Supplementary Protection Certificates - The Appeal in Newron Pharmaceuticals SpA v Comptroller

 

Jane Lambert

Court of Appeal (Lords Justices Lewison, Moylan and Birss) Newron Pharmaceuticals SPA v The Comptroller General of Patents, Trade Marks and Designs [2024] EWCA Civ 128 (15 Feb 2024)

This was an appeal against the decision of Mr Recorder Campbell KC to uphold  Dr L Cullen's refusal to grant a supplementary protection certificate ("SPC") to Newron Pharmaceuticals SpA ("Newron") for the reasons set out in his judgment in Newron Pharmaceuticals SpA v Comptroller-General of Patents, Trade Marks and Designs [2023] EWHC 1471 (Ch).  I discussed the proceedings before Dr Cullen and Mr Campbell in Supplementary Protection Certificates - Newron Pharmaceuticals SpA v Comptroller on 1 July 2023.   

What is an SPC? 

In that article, I quoted from my reference page on Supplementary Protection Certificates which I wrote on 31 Dec 2019 and updated on 11 Jan 2021

"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."

Lord Justice Birss added the following observation in para [2] of the Court of Appeal's judgment in Newron Pharmaceuticals SPA v The Comptroller General of Patents, Trade Marks and Designs [2024] EWCA Civ 128 (15 Feb 2024) which was the appeal against Mr Campbell's judgment: 

"Supplementary protection certificates (SPCs) are a form of patent term extension to compensate for lost time caused by the marketing authorisation regime applicable to pharmaceutical products and such like. The normal 20 year patent term starts when the patent is applied for, once the invention of the new drug as a treatment for a given disease has been made. However the law prevents the marketing of such a product as a medicine without authorisation, and the authorisation is only given on proof to the appropriate authority that the product is a safe and effective medicine for the disease concerned. That proof is only possible after extensive, costly and uncertain clinical trials have been completed to establish safety and efficacy. That takes time, and the result is that the patentee cannot begin to recoup its investment in research and development, by marketing the pharmaceutical, for some years later than would have been possible absent the marketing authorisation regime. Thus the SPC system will extend the relevant term for up to five years provided the various criteria are satisfied (see Recitals [3] to [8] of the SPC Regulation and also Draco's SPC Application [1996] RPC 417 at 436)."

Requirements for Granting an SPC

In the next paragraph, the learned Lord Justice continued:

"To apply the criteria one needs to examine two relevant documents – the patent and the marketing authorisation. Put briefly, a critical requirement for an SPC to be granted is that the patent and the marketing authorisation must match. In the language of the SPC Regulation the product authorised to be placed on the market as a medicinal product by the relevant marketing authorisation must be the product protected by the relevant patent."

Reasons for the Refusal

Lord Justice Birss explained that the problem for the appellant was that the hearing officer and the recorder had concluded that the marketing authorization was for the active ingredient safinamide alone and not for levodopa or PDI.  In the Summary of Product Characteristics (SmPC) in Annex 1 to the marketing authorization decision, the medicinal product was identified simply as Xadago (safinamide), in the form of a 50mg tablet, and not a combination.   In the hearing officer's view which was shared by the recorder, Newron's application had failed to meet the requirements of art 3 (b) of Regulation (EC) No. 469/2009 (“the SPC Regulation”) (see Re SPC/GB15/046, Newron Pharmaceuticals S.p.A v Comptroller BLO/1053/22 1 Dec 2022).

Grounds of Appeal

Newron appealed on the ground that art 3 (b) of the SPC Regulation distinguishes between what a product is and how it is to be used. Secondly, the appellant contended that Dr Cullen and Mr Campbell had erred in not accepting that the marketing authorization related to a combination in which PDI was an element in relation to safinamide in combination with levodopa.  Lord Justice Birss noted that Newron could succeed on the second ground only if it succeeded on the first.

The Appeal

Lord Justice Birss delivered the lead judgment in Newron'a's appeal.   Lords Justices Lewison and Moylan agreed.   

Definitions

Lord Justice Birss's starting point was to consider the definitions of  "medicinal product" and "product" in art 1 (a) and (b) of the SPC Regulation in relation to art 3.  

He said at para [14] that art 1 (a) defined a  "medicinal product" as essentially "any substance or combination of substances presented for treating a disease."  He added that it was no accident that the definition in art 1 (a) of the SPC Regulation was the same as in art 1 (2) of Directive 2001/83/EC  and in Regulation (EC) 726/2004 by virtue of art 2.  That was because the scheme of the SPC Regulation starts with a concept that is taken from the marketing authorization legislation.   The meaning of "medicinal product" in art 1 (a) indicates the meaning of "product" in art 1 (b) of the SPC Regulation, namely that it is "the active ingredient or combination of active ingredients of a medicinal product."

Meaning of Art 3

Armed with those definitions Lord Justice Birss proceeded to construe art 3.   As art 3 (a) requires the product to be protected by the patent, art 3 (b) must require that same product to be placed on the market as a medicinal product in accordance with  Directive 2001/83/EC.  That interpretation was consistent with the Explanatory Memorandum supporting the proposal for the SPC Regulation.  It sought to strike a balance between various interests at stake, including those of pharmaceutical researchers, public health authorities and generic manufacturers.

The Case Law

Lord Justice Birss divided the relevant case law into three categories.  

In C-31/03 Pharmacia Italia SpA [2004] ECR I-10001; C-431/04 Massachusetts Institute of Technology [2006] ECR I-4089 and C-202/05 Yissum Research and Development Company of the Hebrew University of Jerusalem v. Comptroller-General of Patents [2007] ECR I-2839, the Court of Justice of the European Union held that a product must be the active ingredient itself and that it was not necessary to take account of any formulation of the active ingredients such as excipients, physical form or the like or of the intended use of that ingredient.  In Yissun, the Court held that the concept of product referred to in art 1 (b) "must be interpreted strictly to mean "active substance' or 'active ingredient".  "Strictly" in this context refers to the exclusion of other aspects of a product such as its formulation and use.

 In C-130/1Neurim Pharmaceuticals v Comptroller  [2013] RPC 23, [2012] EUECJ C-130/1 the Court seemed to resile from its earlier position in that the use to which a product is put should be taken into account in order to achieve the result of encouraging research into new uses for old ingredients.

Finally, in Santen SAS v Directeur général de l’Institut national de la propriété industrielle  [2020] EUECJ C-673/18, ECLI:EU: C:2020:531, EU: C:2020:531 the Court held at para [43] of its judgment that the definition of product in the SPC Regulation did not include the therapeutic application for which it might be used and went out of its way to contradict at 44 what it had said about that point in Neurim:

"[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)."

Lord Justice Birss also referred to the judgment of Mr Justice Lewsinon as he then was in Yeda Research and Development Company Ltd v Comptroller General of Patents [2010] RPC 29, [2010] EWHC 1733 (Pat) in which the learned judge dismissed an appeal from the hearing officer in circumstances that were similar to those of Newron's appeal.

Newron referred the Court of Appeal to the Advocate-General's opinion in Case C-322/10 Medeva v Comptroller [2012] RPC 25 that a broad or teleological approach should be applied to the definition of product with the effect that art 3 (b) should be taken to include Newron's construction of that provision.  Lord Justice Birss noted that that contention had not been adopted by the Court and he doubted that the opinion had changed the law.

Conclusion

Applying the law to the facts of this case Lord Justice Birss held at para [33] that the hearing officer and recorder were right in their finding that the product which the marketing authorization authorises to be placed on the market was the medicinal product safinamide. and not a combination.   Having found against the appellant on the first ground of appeal it was unnecessary to consider the second.   His lordship therefore dismissed the appeal.

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