A bet both ways wins PTE for Ono for OPDIVO® (nivolumab) patent based on MSD’s KEYTRUDA® (pembrolizumab)

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:

• 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®.

• The Patent Office denied Ono’s request for PTE based on OPDIVO®, which was ultimately upheld by the Court.

• 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.

• 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.

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.