The SPC Blog is grateful to Lars Erik Steinkjer at Wikborg Rein for providing a copy of the Court of Appeal judgement (here), a translation of the decision (here) as well as a summary of the facts of this case and of the Court of Appeal decision for readers of the SPC Blog. Lars Erik Steinkjer and Gunnar Meyer from Wikborg Rein and Ida Gjessing from Grette represented Pharmaq in these proceedings.
"In the MA for Intervet's vaccine, Norvax Compact PD, the active ingredient is identified as “Inactivated Salmon Pancreatic Disease Virus Strain F93-125”. However, to the Norwegian Industrial Property Office Intervet applied for, and was granted, an SPC with a broader product definition, i.e. “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.”
Before the Norwegian courts Pharmaq challenged the validity of Intervet’s SPC on the basis of Article 2, 3 and 4 of the SPC Regulation. The Oslo District Court decided to make a referral to the EFTA-court on the interpretation of said articles and the EFTA-court issued its advisory opinion on the 9th of April 2015 (reported earlier here).
In its subsequent judgment, the Oslo District Court held the SPC valid and infringed by Pharmaq's vaccine (reported earlier on the Blog here). The Court of Appeal, however, overturned the District Court's decision and revoked the SPC as it was held invalid on the basis of article 4 of the SPC regulation.
Although the Court of Appeal agreed with the District Court's opinion that if the SPC scheme shall fulfill its objectives for biological medicinal products, the scope of protection cannot be limited to a strict interpretation of the wording of the active ingredient in the marketing authorisation, the Court of Appeal also stressed that this consideration must be weighed against the other objectives of the SPC regulation and that SPCs 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.
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.
On the evidence, the Court of Appeal held that Pharmaq's vaccine, which is based on a different strain than the strain used in Intervet's vaccine, is "systematically, consistently and significantly more efficient against SAV 3 infection than Intervet's vaccine". Thus, the two strains could not be considered the same active ingredient in the meaning of the SPC regulation. In line with the guidance given by the EFTA-court, the consequence was that the SPC was found invalid.
The judgment is not final as the time limit for appeal to the Norwegian Supreme Court is still running."