Patents: You are not a drug

How much of your intrinsic genetic information do you own? Certainly not all, as maybe 20% is locked away in the vaults of big pharmaceutical companies whose business aim is to make the most money possible from their holdings. CLA Director and National Media Spokesperson Tim Vines explains why there’s a growing debate over the possible need for new laws.

You are not a drug

By Tim Vines*

In Washington DC, Dr James Watson is arguing for his great discovery – the double helix structure of DNA – to be freed from its restrictive bonds. Not from the sugar and phosphate bonds that form the backbone of our genetic code but from bonds of a different, but equally intricate kind: patent monopolies.

In Sydney, Yvonne D’arcy, a woman with breast cancer, has her day in court. Five days in fact, signifying the importance of her case. Ms D’arcy, along with Cancer Voices Australia, is challenging not only a particular patent monopoly, but the decades-old practice of Australia’s patent office, IP Australia, of awarding patent monopolies over isolated human genes.

Connecting these two cases is the right of individuals to access their genetic information and for the democratic diffusion of knowledge about what makes us… us.

On 26 June 2000, US President Bill Clinton and UK Prime Minister Tony Blair announced that the Human Genome Project had completed its first draft map of the human genome. Clinton also said that because the genome had been published it could never be patented.

Despite Clinton’s assertion, possibly 20% of the human genome is under a patent today. While this figure has been disputed, it is nevertheless true that Clinton’s statement has not held true. One patent, Australian Patent 686,004, held by Myriad Genetics Inc., restricts access to the BRCA1 and BRCA2 genes. Women with mutations in either the BRCA1 or BRCA2 genes have a 60% chance of developing breast cancer during their lives, five times the rate of women in the general population. Mutations in BRCA1 or BRCA2 also increase the lifetime risk of developing ovarian cancer, from 1.4% to 15-40%.

Because it has enforced its monopoly ‘rights’ in the United States, Myriad is able to charge between $300-$3000 ($3000 gets you a comprehensive result) for its test and faces no competition, because it can stop new BRCA tests coming on to the market. In Australia, Genetic Technology Ltd (GTL) – the exclusive licensee of Myriad’s BRCA patents – sent ‘cease-and-desist’ letters to Westmead Hospital and the Peter MacCallum Cancer Institute in Victoria in 2003 and 2008, ordering them to stop testing for the BRCA1 and 2 genes.

Public outcry led to GTL withdrawing its threats but Myriad continues to enforce its monopoly rights in the US. And GTL could, legally, commence action against any Australia hospital or clinic that tests for these mutations.

No alternative tests means higher costs for treatments and tests. It also means, in the case of the BRCA patents, that women are denied the chance for a second opinion before making potentially life-changing decisions, such as having both breasts removed to reduce their risk of developing breast cancer (so called ‘prophylactic mastectomies’). In the words of the Royal College of Pathologists of Australasia these patents "restrict a doctor’s freedom to make a diagnosis" — in other words, they chill both research and speech.

More fundamentally, these patents lock up our genetic information (DNA, RNA and naturally-occurring proteins), information the members of the United Nation’s Education, Scientific and Cultural Organisation (UNESCO) unanimously declared was the ‘heritage of humanity’. Gene patents constitute an unethical monetisation of our very essence. It is a practice our Parliament must address and reconsider.

Gene patents also undermine international treaties that promote the right to health and run counter to the Universal Declaration on the Human Genome and Human Rights which, quite unambiguously, states: ‘The human genome in its natural state shall not give rise to financial gains.’

While pharmaceutical companies claim that they need investment certainty, this should not come at the expense of equitable access to healthcare. Indeed, it is often forgotten that patents are a social contract between inventors and the State, with benefits to ultimately flow to the community. The 1624 Statute of Monopolies, from where we get our definition of ‘invention’, originally held that patents should not be granted if they were  ‘contrary to the law … mischievous to the state by raising prices of commodities at home, or hurt of trade, or [be] generally inconvenient.’

Gene patents show all these inconveniences, raising the price of healthcare and undermining ethical norms that hold the human genome as something worthy of special protection. Dr Watson, who refused to patent his original discovery, neatly sums up the scientific reason for excluding DNA from patentability:

Simply put, no other molecule can store the information necessary to create and propagate life the way DNA does. It is a chemical entity, but DNA’s importance flows from its ability to encode and transmit the instructions for creating humans. Life’s instructions ought not be controlled by legal monopolies created at the whim of Congress or the courts.

Of course, inventions that build upon the naturally occurring genetic information, such as new vaccines, medicines and diagnostic tests, should remain patentable — provided they offer something "new".

However, civil liberties groups in Australia and in the US oppose patents over naturally occurring genetic information, because patents have a chilling effect on "speech" (which includes the freedom for researchers to research, and for doctors to diagnose and treat a patient). Patents also restrict the rights of individuals to access their own genetic information, and they involve the privatisation and monetization of genetic information that was never "invented" but rather discovered and published by public laboratories.

While Dr Watson and Ms D’Arcy fight their personal battles in court, the Australian Parliament and various governments have been struggling to resolve the gene patents issue. A series (see timeline) of Senate inquiries and private members’ Bills have failed to resolve the disquiet of parliamentarians; government-appointed commissions, while not recommending changes to the Patents Act, have conceded that arguments against gene patenting were ‘attractive’.

While we wait to see if the US Federal Court of Appeals or Australia’s Federal Court throw out Myriad’s gene patents, backbencher Melissa Parke (Labor, Fremantle, WA) is proposing another Bill to reform the Patents Act 1990. Time will tell if this Bill can address the concerns of many that our genes are hostage to the "whims" of patent holders.

DNA is scientifically and culturally unique from other chemical compounds. It has a special place in our lives and its commercialisation raises challenging ethical questions. But one thing is clear: you are not aspirin or any simple compound, and you shouldn’t be patented as such.

Civil Liberties Australia is supporting Melissa Parke’s new Bill. You can join the conversation about Gene Patents at https://www.twitter.com/freegenesor https://www.facebook.com/freegenes

 

Banning Gene Patents in Australia

• 2003 – GTL attempts to enforce BRCA gene patents. Relents in face of public pressure.
• 2004 Australian Law Reform Commission (ALRC) report (Genes and Ingenuity) recommended against the introduction of a specific patent exemption for genetic material or technologies, although conceded arguments in favour of a ban were ‘attractive’.
• 2008 – GTL attempts again to enforce patent. Backs away again and agrees to ‘gift’ the BRCA patents to the Australian community.
• 2010 – Senate Community Affairs Reference Committee inquiry into Gene Patents. Divided Committee does not support a ban but rejects IP Australia’s justification for patenting genetic information.
• 2010 – Several claims in Myriad’s BRCA patents held ‘invalid’ in US by District Court – appeal is ongoing. In June, Cancer Voices Australia and Yvonne D’Arcy file an action in the Federal Court to challenge Myriad’s Australian patents.
• 2010 – Senator Bill Heffernan (Liberal, NSW) introduces a Bill to ban the patenting of genetic and biological materials, supported by the Greens, Family First and the independents; and in the lower house by Liberals, Nationals and cross-benchers.
• 2011 – A Senate Committee rejects Heffernan’s Bill after fierce lobbying by the pharmaceutical industry. Department of Health and Ageing present evidence at inquiry, supporting the ‘intention’ of the Bill.
• 2011 – US Federal Circuit Court of Appeals overturns District Court’s decision and reinstates Myriad’s US Patents. Appeal lodged to Supreme Court.
• 2012 – US Supreme Court reaffirms 9-0 in a different case that natural phenomena and products of nature are not patentable. The Court orders the US Court of Appeal to review its decision in the Myriad appeal in light of this decision.
• 2012 – ABC Lateline story about another move to ban gene patents, this time led by Labor’s Melissa Parke, with support from the Liberal’s Bill Heffernan, who appear on the program.

*  Tim Vines is a Director and National Media Spokesperson for CLA. In real life, he is a lawyer for a living.

A version of this article first appeared on the New Matilda online magazine site, at:
http://newmatilda.com/2012/07/05/you-are-not-drug

You can join the conversation about Gene Patents at https://www.twitter.com/freegenesOR https://www.facebook.com/freegenes