the ordinary. It’s all about the EPO’s ‘gold standard’ (G 2/10 in ¶4.3, with reference to G 3/89 and G 11/91), i.e.

[…] any amendment […] can […] only be made within the limits of what a skilled person would derive directly and unambiguously, using common general knowledge, and seen objectively and relative to the date of filing, from the whole of [the application as filed].

What is interesting, though, is how the decision addresses the so-called essentiallity-test (‘Wesentlichkeits-Test’), in particular how this test fits with the ‘gold standard’. In brief, in T 331/87 the Board held that the replacement or removal of a feature from a claim may (referred to in the Case Law of the Boards of Appeal as a ‘might’) not be in breach of Art. 123(2) EPC if the skilled person would directly and unambiguously recognise that

  1. the feature was not explained as essential in the disclosure;
  2. it was not, as such, indispensable for the function of the invention in the light of the technical problem it served to solve; and
  3. the replacement or removal required no real modification of other features to compensate for the change.

It is important to note that even this Board apparently (in view of the conditional language used; see mark-up above) did not consider compliance with the above three criteria as a sufficient condition for compliance with Art.123(2) EPC in any given case. Accordingly, the present decision holds that the only thing that really matters is the ‘gold standard’ discussed above, which cannot be deviated from. With reference to the Swiss Supreme Court decision 4A_109/2011, 4A_111/2011 (¶4.3.1), however, the decision further holds that in a case where not even the criteria of the essentiallity test are fulfilled, it must be assumed that an undue extension of subject-matter occured.

What suprises me, though, is that the decision holds (¶31):

Otherwise this would again amount to a materiality test, which was expressly rejected in G 2/98.

Frankly, I don’t see that in G 2/98, at least not expressly (‘ausdrücklich’). One may well conclude from the gist of G 2/98, in particular ¶8.3, that it does not endorse a distinction of technical features which are related to the function and effect of the invention and technical features which are not. But there is no discussion of the essentiallity test at all in G 2/98. Else, if there was, the essentiallity test would surely not be referred to anymore in the most recent edition of the Case Law of the Boards of Appeal and the Guidelines.

But still, my personal take-away message from this decision is that the essentiallity test is of no avail in proceedings at the FPC (until someone comes along and proves me wrong).

The decision is not yet final / may still be appealed to the Supreme Court.

Reported by Martin WILMING

BIBLIOGRAPHY

Case No. O2016_016 | Decision of 6 June 2019

Develco Pharma Schweiz AG
./.
MundiPharma Medical Company

Panel of Judges:

  • Dr. Daniel M. ALDER
  • Dr. Tobias BREMI
  • Dr. Hannes SPILLMANN

Judge-rapporteur:

  • Dr. Tobias BREMI

Court Clerk:

  • Susanne ANDERHALDEN

Representative(s) of Develco:

  • Andrea MONDINI (TIMES)
  • Dr. Cornelia HOFFMANN (SBMP), assisting in patent matters

Representative(s) of Mundipharma:

  • Dr. Simon HOLZER (MLL)
  • Dr. Dirk BÜHLER (Maiwald), assisting in patent matters
  • Dr. Andreas LEDL (Maiwald), assisting in patent matters

DECISION

Don’t be misled by the patent no. on the bottom of the title page. EP 2 245 825 is a typo; this should read EP 2 425 825.
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The first thematically structured main hearing at the FPC: Role model or nonstarter?

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Case No. O2016_016 | Hearing of 8 May 2019

The patent at stake is MundiPharma‘s EP 2 425 825 B9; see EPO Register and Swissreg.

EP’825 pertains to a combination of oxycodone hydrochloride (in an amount of 10 to 150g) and naloxone hydrochloride (in an amount of 1 to 50g), in a weight ratio of 2:1.

This combination is an analgesic drug that is available as modified-release tablets under the trade name Targin® by MundiPharma. Oxycodone is an opioid that has pain-relieving effects. Naloxone opposes the effects of opioids but is poorly absorbed when given orally; it stays within the gastrointestinal tract and reduces the local side effects of oxycodone.

Develco’s logo

Develco seeks annulment of EP(CH)’825 for various reasons, i.e. undue extension of subject-matter, non-enablement and invalidity of the priority claim. On the merits, Develco argues that EP’825 is not novel over WO 01/58451 A1, and that it is obvious in view of EP 0 352 361 A1 or WO 01/58447 A1 or WO 02/092060 A1 or in view of the entry in the ‘Rote Liste’ 2001 for the product Valoron® N capsules from Gödecke.

MundiPharma’s logo

Defendant / patentee MundiPharma countersued for infringement.

It was evident from the pleadings that the expert opinion of the judge-rapporteur had held that the patent was invalid for undue extension of subject-matter. Note that the first instance decision at the EPO (11 December 2018) and the Barcelona Commercial Court No. 4 (19 December 2018) came to the same conclusion. While an appeal is still pending at the EPO, the decision in Spain is already final.

The most interesting part of the hearing was actually how the FPC had structured it. Normally, the parties are just given the floor, one after the other, to plead on all relevant aspects of the case. Not so this time. The FPC wanted to hear the parties on a single aspect only, before moving on to the next aspect. Very much like hearings at the EPO are conducted. Apparently, the FPC had also indicated beforehand that a preliminary opinion would be given on each aspect right after the pleadings relating thereto. However, the patentee / defendant objected, and the court thus abstained from doing so.

Maybe, or maybe not …

On a personal note, I don’t see much value in a ‘preliminary’ opinion of the court being issued in the main hearing. Since one cannot take this opinion for granted, one has to effectively ignore it in all the following pleadings, and be prepared for an outcome to the contrary.

But it still is an interesting approach that could well be taken to the next level, in my perception: What about making a break after the pleadings on each aspect for the judges to deliberate and actually decide on that issue, and pronounce the decision right thereafter? That works perfectly fine at the EPO, and a nullity case at the FPC doesn’t differ much.

Lawyers may prove me wrong, but I do not readily see why this shouldn’t be possible in civil proceedings governed by the CPC.

Reported by Tina VOCI and Martin WILMING

BIBLIOGRAPHY

Case No. O2016_016 | Hearing of 8 May 2019

Develco Pharma Schweiz AG
./.
MundiPharma Medical Company

Panel of Judges:

  • Dr. Daniel M. ALDER
  • Dr. Tobias BREMI
  • Dr. Hannes SPILLMANN

Judge-rapporteur:

  • n/a

Court Clerk:

  • Susanne ANDERHALDEN

Representative(s) of Develco:

  • Andrea MONDINI (TIMES)
  • Dr. Cornelia HOFFMANN (SBMP), assisting in patent matters

Representative(s) of Mundipharma:

  • Dr. Simon HOLZER (MLL)
  • Dr. Dirk BÜHLER (Maiwald), assisting in patent matters

ANNOUNCEMENT

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