News & Insights

In a decision upon appeal, the Federal Court has clarified the start date for pharmaceutical companies applying for a patent term extension (PTE). During the proceedings, Judge Beach confirmed that the start of a six-month application window for a patent term extension (PTE) request is determined by a patentee’s own goods/substances, as opposed to substances listed on the Australian Register of Therapeutic Goods (ARTG) by third parties.

The decision is good news for pharmaceutical companies who were previously required to conduct time consuming research into earlier-listed third party products to determine the start date of the six-month application window for a PTE.

To fully understand the implications of Ono Pharmaceutical Co, Ltd v Commissioner of Patents [2021] FCA 643 (the Ono decision), it’s worth reviewing the key terms of the of the patent extension itself.

overview of patent term extensions

1. The Patents Act 1990 (Cth) (Patents Act) [i] allows a patent term for a pharmaceutical patent to be extended for up to an additional five years.
2. The basis for this extension is recognition that pharmaceutical patentees will almost always lose time to capitalise on their exclusive monopoly due to delays in obtaining regulatory approval (i.e. from the Australian Therapeutic Goods Regulator).
3. A PTE compensates patentees for any time lost between having a patent approved for a pharmaceutical product and obtaining regulatory approval to commercialise that product. [ii]
4. The length of a PTE granted is equal to the period between the filing date of the patent and the date of the first regulatory approval, reduced by a period of five years. [iii]

ono pharmaceutical co, ltd v commissioner of patents [2021] fca 643

This case concerned a request to extend the term of a patent (no. 2011203119) encompassing two cancer drugs: Merck Sharp & Dohme’s KEYTRUDA and Ono Pharmaceutical’s (Ono) OPDIVO, both of which received regulatory approval in Australia, but on different dates.

Historically in Australia, Section 71(2) of the Patents Act requires PTE applications to be filed within six months of the first listing on the ARTG of any product containing a pharmaceutical substance claimed within a patent – regardless of who filed and owned the relevant patent.

The question at issue was therefore which regulatory approval date was relevant for deciding the patentee’s PTE request.

Ono had simultaneously filed two PTE requests:

1. the first PTE request was based on the competitor product – KEYTRUDA, which had a regulatory approval date of 16 April 2015; and
2. the second PTE request was based on their own product – OPDIVO, which had a regulatory approval date of 11 January 2016.

Naturally, Ono would prefer to base their PTE timeframe on their own substance, OPDIVO, as it would result in a longer-term extension (an additional 8 months 26 days).

The Patent Office refused the patentee’s request to base their PTE on OPDIVO. They held that KEYTRUDA was listed on the ARTG first and therefore was to form the regulatory approval date for the basis of the patentee’s PTE request.

Ono elected to have the matter heard before the Federal Court.

the decision: providing commercially viable patent life for pharmaceutical products

Ultimately, Justice Beach of the Federal Court overturned the historical interpretation relied upon by the Commissioner of Patents and granted Ono their elected PTE.

The pertinent question was framed as followed:

1. “whether an application for an extension must be filed within 6 months of the first inclusion in the ARTG of goods containing or consisting of any pharmaceutical substance falling within the claims of the patent:
   • Where the goods were those of the patentee (Ono’s position); or
   • Irrespective of whether the goods were those of the patentee, that is, they could be the goods of a third party that had nothing to do with the patentee and, moreover, might be a competitor (the position taken by the Patent Office).” [iv]

Seemingly relying upon several extrinsic and secondary materials, Justice Beach noted that the purpose of PTE’s was to provide a commercially viable patent life for pharmaceutical products. Justice Beach implied that the reference to ‘substance’ within the legislation should not be construed as referring to the product of a stranger or competitor. [v]

His Honour rhetorically asked how the legislation would provide an effective patent life if the product on the ARTG triggering the start of the extension was not that of the patentee, but rather that of a stranger or indeed a competitor, concluding, “[t]hat would not provide an “effective life” for the patentee at all”. [vi]

His Honour ultimately held that the drug, which is the subject of the PTE application, is intended to be the drug of the patentee (here – Ono), as opposed to the drug of a third party.

implications and takeaways for pharmaceutical companies

Following the decision, the six-month window for filing a PTE application begins from the date on which a patentee’s own goods are included on the ARTG – not those belonging to a third party.

This stance is significantly more commercially viable for pharmaceutical companies as it dispenses the need to conduct time intensive and oftentimes futile research into earlier-listed third party products that may fall within the claims of a patentee’s own patent and related PTE application. [vii]

This stance better aligns Australia with the position adopted by other key markets around the world – including the United States of America.

For further insight on navigating the legal implications of landmark court decisions, contact Special Counsel Mark Metzeling.

[i] Chapter 6, Part 3
[ii] Ono Pharmaceutical Co, Ltd v Commissioner of Patents [2021] FCA 643, [2] – [5].
[iii] Patents Act 1990 (Cth) s 77
[iv][iv] Ono Pharmaceutical (n 1) [27].
[v] Ibid [55]-[72].
[vi] Ibid [62].
[vii] Ibid [163]-[170].