Personalized medicine is an area that seeks to develop and commercialize tests to assess a person’s risk of developing disease, guide treatment decisions and assess risk of disease progression and recurrence. In this regard, many biotech companies develop screening tests for a particular disease that involve looking for the presence or expression level of a particular biomarker associated with the disease. For example, a company may screen for a specific disease by looking for the presence of a particular mutation in a given gene that is correlated with it.
To protect such an innovation and attract investment, a company would typically file for patent protection directed to an “isolated” DNA molecule having the particular mutation in order to prevent others from using, selling or manufacturing tests that rely on the same mutation to screen for the specific disease.
The laws or patent practices of many countries provide that certain subject matter is excluded from patentability, even if the subject matter at issue is novel and non-obvious. For example, to be considered patentable in the United States, an invention must fall within one of the four categories of invention: process, machine, manufacture, or composition of matter. Judicially created exclusions to what can be patented include laws of nature, natural phenomena or abstract ideas.
For over 30 years, the United States has been granting patent protection on “isolated” DNA molecules as a composition of matter. The requirement that the patent claims be directed to “isolated” DNA molecules was important to constructively exclude the naturally occurring version of the genes, which were considered to be unpatentable as products and laws of nature.
While there is substantial history, policy and jurisprudence in several jurisdictions for allowing patents directed to isolated genes, this practice will come under greater scrutiny in the United States in the near future as the Supreme Court will hear Association for Molecular Pathology et al v Myriad Genetics et al (2010-1406) and consider the question of whether human genes are patentable.
This case was initiated in 2009 when a group of plaintiffs challenged a group of patents owned by Myriad Genetics and the University of Utah Research Foundation. The patents at issue covered, among other things, isolated BRCA1 and BRCA2 DNA molecules, particular sequences of which are associated with a predisposition to breast cancer and ovarian cancer. Myriad Genetics is a biotechnology company that commercializes, among other things, the BRACAnalysis® test, which looks for these particular sequences in the BRCA1 and BRCA2 genes to render a diagnosis.
In 2010, a U.S. district court in New York held that the patents directed to the isolated DNA molecules should not be eligible for patent protection as they are directed to products and/or laws of nature. In 2012, that ruling was reversed on appeal by the Court of Appeals of the Federal Circuit (CAFC), which upheld the patent eligibility of isolated genes. The decision of the CAFC, which was split 2-1, was rendered on the reasoning that the claimed isolated DNA molecules were man-made and the product of human ingenuity that did not exist in nature and were markedly different from such natural products because they had a different chemical structure. According to the majority opinion, isolated DNA molecules are distinct from their natural existence as portions of larger entities and their informational content is irrelevant to that fact.
The plaintiffs petitioned the United States Supreme Court asking it to consider some issues in this case. On November 30, 2012, the United States Supreme Court agreed to hear the case and consider the question of whether human genes are patentable. The date on which the Court will hear this case has not yet been set.
The outcome of this case will be of critical importance to early-stage biotech companies wishing to operate in the United States as the position that the Supreme Court takes regarding whether isolated human genes are patent eligible will impact what exclusive rights these companies will be able to procure and will also therefore affect their ability to secure financing through investment.
The preceding is intended as a timely update on Canadian intellectual property and technology law. The content is informational only and does not constitute legal or professional advice. To obtain such advice, please communicate with our offices directly.