Teva UK Ltd v Gilead Sciences, Inc.
| Jurisdiction | England & Wales |
| Judge | Lord Justice Lewison,Lord Justice Dingemans,Lord Justice Floyd |
| Judgment Date | 19 December 2019 |
| Neutral Citation | [2019] EWCA Civ 2272 |
| Date | 19 December 2019 |
| Docket Number | Case No: A3 2018 2542 |
| Court | Court of Appeal (Civil Division) |
[2019] EWCA Civ 2272
Lord Justice Lewison
Lord Justice Floyd
and
Lord Justice Dingemans
Case No: A3 2018 2542
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
Tom Mitcheson QC and James Whyte (instructed by Simmons and Simmons LLP) for the Appellant
Daniel Alexander QC and Lindsay Lane QC (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
Hearing date: 10 December 2019
Approved Judgment
Introduction
This appeal raises, yet again, the interpretation and application of European Parliament and Council Regulation 469/2009/EC of 6 May 2009 concerning the supplementary protection certificate for medicinal products (“the SPC Regulation”). Supplementary Protection Certificates (“SPCs”) have the effect of extending the life of a patent for a medicinal product which has been granted a marketing authorisation for a period of up to 5 years beyond its normal expiry date, under the conditions laid down in the SPC Regulation. Their purpose is to compensate a patentee for the delay in bringing a medicinal product to market consequent on the need to obtain regulatory clearance in the form of a marketing authorisation.
In a set of proceedings which were all heard together, the various claimants all challenged the validity of the defendant's (“Gilead's”) SPC numbered SPC/GB05/041 (“the SPC”). The SPC describes a product containing two ingredients, tenofovir disoproxil (“TD”) in the form of its fumarate salt and emtricitabine. TD and emtricitabine are both inhibitors of reverse transcriptase. The SPC covers a product marketed by Gilead under the trade name Truvada. Truvada is used in the treatment of patients suffering from the effects of the human immunodeficiency virus, HIV.
In order for the SPC to be valid, Article 3(a) of the SPC Regulation states that the product described in the SPC must be “protected by a basic patent in force”. Gilead contends that the product described in the SPC is protected by European Patent (UK) No 0 915 894 (“the patent”), because it has a claim (claim 27) to TD “and optionally other therapeutic ingredients”. Emtricitabine, says Gilead, is another therapeutic ingredient. The claimants contend that claim 27 does not protect the combination in the manner required by the SPC Regulation. The judge, Arnold J as he then was, found in favour of the claimants, declaring the SPC to be invalid. Gilead appeals with permission which I granted on 15 January 2019.
Before us, Mr Tom Mitcheson QC and Mr James Whyte appeared for Gilead. Mr Daniel Alexander QC and Mr Joe Delaney appeared for all the claimants, although other counsel for the various claimants assisted with the written submissions.
The procedural history
The SPC in issue in this case has been extensively litigated. It was applied for on 1 August 2005. Its initial grant was refused by the UK Intellectual Property Office by a decision of Mr Howard, acting for the Comptroller General of Patents, dated 10 January 2008, but an appeal against that refusal was allowed by Kitchin J (as he then was) in a judgment dated 31 July 2008 ( [2008] EWHC 1902 (Pat)). Given the developments in EU law which have taken place since that date, both sides recognise, as did Arnold J, that it was necessary to consider the matter afresh. The present actions came on for a trial lasting a total of one day, in December 2016. Arnold J considered that the case law of the CJEU on the interpretation of Article 3(a) of the SPC Regulation was not clear and so, following a judgment delivered on 13 January 2017 ( [2017] EWHC 13 (Pat)) (“the First Judgment”), referred to the Court of Justice of the European Union (“CJEU”) the following question for a preliminary ruling:
“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?”
The Grand Chamber of the CJEU handed down its judgment on the reference in this case on 25 July 2018: Case C-121/17 [EU:C:2018:585]. As is not uncommon, each of the parties contended that it could yet be the successful party in the light of the CJEU's ruling. The claimants accordingly made an application to the judge for judgment to be entered in their favour, whilst Gilead made a cross-application for permission to rely on further expert evidence, and for the matter to be adjourned to a further hearing at which the evidence could be heard and the questions raised by the CJEU's ruling decided. In the judgment under appeal, handed down on 18 September 2018, Arnold J held that, in the light of the ruling of the Grand Chamber of the CJEU, the SPC was invalid. He refused the application to adduce expert evidence. I will refer to that judgment as the Second Judgment.
The patent
The judge summarised the relevant disclosure of the patent in the First Judgment at [8]–[15] in the following terms:
“8. The Patent was applied for on 25 July 1997 with a claimed priority date of 26 July 1996 and granted on 14 May 2003. It is entitled “Nucleotide analogs”. The specification states at [0001] that the invention relates to “intermediates for phosphonomethoxy nucleotide analogs, in particular intermediates suitable for use in the efficient oral delivery of such analogs.”
9. In the “Summary of the Invention” at [0003]–[0006], the specification states that the invention provides compounds in accordance with two Markush formulae, formula (1a) and formula (1), and methods for preparing such compounds.
10. In the “Detailed Description of the Invention”, the specification first defines the substituents in the two Markush formulae and then gives exemplary embodiments of the claimed compounds at [0007]–[0036]. At [0037] the specification discusses the chemical stability of the claimed compounds. The specification goes on to describe synthetic methods for the preparation of the claimed compounds at [0038]–[0043].
11. The specification then describes the utilities of the claimed compounds at [0044] and [0045]. In the first of these paragraphs it states:
“The compounds of this invention are useful in the treatment or prophylaxis of one or more viral infections in man or animals, including infections caused by DNA viruses, RNA viruses, herpesviruses (CMV, HSV 1, HSV 2, VZV, and the like), retroviruses, hepadnaviruses, (e.g. HBV), papillomavirus, hantavirus, adenoviruses and HIV. Other infections to be treated with the compounds herein include MSV, RSV, SIV, FIV, MuLV, and other retroviral infections of rodents and other animals…”
It can be seen from this that the Patent is directed to the treatment of viral infections generally, not just HIV, and to viral infections in both man and animals.
12. Next, the specification describes a wide range of potential pharmaceutical formulations of the claimed compounds at [0046]–[0065]. The description is very bland and general, rather than being specific to the particular compounds or the particular utilities of those compounds. Counsel for the Claimants aptly described this passage as “boilerplate”. The range of potential formulations extends to (for example) formulations suitable for topical administration to the eye ([0056]) and veterinary compositions ([0063]).
13. Importantly for present purposes, the specification states at [0047]:
“While it is possible for the active ingredients to be administered as pure compounds it is preferable to present them as pharmaceutical formulations. The formulations of the present invention comprise at least one active ingredient, as above defined, together with one or more acceptable carriers and optionally other therapeutic ingredients. The carrier(s) must be ‘acceptable’ in the sense of being compatible with the other ingredients of the formulation and not deleterious to the patient.”
This is the only reference in the specification to the inclusion of “other therapeutic ingredients”. The phrase “other therapeutic ingredients” is not defined or explained in the Patent in any way.
14. The specification goes on at [0068]–[0117] to describe various examples of the invention. Example 16, which is entitled “Antiviral Activity of PMPA and PMPA Carbonates in Tissue Culture”, gives data showing antiviral activity of seven compounds in vitro against HIV-1. There is no example involving one of the claimed compounds in combination with any other therapeutic ingredient.
15. It is common ground that emtricitabine is not mentioned or referred to in the Patent.”
Claims 1 and 2 are claims to classes of compounds defined by the Markush formulae 1(a) and 1 respectively, whilst claims 3–24 are dependent compound claims of increasingly narrow scope. Claim 25 is an independent compound claim specifically to TD, and claim 26 is to the use of any of the compounds of claims 1–25 for the treatment or prophylaxis of viral infections in man or animals. The debate centres on claim 27 which is in the following terms:
“A pharmaceutical composition comprising a compound according to any one of claims 1–25 together with a pharmaceutically acceptable carrier and optionally other therapeutic ingredients.”
As the judge pointed out, the words “comprising” and “optionally” in claim 27 mean that the claim permits, but does not require, the presence of other ingredients, both therapeutic and non-therapeutic. The presence of another pharmaceutical...
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Merck Sharp & Dohme Ltd v Clonmel Healthcare Ltd
...its disagreement with the approach adopted by the Court of Appeal of England and Wales in Teva UK Ltd & Ors v Gilead Sciences Inc [2019] EWCA Civ 2272, made after its receipt of the CJEU's decision. 81. … [Floyd LJ] was of the view that para. 37 [of the CJEU decision in Teva] states that e......
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Merck Sharp and Dohme Corporation v Clonmel Healthcare Ltd
...Gilead appealed to the Court of Appeal and the judgment was delivered by Floyd L.J. ( Teva UK Ltd. & Ors. v. Gilead Sciences Inc. [2019] EWCA Civ. 2272). He carefully considered the relevant provisions of the SPC Regulation and reviewed the judgments of the CJEU commencing with Medeva, Eli......