Microbiomes Expert WitnessesWith respect to agriculture, a good percentage of farmers rely on pesticides to assist their crops, but that could change in the near future. Plant microbiomes, which consist of the genetic material of microorganisms and often include bacteria, are being studied by many corporations to determine their effectiveness in improving harvests. See, e.g., Sarah Zhang, “Farmers Are Manipulating Microbiomes to Help Crops Grow,” Wired, Oct. 10, 2016. There are a number of ethical and legal issues that accompany the manipulation of microbiomes and endophytes (the bacteria that lives inside plants), and microbiomes expert witnesses will surely play a key role in these upcoming challenges. See id. This article explores the potential legal issues that exist with respect to plant microbiome manipulation and examines the functions that experts may play in related litigation.[1]

Discussion:

The human population is expected to exceed 11 billion by 2100, and there may be a need to figure out “new ways to meet the growing demand for food.” Duke University, “Disentangling the plant microbiome,” Nature Communications, Jul. 12, 2016. Accordingly, scientists, particularly geneticists and agriculture engineers, are investigating the ways in which microbiomes might assist in sustaining crops and growing the existing food supply.

These investigations, however, are not without controversy. A group of scientists who argued for a so-called “Unified Microbiome initiative” (UMI) have openly discussed the ethical and legal issues that will undoubtedly arise as research and manipulation of microbiomes increases and becomes more widespread. See, e.g., A.P. Alivisatos, et al., “A unified initiative to harness Earth’s microbiomes,” Science, Oct. 30, 2015. In addition, the group noted that microbiomes expert witnessess were not the only ones they would consult and involve in such a project; instead, they created their proposal by involving physicists, engineers, chemists, and even computer science experts, arguing that each of these types of experts could make important contributions, both to the project itself and the ensuing legal and ethical issues that may arise. See id. Moreover, the group explicitly noted that discovering microbiomes and making them usable in the agricultural community is simply one step; also needed are “people to commercialize these discoveries, as well as ethicists and legal experts.” Id., quoting scientist Jeff Miller.

Many legal issues can be anticipated by attorneys as agricultural microbiome work grows. For instance, every time that items, organisms, and the like have been manipulated to protect or produce particular crops, the matter of the side effects to those manipulations has arisen. For example, personal injury and wrongful death lawsuits came into play once it was discovered that certain pesticides had specific health consequences. In addition, environmental litigation often arises when something is manipulated for agricultural purposes, and conservationists have brought suit many times in an attempt to link certain pesticides to environmental degradation. Similarly, when genetically-modified organisms (GMOs) began to be introduced into crops and the food supply, lawsuits ensued. In fact, perhaps the largest lawsuit to date, involving potentially hundreds of thousands of plaintiffs, involves whether genetically-modified crops caused economic losses and whether the potential side effects of those crops affected the quality of the altered item. Similarly, manipulation of microbiomes for agricultural purposes is a matter that has its own set of ethical and legal concerns. See, e.g., id.

One member of the group of scientists who advocated for the UMI outlined some of the ethical and legal issues surrounding microbiome manipulation, stating “[T]he idea of potentially engineering Earth’s microbial ecosystems raises very legitimate questions. The prospect for doing harm is there.” Id., quoting scientist Jeff Miller. When a new technology is introduced, it tends to have costs as well as benefits. The costs, whether minimal or immense, are what some prospective litigation in the context of microbiomes may be based upon. Expert witnesses are the ones who prove and disprove cases involving environmental damage, health harms, and wrongful death. The types of experts that will be needed, both as consultants and testifying witnesses, include environmental experts, experts on causation in personal injury and/or wrongful death cases, medical experts, and, quite probably, the very experts that the UMI scientists discussed: microbiome scientists, chemists, physicists, and computer science witnesses. See id.

However, perhaps the field which will play the biggest role in litigation over microbiomes is the intellectual property arena. There are clearly intellectual property matters at play, especially with regard to patents, when considering microbiome manipulation. For example, one of the scientist group members questions who, if anyone, owns a particular microbiome. He asks “[D]o you own the microbes in your home in the soil of your garden, and on your plants? If researchers begin to extract commercial value from the microbiome, we need to pay much more attention to those issues.” Id, quoting scientist Rob Knight. Indeed, once a microbiome is discovered, there may be a race to the U.S. Patent & Trademark Office (PTO) in a finder’s effort to secure intellectual property rights on a particular microbiome and to, therefore, prevent others from the commercial and other benefits of ownership. When new technology is introduced or new products of nature are discovered, patent litigation tends to soar. Microbiome cases should be no exception and, if anything, may be more complicated, as ownership may be claimed both by lay people who own property where a specific microbiome was found and by the scientists who actually discovered the genetic material. Moreover, there may be lawsuits in cases where multiple parties’ residences were home to a given microbiome, and the intellectual property (IP) courts will have their hands full trying to parse out various claims. In all such cases, microbiomes expert witnesses will play an important (and perhaps dispositive) role. One other category of prospective IP claimants in these cases is the scientists who actually discover the uses/benefits of a specific microbiome. Their argument, which is one that has also been made in cases involving DNA, is that it is the use of genetic material that should receive a patent, not necessarily the material itself. The types of microbiome expert witnesses who will be essential to these IP claims will include experts in intellectual property and U.S. government regulation of patent cases, biotechnology and/or genetic experts.  Furthermore, because such IP cases involve (potentially enormous) commercial benefits for those who hold a patent on a given microbiome, experts in economic loss and damages will be vital. Patent law experts with experience in handling cases that involve genetic matter may be the most useful of all, and their expertise may be sufficient to determine the outcome of a particular lawsuit.

Conclusion:

With respect to the mapping and manipulation of plant microbiomes, there is the potential for many agricultural benefits, such as healthier and hardier crops. However, such work is not without a number of legal and ethical issues, which attorneys will be called upon to address as microbiome research grows. To be the most prepared, litigators should make an effort to anticipate the types of cases that will potentially arise in this area. Moreover, such attorneys should retain consulting and testifying microbiomes expert witnesses to help explain the scientific aspects of a specific case and to help establish credible theories that will ultimately prove successful in court.

 

 

By: Kat S. Hatziavramidis, Attorney-at-Law

[1]          The legal issues and experts discussed herein are specific to agricultural microbiome research and manipulation. Separate considerations exist with respect to human microbiomes, but they are not discussed or considered in this article.