On 16 February 2024, IP Australia published that Ono Pharmaceutical Co. Ltd (Ono) was granted a patent term extension (PTE) in respect of its Australian Patent No. 2011203119 (Patent). This is the quiet conclusion to Ono’s dispute with the Patent Office relating to OPTIVO® (nivolumab) which culminated in an appeal court decision rejecting its previous application for PTE.
We have previously written about Ono’s application for a PTE for this Patent which, in the absence of PTE, would expire on 2 May 2026. The Patent covers the blockbuster cancer drugs OPDIVO® (Ono’s product) and, indirectly KEYTRUDA® (pembrolizumab, competitor Merck’s product). Regulatory approval for Ono’s OPDIVO® and Merck’s KEYTRUDA® in Australia was obtained on 11 January 2016 and 16 April 2015, respectively.
The Courts have confirmed that an Australian patent can be extended based on a competitor’s product. To recap:
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Ono filed two requests for PTE for AU 2011203119, the first based on its approval for OPDIVO® and the second (which was stayed by the patent office pending resolution of the first) based on KEYTRUDA®.
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The Patent Office denied Ono’s request for PTE based on OPDIVO®, which was ultimately upheld by the Court.
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On appeal to the Federal Court, Beach J overturned the decision, finding that the PTE provisions of the Patents Act which require PTE to be based on the earliest regulatory approval, were not intended to encompass competitor products.
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The Commissioner appealed to the Full Federal Court, which confirmed that PTEs must be based on the first approved product, even if that is a competitor’s product.
While Ono’s request for PTE based on its OPDIVO® failed, the separate extension application based on Merck’s KEYTRUDA® has now succeeded. The new extended expiry date for the Patent (16 April 2030) is about 9 months shorter than the expiry date of 11 January 2031 which the Full Court rejected. A 4 year extension is better than none.
Under Australian law, there is no limit to the number of patents that can be extended for a given product, provided that patentability and eligibility criteria are met. If Ono had separate patents to each of OPTIVO and KEYTRUDA, it would not have had to choose between the two products when considering its PTE. It would be prudent for patentees to now deploy divisional strategies to ensure they secure patents specific to each product covered by the claims of the parent patent to maximise both the number and length of PTE eligibility. Ono’s failure to do so, cost it 9 months in patent term.
The AU PTE issue is a minor part of a global patent dispute between Merck and Ono (and Ono’s collaborator Bristol-Myers Squibb (BMS)). Ono/BMS co-developed the first PD-1 antibody (OPDIVO®) and sued Merck in 2014 alleging patent infringement in relation to the sale of KEYTRUDA® in markets including the US, Europe, Australia and Japan. Ultimately Ono/BMS and Merck reached settlement which resulted in a licence.
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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.
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Chris Vindurampulle PhD
Executive, Patent & Trade Mark Attorney
Chris is a senior Patent and Trade Mark Attorney who is registered to practice before the intellectual property offices of Australia and New Zealand. He is experienced in patent drafting, patent and trade mark prosecution and opposition, and freedom to operate, opinion and due diligence work. Through his experience and delivery of highly-regarded client service, Chris has been recognised as a leading patent practitioner having been listed in the IAM Patent 1000 as a recommended individual for patent prosecution, and a Rising Star in 2021, 2022 and 2023 by Managing IP.
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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.