Eli Lilly and Company v Human Genome Sciences Inc.
| Jurisdiction | England & Wales |
| Judge | Mr Justice Warren |
| Judgment Date | 18 July 2014 |
| Neutral Citation | [2014] EWHC 2404 (Pat) |
| Docket Number | Case No: HC12C00361 |
| Court | Chancery Division (Patents Court) |
| Date | 18 July 2014 |
[2014] EWHC 2404 (Pat)
IN THE HIGH COURT OF JUSTICE
CHANCERY DIVISION
PATENTS COURT
Royal Courts of Justice
Strand, London, WC2A 2LL
Mr Justice Warren
Case No: HC12C00361
Andrew Waugh QC and Tom Mitcheson QC (instructed by Field Fisher Waterhouse LLP) for the Claimant
Michael Tappin QC (instructed by Powell Gilbert LLP) for the Defendant
Hearing dates: 9th May and 4th June 2014
Approved Judgment
I direct that pursuant to CPR PD 39A para 6.1 no official shorthand note shall be taken of this Judgment and that copies of this version as handed down may be treated as authentic.
Introduction
This matter comes back before me following the decision (" the Judgment") of what I shall refer to in this judgment as " the Court" on the reference made by me in October 2012. This judgment should be read together with my earlier judgments on 3 August 2012 (see [2012] EWHC 2290 (Pat)) and 10 October 2012 (see [2012] EWHC 2857 (Pat)). I adopt the definitions found in those judgments (which I will refer to as my first and second judgments).
The Court, as is often the case, reformulated the three questions which I had referred into a single question
"whether Article 3(a) of Regulation No 469/2009 [the SPC Regulation] must be interpreted as meaning that, in order for an active ingredient to be regarded as 'protected by a basic patent in force', within the meaning of that provision, the active ingredient must be identified in the claims of the patent by a structural formula, or whether the active ingredient may also be considered to be protected where it is covered by a functional formula in the patent claims."
The Court answered its own question in the following way. Article 3(a) of the SPC Regulation must be interpreted as meaning
"that, in order for an active ingredient to be regarded as 'protected by a basic patent in force' within the meaning of that provision, it is not necessary for the active ingredient to be identified in the claims of the patent by a structural formula. Where the active ingredient is covered by a functional formula in the claims of a patent issued by the European Patent Office, Article 3(a) of [the SPC Regulation] does not, in principle, preclude the grant of a supplementary protection certificate for that active ingredient, on condition that it is possible to reach the conclusion on the basis of those claims, interpreted inter alia in the light of the description of the invention, as required by Article 69 of the Convention on the Grant of European Patents and the Protocol on the interpretation of that provision, that the claims relate, implicitly but necessarily and specifically, to the active ingredient in question, which is a matter to be determined by the referring court"
As will become apparent, one thing the Judgment does not give is the clear guidance which the reference was designed to obtain. Whilst each side can reasonably find support for their preferred outcome from what the Court says in different parts of the Judgment, some of the language used in the submissions to the effect that the Judgment is absolutely clear (in one direction or the other) – or as Walton J was fond of saying, plain as a pikestaff – is, unfortunately for me and the parties, rather wide of the mark.
Statutory and legal background
In order to deal with and understand the arguments presented to me, and in order to attempt to understand what the answer given by the Court means, it is helpful to consider some of the statutory provisions and some of the case law which form part of the matrix within which the meaning and effect of the Judgment is to be ascertained. I summarised the relevant provisions of the SPC Regulation in [22] of my judgment dated 3 August 2012 and do not repeat it here other than to remind myself that:
i) Article 3(a) states, as one condition for the grant of an SPC, that "the product is protected by a basic patent in force"; and
ii) "product" is defined in Article 3(b) as "the active ingredient or combination of active ingredients of a medicinal product" and "basic patent" is defined in Article 1(c) as "a patent which protects a product as such, a process to obtain such a product or an application of a product…".
So to obtain an SPC what is required, among other things, is a basic patent. The patent can be for a product or for a process to make a product or for an application of a product. The basic patent does not need to have anything about it which is to do with the use of a product.
In the light of the argument now advanced, I also set out recitals (4) and (5) to the SPC Regulation:
"(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 such research.
(5) This situation leads to a lack of protection which penalises pharmaceutical research."
Article 69(1) of the European Patent Convention (" the EPC") deals with "extent of protection" as follows:
"The extent of the protection conferred by a European patent or a European patent application shall be determined by the claims. Nevertheless, the description and drawings shall be used to interpret the claims."
The Protocol on Interpretation of Article 69 provides, on the one hand, that Article 69 "should not be interpreted as meaning that the extent of the protection conferred by a European patent is to be understood as that defined by the strict, literal meaning of the wording used in the claims". But on the other hand "Nor should it be taken to mean that the claims serve only as a guideline and that the actual protection conferred may extend to what, from a consideration of the description and drawings by a person skilled in the art, the patent proprietor has contemplated". The Protocol provides for a balance to be struck: "On the contrary, it is to be interpreted as defining a position between these extremes which combines a fair protection for the patent proprietor with a reasonable degree of legal certainty for third parties".
The provisions are transposed into domestic law by section 125(1) read with sections 125(3) and 130(7). It is worth reminding oneself of what section 125(1) actually says, well-known as it will be to most readers of this judgment:
"For the purposes of this Act an invention for a patent for which an application has been made or for which a patent has been granted shall, unless the context otherwise requires, be taken to be that specified in a claim of the specification of the application or patent, as the case may be, as interpreted by the description and any drawings contained in that specification, and the extent of the protection conferred by a patent or application for a patent shall be determined accordingly."
As to the cases (and the Judgment itself), it is important not to lose sight of the fact that we are dealing with a piece of legislation which provides for the granting of an SPC where the product is protected by a basic patent. The issue is what "protected" means. It is in that context that I am concerned with the meaning of the words "specified" and "identified" used by the Court in various judgments when giving guidance to the national court in deciding what is protected.
I can start with Case C-322/10 Medeva BV v Comptroller General of Patents, Designs and Trade Marks (" Medeva") on which both sides rely. It has been referred to in a number of subsequent cases to some of which I will come in due course. The patent claim concerned is set out at [11] of the Opinion of the Advocate General. It is a claim to a method of preparing an acellular vaccine. One point to note is that although the word "comprises" is used, that is in relation to the method; there is nothing here (or anywhere else in the patent) about including any active ingredient in the vaccine other than those mentioned in the claim.
Mr Tappin, who appears for HCS, has helpfully summarised the facts of Medeva in this way:
i) Medeva had a patent for a method of making a whooping cough vaccine consisting of a combination of two antigens (we can call them A and B) as active ingredients. It filed a number of applications for SPCs in respect of combination vaccines. The applications fell into two categories but for present purposes it is the first category which matters. That category consisted of applications for SPCs in respect of combinations of active ingredients which included extra active ingredients, in addition to A and B. Those extra active ingredients (we can call them X, Y and Z) had nothing to do with the patent or its claims.
ii) The UK IPO refused to grant that first category of SPCs, saying that they did not satisfy Article 3(a). The Court of Appeal referred questions to the Court asking whether Article 3(a) prevented an SPC from being granted in respect of a combination of active ingredients which included active ingredients not mentioned in the claims of the basic patent.
iii) Medeva's case, as recorded in [20] of the judgment of the Court, was that the concept of a 'product … protected by a basic patent in force' within the meaning of Article 3(a) included any combination of substances of a medicinal product which directly infringed the patent. In other words, a product consisting of active ingredients A, B, X, Y and Z was "protected by" its patent because selling that product would infringe the patent – the so-called "infringement test". That case was rejected by the Court.
Mr Tappin spent some time in his written and oral submissions looking at what Advocate General Trstenjak had said in her opinion, referring in particular to her...
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