In a referral of questions from the Oslo District Court relating to the grant of an SPC for a veterinary vaccine the EFTA court1 (“The Court”) has held that:
- A provisional marketing authorisation properly granted under Art 26 (3) Directive 2001/82/EC relating to veterinary medicinal products (“Veterinary Medicines Directive”) may be the first authorisation to place the product on the market under Art 3(b) and (d) of Council Regulation (EEC) No 1768/92 concerning the creation of a supplementary certificate for medicinal products (“SPC Regulation”), 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 referred back 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 International BV (“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.
The EFTA Court Judgment
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 went on to conclude 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 referred back 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. Whilst giving guidance on the referred questions, the Court has left issues to be determined by the National 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 therefor 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 will remain to be seen. However, it is anticipated 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.
Pharmaq was represented in these proceedings by Gunnar Meyer and Lars Erik Steinkjer of Wikborg Rein; Ida Gjessing of Grette; and Dr Penny Gilbert of Powell Gilbert LLP.
Please do not hesitate to contact us if you have questions relating to these issues or to the SPC Regulation generally.
Dr Penny Gilbert
T: 020 3040 8020 email: email@example.com