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Full Federal Court clarifies rules for patent term extensions – Part 1

by , | Mar 25, 2022

Fibre Optics

Merck Sharp & Dohme & Anor v Sandoz Pty Ltd [2022] FCAFC 40




18 March 2022

Full Federal Court of Australia

Allsop CJ, Yates and Burley JJ


Australian patent law permits an extension of term, of up to five years, on patents that cover approved pharmaceutical substances.  Under the relevant provisions, an extension of term application must be made based on the “first regulatory approval date” of a pharmaceutical substance covered by the patent, and at least five years must have elapsed between the effective filing date of the patent application and the first regulatory approval date. 

The case concerned a patent term extension (PTE) granted in respect of Merck’s Patent No. 2002320303 (Patent), covering both sitagliptin and a combination of sitagliptin and metformin, which are used in the treatment of diabetes.  Merck’s Januvia® product (sitagliptin alone) was approved first, and less than five years after the relevant patent date.  Merck’s Janumet®, the combination product, was approved later.

Merck obtained a PTE based on Janumet®.   It commenced proceedings against Sandoz for threatened patent infringement.  Sandoz gave undertakings that it would not launch its sitagliptin product until after the original expiry date of the Patent but refused to give undertakings in respect of the PTE period, alleging that the PTE was not valid since it should have been based on the approval date of Januvia®, as the “first regulatory approval date”.  It counterclaimed in the proceedings seeking revocation of the PTE. 

Key Issues

Merck contended that the term “earliest first approval date” in the context of the relevant PTE provisions did not cover Januvia® because at least five years had not elapsed between the date of the patent and its regulatory approval.  Therefore, Merck’s position was that the regulatory approval of the combination product of sitagliptin and metformin qualified as the earliest first approval date. 

In contrast, Sandoz submitted that the “earliest first approval date” related to any pharmaceutical substances covered by the patent regardless of whether it rendered the patent ineligible for a term extension.  Under this interpretation, the regulatory approval of Januvia® would be considered the earliest first approval date, making the patent ineligible for a term extension.


At first instance, Jagot J concluded that the PTE granted on the basis of Janumet® was invalid.  On her construction of the relevant statutory provisions, the ‘first regulatory approval date’ is the first ARTG approval date for the group of products covered by the patent.  Here, that was the approval date for Januvia® and since it was approved within five years of the relevant patent date, no extension was available.  The submission that the patentee could effectively choose between different approval dates for different products was rejected.

On appeal, the Full Court affirmed Jagot J’s reasoning in a unanimous judgment.  This followed from a straightforward reading of the relevant provisions.  However, the Full Court also rejected the submission that such a result was contrary to policy.  It emphasised that the purpose of the PTE scheme is to balance the competing interests of a patentee whose exploitation of its monopoly has been delayed due to regulatory requirements and the public interest in the unrestricted use of the pharmaceutical invention after patent expiry.  This was consistent with the recently introduced objects clause of the Patents Act 1990 (Cth) which also refers to balancing the interests of producers, owners and users of technology, and the public.  The fact that the earlier product could be exploited from a time less than five years after the relevant patent date achieved the policy objective and a reasonable balance between the competing interests at play.


The Full Court’s confirmation of Merck likely leaves a number of PTEs vulnerable to attack, potentially shortening the effective patent period for significant commercial products.   There has already been one instance of this (see our report on Bayer Pharma Aktiengesellschaft [2022] APO 7 at page 38), in which a third party successfully obtained rectification of the Patent Register in the Patent Office to remove a PTE on Bayer’s patent covering its successful YASMIN and YAZ oral contraceptive products.  Such strategies provide a cost effective and swift avenue to challenge PTEs, noting also that Merck demonstrates that a case of this kind can also be litigated in the Court to appeal conclusion in just over one year from issuing of proceedings.

About Pearce IP

Pearce IP is a boutique firm offering intellectual property specialist lawyers, patent attorneys and trade mark attorneys to the pharmaceutical, biopharmaceutical and life sciences industries.  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.  Pearce IP leaders are well recognised as leading IP practitioners.

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, Women in Law Awards – Partner of the Year, Best Lawyers and Australasian Lawyer 5 Star Awards, Women in Business Law Awards – Patent Lawyer of the Year (Asia Pacific), Most Influential Lawyers (Changemaker), among other awards.

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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.

Kate Legge

Kate Legge

Special Counsel, Lawyer

Kate is an experienced IP and patent lawyer, providing IP leadership for pharmaceutical product development and commercialisation in global markets – from initial scoping through to post-launch.

She has developed and implemented global IP strategies over more than 15 years at multi-national pharmaceutical companies. She is an Australian qualified and registered legal practitioner, and has a Master’s degree in IP Law and a BSc in biochemistry.

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