Janssen-Cilag Limited v The United States of America, as Represented by the Secretary, Department of Health and Human Services

Neutral Citation Number: [2026] EWHC 436 (Pat) Case No: HP-2026-000007 IN THE HIGH COURT OF JUSTICE BUSINESS AND PROPERTY COURTS OF ENGLAND AND WALES INTELLECTUAL PROPERTY LIST (ChD) PATENTS COURT The Rolls Building 7 Rolls Buildings Fetter Lane London EC4A 1NL Date: Wednesday, 25 th February 2026 Before: HIS HONOUR JUDGE HACON (Sitting as a Judge of the Patents Court) - - - - - - - - - - - - - - - - - - - - - Between: JANSSEN-CILAG LIMITED Claimant - and - THE UNITED STATES OF AMERICA, AS REPRESENTED BY THE SECRETARY, DEPARTMENT OF HEALTH AND HUMAN SERVICES - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - DR. JUSTIN TURNER KC, MR. JAMES WHYTE and MR. MICHAEL CONWAY (instructed by Herbert Smith Freehills Kramer LLP) for the Claimant The Defendant did not appear and was not represented - - - - - - - - - - - - - - - - - - - - - Approved Judgment Defendant If this Transcript is to be reported or published, there is a requirement to ensure that no reporting restriction will be breached. This is particularly important in relation to any case involving a sexual offence, where the victim is guaranteed lifetime anonymity (Sexual Offences (Amendment) Act 1992), or where an order has been made in relation to a young person. This Transcript is Crown Copyright. It may not be reproduced in whole or in part other than in accordance with relevant licence or with the express consent of the Authority. All rights are reserved. Transcript of the Stenograph Notes of Marten Walsh Cherer Ltd., 2nd Floor, Quality House, 6-9 Quality Court, Chancery Lane, London WC2A 1HP. Telephone No: 020 7067 2900. DX 410 LDE Email: info@martenwalshcherer.com Web: www.martenwalshcherer.com His Honour Judge Hacon (Sitting as a Judge of the Patent Court) Approved Judgment Janssen-Cilag v The USA as represented By the Secretary, Dept of Health and Human Services HIS HONOUR JUDGE HACON: 1. 2. 3. 4. 5. 6. 7. 8. 9. This is an application for service of the claim form, the particulars of claim and related documents out of the jurisdiction and also an application to serve the defendant by alternative methods pursuant to CPR 6.15. In the substantive action the claimant seeks revocation of the UK designation of the defendant’s patent EP 3 689 383 B1. The claimant is a subsidiary of the well-known healthcare and pharmaceutical company Johnson & Johnson. The defendant is the United States of America as represented by the Secretary of the US Department of Health and Human Services. Justin Turner KC and Michael Conway appear for the claimant. The defendant does not appear, although it was informed of this application and is certainly aware of it, as appears from a letter dated 24th February 2026 from the London Embassy of the United States of America to the Foreign, Commonwealth and Development Office, copied to the court. I will grant the order substantially in the terms sought by the claimant. I do not propose to give a detailed judgment because my reasons for making the order at this ex parte hearing are those advanced by the claimant in counsel's skeleton argument as supplemented to some extent in oral submissions. I accept those reasons. As discussed with counsel, the order will require the claimant to serve a copy of the skeleton argument on the defendant at the same time as service of the claim form, together with a copy of the transcript of today’s hearing, the supporting evidence and a copy of this judgment. The skeleton argument shown to me contains confidential information, as does the witness statement of Mr. Moore, so it will be sufficient to serve those in redacted form. If the defendant’s lawyers wish to have sight of an unredacted copy, no doubt that can be agreed with the claimant under appropriate terms of confidentiality or, in the absence of agreement, the defendant may apply to the court. The order will in any event include the usual term that the defendant may apply to vary or set aside the order in accordance with CPR 23.10. Since the letter from the US Embassy raises two matters, I will say something about them specifically, without implying that my conclusion on the grant of the order rests solely on those two matters. The letter draws attention to section 12(1), (2) and (4) of the State Immunity Act 1978 (the 1978 Act) which provide: “12. Service of process and judgments in default of appearance. (1) Any writ or other document required to be served for instituting proceedings against a State shall be served by being transmitted through the Foreign, Commonwealth and Development Office to the Ministry of Foreign Affairs of the State and service shall be deemed to have His Honour Judge Hacon (Sitting as a Judge of the Patent Court) Approved Judgment Janssen-Cilag v The USA as represented By the Secretary, Dept of Health and Human Services been effected when the writ or document is received at the Ministry. (2) Any time for entering an appearance (whether prescribed by rules of court or otherwise) shall begin to run two months after the date on which the writ or document is received as aforesaid. ... (4) No judgment in default of appearance shall be given against a State except on proof that subsection (1) above has been complied with and that the time for entering an appearance as extended by subsection (2) above has expired.” 10. Section 12(4) does not apply since judgment in default is not sought at this hearing. With regard to sections 12(1) and (2), the claimant draws attention to section 12(7), which provides: “(7) This section shall not be construed as applying to proceedings against a State by way of counter-claim or to an action in rem; and subsection (1) above shall not be construed as affecting any rules of court whereby leave is required for the service of process outside the jurisdiction.” 11. The claimant submits that an action to revoke a patent is an action in rem. Accordingly, pursuant to section 12(7), section 12 of the 1978 Act does not apply to this action. The defendant points out that this is consistent with the policy on state immunity set out in section 7(a) of the 1978 Act, which provides: “Patents, trade-marks etc. A State is not immune as respects proceedings relating to — (a) any patent, trade-mark, design or plant breeders’ rights belonging to the State and registered or protected in the United Kingdom or for which the State has applied in the United Kingdom.” 12. I agree that an action seeking revocation of a UK patent is an action in rem, see Virgin Atlantic Airways Limited v Zodiac Seats UK Limited [2013] UKSC 46, at paragraphs 7 and 32. I also accept the claimant’s contention that section 12 of the 1978 Act does not apply to this action 13. The second matter raised by the letter from the US Embassy is CPR rule 6.44, which provides: “6.44 His Honour Judge Hacon (Sitting as a Judge of the Patent Court) Approved Judgment Janssen-Cilag v The USA as represented By the Secretary, Dept of Health and Human Services (1) This rule applies where a party wishes to serve the claim form or other document on a State. (2) In this rule, ‘State’ has the meaning given by section 14 of the State Immunity Act 197816. (3) The party must file in the Central Office of the Royal Courts of Justice – (a) a request for service to be arranged by the Foreign and Commonwealth Office; (b) a copy of the claim form or other document; and (c) any translation required under rule 6.45. (4) The Senior Master will send the documents filed under this rule to the Foreign and Commonwealth Office with a request that it arranges for them to be served. (5) An official certificate by the Foreign and Commonwealth Office stating that a claim form or other document has been duly served on a specified date in accordance with a request made under this rule is evidence of that fact. (6) A document purporting to be such a certificate is to be treated as such a certificate, unless it is proved not to be. (7) Where – (a) (b) section 12(6) of the State Immunity Act 1978 applies; and the State has agreed to a method of service other than through the Foreign and Commonwealth Office, the claim form or other document may be served either by the method agreed or in accordance with this rule. (Section 12(6) of the State Immunity Act 1978 provides that section 12(1) enables the service of a claim form or other document in a manner to which the State has agreed.)” 14. 15. The claimant has two responses to rule 6.44. The first is that the rule cannot override the 1978 Act. The claimant sets out in paragraph 77 of its skeleton argument authorities in support of that unsurprising proposition, with which I agree. The claimant’s second response is that in any event the court has jurisdiction to order service by a method not otherwise permitted by Part 6 of the rules. See CPR 6.15(1) which states: His Honour Judge Hacon (Sitting as a Judge of the Patent Court) Approved Judgment Janssen-Cilag v The USA as represented By the Secretary, Dept of Health and Human Services “(1) Where it appears to the court that there is a good reason to authorise service by a method or at a place not otherwise permitted by this Part, the court may make an order permitting service by an alternative method or at an alternative place.” 16. My attention was drawn to the authorities set out in paragraph 78 of the claimant’s skeleton argument. 17. I am therefore satisfied that the reasons for service by an alternative method advanced by the claimant, as set out in its skeleton argument and developed in oral argument this morning are sufficient for me to make an order under CPR 6.15 for alternative service. I will make the order sought, subject to discussion about the precise form. (For continuation of proceedings: please see separate transcript) - - - - - - - - - - (This Judgment has been approved by the Judge.) His Honour Judge Hacon (Sitting as a Judge of the Patent Court) Approved Judgment Janssen-Cilag v The USA as represented By the Secretary, Dept of Health and Human Services Digital Transcription by Marten Walsh Cherer Ltd 2nd Floor, Quality House, 6-9 Quality Court, Chancery Lane, London WC2A 1HP Telephone No: 020 7067 2900 DX: 410 LDE Email: info@martenwalshcherer.com Web: www.martenwalshcherer.com