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Can human genes be patented? US Supreme Court to rule

Tuesday 4 Dec 2012 12:58 p.m.

Are human genes patentable? It’s a question which the United States Supreme Court is now seeking to answer – its ruling will go some way to shaping the future of medical research, including the fight against cancer.

Critics of gene patents argue they have been used to monopolise potentially life-saving medical tests – pricing them out of the reach of some patients, and stifling scientific access to the research behind them. But others maintain that without these patents the ability of researchers to fund work on new tests and treatments would be severely limited.

Human gene patenting is not new. The US Patent Office has been awarding these types of patents since the 80s and, according to some estimates, 20 percent of the human genome is now covered by patents. However the practice is now under increased scrutiny following the latest development in a long-running legal challenge to a specific series of patents granted for genes associated with breast and ovarian cancer.

The US Supreme Court announced last week that it would return to considering the contentious issue after referring it to a lesser court earlier this year.

NZ feels effects of US cancer gene patents

The patents in question were granted to Utah-based Myriad Genetics, along with the University of Utah Research Foundation, and relate to genes known as BRCA1 and BRCA2. Mutations in these genes – which normally produce tumour-suppressing proteins – are associated with a higher risk of developing certain cancers. According to Myriad, “approximately seven percent of breast cancer and 11-15 percent of ovarian cancer cases” result from these mutations.

As well as having patents covering the isolated DNA from the genes, Myriad has patents which apply to tests which find the mutations. In the US these tests can reportedly cost upwards of US$3,000 (NZ$3,662) when not covered by health insurance, although Myriad says it offers a financial assistance programme for low-income patients in this position.

The knowledge that someone carries the mutated genes, indicating a familial disposition towards these cancers, can help them make decisions about how to manage that risk. The New Zealand Breast Cancer Foundation (NZBCF) says the importance of BRCA tests is “huge”.

“It has been a vital piece of the puzzle,” says chief executive Evangelia Henderson, “it gives high-risk people the chance to prevent [cancer]”.

However Myriad’s gene patents have been used at times to threaten access to the tests.

New York University professor of the history of science Myles Jackson says that Myriad, on the basis of its patents, has actively worked to block others performing “full sequencing testing” with the BRCA1 and BRCA2 genes in order to protect its business model.

“Indeed, the company has sent cease-and-desist letters to a number of US laboratories to prevent scientists from offering BRCA testing,” he writes in the Huffington Post.

Ms Henderson says in New Zealand and Australia the tests have been offered by different laboratories since the 90s, offering women in this part of the world the chance to know more about their chances of developing cancer.

But the weight of gene patents has been felt here too.

In 2008, the Australian laboratory that was conducting BRCA tests for New Zealand women was threatened by the Melbourne-based Genetic Technologies, which had an exclusive licence to Myriad’s rights over the test in Australia.

Genetic Technologies at the time told eight laboratories including the Peter MacCallum Cancer Centre in Melbourne that it would use its patent rights to stop them using the tests, and become the sole provider of BRCA testing, the New Zealand Herald reported. This was after publicly announcing in 2003 that it would not enforce its BRCA patent rights.

‘It became a dirty word’ - Shelling

Associate Professor Andrew Shelling, principal investigator at the University of Auckland’s Medical Genetics Research Group, has in the past been part of a team which itself registered gene patents. But he says during the BRCA controversy, the patents became very unpopular.

“Gene patents became a little bit of a dirty word and at different times I was probably slightly embarrassed to say I had one, because you immediately got put on the dark side,” he says.

“Genetic Technologies […] became very heavy handed over BRCA 1 and 2. They also had another gene patent over other genetic material which would have just brought research to a halt, and a lot of diagnostic, clinical diagnostic genetic testing would have been very problematic if they’d enforced their patents to the max.”

Later in 2008, however, after a public backlash to its enforcement plans, Genetic Technologies announced it would back down. A new board of directors “resolved to immediately revert to [the company’s] original decision to allow other laboratories in Australia to freely perform BRCA testing”.

‘Myriad did not invent human genes’ - PUBPAT

Since 2009, Myriad’s ability to own patents relating to the BRCA gene mutations and the associated tests for these mutations has been challenged in the US by a group of women’s health organisations, and medical researchers and professionals, represented by the American Civil Liberties Union (ACLU) and the Public Patent Foundation (PUBPAT).

These groups argue that genes are products of nature, and so should not be subject to patent controls in the first place, and that to provide patents of this kind restricts the progress of science as well as the ability of patients to access medical care.

PUBPAT executive director Daniel B Ravicher says simply that people’s own genetic makeup should not be controlled by corporations.

“Myriad did not invent human genes, and has no right to claim ownership of them just because they removed them from the body,” he says.

The plaintiff groups have collected testimony of women with cancer who argue their access to the BRCA tests – and the vital information they can provide – has been restricted by the cost and controls imposed by Myriad on the basis of their ownership of patents.

Despite this, in January this year a spokesperson for Myriad told The Lancet that it had “never denied, opposed, or impeded any research studies” relating to the BRCA sequences, and instead “actively collaborates with researchers”.

DNA and baseball bats

The plaintiffs are concerned with the impact of gene patents, but their case relies on fundamental questions about what can and cannot be patented.

Intellectual property advisor and retired patent lawyer Doug Calhoun says the question of whether patents can be granted for genetic material in the first place is one of interpretation.

“The US Patent Act states that patents should be available for all novel and inventive compositions of matter. ‘Novel’ is interpreted to mean not yet discovered and made available to the public.”

Mr Calhoun says there are exceptions for laws of nature, natural phenomena and abstract theories – which are not patentable – but that the practical application of these laws, phenomena and theories can be patented. The dispute over gene patents, at least for Myriad, is about whether isolated DNA molecules constitute a man made product with a useful application or whether the isolated DNA remains fundamentally the same as it is when found in the human body.

“A good analogy is the one used by the lawyer for Myriad in the first appeal to the US federal court,” says Mr Calhoun.

“He posed the question, ‘Was a baseball bat a product of nature or a man made invention?’ In his view a baseball bat was an ash tree that had been felled, dried and from which all the bits that weren’t a baseball bat had been removed – a manmade object. But the opposing view framed the question as, ‘What is the difference in molecular structure between a baseball bat and an ash tree?’

Mr Calhoun, who also serves on the advisory council for NZBIO – the representative body for the local biotech industry – says New Zealand bio-researchers seeking US patents to license into the US will be adversely affected if the US Supreme Court rules against Myriad. But he adds that patent lawyers may yet have success in “redefining” the technology if the rules change.

A double-edged sword

While medical gene patents have been criticised for being used in the service of profits rather than patients, researchers suggest their virtue lies in their ability to attract investment for research that would otherwise go unpursued.

Genetic researcher Mr Shelling says in his experience, patents provide access to commercial funding in the absence of institutional, charitable or government support.

“The prime reason for [gene patenting], as far as I was concerned, was to generate further funding,” he says.

“Research funding is poor in New Zealand, and fertility funding – which I just happened to be working in at the time – is even poorer. So there was no way I was going to get a big grant from the Government or from a charity to take this to a point where it’s going to have some ultimate benefit for the patient and so the commercial model was sort of presented to me as a way of doing that.”

For its part, Myriad says it is only trying to recoup its investment costs through its patents.

“Myriad devoted more than 17 years and US$500 million [NZ$609 million] to develop its BRACAnalysis test. The discovery and development of pioneering diagnostics and therapeutics require a huge investment and our US patent system is the engine that drives this innovation,” chief executive Peter Meldrum said in a statement.

But Mr Shelling admits that at the same time, the patent system is problematic.

“On one hand, my interest is in seeing research proceed, and bringing benefit for patients. My whole philosophy is – if some of my research is useful and I can find a way of achieving better outcomes for patients, that’s what I’d like. But on the other hand, if by taking out a patent you stop other people’s rights to use that information, if it means that I have to shut up for a few years and not tell anyone about my research or publish it, then I don’t like that either.

“If it starts infringing on other people’s ability to come up with diagnoses of conditions then I’m very uncomfortable about that.”

Timeline of the BRCA patent dispute

  • March, 2010: Following a challenge from groups including the ACLU, a New York district court rules that the patents on the BRCA1 and BRCA2 genes are invalid. Judge Robert W. Sweet declares that DNA in an isolated form is not fundamentally different to DNA as it occurs in the human body, and is not patentable. Furthermore, patents on comparisons of DNA sequences and for methods of drug screenings are also ruled invalid.
  • April, 2011: The US Court of Appeals for the Federal Circuit hears Myriad's appeal of that ruling.
  • July, 2011: The appeals court overturns parts of the district court decision – ruling that companies can obtain patents on the isolated genes, and for drug screening methods. However it agrees with the district court that methods for comparing gene sequences remain patent ineligible.
  • March, 2012: After being asked to review the case by plaintiffs, the US Supreme Court revokes the decision of the appeals court and instructs it to reconsider the case in light of another related case – Mayo v. Prometheus – which dealt with patents for medical diagnostic testing.
  • August, 2012: The federal appeals court rules by two votes to one for the second time that companies can obtain patents on the genes, but invalidates patents on methods to compare those gene sequences.
  • September, 2012: The plaintiffs again ask the Supreme Court to rule on the patentability of genes.
  • November, 2012: The Supreme Court announces it will rule on whether companies can patent human genes. The decision is expected sometime next year.

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