The Supreme Court of Canada has commented on the issue but no Canadian court has directly answered the difficult question of whether genes are patentable. So the answer appears to be yes, for now.

Identifying genetic sequences associated with diseases and creating tests to screen for them are unquestionably valuable scientific innovations. Due to the challenge and expense of pinpointing genes and developing genetic tests, innovators in the field have sought to protect their investments through patents.

While the patentability of genes has been challenged in Canada, Canadian courts have yet to directly face this inquiry — but other jurisdictions have. The highest courts in both the United States and Australia have ruled that certain forms of isolated genes are not patentable subject matter.

Gene Patents

Genes are considered the building blocks of life and the basic unit of heredity. A gene is a functional unit of deoxyribonucleic acid (DNA) that instructs cells in the body to make specific proteins based on the sequence of elementary units called nucleotides. Collectively, genes determine an individual’s physical traits; they are passed from parent to offspring.

Genomic DNA (gDNA) is raw genetic material that is naturally occurring and typically contains segments of nucleotides that code for proteins called exons, and non-coding segments, called introns. On the other hand, complementary DNA (cDNA) is made up exclusively of exons, which generally differs from the gDNA used to derive it. Through scientific research and innovation, the function and precise location of each gene within the human genome can be identified and isolated.

Patents encourage inventive solutions to practical problems into the public domain by the promise of a monopoly for a limited time. However, they are only granted for inventions, defined in the Canadian Patent Act as “any new and useful art, process, machine, manufacture or composition of matter”, and improvements thereon. Natural phenomena, laws of nature and scientific principles are excluded.

A patent for a gene grants the owner the exclusive right to make, use or sell a specific sequence of DNA. The current practice of the Canadian Intellectual Property Office is to grant patents for both isolated gDNA and cDNA, assuming that the other statutory requirements of patentability are fulfilled. But the jurisprudence on gene patentability in Canada is limited. The Supreme Court of Canada has ruled that genetically modified “higher life forms”, such as mice, are not patentable subject matter. However, it has also observed that genetically modified chimeric genes, the cells containing these genes and the process used to modify the genes are all patentable.

The question of whether gDNA or cDNA is patentable subject matter was challenged in Canada in a widely publicized suit, where a hospital sought to invalidate five Canadian patents. The challenged patent claims covered genes known to be implicated in Long QT syndrome (genes per se) and the process of comparing the known genetic mutations with isolated patient genes (genetic testing).

In what has been heralded as a “historic” settlement, the patent holders agreed to allow Canadian public laboratories and public hospitals to test Canadians for Long QT syndrome on a not-for-profit basis; it does not discredit the validity of the patents associated with Long QT syndrome or any other gene patents. Therefore, at least for the time being, gene patents remain valid and fully enforceable in Canada. However, it is instructive to consider how other countries have treated the patentability of genes as a hint to how Canadian courts may consider them in the future.

United States

The United States Supreme Court considered whether an isolated gene is patentable subject matter in Association for Molecular Pathology v. Myriad Genetics Inc. Despite the patentee’s considerable investment to locate, sequence and isolate two mutated genes (BRCA1 and BRCA2) that are strongly linked to early onset familial breast and ovarian cancers, the Court invalidated Myriad’s claims for isolated gDNA, holding that “genes and the information they encode are not patent eligible . . . simply because they have been isolated from the surrounding genetic material.”

The Court observed that an invention is not simply a product of great skill, stating that “[g]roundbreaking, innovative, or even brilliant discovery does not by itself satisfy the . . . inquiry.” Although the Court held that “a naturally occurring DNA segment is a product of nature,” it found that synthesizing cDNA “unquestionably creates something new” and is therefore fully patentable subject matter.

This decision has evolved into a test of patentability enshrined in the Manual of Patent Examining Procedure of the United States Patent and Trademark Office (USPTO). To assess eligibility, the USPTO must give each claim its broadest reasonable interpretation and then evaluate it based on:

  • whether the claimed invention falls within one of the statutory categories of invention: process, machine, manufacture or composition of matter;
  • whether the claimed invention involves one of the judicial exceptions to patentability: abstract idea, law of nature/natural principle, natural phenomenon and natural product; and
  • if the claimed invention is judicially exempted, whether the claim recites something more than the exception to qualify as patentable subject matter.

Altering a naturally occurring gene in some way may make it patent eligible but patentability is assessed on a case-by-case basis. For example, an isolated gene is not patentable subject matter if the sequence is found in nature as the act of isolation alone is not patentable. Alternatively, if some genetic information, such as introns, are removed from a sequence of otherwise naturally occurring gDNA, such as exons, this altered structure generally constitutes something more than the natural product and may be patent eligible.

Australia

Myriad’s BRCA1 patent was challenged at the High Court of Australia in D’Arcy v. Myriad Genetics Inc. The issue was whether Myriad’s isolated gDNA claims satisfied the “manner of manufacture” requirement for an invention in the Australian Patents Act. Despite delivering three separate opinions, all seven justices agreed that the impugned claims did not cover patentable subject matter.

The majority noted that public policy is an important consideration for “unimagined technologies with unimagined characteristics and implications.” The Court rejected the traditional rigid definition of “manner of manufacture” and enumerated new factors relevant to determine patentability of claims involving unimagined technologies.

However, the Court held that the claims were not for a “method of manufacture.” The majority reasoned that the “sequence can properly be described as ‘information’” and the claimed invention is nothing more than “the medium in which that information resides.”

The Australian Patent Office has responded with a narrow interpretation of the D’Arcy decision in its Examiner’s Manual of Practice and Procedure. In considering whether subject matter is patentable, examiners are required to make a case-by-case determination of whether a claimed invention falls within the traditional categories of eligible subject matter.

If not, and if an invention claims an unimagined technology, examiners are required to assess the claims based on the factors enumerated in D’Arcy. Naturally occurring DNA is specifically excluded but synthetic products, such as cDNA, are excluded only where they “merely replicate the genetic information of a naturally occurring organism”.

Future in Canada

Foreign courts appear to be moving away from a rigid definition of “invention” towards a case-by-case assessment that allows for unanticipated technologies. The United States and Australian decisions may serve as persuasive authority in Canada if and when Canadian courts have the opportunity to rule on the issue, but they are by no means binding in this country. The Supreme Court of Canada has been known to go out on its own in decisions regarding patentability. Whether Canada will follow the international trend or again pave its own path remains to be seen.