UK takes uncompromising approach to interpretation of "the product" under Art. 3(a) SPC Regulation (Newron v Comptroller [2023] EWHC 1471)

Recorder Douglas Campbell KC in the High Court recently handed down a decision ([2023] EWHC 1471) considering the interpretation of "product" in the SPC Regulation. The decision considered what it means for "the product" in Article 3(a) to be protected by a marketing authorisation (see also IPKat: The SPC alphabet). The marketing authorisation in the case specifically recited the active ingredient "safinamide". The indication was described as the use of safinamide as an add-on therapy to levodopa in Parkinson's disease (EU/1/14/984). The patent (EP (UK) 1613296) claimed safinamide in combination with levodopa for the manufacture of a medicament for the treatment of Parkinson's disease. The question before the court was whether "the product" under Article 3(a) of SPC Regulation should be interpreted as limited to the specific active ingredient recited by the marketing authorisation, i.e. safinamide by itself.

Case Background: XADAGO

Newron v Comptroller related to Newron pharmaceutical UK SPC application for its branded Parkinson's disease drug XADAGO (SPC/GB15/046). Newron applied for an SPC based on the basic patent EP (UK) 1613296 and the EU marketing authorisation for XADAGO (EU/1/14/984). The basic patent (EP1613296 B1) claimed safinamide in combination with levodopa for use in the manufacture of a medicament for the treatment of Parkinson's Disease (Swiss-style claim). The marketing authorisation recited safinamide, indicated for use in Parkinson's Disease as an add-on therapy to levodopa. The UKIPO refused the SPC application on the grounds that the marketing authorisation recited safinamide alone as the active ingredient, and not safinamide in combination with levodopa, as specified in the patent. 

The presence of levodopa in the label for XADAGO is not a surprise. It is common practice for new therapeutics to be approved for use in patients who are also receiving standard-of-care. For ethical reasons, clinical trials will also often be conducted in patients who continue to receive standard-of-care throughout the trial. 

Xadago

Legal Background: What is "the product"?

An often contentious issue in SPC cases is whether "the product" has the same meaning in different parts of the SPC Regulation. Article 3 states that an SPC shall be granted with respect to a product if the product is (a) protected by a patent, and (b) the subject of a granted marketing authorisation. However, national courts do not currently agree over whether "the product" should be interpreted the same in Article 3(a) as in Article 3(b) (IPKat). The various interpretations of "the product" in SPC Regulation underlie the contradictions for which SPC case law is notorious (IPKat). 

The key question in the present case was what it means for a "product" to be the subject of a granted marketing authorisation (Article 3(b)). The judge agreed with the UKIPO Hearing Office that Yeda ([2010] EWHC 1733 (Pat)) was the relevant UK case for answering this question. Yeda concluded that, under the SPC Regulation, "how a medicinal product is used does not form part of the identification of the product itself”. The judge also found Yeda to be entirely consistent with the (latest) CJEU case law on the topic, specifically Santen (C-673/18) (para. 29). 

The judge was also of the view that "the product" should be interpreted the same in all limbs of Article 3 of the SPC Regulation. The judge particularly rejected Newron's argument that "the product" may have a broader interpretation in Article 3(b) with respect to marketing authorisation than in Article 3(a) with respect to the patent. 

The product is the active ingredient recited by the marketing authorisation

Having decided on Yeda as the relevant case law, the judge then addressed whether the marketing authorisation for XADAGO (EU/1/14/984) should be understood as restricted to safinamide, the sole active ingredient recited by the authorisation. However, whilst safinamide was the recited active ingredient, the authorisation was for safinamide indicated for the treatment of Parkinson's disease "as and add-on therapy to a stable dose of Levodopa". 

Newron argued that because safinamide was an add-on therapy, it would always be used in combination with levodopa. The "product" under Article 3(b) should therefore be considered to be "safinamide as an add-on therapy to levodopa". However, the judge rejected this argument in favour of a rigid application of Yeda. The judge particularly rejected any argument that sought to "import the therapeutic use into the definition of the product", and took the view that such any attempt would be "contrary to the case law" (para. 44). Whilst the judge agreed that the facts of Yeda were different to the case in question, he did not consider this to make any difference "to its logic." (para. 48)

The judge concluded that the marketing authorisation was for safinamide alone, and that the "product" under Article 3(b) was "safinamide", not "safinamide in combination with levodopa". The judge noted Newron's submission that this approach "effectively gave the applicant no route to success”, but rebutted that he did not "consider that to be a proper criticism. The Hearing Officer was obliged to apply the SPC Regulation, not to give the applicant a route to success". 

The judge thus dismissed the appeal, agreeing with the UKIPO that the SPC application did not satisfy the requirement of Article 3(b) SPC. 

Final thoughts

A stumbling block to the SPC application in this case was the claim format of the basic patent. Claim 1 was in the now obsolete Swiss-style format, claiming "The use of [...] safinamide [...] in combination with levodopa [...], for the preparation of a medicament as a combined product for simultaneous, separated or sequential use for the treatment of Parkinson's Disease" (see IPKat: History of the second medical use claim). The hypothetical question remains of how an SPC application based on an EPC 2000 second medical use claim would have fared. Such a claim may have more closely mirrored the marketing authorisation itself, i.e. "safinamide for use as an add-on therapy in the treatment of PD in a patient, wherein the patient is receiving levodopa". [Merpel admits to finding the whole decision rather bizarre, given that both the marketing authorization and the patent in the case were directed to safinamide as an add-on therapy to levodopa, as supported by the clinical data]. 

Notably, patent term extension (PTE) was granted in the US for the corresponding US patent (US8283380 B2), based on the FDA authorisation for safinamide as adjunctive treatment to levodopa, and a patent claim directed to the "method of treatment of Parkinson's disease in a patient receiving a stable dose of levodopa" comprising administering safinamide. It is also worthy of note that the judge in this case applied EU SPC case law given that the SPC application was filed pre-Brexit. The majority of EU countries (including France, Italy and Spain) have granted the corresponding XADAGO SPCs, whilst Sweden has refused the Swedish SPC application (PMÄ 5610-18). If nothing else, the present case highlights the lack of a uniformed interpretation of the SPC Regulation by the national patent offices of Europe. 

Further reading

• The SPC alphabet: Are combination product SPCs precluded by Article 3(a), (c) and/or (d)? (Dec 2021)
• SPCs based on a second marketing authorisation - the fight continues (Novartis C-354/19) (Jun 2019)
• Article 3(a) just keeps on giving: AG Opinion in SPC referrals C-650/17 and C-114/18 (Sep 2019)
• Does the Irish Court of Appeal in Merck v Clonmel part ways from the CJEU's Santen Article 3(d) decision? (May 2021)
• New SPC referral to the CJEU on the interpretation of Art 3(a) and (c) for combination products (Merck v Clonmel) (March 2022)