Developments in patent law and the consequential limitations on patentability for biologic medicines mean that data exclusivity and market exclusivity can be the primary protection afforded to originator biologic medicines. This is most stark in the US where patent protection for biologic medicines can be very limited. This seems to be the reason that the US has twelve years of exclusivity, and is pressing for other nations to have similar protection. In the TPP agreement, Australia has committed to providing a comparable outcome in the market to eight years of exclusivity but is robustly resisting extending its current five years of statutory protection. Partner Sarah Matheson and Special Counsel Ric Morgan report.

Following public consultation on proposed examination guidelines issued on 16 October 2015, the Commissioner of Patents has established a revised examination practice taking into account the High Court’s decision in <em>D’Arcy v Myriad Genetics Inc</em>. Dr Trevor Davies, Partner at Allens Patent &amp; Trade Mark Attorneys, looks at what the new guidelines will mean for innovators.

IP Australia has taken a pragmatic approach to the Myriad decision that will give comfort to Australia’s biotechnology industry and research organisations that they can continue to carry out biological R&D and be able to obtain patent protection for innovation in Australia. Partner Dr Trevor Davies reports.

The Federal Court has found that the packaging of the Little Kids Shredz children’s food range, produced by food giant Heinz, was misleading to consumers because it suggested the high sugar products were nutritious and healthy. A claim that is objectively true, such as ‘made from 99% fruit and vegetables’, may still be misleading if its implication is misleading. Partner Richard Hamer and Lawyer Eliza Lockhart report.

Australia’s unique statutory ‘best method’ requirement continues to get the better of patent applicants and patentees. Associate Claire Gregg looks at two recent decisions that provide some insight into the requirement of disclosing the best method known to the applicant of performing the invention at the time of filing the complete patent specification.

The Full Federal Court has unanimously held that patent term extensions are not available for second medical use claims involving the use of recombinant DNA technology. This decision overturns a controversial finding of the Administrative Appeals Tribunal last year and means that any patent term extensions granted on the basis of the AAT decision are now invalid. Associate Claire Gregg reports.

The Federal Government has released its response to the recommendations proposed by the Productivity Commission following its inquiry into Australia’s IP arrangements. The Productivity Commission’s review covered all areas of IP, as well as IP enforcement and international obligations. The Allens Intellectual Property team considers the Government’s response to some of the key recommendations.

The Therapeutic Goods Administration has released guidance on recent changes to the regulation of human cell and tissue products. Special Counsel Ric Morgan and Senior Associate Tracy Lu dissect the complex regulatory framework, particularly in relation to advertising.

The Intellectual Property Laws (Productivity Commission Response Part 1 and Other Measures) Act 2018 (Cth) commenced on 25 August 2018. The Act implements various recommendations that the Productivity Commission made in its inquiry into Australia’s IP arrangements. We discuss the key changes.