Functional foods and intellectual property rights: the importance of an integrated approach.

• Author: Durell, Karen L.
• Position: Canada

Functional foods are a relatively recent technology, but this form of innovation is almost daily increasing in marketplace importance. One author has stated that the growing importance of functional foods is due to the fact that, "it is estimated that the purchasing decisions of at least eighty percent of primary shoppers in America are influenced by the desire to manage and/or prevent a specific disease or condition, or to follow a doctors' advice." (1) These statistics show that the public is attracted to the promise of significant health benefits that functional foods may offer. These consumers want to optimize their health and may therefore be open to the utilization of therapies that are alternatives to conventional medicines. (2) The market size of functional foods in the US-estimated to be $265 billion--demonstrates the high level of public interest. (3) As with other emerging technologies, the role of intellectual property rights [IPRs] in the functional food sphere is a critical topic. Presently the commercial market all but insists that key technologies seek IPR protection. (4) Functional foods are no exception.

It should be noted that there are two forms of functional foods; those which are developed as a result of scientific research, and those which are familiar foods that naturally offer particular health benefits. The IPRs that may be sought to protect each form of functional foods may differ. This is true because new and existing functional foods have different characteristics, as do the various forms of IPRs which may apply to a functional food project--namely patents, copyright, trademark, etc. The relationship between types of functional foods and forms of IPRs are interwoven, as the combination of IPRs which may apply to a functional food will be dictated by the nature of the functional food itself. For example, processed foods, such as breads with added Omega-3, may attract different IPRs than fruit produce that has been crossbred to comprise increased anti-oxidants. (5)

Of course, the act of seeking IPRs is only one step towards the goal of achieving adequate intellectual property [IP] protection for a functional food. Another crucial step is IP management. This step involves taking a big-picture view of a functional food innovation and its intended application and uses. Only when looking through a wide-angle lens can the interrelation of forms of IPRs and the implication of IPR applications be seen and analysed. This paper will therefore be divided into two sections. First, we will address the different IPRs that may be granted to aspects of a functional food innovation. Second, we will identify how IP property management may be applied to a research project and the benefits of doing so. The culmination of this discussion will be a better understanding of how IPRs granted in a functional food research project are interrelated and how this relationship should shape the application of the IPRs generally.

1. IPRs for Functional Foods

   The form of IPR that is most commonly associated with research projects is patent rights. In fact, in some situations the discussion of IPRs begins and ends with patent rights--if a project is not patentable it is considered not to be eligible for IPR protection. (6) This is a narrow view of IPRs and a misperception of the breadth of rights that may attach to aspects of a research project. The truth is that there are several forms of IPRs in existence and depending upon the nature of a research project, a variety of rights may be utilized to provide protection to elements of a functional foods project.

   Functional foods come in many different forms--yogurts with pro-biotics; fruits with enhanced nutritional value; or eggs, breads and fruit juices with Omega-3 added--just to name a few examples. For the purpose of this paper we will focus on a recent functional food project, the Authentique d'Orleans strawberry. Through crossbreeding, researchers at Agriculture and Agri-foods Canada and the Nutraceuticals and Functional Foods Institute of Laval University have developed a strawberry that has double the antioxidants of traditional strawberries. (7) This characteristic may offer several health benefits to consumers, as antioxidants have been linked to the prevention of cancer and conditions associated with aging. (8) The Authentique d'Orleans will be referenced in this paper to exemplify how IPRs can protect elements of a functional food innovation. However, it should be noted that functional foods, due to their varied nature, may be protected by a variety of combinations of IPRs and that functional foods should be considered individually to ensure the correct combination is achieved for each variety.

   1. Patents

      In Canada, patent rights may be extended to inventions that meet the patentability criteria set by the Patent Act--novelty, (9) utility (10) and non-obviousness. (11) Any invention that fails to meet these three criteria is not patentable. Inventions that attain patent rights are granted twenty years of protection counted from the date the patent was filed. Besides the three criteria, another consideration that may play a role in establishing patentability is the subject matter of the invention. (12)

      A functional food such as the Authentique d'Orleans seeking patent rights may immediately face two patentability hurdles. First, an innovation created through a process of crossbreeding may not represent a patentable subject matter according to common law precedent. The Supreme Court of Canada [S.C.C] in the Pioneer Hi-Bred Ltd. v. Canada (Commissioner for Patents) (13) [Pioneer] decision left open the possibility that crossbreeding may fail to involve the sufficient level of human intervention necessary to represent a patentable innovation. (14) The Pioneer ruling builds upon the consideration as to whether an innovation is truly novel, or whether it is merely a discovery. This topic has been recently re-examined by Canadian courts in Calgon Carbon Corporation v. The Corporation of the City of North Bay, (15) wherein the Court reiterated the rule set out in Reynolds v. Herbert Smith & Co. Ltd., (16) as stated by Justice Buckley:

      Discovery adds to the amount of human knowledge, but it does so only by lifting the veil and disclosing something which before had been unseen or dimly seen. Invention also adds to human knowledge, but not merely by disclosing something. Invention necessarily involves also the suggestion of an act to be done, and it must be an act which results in a new product, or a new result, or a new process, or a new combination for producing an old product or an old result.

      As such, it is vital that any patent application filed on a crossbred fruit prove that the creation of the strawberry involved a high level of human intervention and is more than a mere discovery.

      The second patentability hurdle that may confront a functional food similar to the Authentique d'Orleans is that any patent rights granted in the invention will be unable to claim the plant as a whole entity. Recent S.C.C. decisions in Canada, Harvard College v. Canada (Commissioner of Patents) (17) and Monsanto Canada Inc. v. Schmeiser, (18) have established and upheld the determination that higher life forms are not patentable subject matter in Canada. In Monsanto, the S.C.C. agreed that modified genes and plant cells containing such genes are patentable, but the present law in Canada is that plants cannot be claimed in a patent. (19)

      The reason for raising these two issues is not to suggest that functional foods developed through the crossbreeding of plants are not patentable, but to point out that the patentablity of such innovations is not necessarily a foregone conclusion. The same is true for other types of functional foods as well. A level of human intervention will need to be proven to be part of either the creation of the food product, or the process of creating the functional food. (20) Moreover, patents for plant-based functional foods will not be able to claim the plant itself, although other elements of the innovation may be patentable, such as cells or genes.

   2. Plant Breeders' Rights

      Due to the fact that plants are not patentable, an alternative protection is available to plants in Canada under the Plant Breeders' Rights Act. (21) This Act was drafted post-Pioneer and is intended to provide an IPR to plant varieties. Specifically, the Act states that a plant breeder may be granted rights in new sexually or asexually reproduced plant varieties. To be new a plant variety must be "distinguishable from other varieties, stable in its essential characteristics and sufficiently homogenous." (22) Once granted, a plant...