Life Sciences Insights

15 July 2005

Welcome to the July edition of Life Sciences Insights. In our regulatory section we look at what is in store for complementary medicines, clinical trials and scheduling laws. With the preparations for the new trans-Tasman agency underway, industry regulation is changing.

Our features this month examine the High Court's decision on liability for deep vein thrombosis, and the implications for product bundling of the Baxter decision.

Protecting innovation is always a major issue for the biotech industry, and in our patents section we'll see the latest developments in patent law and whether they help or hinder life sciences patents.

Proposed new model for the scheduling of medicines and poisons

By Julieann Ahern.

The recommendations following the Galbally Review proposed a number of changes to the scheduling of medicines and poisons in Australia. As Julieann Ahern discusses, the proposed new model adopts a number of the Galbally recommendations and applies them in the context of the recent trans-Tasman developments.

Quick dose

In brief: A new committee to harmonise Australian/NZ standards; legislation planned for the life sciences industry; and regulation of gene technology under review.

Deep vein thrombosis - an "accident" or just bad luck?

By Jocelyn Kellam.

Deep vein thrombosis is a recognised complication of air travel, and can disable or kill sufferers. Are the airlines responsible for it, and can sufferers sue? Jocelyn Kellam examines the complexities of the latest case, in which the High Court indicated that the answer could be "no".

ACCC v Baxter Healthcare Pty Limited [2005] FCA 581

By Bruce Lloyd.

Bundling is an attractive way to package goods and services to consumers, but as a recent decision involving health care products shows, it can also lead to trade practices problems. Bruce Lloyd looks at the implications of the Baxter case.

Oh my Lord! - The House of Lords clarifies UK patent law

By Nicholas Tyacke.

A House of Lords decisions on a life sciences patent is likely to have a significant impact on Australian patent law on the issues of claim construction and infringement, explains Nicholas Tyacke.

Claim construction and fair basis considered

By Nicholas Tyacke and Rohan Higgins.

Both the High Court and House of Lords have made important patent decisions recently, but how do they affect pharmaceutical patents? Nick Tyacke and Rohan Higgins discuss the Federal Court's first application of the cases.

Extending the term of a pharmaceutical patent

By Nicholas Tyacke and Jacqueline McStay.

The Federal Court has recently held that all compounds falling within a class disclosed in a patent, even if not specifically identified, are sufficiently disclosed for the purpose of extending the term of such a patent on the basis of any one of those compounds, say Nick Tyacke and Jacqui McStay.

The experimental use exception to patent infringement - a preview

By Nicholas Tyacke.

Exceptions to patent infringement for experimental use are a hot topic, says Nick Tyacke, with a recent US Supreme Court decision and a forthcoming report here in Australia.

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