With over 150 rivaroxaban products approved (9 of them for Bayer), the outcome of the Sandoz challenge to the validity of the AU Bayer (Xarelto®) patents may be the case with the broadest commercial interest this decade.
Nine generic companies have multiple products approved (Accord (32); Alembic (28), Teva (24), Arrotex (23), Cipla (12), DRL (12), Torrent (12), Alphapharm (3), Sandoz (3)) and all of them will be disappointed by the impact of the first instance decision of Rofe J in Sandoz AG v Bayer Intellectual Property GmbH [2023] which was published last Friday.
The patents in suit are:
- AU2006208613 (19 Jan 2026) entitled “Prevention and treatment of thromboembolic disorders”;
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- Finding: valid and infringed.
- AU2004305226 (13 Nov 2024) entitled “Method for the production of a solid, orally applicable pharmaceutical composition”;
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- Finding: valid, but Bayer accepted this was not infringed based on the Court’s construction of the phrase “in hydrophilized form”.
Her Honour found the two Bayer patents in suit valid, and claims 3 and 4 of the ‘613 to be infringed (the 226 was not infringed by Sandoz). The decision is appealable to the Full Federal Court prior to 1 December 2023.
Further information:
Product: Rivaroxaban (Xarelto®)
Parties: Sandoz v Bayer
Stage: Post-judgment: decision handed down 02 Nov 2023
Filed: 19 Nov 2021
Next steps: Open for appeal until 1 December
Last week: Judgment 02 Nov 2023: Rivaroxaban (Bayer) patents valid (with certificate of validity granted); Sandoz threatened to infringe 2026 expiring 613 MOT patent. Open for appeal until 1 December.
Next week: n/a
Time to trial: 427 days
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.
Sian Hope
Lawyer
Sian is a driven intellectual property associate with a background in molecular genetics and experience in both private practice and within State Government. Sian’s experience working in medical research and advanced therapeutics policy supports Pearce IP’s clients on policy issues relating to the regulation of pharmaceutical/biopharmaceutical products in Australia.