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You are here: BAILII >> Databases >> England and Wales Court of Appeal (Civil Division) Decisions >> Newron Pharmaceuticals SPA v The Comptroller General of Patents, Trademarks And Designs [2024] EWCA Civ 128 (15 February 2024) URL: http://www.bailii.org/ew/cases/EWCA/Civ/2024/128.html Cite as: [2024] EWCA Civ 128 |
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ON APPEAL FROM THE HIGH COURT OF JUSTICE, BUSINESS AND PROPERTY COURTS OF ENGLAND AND WALES, INTELLECTUAL PROPERTY LIST (ChD)
Recorder Douglas Campbell KC
Strand, London, WC2A 2LL |
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B e f o r e :
LORD JUSTICE MOYLAN
and
LORD JUSTICE BIRSS
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Newron Pharmaceuticals S.p.A. |
Appellant |
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- and - |
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The Comptroller General of Patents, Trademarks and Designs |
Respondent |
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Dr Stuart Baran (instructed by Governement Legal Department) for the Respondent
Hearing dates: 24 January 2024
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Crown Copyright ©
Lord Justice Birss:
"1. The use of a first agent selected from safinamide from 0.5 to 1, 2, 3, 4 or 5 mg/kg/day in combination with levodopa/PDI, for the preparation of a medicament as a combined product for simultaneous, separated or sequential use for the treatment of Parkinson's disease."
First ground
"Article 1 Definitions
For the purposes of this Regulation, the following definitions shall apply:
(a) 'medicinal product' means any substance or combination of substances presented for treating or preventing disease in human beings or animals and any substance or combination of substances which may be administered to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in humans or in animals;
(b) 'product' means the active ingredient or combination of active ingredients of a medicinal product;
[…]
Article 3 Conditions for obtaining a certificate
A certificate shall be granted if, in the Member State in which the application referred to in Article 7 is submitted and at the date of that application:
(a) the product is protected by a basic patent in force;
(b) a valid authorisation to place the product on the market as a medicinal product has been granted in accordance with Directive 2001/83/EC or Directive 2001/82/EC, as appropriate;
(c) the product has not already been the subject of a certificate;
(d) the authorisation referred to in point (b) is the first authorisation to place the product on the market as a medicinal product.
[…]
"44. Under Article 4 of [the SPC Regulation], the protection conferred on the product by the SPC, although it extends only to the product covered by the MA, covers, on the other hand, any use of that product as a medicinal product which was authorised before the expiry of the SPC. It follows that the term 'product' within the meaning of Regulation 469/2009 is not dependent on the manner in which that product is used and that the intended use of the medicinal product does not constitute a decisive factor for the grant of an SPC (see, to that effect, judgment of 19 October 2004, Pharmacia Italia, C-31/03, EU:C:2004:641, paragraphs 19 and 20)."
[emphasis added]
"[…] I have to concern myself with determining what exactly is the medicinal product that has been approved and not just with its use or uses. Furthermore, such a focus on what the product is, rather than what it does, is consistent with the fact that what it does can change in the life of the MA but the product itself does not. […]"
[…] But as the case law shows, how a medicinal product is used does not form part of the identification of the product itself. In my judgment the brief references to irinotecan in explaining how cetuximab is used are wholly insufficient to amount to a marketing authorisation of a product consisting of both cetuximab and irinotecan. In short, I agree with the hearing officer for the reasons that he gave."
Lord Justice Moylan:
Lord Justice Lewison: