Virus vaccines patents, Nagoya, and access to products 02.09.2014 Marit Rode

Virus vaccines patents, Nagoya, and access to products 02.09.2014 Marit Rode

PHARMAQ business description A leading global Aquatic Animal Health company, specialising in vaccines and therapeutics Established in 2004 as an independent company PHARMAQ s majority shareholder is the private equity investment firm Permira Funds Management and employees hold a significant stake in the company Based in Norway, with manufacturing facilities in Overhalla and Oslo, with subsidiaries in Chile, United Kingdom, Vietnam, Turkey, Panama and Costa Rica PHARMAQ has 180 employees worldwide

What is a vaccine? Isolate pathogens causing disease (usually virus or bacteria) Develop culture process and vaccine product, clinical testing Register product to obtain sales permit (marketing authorisation) Sales of vaccine

Vaccination and disease control in Norwegian fish farming

What is pancreas disease (PD)? Caused by salmonid alphavirus Six different subtypes Can kill between 2-60% of affected fish Reservoir in nature?? SAV Subtype Species Country SAV 1 A.salmon Ireland, Scotland SAV 2 A.salmon /trout France, Scotland, Ireland, Italy, Spain, Croatia, Norway SAV 3 SAV 4 SAV 5 SAV 6 A.salmon Norway A.salmon Scotland, Ireland A.salmon Scotland A.salmon Ireland

History of «PD patent» 1980 s and 90 s: PD a problem mainly in Ireland/Scotland 1994:Virus causing the disease is isolated (SAV) by Agri,food and biosciences institute (AFBI), Northern Ireland AFBI files patent application, sold to Intervet (now part of Merck) in 1995 Vaccine based on virus isolate from Northern Ireland sold from 2003 in Ireland and Norway on exemption licenses, from 2005 in UK on PMA

Disease development in Norway

Still a problem! Oppsummering av hovedfunn og konklusjoner i rapporten De infeksjonssykdommene som ga størst svinn var IPN i tidlig sjøfase og PD i senere sjøfaser PD ga betydelige tap av laks på Sør-Vestlandet Vaksinering mot PD viste ikke positiv effekt på total registrert svinn på lokalitetsnivå

2004 2006 2008 2009 2010 2011 2013 2015 What have we done?

Patent system Developed to promote R&D and make new improved products available. 20 years monopoly. Pharmaceutical products and plant protection products (pesticides, herbicides) are subject to SPC s, adding up to 5 years extra protection Expensive and time consuming to document new products, need more than 20 years monopoly to recoup investments.

Why do we need Nagoya in industrialised countries? We have money, we will get the new products! Should pathogens be included??? Monopoly situation ruled by patent system What does pathogens have to do with maintaining biological diversity? What is the state supposed to contribute?

SAV and Nagoya Should pathogens be included at all? What is the virus natural environment? Don t know Somebody owns the host! Would Nagoya make a better vaccine available for Norwegian fish farmers? No Would the vaccine be more expensive? Probably, if more fees were to be paid

Will the states make money? All patents are worthless (at a 95% confidence interval )

How should availability be solved? I think compulsory licensing (part of TRIPS) Nagoya solves nothing for product availability Loven: 47. Den som i nærings- eller driftsøyemed vil utnytte en oppfinnelse som en annen har patent på, kan få tvangslisens til dette når 1. det finnes påkrevd av hensyn til viktige allmenne interesser. 2. patentrettigheter utnyttes på en måte som kan begrense konkurransen vesentlig.

On 17 May 2006 the European Commission's official journal published Regulation 816/2006, which brings into force the provisions of the Doha Declaration. The declaration allows compulsory licenses to be issued in developed countries for the manufacture of patented drugs, provided they are exported to certain countries. Very difficult to obtain compulsory licenses in developed countries