Hippocratic obligation to shareholder profit? Medical treatment patents and the Australian High Court in Apotex Pty Ltd v Sanofi-Aventis Australia Pty Ltd [2013] HCA 50.

The method of treatment of suffering in patients, including through surgery and the administration of therapeutic drugs, are essential features of medical professionalism. Few, if any practitioners committed to developing the core professional virtue of loyalty to relief of patient suffering through consistently implementing the basic principles of medical ethics, would consider that such beneficial methods of practice are, or should be, the subject of a patent--requiring the practitioner utilising them to pay a royalty or risk infringement proceedings. Indeed a formal opinion of the American Medical Association declares "the use of patents, trade secrets, confidentiality agreements, or other means to limit the availability of medical procedures places significant limitation on the dissemination of medical knowledge, and is therefore unethical".

Government control over health-related not-for-profit organisations: Agency for International Development v. Alliance for Open Society International Inc 570 US_(2013).

The relationship between government and the not-for-profit (NFP) sector has important implications for society, especially in relation to the delivery of public health measures and the protection of the environment. In key health-related areas such as provision of medical services, welfare, foreign aid and education, governments have traditionally preferred for the NFP sector to act as service partners, with the relationship mediated through grants or funding agreements. This service delivery arrangement is intended to provide a diversity of voices, and encourage volunteerism and altruism, in conjunction with the purposes and objectives of the relevant NGO.

Planetary medicine and the Waitangi Tribunal Whanganui River report: global health law embracing ecosystem as patients.

A recent decision of the Waitangi Tribunal granted legal personhood to New Zealand's Whanganui River (appointing guardians to act in its interests). Exploring the impacts of this decision, this column argues that new technologies (such as artificial photosynthesis) may soon be creating policy opportunities not only for legal personhood to be stripped from some artificial persons, but for components of the natural world (such as rivers and other ecosystems) to be granted such enforceable legal rights. Such technologies, if deployed globally, may do this by taking the pressure off ecosystems to be exploited for human profit and survival.

Balancing public health, trade and intellectual monopoly privileges: recent Australian IP legislation and the TPPA.

Over the past year, several significant reforms to Australia's intellectual property regime have been proposed and passed by Parliament. The Intellectual Property Laws Amendment (Raising the Bar) Act 2012 (Cth) made various improvements to Australian patent law, including an improved threshold for patentability, greater clarity around "usefulness" requirements, and the introduction of an experimental use exemption from infringement. Another Bill, the Intellectual Property Laws Amendment Bill 2012 (Cth), currently out for public consultation, would implement a 2003 decision of the World Trade Organisation (WTO) General Council and the 2005 Doha Declaration on the TRIPS Agreement and Public Health (Doha Declaration).

Civil liberties and the critics of safe vaccination: Australian Vaccination Network Inc v Health Care Complaints Commission [2012] NSWSC 110.

Public immunisation programs have, time and again, demonstrated their effectiveness at reducing mortality and morbidity from vaccine-preventable diseases such as measles and pertussis. Governments, health agencies and almost all health practitioners regard vaccines as safe and cost-effective treatments with a low risk profile. Nevertheless, despite, or perhaps because of, their success, immunisation programs and vaccines have increasingly been questioned by various lobby groups, sceptical of the safety of vaccines and the motives of those who administer them.

A bad trip for health-related human rights: implications of Momcilovic v The Queen (2011) 85 ALJR 957.

Momcilovic v The Queen (2011) 85 ALJR 957; [2011] HCA 34 arose from a prosecution for drug trafficking brought under the Drugs, Poisons and Controlled Substances Act 1981 (Vic). The Australian High Court held that the Charter of Human Rights and Responsibilities Act 2006 (Vic) (the Charter) validly conferred a power on the Victorian Supreme Court and Court of Appeal to interpret legislation in a manner consistent with a defined list of human rights. By a slim majority it also held that the Charter validly created a judicial power to "declare" a law inconsistent with one or more enumerated human rights.

Freedom of information applications as an "evergreening" tactic: Secretary, Department of Health and Ageing v iNOVA Pharmaceuticals (Australia) Pty Ltd (2010) 191 FCR 573; [2010] FCA 1442.

A recent decision of the Federal Court of Australia illustrates how patent-holding pharmaceutical companies are attempting to use Australia's Freedom of Information Act 1982 (Cth) to force Australian safety, quality and efficacy regulators to disclose whether generic competitors are attempting to enter the market. In Secretary, Department of Health and Ageing v iNova Pharmaceuticals (Australia) Pty Ltd (2010) 191 FCR 573; [2010] FCA 1442 a single judge of the Federal Court overturned a decision of the Administrative Appeals Tribunal (AAT) that would have compelled the Australian Therapeutic Goods Administration (TGA) to reveal whether they were in possession of an application to register generic versions of two iNova products: imiquimod and phentermine. In its justification to the AAT for refusing to confirm or deny the existence of any application, the TGA argued that to reveal the existence of such a document would prejudice the proper administration of the National Health Act 1953 (Cth) as it could compromise the listing of a generic on the Pharmaceutical Benefits Scheme.

Should I stay or should I go? The Ectodysplasin locus is associated with behavioural differences in threespine stickleback.

Adaptive divergence may be facilitated if morphological and behavioural traits associated with local adaptation share the same genetic basis. It is therefore important to determine whether genes underlying adaptive morphological traits are associated with variation in behaviour in natural populations. Positive selection on low-armour alleles at the Ectodysplasin (Eda) locus in threespine stickleback has led to the repeated evolution of reduced armour, following freshwater colonization by fully armoured marine sticklebacks.

New Australian federal organ and tissue donation legislation: enhanced transplant services but no "opt-out".

Seriously ill people who could achieve many years of high-quality life with organ donation continue to die on waiting lists due to the scarcity of donated organs. Recent advances that suggest donor organs can be coated with host stem cells to reduce or remove the need for long-term recipient immunosupressive medication highlight the importance of encouraging such donation. A wide variation in organ donor rates in developed nations suggests this is one issue in which the right regulation can make a difference.

University of Western Australia v Gray: an academic duty to commercialise research?

In an era of tightening university budgets and pressure to commercialise academic knowledge, many higher education institutions see the exploitation of new inventions and discoveries, through the use of patents, as an additional revenue stream. To that end, many such organisations have in place policies and by-laws which regulate "ownership" and disclosure of inventions created by employees. This can be seen as a continuation of an ongoing process of shifting universities from institutes of "pure research" to commercial operations, seeking to maximise financial gains from the efforts of their researchers.

New forms of evergreening in Australia: misleading advertising, enantiomers and data exclusivity: Apotex v Servier and Alphapharm v Lundbeck.

Two recent decisions of the Federal Court of Australia have provided interesting insights into the ongoing struggle between originator drug manufacturers and the public interest in Australia. In Apotex Pty Ltd (formerly GenRx Pty Ltd) v Les Laboratoires Servier (No 2) [2008] FCA 607 the court held that an advertising campaign by an originator pharmaceutical company, which sought to persuade doctors to issue prescriptions prohibiting substitution of "a-flagged" generics, constituted misleading and deceptive conduct under s 52 of the Trade Practices Act 1974 (Cth). The decision of the court in Alphapharm Pty Ltd v H Lundbeck A/S (2008) 76 IPR 618; [2008] FCA 559 limits the ability of the manufacturer of a drug based on a purified racemate enantiomer to claim a later registration date on the Australian Register of Therapeutic Goods and subsequently obtain an extension of its intellectual monopoly privileges as well as an exclusivity period for the data it had submitted to safety regulators.