Pharmaq AS v. Intervet International B.V., Borgarting Court of Appeal, Norway, 19 December 2016, Case Nos. 15-170539ASD-BORG/01 and 15-204605ASD-BORG/01
Intervet International B.v. (“Intervet”), a subsidiary of MSD, was the proprietor of Norwegian patent NO 317 547 which expired 15 October 2015. Claim 1 and 4 of the patent was formulated as follows:
“1. A virus which 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 ECAVCC under Deposit number V94090731 or closely related strains which share similar genotypic and/or phenotypic characteris-tics to said deposited virus strain,
(b) said virus reacts serologically with covalescent anti-FPDV antiserum or antiserum raised against the deposited virus strain V94090731.
[…]
4. The vaccine according to claim 3 comprising an attenuated or inactivated from of said virus according to claim 1 or 2.”
The patent protected Intervet’s fish vaccine named Norvax Compact PD, a vaccine approved for prophylactic use against pancreas disease (PD) in salmon. PD is found in several European countries including the UK, Ireland and Norway. However, the distribution of subtypes of the virus causing PD in the affected countries is different. Subtype 1, 4 and 5 are predominantly found in Irish and UK waters, while subtype 3 is only found in Norwegian waters.
In the marketing authorisation for Norvax Compact PD, the active ingredient is identified as “Inactivated Salmon Pancreatic Disease Virus Strain F93-125”. This is the same strain as deposited at ECACC under Deposit number V94090731, cf. claim 1 of NO 317 547. The strain was originally isolated in Ireland in the beginning of the 1990’s.
The defendant, Pharmaq AS, has also developed a vaccine against pancreas disease in salmon. The active ingredient in Pharmaq’s vaccine is a virus strain isolated in Norway in 2003. The Pharmaq strain is designated as strain ALV405.
In a previous dispute, Pharmaq’s vaccine was found to infringe Intervet’s Norwegian patent and an injunction was handed down by the courts preventing Pharmaq from launching its vaccine in the Norwegian market until patent expiry 15 October 2015.
In 2011, Intervet filed an application for an SPC to the Norwegian Intellectual Property Office. The application was based on NO 317 547 as the basic patent and the marketing authorisation for Norvax Compact PD. However, the product definition of the SPC application was during the examination of the application formulated as a combination of claim 1 and 4 of the basic patent. Thus, the product definition that NIPO was finally asked to consider was the following:
“Salmonid pancreatic disease virus that, when injected intraperitoneally at a titre of 10 3.5 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.”
NIPO decided to grant the SPC and Pharmaq proceeded to challenge the validity of Intervet’s SPC before the Oslo District Court.
During the case preparations, the District Court decided to make a referral to the EFTA-court. The EFTA-court issued its EFTA-court issued its advisory opinion on the 9th of April 2015 (case E-16/14).
In its subsequent judgment, the Oslo District Court held the SPC valid and infringed by Pharmaqs vaccine. Pharmaq appealed the decision to the Borgarting Court of Appeal which, by its decision 19 December 2016, overturned the District Court’s judgement.
The Court of Appeal agreed with the District Court that if the SPC scheme shall fulfil its objectives for biological medicinal products, the scope of protection cannot be limited to a strict interpretation of the wording of the product, i.e. the active ingredient, as designated in the marketing authorisation. However, the Court of Appeal also stressed that this consideration must be weighed against the other objectives of the SPC regulation and that SPC’s should not be given a wide scope of protection such that improved medicinal products are kept off the market to the detriment of human or veterinary health.
After balancing the conflicting interests that the SPC scheme is intended to protect, the Court of Appeal found that the main consideration of the scheme is to protect against competition from equivalent variants, and that minor differences in the active ingredient do not mean that one is outside the SPC’s scope of protection for a biological product. Still, in the Court of Appeal’s opinion, it was not clear how the limits on the scope of protection from biological medicinal products ought to be established. The court assumed however that the difference between the products must at least be expressed in such a manner that it has a practical and appreciable effect on the quality, safety and efficacy for the products to constitute two different “active ingredients” according to the SPC regulation. However, the court was not convinced that the differences had to be significant before two substances could be regarded as two different active ingredients.
The Court of Appeal then turned to the evidence and the question of differences between the two active ingredients. Based on an overall assessment of the research data presented, in particular laboratory trials with vaccinated fish, the Court of Appel found that there are significant differences in vaccine efficacy, and that Pharmaq’s vaccine has a significantly, consistent and systematic better effect against SAV-3 infection than Intervet’s vaccine.
As a consequence the court held that the SPC was invalid since the product definition including the term “closely related strains which share similar genotypic and phenotypic characteristics to said deposited virus strain”, is a delimitation that prevents vaccines that are systematically, consistently and significantly more effective against PD infection from being made available on the market.
In the opinion of the Court of Appeal such a scope of protection would run counter to one of the main purposes of the SPC scheme, i.e. that a certificate should not unreasonably impede the development and sale of medicinal products with documented significantly better efficacy. Thus, the court concluded that Intervet’s SPC had been grated with a scope of protection exceeding what is allowed under article 4 of the SPC regulation. In line with the guidance given by the EFTA-court, the consequence was that the SPC was declared invalid.
A copy of the judgment (in English) can be found here.
A copy of the judgment (in Norwegian) can be found here.
Summary: Lars Erik Steinkjer, Wikborg Rein