Eli Lilly and Company v Genentech, Inc.
| Jurisdiction | England & Wales |
| Judge | Mr Justice Arnold |
| Judgment Date | 01 March 2019 |
| Neutral Citation | [2019] EWHC 388 (Pat) |
| Court | Chancery Division (Patents Court) |
| Docket Number | Case No: HP-2017-000044 |
| Date | 01 March 2019 |
[2019] EWHC 388 (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 No: HP-2017-000044
Andrew Waugh QC, Thomas Mitcheson QC and Stuart Baran (instructed by Allen & Overy LLP) for the Claimant
Michael Tappin QC, Justin Turner QC, Mark Chacksfield and William Duncan (instructed by Marks & Clerk Solicitors LLP) for the Defendant
Hearing dates: 16–19, 21–25, 30–31 January, 1 February 2019
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
The Defendant (“Genentech”) is the proprietor of European Patent (UK) No. 1 641 822 entitled “IL-17A/F heterologous peptides and therapeutic uses thereof” (“the Patent”). The priority date of the Patent is 8 July 2003. Genentech does not itself have a product covered by the Patent at present. The Claimant (“Lilly”) markets a formulation of an antibody called ixekizumab as a treatment for moderate to severe plaque psoriasis and psoriatic arthritis in adults under the trade mark Taltz by virtue of marketing authorisation EU/1/15/1085 (“the Taltz MA”). Ixekizumab is an antibody to interleukin-17A (“IL-17A”) which also binds to interleukin-17A/F (“IL-17A/F”). Genentech contends that this falls within the scope of protection of the Patent.
Genentech has filed application SPC/GB16/056 (“the Application”) for a supplementary protection certificate (“SPC”) based on the Patent and the Taltz MA. Lilly seeks a declaration that an SPC granted pursuant to the Application would not be valid. There is no dispute that the Court has jurisdiction to grant such a declaration if it would serve a useful purpose. Nor is there any dispute that such a declaration would serve a useful purpose. Accordingly, the only issues are those raised by Lilly's grounds of invalidity.
Lilly contends that, even if it is assumed that the Patent is valid, there are two obstacles to the Application: first, it 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”) because Taltz is not protected by the Patent; and secondly, it does not comply with Articles 2, 3(b) and/or 3(d) of the SPC Regulation because the Taltz MA is not a relevant authorisation since it is a third party marketing authorisation relied upon without that party's consent (“a third party MA”).
This claim was tried together with claim number HP-2017-000041 (“the Patent Action”), in which Lilly attacks the validity of the Patent and seeks a declaration that dealings in ixekizumab do not infringe the Patent. I am giving separate judgments in the two claims at the same time.
Technical background
The general technical background to both claims is set out in my judgment in the Patent Action (“the Patent Judgment”) at [39]–[133]. For the purposes of this judgment, the key point to explain is that the interleukin-17 (IL-17) family of cytokines was known before the priority date to consist of six members, IL-17A to IL-17F, which are homodimers (and hence they are also referred to as IL-17A/A to IL-17F/F).
The Patent
I have summarised the disclosure of the Patent in the Patent Judgment at [134]–[178]. The Patent is concerned with a heterodimer, IL-17A/F, which consists of an IL-17A monomer and an IL-17F monomer. The Patent provides evidence that IL-17A/F exists in humans, being produced in activated T cells and having the effect of inducing the production of the cytokines IL-6 and IL-8 in in vitro tests.
I have set out the claims of the Patent as proposed to be amended by Genentech in the Patent Judgment at [179]–[181]. For the reasons given at [315]–[352], I have concluded that, subject to one very minor point, the amendments are allowable. For the purposes of this judgment, it is sufficient to set out new claims 1 and 12 in the form that I have concluded is allowable:
“1. An isolated antibody which specifically binds to an isolated IL-17A/F heterodimeric complex and which inhibits the activity of the IL-17A/F heterodimeric complex to induce production of IL-8 and IL-6, wherein the isolated IL-17A/F heterodimeric complex consists of SEQ ID NO:3 and SEQ ID NO:4, without their associated signal peptides, and further comprises two interchain disulphide linkages between SEQ ID NO:3 and SEQ ID NO:4; and wherein the antibody is human or humanized.
12. Use of an antagonist anti-IL-17A/F antibody as defined in Claim 1 or 2 in the preparation of a medicament for the treatment of rheumatoid arthritis or psoriasis.”
It can be seen that claim 1 is a claim to a human or humanised antibody defined in functional terms, namely binding to IL-17A/F and inhibition of production of the cytokines IL-8 and IL-6. (SEQ ID 3 and SEQ ID 4 are the sequences of the prior art IL-17A and IL-17F polypeptide monomers.) Claim 12 is a second medical use claim in Swiss form. I should explain that, for convenience, I have chosen to focus upon claim 12 for the purposes of this judgment, but the Patent also contains a second medical use claim in EPC2000 form (claim 22). I do not consider that anything turns upon the difference between these two types of claim for the purposes of this judgment.
The common general knowledge of the skilled team
As explained in the Patent Judgment at [182], as proposed to be amended, the Patent is addressed to two different, but overlapping, teams of persons skilled in the art, namely a psoriasis team and an RA team. For the purposes of this judgment, the relevant skilled team is the psoriasis team, which consists of (i) a dermatologist with both clinical experience of, and a research interest in, the treatment of psoriasis and (ii) one or more persons with expertise in antibody engineering. I have set out the common general knowledge of the dermatologist in the Patent Judgment at [210]–[292] and the common general knowledge of the antibody engineer at [209].
The development of ixekizumab
I have described the development of ixekizumab in the Patent Judgment at [582]–[593]. The key point for present purposes is that Lilly developed ixekizumab as an anti-IL-17A antibody for the treatment for psoriasis without knowing of the existence of IL-17A/F. It subsequently discovered that ixekizumab also bound to IL-17A/F, but only as result of tests carried out following the publication of scientific papers concerning IL-17A/F published in 2007 and 2008.
Ixekizumab
I have described ixekizumab and its properties in the Patent Judgment at [594]–[595]. The key points for present purposes are that it binds to IL-17A/F as well as IL-17A and that it inhibits the production of IL-6 and IL-8.
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.
…
(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 establishment and the functioning of the internal market.
(8) Therefore, the creation 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.
(9) The duration of the protection granted by the certificate should be such as to provide adequate effective protection. For this purpose, the holder of both a patent and a certificate should be able to enjoy an overall maximum of 15 years of exclusivity from the time the medicinal product in question first obtains authorisation to be placed on the market in the Community.
(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. For this purpose, the certificate cannot be granted for a period exceeding five years. The protection granted should furthermore be strictly confined to the product which obtained authorisation to be placed on the market as a medicinal product”
Articles 1, 2, 3 and 4 of the SPC Regulation provide, so far as relevant:
“ Article 1
Definitions
For the purposes of this Regulation, the following definitions shall apply:
(a) ‘medicinal product’ means any substance or combination of substances presented for...
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