Pharmaceutical Insights

13 August 2007

Welcome to the August edition of Pharma Insights. In this edition, we consider the recent suspension of plans to create the joint Trans-Tasman therapeutic products authority, ANZTPA. We ask what the future holds now for industry regulation?

We consider the implications of the Australian Competition Tribunal’s decision to reauthorise the 15th edition of the Medicines Australia Code of Conduct and the proposed reform of the Private Health Insurance Regime as evidenced by the Private Health Insurance Act 2007. We also address the release of a draft rule regarding proposed regulatory requirements for sponsors and manufacturers of in vitro diagnostic devices.

In a round up of recent patent law developments, we look in particular at the High Court's re-examination of the issue of obviousness and the test for determining "inventive steps" in Australia.

The future with the Medicines Australia Code of Conduct

By Greg Williams and Zöe Kimberley.

Greg Williams and Zoë Kimberley explain the implications for pharmaceutical companies' future marketing practices following the Australian Competition Tribunal's decision on the Medicines Australia Code of Conduct and the new disclosure rules.

Reform of the private health insurance regime

By Robyn Baker and Lisa Simonds.

Private health insurers will now be able to fund chronic disease management programs, say Robyn Baker and Lisa Simonds.

More rigorous IVD regime one step closer - but will it be trans-Tasman?

By Andrew Morrison and null null.

Andrew Morrison and Jodi Ainsworth explore the proposed new regulatory requirements of sponsors and manufacturers of in vitro diagnostic devices.

Labelling of complementary medicines

By Wayne Condon and Jocelyn Kellam.

Are your products made in Australia? As Wayne Condon and Jocelyn Kellam warn, you must be careful when making this sort of claim.

Meet the team

This is a new section where we will introduce members of the Life Sciences legal team who are also scientifically qualified.

Australia’s High Court grapples with the issue of obviousness again

By Wayne Condon .

Wayne Condon explains how the High Court has stepped away from the UK view of "inventive step" - and what that means for patents.

Patenting enantiomers - court decides there is nothing sinister

By Nicholas Tyacke and Simone Mitchell.

As enantiomeric compounds have become increasingly important to the pharmaceutical industry has increased, so has patent protection for them. Nicholas Tyacke and Simone Chernishev look at the first decision in Australia on the infringement and validity of an enantiomer patent.

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