Pharmaq may appeal MSD vaccine ruling

OSLO District Court has ruled in favour of MSD Animal Health in a case against rival Pharmaq involving MSD’s pancreas disease vaccine.
The Norwegian Industrial Property Office had already granted the company five years’ extension of protection for its SPDV based vaccine, and Oslo District Court has now confirmed that this decision was correct.
For such patents, it is common practice to grant an extension of protection of products commercialised late in the patent period.
Petter Frost, managing director of MSD Animal Health Innovation, the company’s Bergen-based research and development centre, said this provides an incentive for companies to commit large resources to research for the public good.
Pharmaq said today it was considering whether to appeal the decision.
The SPDV virus (also known as SAV) causes pancreas disease (PD) in salmon. PD-infected fish is safe for human consumption, but the disease is one of the most costly for the salmon industry.
Vaccination is an important measure in the battle against diseases in fish and MSD Animal Health developed the world’s first vaccine in this area. After many years of Norwegian-led research, MSD recently launched new vaccines.
At the heart of the Oslo district court case issue was MSD Animal Health’s decision to make vaccine available to the aquaculture industry before the company had been granted the final marketing authorisation.
MSD had been challenged by competitor Pharmaq, which believed that MSD should be denied its right to obtain the extension.
After the ruling, Pharmaq said: ‘We note that the Oslo Court has not followed our line of arguments in the first part of this case, and this is of course disappointing,  not only for Pharmaq, but also for the aquaculture industry because this will mean a continued monopoly going forward.
‘Over the next days and weeks, we will perform a careful review of the ruling before deciding on whether or not to appeal.
‘We are also continuing our preparations for the next court hearing which is scheduled for the second half of September in the Oslo Court.
‘In this hearing, we will present our arguments for granting Pharmaq a licence for market access.’
Frost said MSD is ‘committed to advancing science to meet customer needs and we are very pleased with the District Court decision’.
Pharmaq also claimed that MSD’s patent protection did not apply to a Pharmaq vaccine in development because it is based on a different isolate of the same virus.
MSD said after the court ruling that the decision was ‘of fundamental importance’. It has established that companies that make some vaccines available before full approval has been obtained do not risk losing the right to a supplementary protection period for that product.
Frost said: ‘The court has also concluded that such a supplementary protection of a vaccine, where a virus is the active ingredient, cannot be bypassed by making a vaccine based on a different isolate of the same virus, when the isolates has the same vaccine related characteristics.
‘In terms of virus properties relevant for vaccine efficacy, it has been scientifically shown that there are no differences between the various isolates of SPDV/SAV.
‘It cannot be the case that after the basic research has been done by others anyone can make a vaccine outside the protection by simply taking another PD-infected salmon and re-isolate the same virus guided by the then published science.
‘If so a protection granted by society, represented by the Norwegian Industrial Property Office, in exchange for making the information public, would be futile,’ said Frost.
He added that it was of utmost importance also to the fish farming industry that the patent system, including the system of supplementary protection certificate, is not compromised.
‘Due to the high costs involved in developing new pharmaceuticals, there are just a few companies developing new vaccines for salmon and trout in Europe.
‘The possibility of protecting intellectual properties is a key incentive for commercial companies to continue to invest money and skilled personnel in basic research on fish diseases and future vaccine technology,’ said Frost.