(1) Sandoz Ltd v (1) G.D. Searle LLC
| Jurisdiction | England & Wales |
| Judge | Lord Justice Lewison,Lord Justice Floyd,Lord Justice Kitchin |
| Judgment Date | 25 January 2018 |
| Neutral Citation | [2018] EWCA Civ 49 |
| Court | Court of Appeal (Civil Division) |
| Docket Number | Case No: A3 2017 1483 |
| Date | 25 January 2018 |
[2018] EWCA Civ 49
IN THE COURT OF APPEAL (CIVIL DIVISION)
ON APPEAL FROM THE HIGH COURT OF JUSTICE
CHANCERY DIVISION
PATENTS COURT
Mr Justice Arnold
Royal Courts of Justice Strand, London, WC2A 2LL
Lord Justice Lewison
Lord Justice Kitchin
and
Lord Justice Floyd
Case No: A3 2017 1483
Charlotte May QC and William Duncan (instructed by Fieldfisher LLP) for the Appellants
Thomas Mitcheson QC and Stuart Baran (instructed by Bristows LLP) for the Respondents
Hearing date: 14 December 2017
Judgment Approved
This appeal concerns the meaning of “the product is protected by a basic patent in force” in Article 3(a) of Regulation (EC) No 469/2009 concerning the supplementary protection certificate for medicinal products (“the SPC Regulation”). The SPC Regulation regulates the grant of supplementary protection certificates or SPCs which are instruments which, in effect, extend the term of granted patents beyond their originally allotted term in relation to a particular product which is the subject of a marketing authorisation. Their purpose is to compensate the patent proprietor for the time which it takes between filing a patent application and bringing a medicinal product to the market. This issue of interpretation of the SPC Regulation has been the subject of repeated references to the CJEU from the courts of the United Kingdom and elsewhere, without, thus far, the emergence of a clear legal criterion for national courts to apply in all cases.
The first respondent is the proprietor (and the second respondent the exclusive licensee) of SPC/GB07/038 for a product described in the SPC as “Darunavir or the pharmaceutically acceptable salt, ester, or prodrug thereof”. The SPC covers a product marketed in Europe by companies associated with the second respondent under the trade mark “Prezista”. It is a protease inhibitor used in an anti-retroviral medication for the treatment of the HIV virus and AIDS. The respondents contend that the product described in the SPC was protected by European Patent (UK) No 0 810 209 (“the patent”) of which the first and second respondents were again, respectively, the proprietor and the exclusive licensee.
The SPC will expire on 23 February 2019. The appellants brought the present proceedings in order to clear the way for the marketing of a generic darunavir product prior to the expiry of the SPC. The appellants' product is not yet on the market. It is common ground, at least for the purposes of these proceedings, that the marketing of the appellants' product would infringe the SPC, if the SPC is valid. The appellants contend that it is invalid because, on the true construction of Article 3(a) of the SPC Regulation, darunavir is not a product “protected” by the patent. There is no challenge to the validity of the patent itself.
In a decision dated 3 May 2017, Arnold J decided that darunavir was a product protected by the patent. He declined to refer questions to the CJEU on the interpretation of Article 3(a) of the SPC Regulation because he considered that, on all tenable constructions of Article 3(a), darunavir was protected by the patent. This is an appeal from that decision and his consequent order.
On the appeal the appellants were represented by Ms Charlotte May QC and Mr William Duncan. The respondents were represented by Mr Thomas Mitcheson QC and Mr Stuart Baran.
The SPC Regulation and the Explanatory Memorandum
The SPC Regulation was preceded by the Commission's Explanatory Memorandum COM 90 101 on the proposed Regulation (“the Memorandum”), a document which it is common ground is admissible as an interpretive aid to the Regulation. The Memorandum made the point that the Regulation was intended to be “simple and transparent”, not to “lead to excessive bureaucracy” and to be capable of implementation without “an excessive administrative burden being placed on” patent offices or the parties, or there being any requirement for the creation of a new administrative body. In particular, it was foreseen that “examination of the conditions to be fulfilled for the certificate to be granted involves the use of objective data that are easy to verify.”
The Memorandum also made it clear that it was all types of research which were to be protected, not merely that part of the research programme which moved from the discovery of a structure-activity relationship to the individual compound: see e.g. paragraph 29:
“The proposal does not provide for any exclusions. In other words, all pharmaceutical research, provided that it leads to a new invention that can be patented, whether it concerns a new product, a new process for obtaining a new or known product, a new application of a new or known product or a new combination of substances containing a new or known product, must be encouraged, without any discrimination, and must be able to be given a supplementary certificate of protection provided that all of the conditions governing the application of the proposal for a Regulation are fulfilled.”
The Memorandum suggests, at paragraph 39, and albeit in the context of Article 4, that a patent which protects a series of compounds based on a formula can be used as the basis for the SPC:
“It is thus often the case in the chemical and pharmaceutical field that a patent protects a series of products based on the same formula. However, only some of these products will subsequently be developed and possibly only one may be put on the market. In such a case, the certificate will only protect the product covered by the authorization and not all of the products protected by the patent.”
The recitals of the SPC Regulation which are material are set out below:
[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;
(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.
…
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.”
It is common ground in the present case that the SPC satisfies the conditions specified in Article 3 (b), (c) and (d).
The patent
The patent is entitled “Alpha- and beta-amino acid hydroxyethylamino sulfonamides useful as retroviral protease inhibitors”. It claims a priority date of...
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