New Report: UK's Cell and Gene Therapy Sector Growing at a (very) Healthy Rate

The Alliance for Regenerative Medicine and the Bioindustry Association of the UK have released a report (Report) concerning development and growth of the cell and gene therapy field in the United Kingdom.  The Report notes “four key takeaways”: 

[1] The UK is a leading source of innovation in the research and development of advanced therapy medicinal products (ATMPs) in Europe.  [2] There is strong government support for scientific innovation, capital formation, and patient access to cell and gene therapies in the UK. [3] There is significant investment in the UK   to support the development of these life-changing therapies. [and 4] The clinical pipeline in the UK, both in terms of UK-based companies and other companies interested in clinical development in the UK, is robust and growing.

The Report states that 24% of ATMP companies in Europe are headquartered in the United Kingdom, additionally there was over a billion US dollars in funding.  The funding in 2019 is on track to meet or exceed 2018’s funding.  There are detailed stats on funding by type in the Report.  Moreover, since 2012, there has been a substantial uptick in ATMP activity—from 22 companies to over 70 companies, some of which is attributed to significant government support and organization.  The Report also contains data regarding current and past clinical trials and case studies concerning relevant companies and their technology.  


The Report concludes with the following recommendations: 

Support scientific research to develop and advance both cell and gene therapies and ancillary processes, including manufacturing and scale up.

Foster economic development and the creation of a skilled workforce to promote the continued growth of this industry in the UK.

Cultivate a positive regulatory environment for the research and development of cell and gene therapies, including fostering accelerated pathways to ensure that patients are able to access safe and effective therapies in a timely manner.

Develop the necessary infrastructures within NICE and its counterparts in Scotland, Wales, and Northern Ireland to ensure health technology assessments are able to address the long-term value provided by cell and gene therapies.

Collaborate with the NHS and other public and private payers in the UK to develop innovative financing models to ensure patients can access approved therapies in an efficient manner.

The development of a skilled workforce (and attraction of one) and the related issue of international collaboration is important, but not expressly tied together in the recommendations. The full Report is available, here. 

Brüstle: counting the cost of an ethical ruling

The ruling of the Court of Justice yesterday in Case C-34/10 Brüstle v Greenpeace (reported here; see IPKat comment here) has already attracted a good deal of media attention on account of its ethical content. However, readers of IP Finance will doubtless be thinking about the other side of the coin (almost literally): the impact of the ruling on R&D investment.

In this context Dr Philip Webber (a biotech patent attorney with Dehns) has observed as follows:

"The irony of the situation is that the original intention of the Biotech Directive was to protect biotech inventions and to promote investment in this area in Europe, whereas the application of the Biotech Directive by the Court of Justice in this case could well lead to the destruction of a significant part of the European stem cell industry. 

The Court has gone much further than the European Patent Office (EPO) in applying the "uses of human embryos" exclusion. While the EPO shut their eyes to the history of the invention, the Court has said that you cannot ignore the invention's history and that, if the invention is built on immoral foundations, then the whole patent will fall.

The big question that is left unanswered is this: what distance must there be between an immoral act and the possibility of patenting a downstream product or process? The decision refers to a "stage long before the implementation of the invention". So are any inventions ever going to be patentable if - at some point in their (potentially long) past - they required the destruction of a human embryo?"

It's certainly true that the absence of patent protection will be a disincentive to commit funding to research and to what in many cases what will be the perfectly lawful commercialisation of its results. And what we have is only a partial absence: some jurisdictions tolerate stem cell patents while others don't.  We may see the transatlantic flight of a good deal of R&D funding in the near future.

The Scotsman reports that the future funding of stem cell companies is Scotland is dependent on a ruling next month by the European Patent Office's Enlarged Board of Appeals about whether stem cells are patentable or not.

The decision is on a patent application filed by the Wisconsin Alumni Research Foundation (WARF) - which holds the rights to a number of stem cell lines. Initially rejected by the Patent Office, WARF filed an appeal which was passed by the Appeal Board to the Enlarged Board of Appeal for a ruling (see decision here).

Personally I always find it interesting the various excuses made for not funding projects. Whilst the availability of patent protection is clearly one factor, the ruling will only effect the availability in Europe and the conditions that might be placed on the granting of patents in the stem cell field. Patent protection will still be available in other countries, such as the United States. I venture to doubt whether the effect on Scottish research will dependent on this ruling or not. It would be more serious if other countries came to a similar conclusion which would effectively allow a free-for-all in the stem cell field - and that outcome is unlikely to be either beneficial to the financing of research or on ethical grounds.