Following on from our previous post in this series, in this article we look at the relevance of some major Australian cases, applications and appeals (referring to the Australian Register of Therapeutic Goods (ARTG) requirements) and by comparison, cases in the US and Europe.
First regulatory approval
i. Australia
In Australia, where claims in a pharmaceutical patent application encompass several pharmaceutical substances, the meaning of the phrase “first inclusion in the ARTG” is reference to the earliest date on which at least one substance falls within the scope of the claims, was included in the ARTG (Pfizer Corp v Commissioner of Patents (No 2) [2006] FCA 1176 at para [34]). The phrase “first inclusion in the ARTG” was also discussed in the case of Abbvie Biotechnology Ltd [2015] APO 45, whereby it was emphasised that the earliest regulatory approval date, was the date that the goods were first registered, and not the date of subsequent inclusions for various different indications.
However, in further illustrating the concept of “first inclusion in the ARTG”, the Australian case of Ono Pharmaceutical Co, Ltd v Commissioner of Patents [2021] FCA 643, has been significant, in that it was discussed whether a third-party pharmaceutical product falling within the scope of the claims of a pharmaceutical patent, constituted “first inclusion” on the ARTG. In this case, Ono Pharmaceuticals sought an extension of term on their patent for the pharmaceutical product Opdivo. The Australian Patent Office rejected Ono Pharmaceuticals’ application for an extension of term, on the grounds that Keytruda, a third party’s product, fell within the scope of the claims, and for which received an earlier regulatory approval date 9 months prior. Thus, in the Patent Office’s opinion, Keytruda was the “first inclusion” on the ARTG of a pharmaceutical product falling within the scope of the patent claims. Ono Pharmaceuticals subsequently appealed this decision, which was overturned by the Federal Court of Australia as it was held that an application for a patent term extension should be based on the patentee’s own product, and not that of a third-party. Therefore, interpretation of the terms “first inclusion in the ARTG” is reference to the earliest registered product on the ARTG of the patentee, and not to goods registered to third parties.
This interpretation was considered the more sensible approach, since this would be consistent with the entire purpose of the patent term extension regime, whereby patentees are able to restore time lost on their patent term due to the need to gain marketing approval when developing and commercialising a new pharmaceutical substance. The alternative interpretation would have required extensive searches to be conducted on the ARTG to check the “first inclusion” on the ARTG and whether or not this was a product of the Applicant to the extension of term or to a third party, which would be onerous and a burden to determine. In the Federal Court’s words, “a liberal rather than a literal construction (of the term “first inclusion in the ARTG”) is to be preferred”. Whilst the case did not discuss licensees or sponsors of an ARTG product, it is likely that such commercial arrangements will be considered favourably when assessing patent term extensions.
ii. United States
In the US, the first regulatory approval is in fact reference to the first regulatory approval of the “active ingredient”. Specifically, the “active ingredient” of a product must not have previously been approved by the FDA, either alone or in combination, for the patent claiming such to be eligible for a patent term extension. In considering chemical compounds, in the case of Ortho-McNeil v. Lupin (Fed. Cir. 2010) the Federal Circuit held that the enantiomer Levofloxacin, was eligible for a patent term extension, as it was different from its racemic compound ofloxacin, which was previously approved by the FDA. In another case of Photocure v Kappos (Fed. Cir. 2010) it was held that a patent covering the active methyl ester form of a drug product was not eligible for a patent term extension on the grounds that a previously approved product utilized the same active moiety for the same therapeutic use.
Even if a patent covered the same active ingredient but for a different therapeutic use, this would also not be eligible for a patent term extension, on the basis that the pharmaceutical product would have already received approval for marketing or use of this active ingredient. To illustrate this further, the case of Fisons v Quigg, 876 F.2d 99 (Fed. Cir. 1989) three different forms of a drug product were covered by separate patents, which all contained the same active ingredient, cromolyn sodium. Three separate applications for a patent extension of term were made for each of the three patents. However, in all three cases, the application was refused on the grounds that cromolyn sodium received prior FDA approval for a different use back in 1973. It was held by the Federal Circuit that the term “product” in the Act should be interpreted as the “active ingredient of a new drug”.
In considering this interpretation further, the case of Glaxo Operations UK Ltd v Quigg, 894 F.2d 392, 394 (Fed. Cir. 1990) discussed that the “active ingredient of a new drug” includes “any salt or ester of the active ingredient”. Specifically, in this case FDA approval was obtained for cefuroxime axetil, an ester of cefuroxime, an organic acid. The test used by the Federal Circuit in deciding whether the patent covering cefuroxime axetil was eligible for a patent term extension, relied on assessing whether cefuroxime axetil, or a salt or ester of cefuroxime ester had previously received FDA approval. Upon review, it turned out that there was prior regulatory approval of salts of cefuroxime acid, but not for cefuroxime axetil, or a salt or ester of cefuroxime ester. Thus, the patent covering cefuroxime axetil was eligible for a patent term extension.
Patentee seeking patent term extensions in the US must therefore be cautious, especially if their patent portfolio includes multiple patents covering different aspects of a particular FDA-approved product, for example one patent covering methods of use of the product, and another patent covering the composition of the product, since only one patent containing the “active ingredient” can receive a patent term extension.
Noticeably, this contrasts with the position in Australia, in that one patent term extension can be granted per patent, and patent term extensions can be applied to multiple patents that rely on the ARTG registration of a single pharmaceutical substance.
iii. Europe
A similar scenario exists in Europe, in that a product protected by a patent for which a SPC is sought, must not have previously received marketing authorisation (Santen, C-673/18). Thus, any new use of a product that previously received marketing authorisation is not eligible for a SPC (Abraxis Bioscience, C-443/17; Santen, C-673/18).
Crucially, the decision in Santen overturned the earlier decision of Neurim Pharmaceuticals (C-130/11), which otherwise held that SPCs could be granted on patents that covered second medical use on a pharmaceutical product that had already received marketing authorisation for a different application. The reason why the decision in Neurim Pharmaceuticals was overturned was because in Santen, the scope of the meaning of “different (therapeutic) application” was discussed on whether this term encompassed different formulations, dosages and/or other methods of administering the product. It was held by the Court of Justice of the European Union (CJEU) that a narrow interpretation should be applied. Specifically, it was held that “the first marketing authorisation” for a product is reference to the “first marketing authorisation for a medicinal product incorporating the active ingredient or the combination of active ingredients at issue irrespective of the therapeutic application of that active ingredient, or of that combination of active ingredients, in respect of which that marketing authorisation was obtained”. Thus, it was considered that the interpretation applied in Neurim would be erroneous, since this would otherwise result in SPCs being granted for all types of research. Specifically, it was held that the purpose of the SPC Regulations was “to protect research leading to the first placing on the market of an active ingredient or a combination of active ingredients as a medicinal product” (paragraph 55 of Santen), interpretations to the contrary would therefore not protect the interests of the public.
Part 4 of this guide will provide answers to some frequently asked questions about requirements and rights during the (pharmaceutical) extension of term
At Michael Buck IP, we have highly experienced attorneys who can assist in navigating this complex area. For additional information or advice relating to your pharmaceutical patent/s, please don’t hesitate to contact us.