Earlier this month The SPC Blog broke the news that the EFTA Court had given its ruling in Case E 16/4 Pharmaq v Intervet International BV. Given the length and complexity of the ruling, this blogger has done his best to hide from it till such time should become available to him as to enable him to read it carefully and write it up for this weblog. Fortunately for him, no less a person than Penny Gilbert of Powell Gilbert LLP has come to his rescue with a note on the case which is agreeably accessible -- not least because Penny, together with Gunnar Meyer and Lars Erik Steinkjer (Wikborg Rein) and Ida Gjessing (Grette), represented Pharmaq in these proceedings and therefore had first-hand knowledge of the case. This is what Penny writes:
The EFTA Court rules on the application of Articles 2, 3 and 4 of the SPC Regulation in the context of veterinary vaccine products
In a referral of questions from
the Oslo District Court relating to the grant of an SPC for a veterinary
vaccine the EFTA Court equivalent to the CJEU for matters referred by the national courts of the three EFTA states (Norway, Iceland and Liechtenstein)] has held that
- a provisional marketing authorisation
properly granted under Art 26 (3) Directive 2001/82 relating to
veterinary medicinal products may be the first authorisation to place the
product on the market under Art 3(b) and (d) of Council Regulation 1768/92 concerning the creation of a supplementary certificate for
medicinal products, so can be the basis for an SPC application.
- a provisional permission
to place a product on the market under Art 8(1) Veterinary Medicines
Directive will not amount to an authorisation for the purposes of Art 3(b)
and (d) provided that it has been properly granted. Art 8(1) permissions being strictly
limited to the use of immunological veterinary medicinal products , without
a marketing authorisation, in the
event of serious epizootic diseases where there is an absence of suitable
medicinal products and after informing the Commission /EFTA surveillance
authority of the detailed conditions of use.
- an SPC
is invalid as in breach of Art 4 SPC Regulation to the extent it has been granted
with wider scope “than that set out in the relevant Marketing
Authorisation (“MA”)”.
The case has been remitted to the Oslo District Court for interpretation of the EFTA Court’s judgment on
the specific facts of the case.
The case before the Oslo District Court concerns
the validity and scope of an SPC granted to Intervet on a Norwegian patent
which broadly claims the F93-125 strain of Salmonid Pancreatic Disease (“PD”) Virus together with all strains
which share “similar genotypic and/or
phenotypic characteristics and react serologically [with F93-125]”, effectively
the entire PD species. The patent also
claims vaccines containing inactivated PD virus. The strain F93-125 belongs to the PD subtype
SAV1, found mainly in Ireland and Scotland.
PD virus affects farmed fish (salmon and
trout) and is considered to be one of the most serious fish health problems in
the fish farming industry involving high mortality rates, reduced production
and significant loss to the industry. PD continues to be a serious problem in
Norway, where fish farming is a major industry, and fish farmers have called
for better vaccines against PD to be made available to prevent the spread of
the disease.
Intervet’s vaccine (Norvax) was granted an
MA in 2011 for “Inactivated Salmon
Pancreatic Disease Virus Strain F93-125”.
An SPC was granted by the Norwegian Patent Office in the same broad terms
as the patent claims rather than reflecting the wording of the MA, in effect
granting a general patent term extension. Pharmaq developed its own vaccine based on a
different subtype of PD (SAV3) that it isolated from a diseased fish in
Norway. SAV3 is genetically distinct
from SAV1 (and also SAV2). In previous
patent litigation before the Norwegian court Pharmaq’s vaccine was held to
infringe the broad claims of Intervet’s patent and launch of the product is
currently prevented pending expiry of the SPC
These proceedings relate to Pharmaq’s
challenge to the validity of Intervet’s SPC on the basis of Art 2, 3 and 4 of
the SPC Regulation and the following facts:
- Between 2003
– 2011 Intervet had sold its vaccine to fish farmers in Norway under
“Special Approval Exemptions” (“SAEs”)
under sections 2-7 (or 2-6) of the Norwegian Medicines Regulation.
- During this
period the vaccine was also sold in Ireland under a corresponding scheme
known as AR16 Licences.
- A provisional
MA was granted in the UK in 2005.
- A full MA was
first granted in the UK and Norway in 2011.
- Total sales
of Norvax in the period 2003 – 2011 amounted to well over 73 Million
Euros.
In essence, the Oslo District Court sought
guidance on whether the SPC is invalid on the basis that Norvax was “placed on the market” prior to an
administrative authorisation procedure within the meaning of Art 2 SPC
Regulation as a result of the prior sales under the SAEs and AR16 Licences. If not, then to the extent that the SAEs and
AR16 Licences were to be considered as an “administrative
procedure”, was the SPC granted in breach of Art 3 of the SPC Regulation?
The Oslo Court further asked whether the SPC
was granted in breach of Art 4 SPC Regulation, since the broad wording of the
granted SPC extends beyond the “product covered by the authorisation to place
the corresponding medicinal product on the market”. If so, is it invalid?
The questions referred by the Oslo District Court are set out at pages
10-11 of the judgment of the EFTA court which can be found here.
Art 2 & 3 SPC Regulation
In summary,
the Court decided that the supply of a vaccine without an MA on the basis of Art
8(1) Veterinary Medicines Directive may not amount to a general placing on the
market. Article 8(1) allows the grant of
provisional permission, without the same safety and efficacy testing for a full
MA, to supply to the extent necessary to combat a “serious epizootic disease”, but does not entitle the producer to
market the product. Consequently, such
supply does not generally constitute a placement on the market for the purpose
of Art 2 SPC Regulation.
The Court concluded that, since it does not involve an administrative procedure, a
provisional permission to supply under Art 8(1), may not be considered an
authorisation to place the product on the market within the meaning of Art 3(b)
and (d) of the SPC Regulation. However, the
grant of a provisional marketing authorisation in exceptional circumstances,
under Art 26(3) Veterinary Medicines Directive does constitute an
administrative authorisation for the purposes of Art 3(b) and (d) of the SPC
Regulation. Art 26(3) permits the grant
of an MA, for objective, justifiable reasons, in exceptional
circumstances. Such authorisations are
subject to specific procedures, including safety reporting, and also subject to
annual assessment.
The Court
acknowledged the dispute between the parties as to whether, in fact, Intervet
had been able to place the Norvax product on the market since it had been
supplied in significant quantities prior to the grant of a full MA. The question of fact as to whether the SAEs, AR16
Licences and UK provisional MA in the present case were based on national
provisions correctly implementing Art 8(1), or were based on Art 26(3)
Veterinary Medicines Directive, was therefore remitted to the National
Court for determination.
The Court
noted that the SPC Regulation is intended to provide an adequate period of
effective protection of a basic patent, intended to compensate - at least in
part - for the delay to the commercial exploitation of the invention by reason
of the time elapsed between the date on which the patent application was filed
and the date on which the first marketing authorisation was granted. In this
case, however, the patentee was able to sell the product, at the same time as
compiling clinical data for over 7 years prior to grant of a full MA.
Art 4 SPC Regulation
Art 4 provides
that an SPC “shall only extend to the
product covered by the authorisation” and Recital 9 of the SPC Regulation
confirms that the protection granted should be “strictly confined” to the authorised product.
The Court nevertheless went
on to propose that an SPC can extend to cover a specific strain of virus
(included in the basic patent but not mentioned in the MA), but only if the
specific strain:
- Constitutes
the “same active ingredient as the
approved medicinal product”; and
- Has “therapeutic effects that fall within
the same therapeutic indications for which a MA was granted”.
By its answers to the
referred questions the Court appears to have introduced a new requirement for interpreting
the scope of Art 4, namely whether the same active ingredient in another,
separate product would have “therapeutic
effects falling within the therapeutic indication” for which the MA was
granted. This is not a phrase which is
found in the SPC Regulation but derives from the CJEU’s decision in Forsgren, C-631/13.
In Forsgren, the question was whether a patented component, Protein D
- an IgD-binding protein of H.Influenzae which
functioned as a covalently bound carrier protein in a vaccine, Synflorix, used against S. pneumonia, and was itself mentioned
in the relevant MA - could be the subject of its own SPC. The Synflorix MA expressly stated that there
was not sufficient evidence that it had any protective effect against H. influenzae. The answer from the CJEU
was that an SPC could not be granted unless the patented component found in the
combination product had its own “therapeutic
effects falling within the same therapeutic indication” of the MA. Thus, the issues in Forsgren were entirely different to those here: both parties’
vaccines are mono-products, not combination products, containing a single
active ingredient (their respective strain of PD virus) which is not bound to
any other active ingredient.
Nevertheless, the Court noted that the SPC granted to Intervet is
expressly limited to the F93-125 strain.
It confirmed that since an SPC can only be granted for the active
ingredient in the product which is the
subject of the relevant MA then an SPC is invalid to the extent that it is
granted a wider scope than set out in that MA.
The case now returns to the
Oslo District Court to decide the matter on its facts.
This case is the first occasion on which the EFTA
Court has been required to interpret the SPC Regulation. While giving guidance on the referred
questions, the Court has left issues to be determined by the mational court,
based on the specific facts of this unusual case.
The case goes to trial in Oslo during late April,
with the District Court having to determine whether the SAEs, AR16 Licences and
Provisional MA were properly granted under either Art 8(1) or Art 26(3)
Veterinary Medicines Directive and, if not, whether the SPC is therefore invalid
under Art 2 or Art 3 SPC, a question of regulatory law and fact.
Likewise the Oslo District Court must decide whether,
in fact, the SPC is invalid on the basis that it extends beyond the scope of
the granted MA, which is expressly limited to Intervet’s F93-125 strain. Since the
EFTA Court’s decision is not binding on the referring Court (unlike the
position with the CJEU) one might also expect the EFTA Court’s assumptions,
based on Forsgren, to be reviewed.
Quite how the EFTA Court’s judgment will apply to other
biological products remains uncertain. However, it is expected that future
referrals to the CJEU on the scope of protection of Art 4 are almost inevitable, given the importance of the market for biosimilar and biobetter products.
