Protecting the future: the regenerative medicine evolution
Regenerative medicine has left the realms of sci-fi to become a practical, new form of technology, which can give patients amazing results with serious, previously untreatable injuries. However, the legalities around how to protect it for commercial exploitation present many hurdles.
The concept of regeneration is not new and regenerative medicine has experienced a long, slow evolution alongside scientific exploration, rather than because of it. Regeneration is a concept in nature which, to the envy of us humans, is used by animals and plants to cope with injuries and age. As science has evolved and new treatments developed, this new version of regenerative medicine has been born, including the development of blood transfusions, skin grafts, transplant technology and, most recently of all, stem cell therapies and gene manipulation.
Problems with protection – biotech patents
While there is little argument that these forms of regenerative technology are amazing, there is a lot of argument over who should own the rights to them and where the line should be drawn in terms of what technology commercial entities should own which involve natural or living organisms, such as human genes.
Patents are the most sought-after form of protection for biotechnology as they give the patent holder the right, for a limited period, to stop others making, using or selling that invention without their permission. It is during this limited period of monopoly protection that patent holders hope to recover the millions (or even billions) spent in research and development.
"Ground-breaking regenerative technology is not patentable simply because it is extraordinary"
The other difficulty is that ground-breaking regenerative technology is not patentable simply because it is extraordinary. For example, in 2013, the US Supreme Court rejected a patent application for the BRCA genes implicated in breast cancer. This case was particularly important as it prompted the question as to whether 'natural DNA' and 'synthetic' DNA needed to be classified differently and protection allowed in respect of lab-created DNA. Natural DNA would remain patentable.
Even earlier, in 2010, the European Court of Justice (ECJ) decided that patents based on technology involving the commercial or industrial use of human embryos which could commence development into a human being were banned from patentability. The case presented two problems for embryonic stem cell scientists: first, it suggested that technology which required a human embryo that was capable of development into a human being could not be patented; and second, for stem cell research to be patented, it should be obtained by a method which did not involve the destruction of a human embryo.
The scientific community was pessimistic about the decision and argued it was seriously damaging to stem cell research in Europe. Other scientists and civil rights campaigners saw the rejection of biotech patents of this nature as a victory for patient care and medical innovation. Commercial entities, however, see the limitations on protection as commercially deadly as businesses are reluctant to invest millions (or even billions) in regenerative medicine when there is no certainty that this investment will be rewarded by patent protection.
Other patents have seen very little resistance, despite containing controversial material. A good example of a controversial biotech patent was when Geron Bio-Med was granted patents to cover the 'nuclear transfer technology' used to create cloned animals – the 'Dolly the sheep' patents. Geron argued that the patents would inspire other commercial entities to invest in this form of technology owing to the fact that the millions required to create it would be recouped through patent protection. Others were not so comfortable and expressed concern about animal clones being the first step towards human cloning; even the Church of Scotland went on record as asking the scientists involved not to abuse this new form of technology.
Jumping the hurdles
In the UK, there are strict rules about what can and cannot be patented, as well as more stringent exclusions for inventions involving medical use or contrary to public order. The basics are simple; for an invention to be patentable it must be: (1) new; (2) involve an 'inventive step' i.e. not obvious to a person skilled in that area; and (3) it must be capable of industrial application.
In relation to patents involving medical treatments, there is an additional hurdle. Under English law, an invention of a method of treatment of the human or animal body by surgery or therapy, or a method of diagnosis practised on the human or animal body, is not patentable. However, this exclusion applies to method of treatment and diagnosis and not to the materials used in such methods. If the BRCA patent application was to be made in the UK rather than the US, this exclusion could prove problematic during examination.
Even if you manage to get past all of these hurdles, there is one more, lesser-known hurdle, which has caught a number of biotechnology patents, especially those in relation to embryonic stem cell research. This is the requirement that the commercial exploitation of the invention must not be contrary to public policy or morality. It was under this particular exclusion that the original Brüstle case was caught in Germany.
Navigating new territory
You cannot be blamed for thinking patent protection for regenerative medicine technology is a minefield and wondering how protection can be guaranteed before millions of pounds are invested in a product. The answer is that there is no 100 per cent guarantee. The earlier a patent application is submitted and tested before an examiner, the better. However, be very cautious about this approach. As soon as a patent application is published (even if not granted), it becomes prior art and the unwise (and often unadvised) applicant could find themselves prevented from amending or resubmitting a patent application because it has inadvertently released the material into the public domain so that the invention is no longer 'new'.
"Parthenogenetic stem cells, which cannot commence development into a human being, are not excluded from patentability"
The basic position is that, even if you manage the hurdles without falling, finding your way through the maze to a granted patent can be difficult. For example, the Brüstle case determined that embryonic stem cell research which involved the use of a human embryo capable of commencement of development into a human being was not patentable. The questions which arose from this case concerned the stem cell community as they asked whether this now prevented all embryonic stem cell inventions being patentable. Thankfully not, as only a few months ago a new case (International Stem Cell Corporation 'ISCC' v Comptroller General of Patents) came before the ECJ which decided that parthenogenetic stem cells, which cannot commence development into a human being, are not excluded from patentability. This was a victory for the patentability of regenerative technology in EU.
As a result, what may have seemed like a clear case for a patent application being rejected in the first instance, on appeal, may be decided as patentable. The patent granting authorities in the EU work to a strict set of rules on patentability, which only a court can overturn. However, the ECJ is open to argument (as shown by the ISCC case) and a form of technology originally rejected as patentable may, with considerable time and cost, be concluded as patentable.
Take action – cautiously
This article can be concluded with one sound, simple commercial lesson – some protection is better than no protection; whether this is patent protection is an open question. There are other forms of protection for research, such as confidentiality (trade secrets), but each form of protection carries its own pros and cons and, despite its complexities, patent protection is often the first choice of protection for life science/pharma organisations. As can be seen from the cases cited here, applying for patent protection can be a long, difficult and expensive process and the outcome is never guaranteed. The most important consideration is to make sure you get it right first time; don't risk guessing when it comes to submitting your application. Seek qualified guidance; it could make all the difference.
About the author:
Laura Barrell is a solicitor and member of the Life Sciences and Healthcare Sector at Matthew Arnold & Baldwin LLP.
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