Chugai Pharmaceutical Company Ltd v UCB Pharma SA
| Jurisdiction | England & Wales |
| Judge | Mr Justice Henry Carr |
| Judgment Date | 26 May 2017 |
| Neutral Citation | [2017] EWHC 1216 (Pat) |
| Docket Number | Case No: HP-2016-000063 |
| Court | Chancery Division (Patents Court) |
| Date | 26 May 2017 |
[2017] EWHC 1216 (Pat)
The Hon Mr Justice Henry Carr
Case No: HP-2016-000063
HP-2017000012
IN THE HIGH COURT OF JUSTICE
CHANCERY DIVISION
PATENTS COURT
Royal Courts of Justice
Rolls Building, Fetter Lane.
London, EC4A 1NL
Mr Thomas Raphael QC and Mr Mark Chacksfield (instructed by Marks & Clerks Solicitors LLP) for the Claimant
Mr Alexander Layton QC, Mr Oliver Caplin and Mr Michael Tappin QC (instructed by Powell Gilbert LLP) for the Defendants/Part 11 Applicants
Hearing dates: 28 th April and 2 nd May 2017
Judgment Approved
Introduction
In these proceedings, the Claimant ("Chugai") seeks a declaration against the Defendants (collectively "UCB") that it is not obliged to continue to pay royalties under a patent licence ("the Licence") granted by the First Defendant ("UCB Pharma"). Although the claim is advanced in two separate actions against different companies in the UCB group, as far as the applications before me are concerned, the facts relied upon and the relief sought are identical.
UCB Pharma is a Belgian company with an English branch which entered into the Licence with Chugai in respect of a portfolio of patents relating to products containing a humanised anti-IL-6 receptor antibody known as tocilizumab. Since 12 January 2016, the only patent still in force to which the Licence applies is US Patent 7,556,771 ("the 771 Patent"). The Second Defendant in the first action ("Celltech") is the registered proprietor of the 771 Patent and is a member of the UCB group. The Defendant in the second action ("UCB Biopharma") is also a member of the UCB group and is alleged by UCB to be the current proprietor of the 771 Patent.
Tocilizumab is an immunosuppressive drug principally used in the treatment of rheumatoid arthritis. It is a humanised antibody made by grafting elements of the complementary determining regions of the donor murine anti-human IL-6 receptor antibody PM-1 into human heavy and light chain antibody sequences and by further modifying the human heavy chain residues with murine residues from PM-1 at certain specified positions. Chugai's tocilizumab product is sold under the brand name Actemra in the USA and RoActemra in Europe.
Chugai claims that its tocilizumab products, which are, in part, manufactured and sold in the USA, fall outside the scope of the claims of the 771 Patent. Accordingly, Chugai seeks a declaration that it owes no royalties for the manufacture and sale of tocilizumab products manufactured after 12 January 2016.
UCB alleges that, although framed as a claim for a declaration relating to a contract, a part of these proceedings, in substance, concerns not only the scope but also the validity of the 771 Patent. UCB submits that the validity of a US patent is non-justiciable, since the English court has no power to determine the validity of a foreign patent. Accordingly, it submits that those parts of Chugai's pleading which are said to raise issues of invalidity fall outside the subject matter jurisdiction of the English court.
UCB originally claimed that the English court had no personal jurisdiction over the entire claim, and that the whole claim was non-justiciable. For this reason, it argued that the trial should not be listed within a year of issue of the claim, as is now generally the case for actions in the Patents Court. UCB claimed that the listing should be delayed pending resolution of its jurisdiction challenge. Rose J did not accept this submission, for the reasons given in her judgment of 28 February 2017; [2017] EWHC 444 (Pat). Pursuant to her order made on the same date, the trial is now listed for February 2018.
After that judgment and order, by a letter dated 30 March 2017, UCB conceded personal jurisdiction and limited its challenge to justiciability to certain specified paragraphs of Chugai's Statement of Case, namely paragraphs [2(h)] and [25] – [35] ("the Disputed Paragraphs"). Powell Gilbert on behalf of UCB indicated that UCB would apply to strike out the Disputed Paragraphs, or for summary judgment in respect of them, and UCB put its application in this manner.
In its skeleton argument on this application, UCB states that:
"For present purposes UCB's application is limited to arguing that issues concerning the validity of a foreign patent are non-justiciable. Should this case proceed further, UCB reserves its right to argue that any issue relating to the scope of a foreign patent is equally non-justiciable."
I do not accept that UCB is entitled to make this reservation. It commenced this application with a general challenge to jurisdiction. It then abandoned its application, save in respect of the Disputed Paragraphs. No reservation in relation to a further jurisdiction challenge was made by Powell Gilbert in its letter of 30 March, sensibly in my view. Against this background, UCB is not entitled to have a third bite at the cherry, by resurrecting jurisdictional issues at some future date.
Given that these applications raise points of law and the facts are not in dispute, the parties are agreed, insofar as possible and appropriate, that I should decide them, rather than merely considering whether the issues raised by the Disputed Paragraphs are arguable. The parties are also agreed that I am not concerned with the technical aspects of this case, and it has not been necessary for me to consider the description of the 771 Patent or the prior art.
Chugai's Pleading
In its Particulars of Claim, Chugai asserts that tocilizumab is not a substance the manufacture and/or sale of which would (but for the licence granted under the Licence) infringe any claim of the 771 Patent, properly construed. It claims, as is common ground, that the proper construction of the claims of the 771 Patent is governed by the laws of the United States, and it sets out its position on US law in a separate Statement of Case. Chugai pleads its primary contention at paragraph [3]:
"When properly construed in accordance with these principles [of US law], the requirement in the claims of the Patent that residues at particular positions in the framework regions of the humanised antibody molecule be "non-human donor" is not satisfied by residues at the relevant position(s) that are identical in both the human acceptor antibody and non-human donor antibody sequences. "Non-human donor" residues must be residues at the relevant positions that are not identical in both the human acceptor antibody and non-human donor antibody sequences and which must therefore be changed to the residue present in the donor sequence at that position."
This is denied by UCB at paragraph [3] of its Statement of Case. It states that:
"UCB disagrees with Chugai's conclusion in paragraphs 3 and 25 that the term "non-human donor" in the claims of the 771 Patent excludes "residues at the relevant positions that are identical in both the human acceptor antibody and the non-human donor antibody sequences." When properly construed in accordance with the principles described above, the term "non-human donor" in the claims of the 771 Patent means a residue in the humanised antibody that is present in the non-human donor antibody sequence at the relevant position, whether or not the same residue is present in the human acceptor antibody at the same position."
It will be seen that the dispute between the parties identified by these paragraphs concerns the scope of the relevant claims of the 771 Patent, and in particular, the correct interpretation of the term "non-human donor" in those claims, having regard to the relevant principles of US claim construction
However, Chugai has two additional arguments which it alleges should lead to the same conclusion concerning the scope of the claims of the 771 Patent. First, it relies on the prosecution history of the 771 Patent. In particular, it relies upon statements made to the examiner in connection with US Patent No. 5,530,101; and Queen et al. Proc. Nat Acad. Sci. USA 1989; 86: 10029– 10033 (collectively "the Queen Prior Art"). At paragraph [23] of its Statement of Case, Chugai pleads that the Queen Prior Art documents were " the key pieces of prior art cited during prosecution and were considered at length by the examiner. The USPTO would not have granted the patent based on a construction that would be invalidated by Queen." Chugai pleads at paragraph [24] of its Statement of Case that, based on the prosecution history, it would have been clear to a skilled person that the 771 Patent should be construed in such a way as to exclude tocizilumab.
Even though this plea will involve consideration by the English court of the Queen Prior Art to evaluate whether, on UCB's construction, the US Patent Office would have refused to grant the 771 Patent, UCB does not seek to strike out this part of Chugai's pleading. This makes sense, because Chugai is contending that UCB's construction is wrong, and relies on the prosecution history in support of its construction. It is not suggested in Chugai's Statement of Case that the USPTO would not have granted the 771 Patent in the light of the Queen Prior Art based on Chugai's construction.
Secondly, Chugai relies upon United States principles of construction in relation to ambiguous claims. It pleads at paragraph [2(h)] of its Statement of Case that:
"Where the court concludes, after applying all...
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