Both Acino Pharma and Develco had raised essentially the same arguments with respect to undue extension of subject-matter. Unsurprisingly, the FPC came to the same conclusion: The patent is invalid, the counterclaim for infringement has been dismissed accordingly. Thus, I cannot add much on the merits over what I have already discussed on this Blog here.
On the more procedural side, I would assume that these two cases could pretty efficiently be dealt with by the FPC: Same panel of judges, same judge-rapporteur, same patent, essentially the same arguments. Actually, the expert-opinion of the judge-rapporteur had been issued on the same day, and the judgments are literally identical to large extent. Still, the court fee has been set to kCHF 60, i.e. well according to the regular tariff. Given the circumstances, I wonder whether the court fees could (should?) have been significantly reduced?
This combination is an analgesic drug that is available as modified-release tablets under the trade name Targin® by MundiPharma.
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.
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
the feature was not explained as essential in the disclosure;
it was not, as such, indispensable for the function of the invention in the light of the technical problem it served to solve; and
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.
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.
Acino 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, Acino argues that EP’825 is not novel over WO 01/58451 A1, and that it is obvious in view of WO 01/58447 A1 (if the claim to priority is invalid) or in view of WO 02/092060 A1. Further documents referred to by the plaintiff in the assessment of obviousness are US 3,966,940, US 3,773,955 (erroneously referred to as US 3,773,995 in the announcement) and a paper of Skarin (most likely this one).
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) came to the same conclusion, but an appeal is still pending at the EPO.
The hearing has again been thematically structured, similar to O2016_016. I could only attend until noon, and not even the most controversial issue of undue extension of subject-matter had been finished. Still, I believe that the major issues had already been raised at that time. Patentee had submitted that if the ‘pointer concept‘ in the assessment of whether or not sth is clearly and unambiguously disclosed in the application as filed would be properly used, no undue extension of subject-matter had occured. The ‘two lists concept‘ must not be used as an end in itself, but it is rather only the so-called gold standard that applies (clear and unambiguous disclosure in the application as filed, in the skilled persons understanding).
It will be very interesting to see how this will play out. Stay tuned.