THE future of Scottish stem cell companies is dependent on next month's European Patent Office (EPO) ruling on whether inventions involving human embryonic stem cells (HESCs) can be patented, experts have claimed.
The industry, which includes firms such as Stem Cell Services and Geron, is bracing itself for a flurry of consolidation or welcome major investment, according to a leading Glasgow-based patenting attorney.
The enlarged board of appeal (EBA) of the EPO is due to meet in Munich on 24 and 25 June to consider a patent application filed by Wisconsin Alumni Research Foundation (Warf) in 1995.
The application was initially rejected, but was sent to the EPO's technical board of appeal, which in turn referred the matter to the higher EBA.
The UK patent office allows patents to be filed for inventions concerning pluripotent HESCs – which have the potential to become most but not all cells – but not totipotent HESCs, which could turn into any cell. It also does not accept claims to methods of isolating HESCs that involve the destruction of a human embryo.
The decision could have implications for Scottish firms competing in the Europe and for those looking to move into the sector. It might also affect larger international companies that may consider investing in Scotland due to its growing reputation in the field. Dr Paul Chapman, a partner at patent attorneys Marks & Clerk, said: "Anyone in the field is watching this decision because they will have to strategically align themselves with it."
If patents can be granted, then it could lead to more money being pumped into research, but if the EBA decides not to allow patents, then there could be consolidation in the sector.
Chapman added: "The companies that are well-established in the marketplace will survive – it's perhaps the people who have come late into the stem cell arena that may find it most difficult.
"Maybe there's going to be consolidation in the field because more companies will pool their resources and intellectual property. That's not necessarily a bad thing.
"As Scotland has already got a number of players in the field, hopefully the vast majority of them will still be working in this area. They may just need to change their strategy."
Chapman thinks the bigger drug firms – which use HESCs to develop therapies for diseases such as Parkinson's and heart disease – could be affected to a greater extent if European patents are not allowed because much of their business plans will depend on securing patents. He said companies that had gone down other routes – such as developing stem cells into media in which drugs can be tested – are less likely to be affected by any judgment.
Dr Marilyn Robertson, executive director of the Scottish Stem Cell Network (SSCN), which is running a patent database workshop on Wednesday focusing on life science patent searching, said: "The patent landscape for this particular field is extremely complex given the different laws in Europe and the US.
"The SSCN's current policy is to raise awareness in our community on what is 'patent-able' and what is not. Patent awareness is critical in the field of stem cell research if we are going to move forward with a healthy regenerative medicine industry in Scotland.
"The SSCN has a key role to play in assisting and advising academics, clinicians and researchers who might not realise what patent opportunities may exist."