Pharmaq v Intervet - an English language version of the decision has arrived

The SPC blog is grateful to the attorneys at Thommessen in Norway for providing an unofficial English language translation here (and also on the blog resources page) of the Oslo District Court’s Judgement of 25 August 2015 in the Pharmaq and Intervet matter.   

A summary of the Judgement, reproduced below,  is authored by the advocates Eirik W. Raanes, Camilla Vislie and Magnus Hauge Greaker at Thommessen who represent Intervet Internatinal B.V. in the proceedings.  Thanks to all of them.

They write:

Pharmaq v Intervet International BV: Oslo District Court’s Judgment 25 August 2015

Oslo District Court has delivered a Judgement in the case between Pharmaq AS and Intervet International BV, where the EFTA Court delivered its Advisory Opinion on 9 April 2015 (Case E 16/13 Pharmaq v Intervet International BV). The case inter alia concerns the validity and scope of protection of Intervet’s Norwegian SPC protecting the active ingredient in Intervet’s vaccine against Pancreas Disease in salmon. 

In Oslo District Court’s Judgment 25 August 2015, Pharmaq’s claims for invalidity and non-infringement of the SPC on the basis of Article 2, 3 and 4 of the SPC Regulation, were rejected.

Pharmaq has appealed the Judgement, and the hearing at Court of Appeal is preliminary scheduled to take place in the late autumn of 2016.

Before Oslo District Court, Pharmaq challenged the validity of Intervet’s SPC on the basis of Article 2, 3 and 4 of the SPC Regulation. Pharmaq also submitted an alternative claim for non-infringement on the basis of Article 4 of the SPC Regulation.

Article 2 of the SPC Regulation:

With respect to the validity challenge under Article 2 Pharmaq submitted that Intervet’s vaccine was placed on the market prior to being granted a market authorisation in accordance with Directive 2001/82/EC. In support of this challenge Pharmaq invoked that Intervet between 2003 and 2011 had delivered its vaccine to fish farmers in Norway and Ireland under Special Approval Exemptions and AR16 licenses.

A provisional MA was granted for the vaccine in the UK in 2005. An ordinary MA was granted for the vaccine in Norway in 2011. Pharmaq submitted that the UK PMA from 2005 could not be considered to be a marketing authorisation within the meaning of Article 2 of the SPC Regulation, which would have the consequence that Intervet’s supply of the vaccine under Special Approval Exemptions and AR16 licenses subsequent to the grant of the UK PMA would be relevant for the assessment under Article 2 of the SPC Regulation.

Oslo District Court started by concluding that the UK PMA was the first MA granted within the EEA area for the purpose of Article 2 of the SPC. This had the consequence that only events that took place prior to 6 May 2005 (the date the UK PMA was granted) was relevant for the assessment of whether the vaccine was placed on the market within the meaning of Article 2 of the SPC Regulation.

Further, Oslo District Court held that it is only authorisations granting full market access that entail that a product has been “placed on the market” within the meaning of Article 2 of the SPC Regulation. According to Oslo District Court, this interpretation of Article 2 was supported by the wording of the SPC Regulation, the purpose of the SPC Regulation and the system which it is a part. The Court referred to that the objective of the SPC Regulation is to compensate the patent holder for the time that has passed between the filing of the patent application and the completion of the regulatory process for obtaining a marketing authorisation, i.e. in other words the SPC Regulation is intended to compensate for lack of full market access. The Court went on pointing out that the term “placed on the market”, or similar, in the SPC Regulation is only used in connection with marketing authorisations pursuant to Directive 2001/82 (Veterinary Medicinal Products Directive) and that under the Veterinary Medicinal Products Directive it is only marketing authorisations that allow for a product to be “placed on the market”.

With respect to the CJEU’s Judgement in the Cases C-195/09 Synthon and C-427/09 Generics, that Pharmaq had relied on, Oslo District Court noted that those cases concerned products that had been granted full market access and consequently were not comparable with the case at hand.

Pharmaq also submitted that the Special Approval Exemptions and AR16 licenses only could be considered as permissions that did not allow for “placing on the market” if they were granted on the basis of national rules that implement Article 8 of the Veterinary Medicinal Products Directive correctly. The Court, however, rejected this argument and held that the relevant question rather was whether the Special Approval Exemptions and AR16 licenses in legal terms conferred a market access that corresponds with the rights a market authorisation affords. Oslo District Court noted that the Advisory Opinion of the EFTA Court must be interpreted in the light of other sources of EU/EEA law and must be understood such that the relationship between the Special Approval Exemptions/AR16 licenses and the Veterinary Medicinal Products Directive was not decisive.

Oslo District Court found that strong policy concerns supported its interpretation of Article 2 of the SPC Regulation. In the Court’s view it would counteract supplies under limited authorisations according to Articles 7 to 11 of the Veterinary Medicinal Products Directive if such authorisations were to disqualify the product from SPC protection. This consideration also indicated that it should not be of significance whether a limited authorisation is granted within the framework of the Veterinary Medicinal Products Directive, because it is not possible for manufacturers to know whether the authorities have complied with the Directive.

Under the concrete assessment of the Special Approval Exemptions and AR16 licenses, Oslo District Court found that there were decisive differences between the market access under a marketing authorisation and the market access on the basis of the Special Approval Exemptions/AR16 licenses. The Court inter alia pointed out that the Special Approval Exemptions/AR16 licenses only could be granted in special situations and at the authorities’ discretion, and that the permissions were limited both with respect to volume and time. In the Court’s view there are thus significant qualitative and quantitative differences between Special Approval Exemptions/AR16 licenses and marketing authorisations, since the latter gives the holder an unlimited right to market and sell the product, subject to the restrictions that apply generally to medicinal products.  

Based on this the Court concluded, noting that it had not been in doubt, that the authorisations prior to 6 May 2005, could not entail that the product had been “placed on the market” within the meaning of Article 2 of the SPC Regulation.

Article 3:

Pharmaq submitted that the Special Approval Exemptions in any event amounted to marketing authorisations within the meaning of Article 3 of the SPC Regulation, and that Intervet’s SPC therefore was granted in breach of Article 3(d) and 7(1) of the SPC Regulation.

Oslo District Court rejected this submission, noting inter alia that a marketing authorisation within the meaning of Article 3 of The SPC Regulation must, as in other provisions of the Regulation, be understood as a marketing authorisation granted in accordance with Veterinary Medicinal Products Directive, and that the Special Approval Exemptions were not such authorisations.

Article 4:

In Intervet’s marketing authorisation the active ingredient in the vaccine was identified as “Inactivated Salmon Pancreatic Disease Virus Strain F93-125”. The product description of Intervet’s SPC comprised: 

“Salmonid pancreatic disease virus that, when injected intraperitoneally at a titre of 103.5 TCID50 into Atlantic salmon post-smolts held in sea water at 14°C causes the fish to develop symptoms of pancreatic disease, wherein

a) said virus is the virus strain as deposited at ECACC under Deposit number V94090731 or closely related strains which share similar genotypic and/or phenotypic characteristics to said deposited virus strain and

b) said virus reacts serologically with convalescent anti-FPDV antiserum or antiserum raised against the deposited virus strain V94090731 and

c) said virus is in an inactive form.”

Pharmaq submitted that the SPC was granted in breach of Article 4 of the SPC Regulation, since this provision required that the SPC should be confined to the strain identified in the marketing authorisation. In the alternative Pharmaq submitted that the SPC did not cover their virus strain (ALV 405).

On this topic Oslo District Court split into a majority, consisting of the legal judge and one expert lay judge, and a minority, consisting of one expert lay judge.

The majority held that the SPC was not granted in breach of Article 4 of the SPC Regulation and that a vaccine based on Pharmaq’s virus strain would infringe the SPC.

The majority referred to the opinion of the Advocate General in case C-392/97 Farmitalia, where the Advocate General emphasized that the meaning of the term “product” in the SPC Regulation could not be determined based only on textual grounds. The majority found it difficult to determine the meaning of the product definition without also considering the purpose of the SPC Regulation, because a literal interpretation based on the marketing authorisation would, for a vaccine that is based on inactivated whole-virus particles, imply that it would be possible for a competitor to make a new vaccine based on a different isolate of an identical or similar virus, without infringing the SPC. In the majority’s view this seemed to give an unreasonable result.

The majority went on by ascertaining that case law provided support for a purpose oriented interpretation. The Court inter alia referred to case C-392/97 Farmitalia and the EFTA Court’s Advisory opinion.

On this backdrop the majority concluded that Article 4 of the SPC Regulation permits that a SPC covers other strains than identified in the marketing authorisation, provided that the other strain can be said to constitute the same active ingredient with a similar prophylactic effect as the strain identified in the marketing authorisation.

On the basis of this criterion the majority continued with a comparison of Intervet’s and Pharmaq’s virus strains. Based on a comprehensive material, inter alia studies, submitted by the Parties, the majority concluded that the differences between the virus strains F93-125 and ALV 405 are insignificant and that they thus must be considered to be the same active ingredient. Further, the majority concluded that both strains may be used in the same prophylactic field. Thus, it was held that the SPC was valid and that Pharmaq’s virus strain was covered by the SPC’s scope of protection.  

The minority interpreted Article 4 of the SPC Regulation such that the product description of the SPC must be confined to the strain that is identified in the marketing authorisation, and thus held that the SPC granted to Intervet is invalid.