Supplementary Protection Certificates - Newron Pharmaceuticals SpA v Comptroller
This was an appeal by Newron Pharmaceutical SpA ("Newron") against the decision of Dr L Cullen in Re SPC/GB15/046, Newron Pharmaceuticals S.p.A v Comptroller BLO/1053/22 1 Dec 2022. Newron is the proprietor of European patent (UK) 1613296 B1 for Methods for treatment of Parkinson's disease ("the Patent") which will expire on 24 April 2024. The appellant sought a supplementary protection certificate ("SPC") for a combination product comprising safinamide and “levodopa/PDI”, that is to say, a levodopa and a peripheral decarboxylase inhibitor (PDI) such as carbidopa. The hearing officer refused the application on the grounds that it did not meet the requirements of art 3 (b) of Regulation (EC) No. 469/2009 (“the SPC Regulation”). The appeal came on before Mr Douglas Campbell KC sitting as a deputy judge of the High Court on 26 May 2023. By para [57] of his judgment in Newron Pharmaceuticals SpA v Comptroller-General of Patents, Trade Marks and Designs [2023] EWHC 1471 which he handed down on 16 June 2023, Mr Campbell dismissed the appeal.
Supplementary Protection Certificates
In Supplementary Protection Certificates I wrote:
"A supplementary protection certificate ("SPC") is an intellectual property right ("IPR") that protects the active ingredients in pharmaceutical or plant protection products. The right comes into force upon the expiry of a patent for such a product. The rationale for SPCs is that new pharmaceutical and plant protection products cannot be marketed unless and until they are found to be safe by the relevant national or European authorities. Evaluating the safety of a new drug or plant protection product can take time. As the maximum term of a patent is 20 years the time waiting for such evaluation reduces the effective term of the monopoly. The purpose of an SPC, as Lord Justice Floyd explained in Teva UK Ltd and others v Gilead Sciences, Inc [2019] EWCA Civ 2272 (19 Dec 2019), is, therefore, to compensate the patentee for such lost time by protecting the active ingredient of the pharmaceutical or plant protection patent for up to 5 years (or in the case of a product used for treating children a further 6 months) after the expiry of the patent."
"A supplementary protection certificate ("SPC") is an intellectual property right ("IPR") that protects the active ingredients in pharmaceutical or plant protection products. The right comes into force upon the expiry of a patent for such a product. The rationale for SPCs is that new pharmaceutical and plant protection products cannot be marketed unless and until they are found to be safe by the relevant national or European authorities. Evaluating the safety of a new drug or plant protection product can take time. As the maximum term of a patent is 20 years the time waiting for such evaluation reduces the effective term of the monopoly. The purpose of an SPC, as Lord Justice Floyd explained in Teva UK Ltd and others v Gilead Sciences, Inc [2019] EWCA Civ 2272 (19 Dec 2019), is, therefore, to compensate the patentee for such lost time by protecting the active ingredient of the pharmaceutical or plant protection patent for up to 5 years (or in the case of a product used for treating children a further 6 months) after the expiry of the patent."
The Patent
Claim 1 of the Patent claimed:
Mr Campbell described its operation in para [3] of his judgment:
"PDI is the abbreviation for a Peripheral Decarboxylase Inhibitor. As the Hearing Officer explained at [10] of his decision, the role of the PDI is to inhibit the breakdown of levodopa while travelling through the bloodstream of the body to the brain. Once the levodopa crosses the blood-brain barrier, which the PDI cannot, the levodopa exerts its therapeutic effect."
The hearing officer held that the above claim related to a combination of safinamide, levodopa and PDI to treat Parkinson's disease and that it was this combination that had been patented.
The Hearing Officer's Decision
Art 3 of the SPC Regulation provides:
"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:
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(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.
"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:
.......................
(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.
........................................................"
The SPC application was for the patented combination. Dr Cullen rejected the application on the ground that the marketing authorization had been for XADAGO alone and not for the patented combination. XADAGO is the brand name for safinamide which was the active ingredient, In the hearing officer's view, the marketing authorization did not extend to safinamide in combination with both levodopa and a PDI. He therefore dismissed the application,
The Appeal
Newron appealed against the hearing officer's finding that the marketing authorization was for the active ingredient safinamide alone and contended that that authorization related to safinamide in combination with both levodopa and a PDI.
Relying on the opinion of Mrs Advocate-General Trstenjak in Case C-322/10, Medeva BV v Comptroller-General of Patents Designs and Trade Marks [2011] EUECJ C-322/10 (13 July 2011), RPC 25 Newron argued that the word "product" in art 3 (b) of the SPC Regulation had a wider meaning than in the other paragraphs of the article and contended that it could include a combination of ingredients. Mr Campbell rejected that submission on the grounds that "product" had been defined by art 1 (b) of the SPC Regulation, that Medeva was about art 3 (a) and the Court of Justice's judgment was more limited than the opinion of the Advocate-General had been (Case C-322/10, Medeva BV v Comproller-Geberal of Patents, Designs and Trade Marks ECLI:EU: C:2011:773, [2011] EUECJ C-322/10, EU: C:2011:773).
Yeda
Most of the litigation on SPCs has concerned art 3 (a) and not art 3 (b) of the SPC Regulation. The most relevant authority on art 3 (b) was Yeda Research and Development Company Ltd v Comptroller General of Patents [2010] EWHC 1733 (Pat). In that case, the applicant applied for an SPC for cetuximab and irinotecan, in combination where the marketing authorization had been for “Erbitux - cetuximab". Erbitux was the name of the relevant medicinal product and cetuximab had been the active ingredient. The hearing officer concluded that the marketing authorization could not be the basis for an SPC (see Imclone Systems Inc. and another v Comptroller BL9/066/10 23 Feb 2023). On appeal, Mr Justice Lewison considered what was meant by a "product" for the purpose of art 3 (b). He said in para [19] of his judgment:
"To my mind it is clear from recital (10) and from the case law that what constitutes a “product” is to be strictly construed: Generics (UK) Ltd v Daiichi Pharmaceutical Co Ltd [2009] EWCA Civ 646, [2009] RPC 23, CA. In deciding what is a 'product' one must focus, as the hearing officer put it, 'on what the product is, rather than what it does.' As the ECJ said in Case C-202/05 Yissum Research and Development Co v Comptroller-General (§ 18): 'It follows that the concept of “product” cannot include the therapeutic use of an active ingredient protected by a basic patent.'”
Most of the litigation on SPCs has concerned art 3 (a) and not art 3 (b) of the SPC Regulation. The most relevant authority on art 3 (b) was Yeda Research and Development Company Ltd v Comptroller General of Patents [2010] EWHC 1733 (Pat). In that case, the applicant applied for an SPC for cetuximab and irinotecan, in combination where the marketing authorization had been for “Erbitux - cetuximab". Erbitux was the name of the relevant medicinal product and cetuximab had been the active ingredient. The hearing officer concluded that the marketing authorization could not be the basis for an SPC (see Imclone Systems Inc. and another v Comptroller BL9/066/10 23 Feb 2023). On appeal, Mr Justice Lewison considered what was meant by a "product" for the purpose of art 3 (b). He said in para [19] of his judgment:
"To my mind it is clear from recital (10) and from the case law that what constitutes a “product” is to be strictly construed: Generics (UK) Ltd v Daiichi Pharmaceutical Co Ltd [2009] EWCA Civ 646, [2009] RPC 23, CA. In deciding what is a 'product' one must focus, as the hearing officer put it, 'on what the product is, rather than what it does.' As the ECJ said in Case C-202/05 Yissum Research and Development Co v Comptroller-General (§ 18): 'It follows that the concept of “product” cannot include the therapeutic use of an active ingredient protected by a basic patent.'”
He added in para [26]:
“… art.1 of the decision plainly identifies the medicinal product, “Erbitux—cetuximab” as the subject-matter of the authorisation. No other medicinal product is identified. The direction to enter that product in the Community Register of Medicinal Products is to the same effect. Art.3 specifies the form of the labelling and package leaflet. The outer packaging makes no mention of irinotecan at all. The package leaflet contains two brief mentions of irinotecan in explaining how cetuximab is used. The summary of the product characteristics likewise contains brief mentions of irinotecan in explaining how cetuximab is used. 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.”
Whether Yeda was wrongly decided
Newron contended that Yeda had been wrongly decided and should not be followed. The learned deputy judge disagreed.
In Case C-31/03, Pharmacia Italia SpA v German Patent Office [2004] EUECJ C-31/03, [2005] RPC 27, [2004] ECR I-10001, the Court of Justice of the Europen Union said at para [20]:
“… art.1 of the decision plainly identifies the medicinal product, “Erbitux—cetuximab” as the subject-matter of the authorisation. No other medicinal product is identified. The direction to enter that product in the Community Register of Medicinal Products is to the same effect. Art.3 specifies the form of the labelling and package leaflet. The outer packaging makes no mention of irinotecan at all. The package leaflet contains two brief mentions of irinotecan in explaining how cetuximab is used. The summary of the product characteristics likewise contains brief mentions of irinotecan in explaining how cetuximab is used. 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.”
Whether Yeda was wrongly decided
Newron contended that Yeda had been wrongly decided and should not be followed. The learned deputy judge disagreed.
In Case C-31/03, Pharmacia Italia SpA v German Patent Office [2004] EUECJ C-31/03, [2005] RPC 27, [2004] ECR I-10001, the Court of Justice of the Europen Union said at para [20]:
"It follows, first, that the decisive factor for the grant of the certificate is not the intended use of the medicinal product and, second, that the purpose of the protection conferred by the certificate relates to any use of the product as a medicinal product without any distinction between use of the product as a medicinal product for human use and as a veterinary medicinal product."
Mr Campbell observed in para [15] of his judgment:
"Thus the important point was the product itself, not how it had been (or how it was intended to be) used."
"Thus the important point was the product itself, not how it had been (or how it was intended to be) used."
That point was confirmed by the Court's judgment in Case C-431/04, Massachusetts Institute of Technology v German Patent Office [2006] EUECJ C-431/04, [2006] RPC 34, [2006] ECR I-4089, EU: C:2006:291, ECLI:EU: C:2006:291. There it was asked to consider whether an SPC could be granted for an already authorized ingredient when used in a different combination. The Court held that the use of the already authorized ingredient in combination with a different ingredient was irrelevant for the following reasons:
"[25] In the light of the foregoing, the inevitable conclusion is that a substance which does not have any therapeutic effect of its own and which is used to obtain a certain pharmaceutical form of the medicinal product is not covered by the concept of “active ingredient”, which in turn is used to define the term 'product'.
[26] Therefore, the alliance of such a substance with a substance which does have therapeutic effects of its own cannot give rise to a “combination of active ingredients” within the meaning of Art.1 (b) of Regulation No 1768/92.
[27] The fact that the substance without any therapeutic effect of its own renders possible a pharmaceutical form of the medicinal product necessary for the therapeutic efficacy of the substance which does have therapeutic effects cannot invalidate that interpretation”
"[25] In the light of the foregoing, the inevitable conclusion is that a substance which does not have any therapeutic effect of its own and which is used to obtain a certain pharmaceutical form of the medicinal product is not covered by the concept of “active ingredient”, which in turn is used to define the term 'product'.
[26] Therefore, the alliance of such a substance with a substance which does have therapeutic effects of its own cannot give rise to a “combination of active ingredients” within the meaning of Art.1 (b) of Regulation No 1768/92.
[27] The fact that the substance without any therapeutic effect of its own renders possible a pharmaceutical form of the medicinal product necessary for the therapeutic efficacy of the substance which does have therapeutic effects cannot invalidate that interpretation”
Mr Campbell noted that the definition of “product” did not include the new ingredient, even though its presence improved the performance of the previously authorized ingredient.
In Case C-202/05, Yissum Research and Development Co v Comptroller of General of Patents [2007] ECR I-2839, [2007] EUECJ C-202/05 the applicant relied on a second medical use patent relating to the rise of an ingredient for the relief of skin disorders where there had already been two marketing authorizations for the combinations that had included that ingredient. The Court held as follows:
"[17] It is clear from Massachusetts Institute of Technology, and, in particular, from paragraphs 19, 21, 23 and 24 of that judgment, that the concept of 'product' referred to in Article 1(b) of Regulation No 1768/92 must be interpreted strictly to mean ‘active substance' or active ingredient'.
[18] It follows that the concept of 'product' cannot include the therapeutic use of an active ingredient protected by a basic patent.
[19] Moreover, the same interpretation can be inferred from paragraph 20 of the judgment in Case C-31/03 Pharmacia Italia [2004] ECR I-10001, in which the Court held that ‘the decisive factor for the grant of the certificate is not the intended use of the medicinal product and … the purpose of the protection conferred by the certificate relates to any use of the product as a medicinal product without any distinction between use of the product as a medicinal product for human use and as a veterinary medicinal product’
"[17] It is clear from Massachusetts Institute of Technology, and, in particular, from paragraphs 19, 21, 23 and 24 of that judgment, that the concept of 'product' referred to in Article 1(b) of Regulation No 1768/92 must be interpreted strictly to mean ‘active substance' or active ingredient'.
[18] It follows that the concept of 'product' cannot include the therapeutic use of an active ingredient protected by a basic patent.
[19] Moreover, the same interpretation can be inferred from paragraph 20 of the judgment in Case C-31/03 Pharmacia Italia [2004] ECR I-10001, in which the Court held that ‘the decisive factor for the grant of the certificate is not the intended use of the medicinal product and … the purpose of the protection conferred by the certificate relates to any use of the product as a medicinal product without any distinction between use of the product as a medicinal product for human use and as a veterinary medicinal product’
The deputy judge summarized the case law as follows in para [20]:
"The word 'product' must be interpreted strictly to mean the relevant active ingredient, and does not include the therapeutic use of that product. Hence it is not relevant to consider whether any new therapeutic use of the product provides valuable benefits."
"The word 'product' must be interpreted strictly to mean the relevant active ingredient, and does not include the therapeutic use of that product. Hence it is not relevant to consider whether any new therapeutic use of the product provides valuable benefits."
In Abraxis Bioscience LLC v The Comptroller-General of Patents, Designs and Trade Marks [2017] EWHC 14 (Pat), Mr Justice Arnold had to consider whether art 3 (d) of the SPC Regulation permitted SPCs to be obtained for new formulations of old ingredients. He held that it did not even though this might deprive meritorious inventions of extended protection. It was more important that the SPC Regulation should provide a simple and predictable system which could be operated by national patent offices in a uniform manner. Also, the SPC Regulation aimed to balance the interests of patentees with those of other stakeholders.
In Case C‑673/18 Santen SAS v Directeur général de l’Institut national de la propriété industrielle, EU: C:2020:531, [2020] EUECJ C-673/18, ECLI:EU: C: 2020:531 which was decided in the transition or implementation period after the UK had left the EU but while EU law still applied, the applicant sought an SPC for a product containing the active ingredient ciclosporin, used to treat severe keratitis in adult patients with dry eye disease. A previous marketing authorization was for a product containing ciclosporin as an active ingredient which was used for a range of indications including preventing organ rejection, The Court ruled:
"[43] Moreover, it follows from a reading of Article 1 (b) of Regulation No 469/2009 in conjunction with Article 4 thereof that the term ‘product’ is understood, for the purposes of applying that regulation, to mean the active ingredient or combination of active ingredients of a medicinal product, without its being necessary to limit its scope only to one of the therapeutic applications to which such an active ingredient or combination of active ingredients may give rise.
[44] Under Article 4 of that 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 No 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, a judgment of 19 October 2004, Pharmacia Italia, C-31/03, EU: C:2004:641, paragraphs 19 and 20).
…
[46] That strict view of the term ‘product’ was given concrete form in Article 1(b) of Regulation No 469/2009, which defines that term by reference to an active ingredient or combination of active ingredients and not by reference to the therapeutic application of an active ingredient protected by the basic patent or a combination of active ingredients protected by that patent.
[47] It follows from the foregoing considerations that Article 1 (b) of Regulation No 469/2009 must be interpreted as meaning that the fact that an active ingredient, or a combination of active ingredients, is used for the purposes of a new therapeutic application does not confer on it the status of a distinct product where the same active ingredient, or the same combination of active ingredients, has been used for the purposes of a different, already known, therapeutic application.”
In Case C‑673/18 Santen SAS v Directeur général de l’Institut national de la propriété industrielle, EU: C:2020:531, [2020] EUECJ C-673/18, ECLI:EU: C: 2020:531 which was decided in the transition or implementation period after the UK had left the EU but while EU law still applied, the applicant sought an SPC for a product containing the active ingredient ciclosporin, used to treat severe keratitis in adult patients with dry eye disease. A previous marketing authorization was for a product containing ciclosporin as an active ingredient which was used for a range of indications including preventing organ rejection, The Court ruled:
"[43] Moreover, it follows from a reading of Article 1 (b) of Regulation No 469/2009 in conjunction with Article 4 thereof that the term ‘product’ is understood, for the purposes of applying that regulation, to mean the active ingredient or combination of active ingredients of a medicinal product, without its being necessary to limit its scope only to one of the therapeutic applications to which such an active ingredient or combination of active ingredients may give rise.
[44] Under Article 4 of that 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 No 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, a judgment of 19 October 2004, Pharmacia Italia, C-31/03, EU: C:2004:641, paragraphs 19 and 20).
…
[46] That strict view of the term ‘product’ was given concrete form in Article 1(b) of Regulation No 469/2009, which defines that term by reference to an active ingredient or combination of active ingredients and not by reference to the therapeutic application of an active ingredient protected by the basic patent or a combination of active ingredients protected by that patent.
[47] It follows from the foregoing considerations that Article 1 (b) of Regulation No 469/2009 must be interpreted as meaning that the fact that an active ingredient, or a combination of active ingredients, is used for the purposes of a new therapeutic application does not confer on it the status of a distinct product where the same active ingredient, or the same combination of active ingredients, has been used for the purposes of a different, already known, therapeutic application.”
Review of the Hearing Officer's Decision
Mr Campbell reviewed the hearing officer's analysis of the marketing authorization. He said at [39] that Dr Cullen's view was that, the marketing authorization was for safinamide alone and not for the combination of safinamide, levodopa and a PDI. It followed that the marketing authorization was not for the same product as the patent. Consequently, the application failed. Despite Newron's best efforts to persuade him otherwise. Mr Campbell had no doubt that the hearing officer had been right to find that the marketing authorization had been for the active ingredient safinamide alone.
Mr Campbell reviewed the hearing officer's analysis of the marketing authorization. He said at [39] that Dr Cullen's view was that, the marketing authorization was for safinamide alone and not for the combination of safinamide, levodopa and a PDI. It followed that the marketing authorization was not for the same product as the patent. Consequently, the application failed. Despite Newron's best efforts to persuade him otherwise. Mr Campbell had no doubt that the hearing officer had been right to find that the marketing authorization had been for the active ingredient safinamide alone.
Whether the Marketing Authorization related to Safinamide in Combination with both Levodopa and a PDI
The hearing officer concluded that references to the use of a PDI were too few, too deeply buried in the marketing authorization, and too equivocal to permit a conclusion that the marketing authorization was for a safinamide in combination with both levodopa and a PDI. The deputy judge held that that was a finding open to Dr Cullen and that he happened to agree with it.Newron's Central Submission
According to para [41] of the judgment, Newron's central submission was that it had done valuable research and that it must therefore be entitled to an SPC unless there was a good reason why not. The deputy judge replied that that was the wrong approach. As Mr Justice Arnold had pointed out in Abraxis, the SPC Regulation is a balance of competing interests and that means that some meritorious inventions do not qualify for extended protection.
Further Information
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