Life Sciences Insights

01 December 2006

Welcome to the December edition of Clayton Utz Life Sciences Insights which is now being published quarterly. In this edition we will look at issues of interest to the pharmaceutical industry from August to November 2006.

We will address significant regulatory developments including the current steps towards the Trans-Tasman Scheme and amendments to the Therapeutic Goods Advertising Code.

In our features section you will find the second chapter in the "wrongful life" claims saga. We also consider the recent Federal Court interlocutory decision in CSL Limited v GSKA GlaxoSmithKline Australia Pty Ltd [2006] FCA 1301, along with the global implications arising from the recommendations given by the UK expert scientific group appointed following problems with the TGN1412 trial.

As usual, you will find a round-up of recent key developments in patent law and events of interest overseas.

ANZTPA: Second phase of consultation is underway

By Andrew Morrison and null null.

We're another step closer to the new Joint Agency with the release of the second tranche of consultation drafts. Andrew Morrison and Jodi Ainsworth look at the new proposals.

Advertising Code 2006: Further steps towards a Trans-Tasman scheme

By Jocelyn Kellam, Lisa Kurian and Madeleine Kearney.

Sponsors should familiarise themselves with the new provisions of the Advertising Code, say Jocelyn Kellam, Lisa Kurian and Madeleine Kearney.

Meet the team: Dr Teresa Baker, Legal Co-ordinator - Pharmaceutical Regulatory Affairs, Sydney

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

The challenges of interlocutory injunctions: CSL Ltd v GlaxoSmithKline Australia

By Colin Loveday and Madeleine Selwyn.

Colin Loveday and Madeleine Selwyn explain why a recent case is a timely reminder of the complications of comparative advertising and neatly illustrates the challenges of obtaining interlocutory injunctive relief.

Will springboarding changes have a significant impact on the Australian pharmaceutical industry?

By Nicholas Tyacke and Isabel Kratzing .

Nicholas Tyacke and Isabel Kratzing say that although the springboarding exemption to patent infringement has been significantly broadened, this won't lead to significant impacts on the Australian pharmaceutical industry.

Can a pharmaceutical patent term extension, once granted, be shortened or cancelled?

By Nicholas Tyacke.

Nicholas Tyacke discusses two cases in the Federal Court tackling patent extensions and their importance for the industry.

Pharmaceutical patent term extensions - eligibility, application deadline and length clarified

By Nicholas Tyacke and Dominic Carew.

For pharmaceutical companies, patent term extensions can mean millions of dollars of additional sales, but whether one is available depends upon what the "first regulatory approval date" is, as Nicholas Tyacke and Dominic Carew show.
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