Sandoz Ltd and Another v G.d. Searle LLC and Another
| Jurisdiction | England & Wales |
| Judge | Mr Justice Arnold |
| Judgment Date | 03 May 2017 |
| Neutral Citation | [2017] EWHC 987 (Pat) |
| Court | Chancery Division (Patents Court) |
| Date | 03 May 2017 |
| Docket Number | Case No: HP-2016-000044 |
[2017] EWHC 987 (Pat)
IN THE HIGH COURT OF JUSTICE
CHANCERY DIVISION
PATENTS COURT
Rolls Building
Fetter Lane, London, EC4A 1NL
Mr Justice Arnold
Case No: HP-2016-000044
Charlotte May QC and William Duncan (instructed by Fieldfisher LLP) for the Claimants
Thomas Mitcheson QC and Stuart Baran (instructed by Bristows LLP) for the Defendants
Hearing date: 26 April 2017
| Topic | Paras |
| Introduction | 1–2 |
| The SPC Regulation | 3–5 |
| Interpretation of the SPC Regulation | 6 |
| Interpretation of Article 3(a) | 7–11 |
| Markush formulae | 12–18 |
| The Patent | 19–33 |
| The claims | 34–35 |
| Presumption of validity | 36–37 |
| Darunavir | 38–39 |
| The evidence | 40–57 |
| The Claimants' expert evidence | 41–49 |
| The Defendants' expert evidence | 50–55 |
| The Defendants' evidence as to foreign law | 56–57 |
| Summary of the Claimants' case | 58 |
| Summary of the Defendants' case | 59 |
| Analysis | 60–68 |
| Conclusion | 69 |
Introduction
In these proceedings the Claimants challenge the validity of supplementary protection certificate SPC/GB07/038 ("the SPC") for a product described in the SPC as "Darunavir or the pharmaceutically acceptable salt, ester or prodrug thereof". The proprietor of the SPC is the First Defendant ("Searle") and the exclusive licensee is the Second Defendant ("JSI"). The SPC covers a product which is marketed in Europe by companies related to JSI under the trade mark Prezista. Prezista is an anti-retroviral medication used in the treatment of human immunodeficiency virus (HIV). More specifically, it is a protease inhibitor. The Defendants contend that the product described in the SPC was protected by European Patent (UK) No. 0 810 209 ("the Patent"), of which Searle was the proprietor and JSI was the exclusive licensee. The Claimants dispute this. Accordingly, the Claimants contend that the SPC does not comply with Article 3(a) of European Parliament and Council Regulation 469/2009/EC of 6 May 2009 concerning the supplementary protection certificate for medicinal products (codified version) ("the SPC Regulation").
The Claimants seek to revoke the SPC, which expires on 23 February 2019 (including a paediatric extension of six months), in order to clear the way for the marketing of a generic darunavir product. The Claimants have admitted for the purpose of these proceedings only that, if the SPC is valid, then the marketing of their product prior to the expiry of the SPC would infringe it. The Claimants have agreed to give the Defendants 30 days' notice before launching their product. Nevertheless the Defendants have counterclaimed for an injunction to restrain (threatened) infringement.
The SPC Regulation
The SPC Regulation enables the proprietor of a patent for a medicinal product to obtain an SPC which extends the duration of the patent with respect to that product so as to compensate the proprietor for the effective loss of patent term caused by the need to obtain a marketing authorisation before the product can be marketed.
The SPC Regulation includes the following recitals:
"[3] Medicinal products, especially those that are the result of long, costly research will not continue to be developed in the Community and in Europe unless they are covered by favourable rules that provide for sufficient protection to encourage such research.
[4] At the moment, the period that elapses between the filing of an application for a patent for a new medicinal product and authorisation to place the medicinal product on the market makes the period of effective protection under the patent insufficient to cover the investment put into the research.
[5] This situation leads to a lack of protection which penalises pharmaceutical research.
[6] There exists a risk of research centres situated in the Member States relocating to countries that offer greater protection.
[7] A uniform solution at Community level should be provided for, thereby preventing the heterogeneous development of national laws leading to further disparities which would be likely to create obstacles to the free movement of medicinal products within the Community and thus directly affect the functioning of the internal market.
[8] Therefore, the provision of a supplementary protection certificate granted, under the same conditions, by each of the Member States at the request of the holder of a national or European patent relating to a medicinal product for which marketing authorisation has been granted is necessary. A regulation is therefore the most appropriate legal instrument.
…
[10] All the interests at stake, including those of public health, in a sector as complex and sensitive as the pharmaceutical sector should nevertheless be taken into account. …"
Articles 1, 3, 4 and 5 of the SPC Regulation provide, so far as relevant:
" Article 1
Definitions
For the purpose of this Regulation:
(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;
(c) 'basic patent' means a patent which protects a product as such, a process to obtain a product or an application of a product, and which is designated by its holder for the purpose of the procedure for grant of a certificate;
…
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;
…
Article 4
Subject matter of protection
Within the limits of the protection conferred by the basic patent, the protection conferred by a certificate shall extend only to the product covered by the authorisation to place the corresponding medicinal product on the market and for any use of the product as a medicinal product that has been authorised before the expiry of the certificate.
Article 5
Effects of the certificate
Subject to the provisions of Article 4, the certificate shall confer the same rights as conferred by the basic patent and shall be subject to the same limitations and the same obligations."
Interpretation of the SPC Regulation
I have considered the correct approach to the interpretation of the SPC Regulation in a number of judgments, including Teva UK Ltd v Gilead Sciences Inc [2017] EWHC 13 (Pat) at [30]–[31].
Interpretation of Article 3(a)
I considered the interpretation of Article 3(a) of the SPC Regulation at some length in Teva v Gilead at [32]–[88]. I shall take that exposition as read and will not repeat it here. For convenience, however, I shall recapitulate the key points.
First, it is clear that it is not sufficient for a product to be "protected" by a basic patent within the meaning of Article 3(a) that dealings in the product would infringe a claim of the patent applying the Infringing Act Rules (as to which, see Teva v Gilead at [36]).
Secondly, it is also clear that it is necessary that the product falls within at least one claim of the patent applying the Extent of Protection Rules (as to which, see Teva v Gilead at [35]).
Thirdly, it is not clear whether it is sufficient that the product falls within at least one claim of the patent applying the Extent of Protection Rules. It appears from the case law of the Court of Justice of the European Union that this is not sufficient, and that more is required; but it is not clear what more is required. In Case C-322/10 62010CJ0322">Medeva BV v Comptroller-General of Patents, Designs and Trade Marks [2011] ECR I-12051 the CJEU ruled that Article 3(a) precluded the grant of an SPC "relating to active ingredients which are not specified in the wording of the claims of the basic patent". It made the same ruling in a number of other cases decided at the same time, including Case C-630/10 University of Queensland v Comptroller-General of Patents, Designs and Trade Marks [2011] ECR I-12231, except that it used the word "identified" instead of the word "specified". In Case C-493/12 Eli Lilly & Co Ltd v Human Genome Sciences Inc [EU:C:2013:835], [2014] RPC 21 the CJEU ruled that Article 3(a) must be interpreted as meaning that it was not necessary for the active ingredient to be identified in the claim by means of a structural formula: it is sufficient for the active ingredient to be covered by a functional description provided that the claims when interpreted in accordance with the Extent of Protection Rules "relate, implicitly but necessarily and specifically, to the active ingredient". These are unclear tests which are difficult to apply in cases involving combinations of products like Teva v Gilead, however.
Fourthly, I have suggested to the CJEU that Article 3(a) should be interpreted as meaning that the product is "protected" by the basic patent if (i) the product falls within the scope of the claim when interpreted in accordance with the Extent of Protection Rules and (ii) the product does so because it contains an active ingredient, or a combination of active ingredients, which embodies the inventive advance (or technical contribution) of the patent. The application of this test is exemplified, albeit in the context of Article 3(c) of the SPC Regulation, in my recent decision in Teva UK Ltd v Merck Sharp & Dohme Corp [2017] EWHC 539 (Pat).
Markush formulae
Since this is a case about Markush formulae, I should...
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