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.
