Changes in costs for Australian patents
An important procedural change is being introduced in the process for obtaining an Australian patent.
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A Supplementary Protection Certificate (SPC) is a form of intellectual property designed to extend the protection period for patented active ingredients found in pharmaceutical or plant protection products. It compensates for the time lost during the patent term due to regulatory approval processes for such products.
A key requirement for obtaining an SPC for a patented pharmaceutical product in the UK is that a valid authorisation to place the product on the market has been granted (Article 3(b) of Regulation (EC) No. 469/2009).
A recent UK Court of Appeal decision ([2024] EWCA Civ 128) tackled the question of how the term “product” is interpreted in the context of SPCs for pharmaceuticals.
This case involved a further appeal by Newron Pharmaceuticals against the Comptroller’s refusal to grant an SPC under Article 3(b) of Regulation (EC) No. 469/2009. The refusal was based on the contention that the product claimed in the patent differed from the product covered by the marketing authorisation.
The patent held by Newron and on which the SPC application was based (EP (UK) 1613296) pertained to a Parkinson’s disease treatment involving the use of a combination of three active ingredients, safinamide, levodopa and a peripheral decarboxylase inhibitor (PDI).
Marketing authorisation was obtained for safinamide under the brand name Xadago. Although the authorisation was for safinamide alone, the Summary of Product Characteristics (SmPC) section of the marketing authorisation indicated its use as an add-on therapy to levodopa alone or with other PDIs.
The Comptroller refused the SPC, arguing that the marketing authorisation only applied to safinamide, not the combination of all three active ingredients as claimed in the patent.
The judge emphasised that an SPC requires alignment between the patent and the marketing authorisation – the patented product must match the authorised product.
The judge stated it was clear that the claims of the patent related to a combination of three active ingredients: safinamide, levodopa and PDI; and defined this combination as the “product” protected by the patent
The judge recognised that the SmPC showed that safinamide could be used as an add-on therapy to levodopa alone or in combination with other Parkinson’s disease medicinal products. However, the crucial question was whether the marketing authorisation “authorised” the combination claimed in the patent.
With reference to previous UK and EU case law, the judge determined that the definition of the term “product” in relation to a marketing authorisation is the actual active ingredient or combination of active ingredients for which the authorisation has been obtained. The intended use of the authorised active ingredient is not taken into account when defining the term “product” and is not a decisive factor for the grant of an SPC.
Whilst the SmPC described that safinamide could be used with other compounds, this description did not “authorise” the marketing of the other compounds. In fact, the judge stated that all the marketing authorisation actually authorised was for safinamide to be placed on the market as the medicinal product Xadago. As such, the description in the SmPC did not contribute towards the definition of the “product” in the context of the SPC regulations.
Based on this, the judge concluded that the product protected by the patent (combination of safinamide, levodopa and a PDI) was not the same as the product for which marketing authorisation was obtained (safinamide alone).
The judge therefore upheld the Comptroller’s initial decision to refuse the SPC.
This decision clarifies that the term “product” is interpreted strictly and refers to the specific composition for which marketing authorisation is obtained, and not to the composition’s intended therapeutic use.
It underscores the importance of aligning the patented product precisely with the authorised product. If seeking an SPC for a combination product, obtaining authorisation for that specific combination is essential, not just for individual ingredients.
For more advice regarding the Supplementary Protection Certificates, please get in touch with us.