A Swiss approach to the EPO’s gold standard

Reading time: 4 minutes

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?

Reading time: 3 minutes

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

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