Teva UK Ltd v Gilead Sciences Inc.
| Jurisdiction | England & Wales |
| Judge | Mr Justice Arnold |
| Judgment Date | 18 September 2018 |
| Neutral Citation | [2018] EWHC 2416 (Pat) |
| Court | Chancery Division (Patents Court) |
| Docket Number | Case Nos: HP-2016-000004/000023/000032/000034 |
| Date | 18 September 2018 |
[2018] EWHC 2416 (Pat)
IN THE HIGH COURT OF JUSTICE
BUSINESS AND PROPERTY COURTS
INTELLECTUAL PROPERTY LIST (CHANCERY DIVISION)
PATENTS COURT
Rolls Building
Fetter Lane, London EC4A 1NL
Mr Justice Arnold
Case Nos: HP-2016-000004/000023/000032/000034
Daniel Alexander QC and Lindsay Lane (instructed by Pinsent Masons LLP) for Teva
Daniel Alexander QC and Kathryn Pickard (instructed by Taylor Wessing LLP) for Accord
Daniel Alexander QC and Joe Delaney (instructed by Taylor Wessing LLP) for Mylan
Daniel Alexander QC and Jaani Riordan (instructed by Mishcon de Reya LLP) for Lupin
Thomas Mitcheson QC and James Whyte (instructed by Simmons & Simmons LLP) for Gilead
Hearing date: 12 September 2018
Judgment Approved
Introduction
In these proceedings the Claimants challenge the validity of the Defendant's (“Gilead's”) supplementary protection certificate SPC/GB05/041 (“the SPC”) for a product described in the SPC as “Composition containing both Tenofovir disoproxil, optionally in the form of a pharmaceutically acceptable salt, hydrate, tautomer or solvate, together with Emtricitabine”. The SPC covers a product which is marketed by Gilead under the trade mark Truvada. Truvada is an anti-retroviral medication used in the treatment of human immunodeficiency virus (HIV). It is a combination product consisting of two active ingredients, namely (i) 245 mg tenofovir disoproxil (“TD”) in the form of 300 mg of the fumarate (“TDF”) and (ii) 200 mg emtricitabine (also known as FTC) in a single, fixed dose tablet. TD and emtricitabine are both inhibitors of a viral enzyme known as reverse transcriptase. Gilead contends that the product described in the SPC is protected by European Patent (UK) No. 0 915 894 (“the Patent”), but 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' claim was tried before me on 15 and 16 December 2016. For the reasons given in my judgment dated 13 January 2017 ( [2017] EWHC 13 (Pat), “my first judgment”), I referred to the Court of Justice of the European Union the following question concerning the interpretation of Article 3(a) of the SPC Regulation: “What are the criteria for deciding whether ‘the product is protected by a basic patent in force’ in Article 3(a) of the SPC Regulation?”. I shall assume that the reader of this judgment has read my first judgment.
On 25 July 2018 the Grand Chamber of the CJEU handed down its judgment in Case C-121/17 [EU:C:2018:585]. It ruled as follows:
“Article 3(a) of [the SPC Regulation] must be interpreted as meaning that a product composed of several active ingredients with a combined effect is ‘protected by a basic patent in force’ within the meaning of that provision where, even if the combination of active ingredients of which that product is composed is not expressly mentioned in the claims of the basic patent, those claims relate necessarily and specifically to that combination. For that purpose, from the point of view of a person skilled in the art and on the basis of the prior art at the filing date or priority date of the basic patent:
– the combination of those active ingredients must necessarily, in the light of the description and drawings of that patent, fall under the invention covered by that patent, and
– each of those active ingredients must be specifically identifiable, in the light of all the information disclosed by that patent.”
On 9 August 2018 the Claimants issued applications for final judgment in their favour in the light of the CJEU's ruling.
On 13 August 2018 Gilead issued an application seeking permission to adduce further expert evidence and directions for a second trial.
The judgment of the CJEU
In its judgment the Court of Justice confirms that, in order to be “protected by a basic patent in force” within the meaning of Article 3(a) of the SPC Regulation, it is necessary, but not sufficient, that the product falls within the scope of protection of the basic patent applying what I called in my first judgment the Extent of Protection Rules, which in the case of a European patent are those contained in Article 69 EPC and the Protocol on the Interpretation of Article 69. More is required, as the Court explains.
In its exposition of what more is required, the Court's starting point is its judgment in Case C-493/12 Eli Lilly & Co Ltd v Human Genome Sciences Inc [EU:C:2013:835], [2014] RPC 21:
“36. In this respect, the Court has held that Article 3(a) of Regulation No 469/2009 does not, in principle, preclude an active ingredient which is given a functional definition in the claims of a basic patent issued by the EPO being regarded as protected by the patent, on condition that it is possible, on the basis of those claims as interpreted inter alia in the light of the description of the invention, as required under Article 69 of the EPC and Protocol on the Interpretation of that provision, to conclude that the claims relate implicitly but necessarily and specifically to the active ingredient in question (see judgment of 12 December 2013, Eli Lilly and Company, C-493/12, EU:C:2013:835, paragraph 39).
37. Therefore, a product cannot be considered to be protected by a basic patent in force within the meaning of Article 3(a) of Regulation No 469/2009 unless the product which is the subject of the SPC is either expressly mentioned in the claims of that patent or those claims relate to that product necessarily and specifically.”
In a case such as the present, where the product is not expressly mentioned in the claims of the Patent, the claims must relate to the product necessarily and specifically. In the remainder of the judgment, the Court explains what this requires.
Having drawn attention at [38] to the requirement, under Article 69 EPC and the Protocol, to interpret the claims of the basic patent in the light of the description and drawings, the Court identifies a series of policy considerations which are relevant to the interpretation of Article 3(a):
“39. That requirement is in line with the objective of the SPC, which is to re-establish a sufficient period of effective protection of the basic patent by permitting the holder to enjoy an additional period of exclusivity on the expiry of that patent, which is intended to compensate, at least in part, for the delay to the commercial exploitation of his invention by reason of the time which has elapsed between the date on which the application for the patent was filed and the date on which the first MA in the European Union was granted. As indicated in recital 4 of Regulation No 469/2009, the purpose of that additional period of exclusivity is to encourage research and, to that end, it is designed to ensure that the investments put into such research are covered (see, to that effect, judgment of 12 December 2013, Eli Lilly and Company, C-493/12, EU:C:2013:835, paragraphs 41 and 42 and the case-law cited).
40. However, it is not the purpose of the SPC to extend the protection conferred by that patent beyond the invention which the patent covers. It would be contrary to the objective of Regulation No 469/2009, reiterated in the preceding paragraph, to grant an SPC for a product which does not fall under the invention covered by the basic patent, inasmuch as such an SPC would not relate to the results of the research claimed under that patent.
41. In the light of the need, referred to inter alia in recital 10 of the preamble to Regulation No 469/2009, to take into account all the interests at stake, including those of public health, to accept that an SPC could grant to the holder of the basic patent protection which goes beyond the protection guaranteed by that patent in connection with the invention it covers would be contrary to the requirement to balance the interests of the pharmaceutical industry and those of public health as regards the encouragement of research within the European Union by the use of SPCs (see, by analogy, judgment of 12 March 2015, Actavis Group PTC and Actavis UK, C-577/13, EU:C:2015:165, paragraph 36 and the case-law cited).
42. It must be added that, in view of the interests referred to in recitals 4, 5, 9 and 10 of Directive 469/2009, it cannot be accepted that the holder of a basic patent in force may obtain an SPC each time he places on the market in a Member State a medicinal product containing, on the one hand, an active ingredient, protected as such by the holder's basic patent and constituting the subject matter of the invention covered by that patent, and, on the other, another substance which does not constitute the subject matter of the invention covered by the basic patent (see, to that effect, judgment of 12 March 2015, Actavis Group PTC and Actavis UK, C-577/13, EU:C:2015:165, paragraph 37 and the case-law cited).”
In a nutshell, what the Court is saying is that the purpose of the SPC Regulation is to enable the holder of the basic patent to obtain supplementary protection for what the patentee actually invented and not for what the patentee did not invent.
Accordingly, the Court concludes at [43]:
“… having regard to the objectives pursued by Regulation No 469/2009, the claims cannot allow the holder of the basic patent to enjoy, by obtaining an SPC, protection which goes beyond that granted for the invention covered by that patent. Thus for the purposes of the application of Article 3(a) of that regulation, the claims of the basic patent must be construed in...
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