Food of the future – regulating and protecting gene-edited crops

A recent episode of the BBC World Service’s excellent series “50 Things that made the modern economy” (now up to ‘thing’ 75) concerned plant breeding and “Dwarf wheat”.  The episode highlighted concerns that while the world’s population continues to grow apace, food yields are increasing more slowly.  As stated by one yield specialist at the University of Nebraska: “Basically, the breeders have been pulling rabbits out of their hats for fifty years, well they’re starting to run out of rabbits”.

The episode finishes with an expression of hope that the latest technological advances will be brought to bear on the problem of increasing yields.  Precision gene-editing methods such as CRISPR are highlighted as presenting a quicker way of introducing the kind of global game-changing modifications which took Norman Borlaug many years, when he developed semi-dwarf, high-yield, disease-resistant wheat varieties using conventional breeding in the 50’s.

A difficult environment in which to thrive

Alas the current European IP and regulatory regime seems to be anything but conducive to protecting novel plants and bringing them to market.

On the regulatory side, back in July 2018 the Court of Justice of the European Union (ECJ) ruled that gene-edited crops should be subject to the same stringent regulations as conventional genetically modified (GM) organisms.  That was huge blow for the innovators who had hoped that organisms created using precise gene-editing technologies would be exempted from existing the European law that had limited the planting and sale of GM crops.  It has also led to Europe being out of step with regulators elsewhere, such as the US Department of Agriculture and others in South America.  A further problem in Europe now is that of enforcement i.e. the difficulty in identifying gene-editing mutations which may otherwise be identical to those which could occur naturally.

On the patent side we have reported previously on the ongoing saga relating to the EPO’s prohibition against the grant of patents for plants resulting from steps of crossing and selection.  Such steps are often used when developing plants using GM and gene-editing approaches, as well as in conventional breeding.

At present this prohibition is the subject of questions referred by the President of the EPO to the Enlarged Board of Appeal at the EPO.  The questions focus on whether the rule excluding the grant of patent claims to plants (Rule 28(2) EPC) is in conflict with the European Patent Convention itself, which is silent on such a prohibition.  The referral is pending under reference G3/19 and amicus briefs have already being filed, both in favour or against the prohibition being upheld.  In the meantime the grant of such claims is suspended at the EPO.

A growing mistrust

Certainly there are very good arguments to be made that the prohibition against patenting certain plants, and indeed the President’s referral itself, is unlawful.   However, beyond the strict legal correctness of these things, there are more general and fundamental questions about how best the IP system should be used to incentivise the kind of innovation that might help to solve the problem of present and future global food supply and food security.   Of course, patents are not the only IP rights available:  there are also Plant variety rights, intended to reward plant breeders for the expensive and time consuming process of developing new plant varieties.  Plant innovations can also be protected by trade secrets or other control of proprietary material.  Yet other legislation is intended to balance the need for finding and utilising wild specimens in plant improvement programmes against the need to recognise the rights and traditional uses of those specimens by local people where they are found (“traditional knowledge”).

Most of the pressure to limit the patent protection in the area of plants has been brought by plant breeders, who are suspicious that patents will block their access to plant characteristics and base materials, and prevent public dissemination of knowledge.  It has also been argued that monopoly rights like patents can be bad for biodiversity and lead to market domination by large corporations.  Set against this is the fact that there exists exemptions in patent rights to allow breeders to make certain uses of patented plant materials, and there is arguably little evidence that patents have these other counter-productive outcomes which are alleged against them.

Public health risks sow seeds of concern

On the regulatory side, the treatment by the EU of precision gene-edited crops as “conventional” GM organisms, rather than simply an extension of traditional mutagenic methods, is on the face of it rather illogical.  However the decision is simply one instance of the EU’s “precautionary principle” which they apply when considering potential risks to the environment or to public health.  That in turn reflects a natural caution, and indeed mistrust, that some European countries have in relation to food and the national regulatory authorities.

It’s hard not to conclude that whatever the final outcome on these matters of regulation and protection, some of the stakeholders will be unhappy.  However with the critical issue of providing the future crops to feed a growing global population in the balance, one can only hope that the innovations which might achieve this, like the crops of the future, are given the right environment in which to flourish.