This leads us to the second question of what form of IP should be deployed in relation to each component of the breeding program as well as the breeding program as a whole. IP comes in a number of different forms, including patents, confidential information and copyright, each with their pros and cons. For example, using a confidential information strategy means you seek to protect your genomic innovation through keeping it “secret”. However, using a confidential information strategy does not prevent someone else from later and independently developing the same genomic innovation. On the other hand, a patenting strategy gives you a statutory monopoly over your genomic innovation for the patent term. So you can then rely on your patent rights to prevent others using the genomic innovation the subject of your patent.
A foundation consideration here is which forms of IP are available to you, and this may differ from country to country – so think globally. For example, the position on the patentability of biological materials and methods utilizing these materials differs from country to country, so it is vital that you are alive to this issue.
In Australia, the High Court (which is the equivalent of the US Supreme Court) has ruled that genes per se are not patentable in the Australian Myriad case ( HCA 35). The Myriad litigation played out globally. In Australia, the High Court was asked to consider whether claims directed to the isolated nucleic acid sequences coding for the BRCA1 mutant polypeptide were patentable. The High Court unanimously held that such claims were not patentable. The High Court found that, despite the formulation of the claimed invention as a class of product, in substance the claims were to information embodied in arrangements of nucleotides. The information was not made by human action, it was discerned. An “invention” as recognized by the Australian Patents Act is something which involves “making”. It must be brought about by human action. The requirement in each claim that the sequence in the isolate bear specified mutations or polymorphisms was a characteristic of the human being from whom the nucleic acid was isolated. According to the High Court, it had nothing to do with the person who isolated the nucleic acid bearing the mutant sequence.
The High Court, however, left open the question of whether other types of genomic inventions, such as methods which use or apply genomic material, are patentable. This question has very recently been answered in the livestock breeding context in the Australian Federal Court decision of Meat & Livestock Australia Limited v Cargill  FCA 51. Here, the Court held patent claims directed to a specified method of identifying a bovine trait from a nucleic acid sample are patentable.
The Australian position on the patentability of biological materials and methods utilizing these materials is in contrast to the US position on these issues. In the field of human medical diagnostics, US Courts have considered the patentability of biological materials and methods utilizing these materials in a series of cases including Mayo Collaborative Services v Prometheus Laboratories, Inc., 132 S.Ct. 1289 (2012), Association for Molecular Pathology v Myriad Genetics, Inc., 133 S.Ct. 2107, (2013) and Ariosa Diagnostics, Inc. v Sequenom, Inc., 788 F.3d 1371 (Fed. Cir. 2015). The net outcome of these cases is that in the US both biological materials as well as methods utilising biological materials or biological markers are not patentable.