Gene patents: Matters of interpretation

At the time of writing, genetic diagnostics company Myriad has settled all but one of its gene patent disputes with firms offering BRCA tests in the US.

The tests determine an individual’s chance of developing breast or ovarian cancer by analysing mutations on genes BRCA1 and BRCA2. Myriad holds a number of patents covering ways to isolate these genes, although some were invalidated by the US Supreme Court in a June 2013 decision.

However, gene patents remain in force in many jurisdictions around the world, including China, the EU, Japan, Russia and South Korea, where isolated DNA is considered patentable subject matter. Australia’s Full Federal Court last September upheld Myriad’s patents covering BRCA genes after a challenge by cancer survivor Yvonne D’Arcy.

Meanwhile, Canada may be about to see its first gene patent challenge play out in court, as the Children’s Hospital of Eastern Ontario (CHEO) last November filed for a declaration of non-infringement of five patents covering a test for heart disorder long QT syndrome, at the Federal Court of Canada.

What points will the Canadian court need to consider before rendering its decision, and how do they compare to those in other jurisdictions? LSIPR examines the playing field for gene patents in the US, Australia and Canada.

The aftermath of Myriad

The US Supreme Court’s decision in Myriad dramatically altered the landscape for diagnostic patents in the US, dealing a severe blow to the fate of the gene patent and leaving a great deal of confusion in its wake. The ruling subsequently narrowed the scope of protection, and not just for genes.

After the case, the US Patent and Trademark Office (USPTO), to clarify matters, issued guidelines on determining patentable subject matter, although many felt these narrowed the scope for patentability even further.

Lisa Haile, partner at law firm DLA Piper in San Diego, says that the case seems to have created a “roadblock” to the patentability of other naturally occurring biologics.

A day after the Myriad decision was handed down, several genetic diagnostic companies started making their own BRCA tests available. Myriad sued six of those companies for patent infringement, including the California-based Ambry Diagnostics.

Judge Robert Shelby at the US District Court for the District of Utah denied Myriad’s request for a preliminary injunction against Ambry in March 2014.

After the US Court of Appeals for the Federal Circuit affirmed the decision in December, Myriad settled pending litigation with Pathway, Invitae, Ambry and Quest. It had already settled with Gene-by-Gene in February 2014.

In rendering its decision, the Federal Circuit considered the Supreme Court’s 2013 decision in Myriad, as well as the higher court’s 2014 ruling on Alice Corp v CLS Bank, in which it said computer-implemented inventions are not patentable.

Haile continues: “It is clear that the biotechnology industry in the US requires certainty following the uncertainty introduced by the Myriad and Ambry decisions.

“Without such certainty, pharmaceutical and biotech companies are unlikely to be incentivised to continue to research and develop new and useful diagnostic or therapeutic products from subject matter that is of biological origin.”

Business Down Under

The picture in Australia could hardly look more different. There, for now, the gene patent is safe. The Full Federal Court (the appeal level court) favoured Myriad in D’Arcy’s challenge against it, relying on a definition of patentable subject matter that contrasts with that of the US.

Australia defines patentable subject matter as “a manner of manufacture”, in accordance with the 1623 Statute of Monopolies. The meaning of the term was considered in a landmark Australian High Court case of 1959, in National Research Development Corporation v Commissioner of Patents (NRDC).

In that decision, explains Grant Shoebridge, a partner at law firm Shelston IP in Sydney, the court gave a broad interpretation of the intended purpose of the term “manner of manufacture”, so it is considered to encompass “an artificially created state of affairs in the field of economic endeavour”.

There has been some suggestion that Australia’s laws in relation to patentable subject matter are outdated, as they have their foundations in laws laid down in the 17th century, Shoebridge says.

However, he adds, the ‘manner of manufacture’ test under Australian law is adaptable to any field of technology at any time, as it considers the purpose of patent protection: to encourage innovation.

"Without technical intervention, isolated genes would never come into existence, and genes in an isolated state permit uses that are economically valuable.”

“This contrasts with the current US laws, which do not permit the patenting of isolated naturally occurring material and which, arguably, will impact on the development and commercialisation of new treatments and medicines that are derived from natural sources,” he says.

What does this mean for the gene patent? Shoebridge says the NRDC decision guided the Full Federal Court on its Myriad ruling, and that in contrast to the US Supreme Court judges, the Australian judges were not influenced by expressions such as “the work of nature” or “the laws of nature”.

“In other words, an isolated gene was considered to be an artificially created state of affairs in the field of economic endeavour,” he says.

“This makes sense because without technical intervention, isolated genes would never come into existence, and genes in an isolated state permit uses that are economically valuable.”

Indeed, after the US Supreme Court decided the Myriad case, some commentators suggested that the judges did not understand the technology behind gene isolation. The New Republic magazine said that the court had “revealed its ignorance of genetics” in its decision.

In fact, Justice Antonin Scalia even confessed in the decision that he was not necessarily familiar with the science behind the technology, writing: “I join the judgment of the court, and all of its opinion except [portions] going into fine details of molecular biology.

“I am unable to affirm those details on my own knowledge or even my own belief.”

It seems the US proceedings were “bogged down” in various analogies to explain the technologies, Shoebridge adds, and in one instance isolated genes were likened to snapping a branch off a tree.

Australia’s Full Federal Court decision rejected the simplicity of such analogies, he says, adding that while the US Supreme Court seemed to take a “microscopic view” of claims defining isolated genes, the Australian courts took a “panoramic view”.

Why Alice?

In its December 2014 decision in Myriad v Ambry, the US Federal Circuit applied reasoning from the Supreme Court’s 2013 ruling in Myriad, as well as the June 2014 decision in Alice Corp v CLS Bank.

Australia’s Full Federal Court handled a similar case last year in Research Affiliates v Commissioner of Patents, which found that computer-implemented inventions were not patentable subject matter under Australian law.

But Shoebridge says he does not believe this decision will have any bearing on the patentability of isolated genes.

“Isolated genes are physical entities which, if not for the intervention of technology, would fail to exist and which can be used in commercially beneficial applications,” he says.

Canadian club

Like Australia, Canada does not place any restrictions on patenting genes, though the CHEO’s challenge of patents covering a diagnostic test will throw these patentability issues into the limelight.

CHEO filed for declaratory judgment of non-infringement against patent holders University of Utah Research Foundation, Genzyme Genetics and Yale University so that it could offer tests for long QT syndrome.

The US and Canada define “patentable subject matter” fairly similarly, but how significant are these similarities in the context of gene patents?

“Canada and the US have a similar definition of ‘invention’, although at least until recently, the US generally had a broader conception of what constituted patentable subject matter compared to Canada,” says Carmela DeLuca, partner at law firm Bereskin & Parr in Toronto.

However, she adds, in the context of diagnostic and personalised medicine innovations, there are some key differences between the jurisdictions in terms of what is patentable.

Crucially, methods of medical treatment are not patentable per se in Canada, whereas they are in the US, DeLuca explains, although Canada does allow some types of use claims.

Isolated DNA that meets the criteria of patentability (for example, novelty, non-obviousness and utility) is patentable in Canada, she explains.

“The Supreme Court of Canada has favourably commented on the patentability of DNA in Monsanto Canada v Schmeiser and Harvard College v Canada (Commissioner of Patents).”

Judicial interpretation is another main difference between the jurisdictions, DeLuca says.

“In both countries applications of fundamental principles can be patentable but what differs at present in the realm of diagnostics is what elements are sufficient to cross the dividing line between a natural phenomenon and an application of such.

“The differences are particularly relevant for some types of personalised medicine claims.”

If the Federal Court of Canada decides to assess the broader question of “gene patents”, the case would have an important impact on diagnostic patents in Canada, DeLuca says.

“In light of previous case law, I would expect that isolated DNA will be found patentable,” she says.

“The case will also likely provide guidance on the scope of diagnostic claims that are patentable and would provide useful guidance for the Canadian Intellectual Property Office, which has generally placed prosecution of diagnostic type applications on hold as it develops its policy regarding diagnostic patents.”

For now at least, it appears the gene patent is safe in many jurisdictions, although with genetic diagnostics such a crucial component in personalised medicine, it will be interesting to see how the CHEO case plays out, especially as Canada’s definition of patentable subject matter has so many parallels with that of the US, where the picture is, alas, nearly two years after the Myriad decision, still not very clear.