Bryn Aarflot successfully helped Intervet International in winning appeal

Bryn Aarflot has successfully helped Intervet International BV in winning appeal proceedings between Intervet (Defendant) and Pharmaq AS (Appellant).

Pharmaq decided to appeal the Norwegian Industrial Property Office’s (NIPO) decision to revoke Norwegian patent No. 333242 after opposition proceedings initiated by Intervet represented by Bryn Aarflot.

The patent concerned a vaccine against pancreas disease in fish. Intervet argued that the patent claims were not novel in view of an oral presentation. NIPO had in their patentability assessment during the opposition proceedings decided that it was unclear whether there was sufficient evidence proving that the presentation was presented and publically available prior to the date of filing.

The Board of Appeal concluded that the evidence was sufficient. They rejected the appeal and the patent remains revoked.

Appeal Decision in Norway Concerning Patent for Pancreas Disease Fish Vaccine

The Norwegian Board of Appeal for Industrial Property Rights’ (KFIR) Decision of 31 October 2017 in Case 16/00071 to maintain Norwegian patent No. 333242 as revoked.

The case concerns an appeal against the Norwegian Industrial Property office’s (NIPO) decision of 18 January 2016, wherein Norwegian patent No. 333242 was revoked after opposition by Intervet International BV.

The parties to the appeal proceedings held by the Norwegian Board of Appeal were Pharmaq AS as Appellant (patentee) represented by Onsagers AS and Grette and Intervet International BV as Defendant (opponent) represented by Bryn Aarflot AS and Thommesen AS.

The patent No. 333242 of Pharmaq AS concerned a composition comprising inactivated salmonid alphavirus (SAV) combined with one or several components consisting of: an inactivated or killed bacteria, an inactivated virus not being salmonid alphavirus, and an antigenic and/or immunogenic material derived from these components. The invention claimed, further concerned a dosage form comprising the composition, and use of the composition for manufacturing a vaccine. The invention also concerned a method for preparing the composition described above.

The grant and revocation by NIPO

The patent was granted 15 April 2013 and an opposition was filed by Bryn Aarflot 14 January 2014.

NIPO’s revocation, after opposition proceedings, was due to lack of inventive step based on a leaflet concerning Intervet’s PD (Pancreas Disease)-vaccine (DK32) comprising 1.58 x 107 TCID50/dose inactivated SAV, as the closest prior art.

There was no prejudice found against that SAV1 can be administered as part of multivalent vaccines. The EP1075523 (DK36) patent of Intervet discloses that fish vaccines normally are multivalent vaccines, and that a significantly higher amount of inactivated virus is normally required in such vaccines compared to monovalent vaccines to compensate for potency loss.

With the label information of Intervet’s PD-vaccine (DK32) as closest prior art, the skilled person would from DK36 expect that the concentration of inactivated SAV must be increased when producing a multivalent vaccine to avoid potency loss. NIPO was therefore of the opinion that it was obvious for the skilled person to combine the techniques of DK32 and DK36 and thereby increase the concentration of inactivated SAV in the multivalent vaccine, as the patentee has done to arrive at the claimed invention. NIPO concluded that Claim 1 therefore did not have an inventive step.

The other independent claims and the dependent claims concerned the same technical problem and merely provided small professional modifications.

Norwegian patent No. 333242 was thus revoked by NIPO 18 January 2016.

Four oral presentation documents (DK28, DK29, DK30 and DK31) were also cited during the opposition proceedings. However, NIPO concluded that there was a legitimate doubt whether these documents could be regarded as publicly available. NIPO applied the EPO standard “beyond any reasonable doubt” regarding the burden of proof for oral presentations as evidence. These citations were therefore not utilised in the patentability assessment.

The revocation by the Board of Appeal

An appeal was filed 18 March 2016 by Onsagers on behalf of Pharmaq AS to the Norwegian Board of Appeal for Industrial Property Rights. A hearing was held the 23 August 2017. The Board of Appeal came to the same conclusion as NIPO, but for different reasons, and decided that the patent is to remain revoked.

The main difference between the reasoning of NIPO and the Board of Appeal was that the Board of Appeal decided that at least one of the oral presentations (DK29) must be regarded as publically available and thus is valid as prior art.

In this regard, the Board of Appeal pointed out that the EPO assumes that for matters such as the present, the burden of proof for evidence must be “beyond any reasonable doubt”. However, according to Norwegian practice in civil matters, the burden of proof is stated as “more likely than not”. The Board of Appeal decided that the threshold for burden of proof lies somewhere in-between “beyond any reasonable doubt” and “more likely than not”. Presentations would otherwise not actually be suitable as evidence. Based on the documentation in the case, KFIR concluded that DK29 and the information contained herein was publically available at the date of the application. DK29 ended up being novelty destroying for independent claims 29 and 37 of the main claim set.

The other independent claims 1 and 46 were considered novel, but lacking inventive step generally for the same reasons as provided by NIPO.

Pharmaq AS filed an alternative claim set during the appeal proceedings, but the Board of Appeal arrived at the same conclusions as for the main claim set.

The patent is thus revoked.
Written by and for further details – please contact one of our attorneys :

Arne Lund Kvernheim    Marianne Weiby Wulff    Live Marie Hansen

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