Last year, we reported on Sandoz’ victory in its appeal regarding the validity of two of Bayer’s Australian Xarelto® (rivaroxaban) patents. In that appeal, the Full Court unanimously overturned the primary judge’s decision, holding that the two Bayer patents lacked an inventive step in light of the common general knowledge taken together with a prior art patent specification. Bayer applied to the High Court of Australia for special leave to appeal the Full Court’s decision. Last week, the High Court refused Bayer’s special leave application on the basis that Bayer’s application did not raise an issue of principle sufficient to warrant a grant of special leave and that the proposed appeal had insufficient prospects of success.
The High Court’s rejection of Bayer’s special application is important for two key reasons. First, it marks the end of the road for Bayer’s domination of the Australian rivaroxaban market. Secondly, it means that the Full Court’s decision stands, a significant decision which has clarified the bar that needs to be met to prove obviousness and which has recalibrated the “ascertainment” test under the “pre-Raising the Bar” version of the Australian Patents Act.
About Pearce IP
Pearce IP is a boutique firm offering intellectual property specialist lawyers, patent attorneys and trade mark attorneys to the life sciences industries (in particular, pharmaceutical, biopharmaceutical, biotech, ag-tech and food tech). Pearce IP is the 2021 ‘Intellectual Property Team of the Year’ (Lawyers Weekly Australian Law Awards) and was shortlisted for the same award in 2022. Pearce IP is ranked in IAM Patent 1000 and Managing IP (MIP) IP Stars, in Australasian Lawyer 5 Star Awards as a ‘5 Star’ firm, and the Legal 500 APAC Guide for Intellectual Property.
Our leaders have been recognised in virtually every notable IP listing for their legal, patent and trade mark excellence including: IAM Patent 1000, IAM Strategy 300, MIP IP Stars, Doyles Guide, WIPR Leaders, 5 Star IP Lawyers, Best Lawyers, and Australasian Lawyer 5 Star Awards, and have been honoured with many awards including Australian Law Awards – IP Partner of the Year, Women in Law Awards – Partner of the Year, Women in Business Law Awards - Patent Lawyer of the Year (Asia Pacific), Most Influential Lawyers (Changemaker), among other awards.
Naomi Pearce
CEO, Executive Lawyer (AU, NZ), Patent & Trade Mark Attorney (AU, NZ)
Naomi is the founder of Pearce IP, and is one of Australia’s leading IP practitioners. Naomi is a market leading, strategic, commercially astute, patent lawyer, patent attorney and trade mark attorney, with over 25 years’ experience, and a background in molecular biology/biochemistry. Ranked in virtually every notable legal directory, highly regarded by peers and clients, with a background in molecular biology, Naomi is renown for her successful and elegant IP/legal strategies.
Among other awards, Naomi is ranked in Chambers, IAM Patent 1000, IAM Strategy 300, is a MIP “Patent Star”, and is recognised as a WIPR Leader for patents and trade marks. Naomi is the 2023 Lawyers Weekly “IP Partner of the Year”, the 2022 Lexology client choice award recipient for Life Sciences, the 2022 Asia Pacific Women in Business Law “Patent Lawyer of the Year” and the 2021 Lawyers Weekly Women in Law SME “Partner of the Year”. Naomi is the founder of Pearce IP, which commenced in 2017 and won 2021 “IP Team of the Year” at the Australian Law Awards.
Helen Macpherson
Executive, Lawyer (Head of Litigation –Australia)
Helen has over 25 years’ experience as an intellectual property specialist and is recognised as an industry leader. Helen advises on all forms of intellectual property including patents, plant breeder’s rights, trade marks, copyright and confidential information.
Throughout her career, Helen has maintained a strong focus on high-value patent mandates involving complex technologies. In these mandates, Helen has been able to draw upon her technical training in biochemistry and molecular biology, as well as her ability to up-skill swiftly in relation to diverse technologies. Helen’s patent work has encompassed the technical fields of inorganic, organic, physical and process chemistry, biochemistry, biotechnology (including genetics, molecular biology and virology) and physics.
Helen is a member of the Intellectual Property Committee of the Law Council of Australia, as well as a member of the Intellectual Property Society of Australia and New Zealand.