If you aren’t familiar with the world of biotechnological patents, then you might reasonably wonder what is and is not permissible. Recent advances have made it possible for the general public to try their hand at manipulating DNA as a hobby, known colloquially by the term ‘biohacking’, although this encompasses more than just DIY biology.
For a reasonable monetary outlay, you can set up a mini-lab at home and splice genes for bioluminescence, for example, into bacteria. Soon, it may be as easy to ‘edit biology’ as it is to edit software, but what are the implications of this? The effect of such editing on human beings is the most controversial possibility – just think back to the furore surrounding genetically-modified (GM) crops at the turn of the century. The idea is already being explored in a fictional setting, but how long before it becomes reality?
Patents in popular culture
You might not normally expect a TV show involving the concept of patents to be anywhere near the prime time viewing schedule, but ‘Orphan Black’ changes that. It is an exciting addition to the genre of science-fiction television, and I thoroughly recommend watching it.
The show is based on the premise of cloning (human cloning, to be specific), which is clear from the first episode. A dark, sinister corporation naturally provides the backdrop to the series, having created numerous clones to unwittingly participate in a long-term experiment, replete with hidden ‘minders’ who report on the behaviour and well-being of the clones. The corporation patented each clone to protect their investment, which is achieved (in the fictional world of ‘Orphan Black’) by including a specific DNA sequence to this effect in each clone’s genome. Keen to protect (and control) their research, the company is not happy with the clones becoming self-aware, and seeks to assert their rights by tracking down the errant clones.
Can you patent a human being?
Thankfully, the answer is a resounding ‘no’, as stated in the UK Patents Act, including a full or partial gene sequence, amongst others. The moral and ethical issues that would otherwise arise are unimaginable.
However, patenting biotechnological inventions is still a fascinating area of IP. A judgment in the USA in 2013 ruled that “a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated”. Importantly, however, this still allows for the possibility of patenting artificial DNA (i.e. non-naturally occurring DNA, known as complementary DNA), which is often used in cloning processes, amongst others. This ruling essentially prevents new gene technology companies from patenting large swathes of DNA and limiting innovation with patent enforcement, whilst still encouraging research companies to develop novel biotechnology. Although there are plenty of granted patents in the US which cover aspects of the human genome, it is unlikely that such patents will be granted in the future without solving a significant technical problem.
Patent limitations in the UK mean that you cannot patent the human body, human cloning processes, the use of human embryos for industrial or commercial processes, or essential biological processes or their products in animals/plants, amongst others. Similarly, in Europe, any biotechnological patent which would be contrary to public policy or morality is not patentable, and patents cannot be granted for varieties of animal/plant, essential biological processes for the production of animals/plants, or methods of treatment/diagnosis for humans or animals.
A case involving WARF/Thomson in 2008 addressed the question stem cell patentability head-on. Thomson was able to isolate stem cells from human embryos just days old where others had failed, but the EPO refused to grant the patent as it used human embryos for industrial/commercial purposes. To discuss the proceedings here at length would take too much of a detour, but suffice it to say that the refusal was upheld as the lack of claims involving human embryos did not obviate the fact that they were essential to the production of the “cell cultures” that were claimed. The outcome of this case influenced both UK and European patent law regarding the use of human stem cells, but only where destruction of human embryos was a necessity. Therefore the general question around the patentability of human stem cells remains without a definitive answer.
Another landmark case involved relaxin and the Howard Florey Institute of Experimental Physiology, who isolated, characterised and then synthesised the compound. Their subsequent patent application was opposed by the Green Party in European Parliament on multiple grounds including novelty, inventive step, and the moral boundaries they perceived it to cross. To cut a long story short, the opposition and subsequent appeal were dismissed because it was clear that the compound was novel and there was no previous indication it existed (hence the sequence for human relaxin was unknown), and also that consent was given by the original tissue donor.
As a result, UK patent law now states that an element isolated from a human body or produced by means of a technical process may be patentable, even if identical to a naturally-occurring element (e.g. hormones, gene sequences). Similar approaches in Europe and US make pharmaceutical research economically viable. For instance, news broke earlier this year that Sanofi Aventis was planning to sue Eli Lilly over infringement of its insulin patents in the US. Whether the infringement case is valid or not, it will delay the release of Lilly’s product which works to Sanofi’s advantage. Merely having discovered insulin would not have been sufficient to grant a patent, but its synthesis and application were indeed patentable.
Looking to the future, with antibiotic resistance in bacteria becoming more widespread, it is likely now in the interests of pharmaceutical companies to research, identify and find ways to synthesise new antibiotics. There have been some suggestions that ocean-based organisms may lead to a treasure trove of new compounds with antibiotic properties, and the possibility of patent protection for applications of such compounds can make highly expensive research worthwhile (especially if looking to test such compounds with cloned cells or animals).
The sky’s the limit
The field of biotechnological inventions may only have begun to expand in the last few decades, but as companies push the envelope of IP protection, the boundaries are becoming more clearly established. With recent advances in engineering such as 3D printing, those in the field of biotechnology now have further options for experimentation. This may well be the best time to take a foray into the world of biotechnological patents, with a world of possibilities still to be explored.
As a final thought, whilst the protagonists in ‘Orphan Black’ might try and enforce their patents, it would not hold up to scrutiny in the real world, although it doesn’t stop the show from being very compelling. In any case, with new discoveries comes new IP, and it is almost always worth protecting, just not to the extent seen in ‘Orphan Black’!