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

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