Bristol-Myers Holdings Ireland Unlimited Company v Norton (Waterford) Ltd

• Jurisdiction: Ireland
• Judge: Ms. Justice Costello
• Judgment Date: 29 June 2023
• Neutral Citation: [2023] IECA 173
• Court: Court of Appeal (Ireland)
• Docket Number: Court of Appeal Record Number: 2023/67

Between

Bristol-Myers Squibb Holdings Ireland Unlimited Company

Plaintiff/Respondent

and

Norton (Waterford) Limited T/A Teva Pharmaceuticals Ireland

Defendant/Appellant

[2023] IECA 173

Costello J.

Noonan J.

Allen J.

Court of Appeal Record Number: 2023/67

High Court Record Number: 2021/4758P

THE COURT OF APPEAL

CIVIL

[Uapproved]

[No Redaction Needed]

JUDGMENT of Ms. Justice Costello delivered on the 29 ^th day of June 2023

1 . This is an appeal from the Order of the High Court of 23 March 2023 restraining the defendant (“Teva”) from infringing Supplemental Protection Certificate No. 2011/032 (“the SPC”) in respect of the plaintiff's (“BMS”) medicinal product Eliquis ^® (whose active ingredient is Apixaban) pending the determination of proceedings challenging the validity of Irish Patent No. EP (IE) 1 427 415 (“the patent”) and the SPC in respect of the product. The trial is currently listed to commence on 4 July 2023 and is listed to run for 4 weeks.

Background

2 . BMS is the owner of the rights in the SPC which protects the active ingredient in BMS's product, Eliquis ^®, namely Apixaban. Apixaban is an anticoagulant agent which treats and prevents the formation of blood clots. It works by inhibiting the factor Xa enzyme. Factor Xa is an important enzyme in the biological pathway that leads to the coagulation of the blood. Apixaban was discovered following extensive research and substantial costs, including clinical trials, leading to the development and authorisation of Eliquis ^®. Eliquis ^® is the largest brand by revenue for BMS. The market is very valuable and expanding in Ireland. The list price value of Eliquis ^® in Ireland for 2021 was €47,521,689.

3 . Eliquis ^® is sold as a 2.5mg or 5mg film coated tablet in Ireland and it is a direct oral anti-coagulant product. In Ireland it is licensed and reimbursed by the Health Service Executive for three main conditions in adult patients:

• (a) Prevention of venous thromboembolic events in adult patients who have undergone elective hip or knee replacement surgery (indication is approved for the 2.5mg tablets only);

• (b) Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation, with one or more risk factors, such as prior stroke or transient ischaemic attack; age greater than or equal to 75 years; hypertension; diabetes mellitus; symptomatic heart failure (NYHA Class greater than or equal to II); and

• (c) Treatment of deep vein thrombosis and pulmonary embolism, and prevention of recurrent deep vein thrombosis and pulmonary embolism in adults.

4 . In order to place a medicinal product on the market, the manufacturer must obtain a marketing authorisation. As regards Apixaban in Ireland, five generic suppliers, in addition to Teva, have obtained marketing authorisations for generic Apixaban products.

5 . The vast majority of sales of Eliquis ^® in Ireland take place under one of the State funded reimbursement schemes. The HSE approves medicines for reimbursement under the schemes. The setting of reimbursement prices is governed by the Health (Pricing and Supply of Medicinal Goods) Act 2013. A framework agreement, referred to as the Generic Medicines Framework Agreement, was entered into by Medicines for Ireland (which represents the generic and bio-similar medicines industries in Ireland) and the Department of Health, the Department of Public Expenditure and Reform and the HSE. It came into effect on 1 December 2021. Under the Generic Medicines Framework Agreement the reimbursement price for new generic medicines must be no greater than 40% of the 1 October 2021 price of the equivalent branded original medicines. Thus, the introduction of generic products results in products being available at a fraction of the price payable by the HSE in respect of the branded products.

6 . BMS holds various intellectual property rights relating to Apixaban, including the patent and the SPC which is based on the patent. The patent expired on 17 September 2022. Unless revoked as a result of the action by Teva, the SPC will remain in force until its expiry on 19 May 2026, subject to potential for a paediatric extension until November 2026.

7 . Teva is a manufacturer of generic medicines. In March 2021 it indicated that it intended to launch a generic medicinal product, Apixaban Teva. It commenced proceedings seeking the revocation of the patent and of the SPC based upon the patent on 19 March 2021. As is more fully discussed below, BMS instituted these infringement proceedings thereafter. It is common case that Teva has no infringement defence to these proceedings as its product is generic Apixaban and it admits that it comes within the claims of the patent and is therefore caught by the SPC. Teva's only defence is to assert that the patent, and therefore the SPC, is invalid. Teva has no separate ground of challenge to the SPC.

The progress of the proceedings

8 . Teva issued revocation proceedings on 19 March 2021 challenging the validity of the patent and the SPC (“the revocation proceedings”).

9 . Teva pleads that the claims of the patent do not describe a patentable invention in that the patent did not involve an inventive step having regard to matter which formed the state of the art at the priority date; that the specification of the patent does not disclose the invention in the claims of the patent clearly enough and completely enough for it to be performed by a person skilled in the art at the priority date (or the application date); and that the matter disclosed in the specification of the patent extends beyond that disclosed in the application. During the course of argument these grounds of challenge were referred to in shorthand as the plausibility issue.

10 . On 12 April 2021 the revocation proceedings were entered into the Commercial List of the High Court and directions were made on consent. On 11 June 2021 a defence was delivered and on 2 July 2021 a reply to defence was delivered. On the same day, Teva's solicitors sought a hearing of the revocation proceedings on an expedited basis and confirmed that its current intention was to launch its generic brand of Apixaban on the Irish market in mid-2022 or as close to that date as possible. By letter dated 15 July 2021 the solicitors for BMS sought an undertaking from Teva that it would not launch its generic product prior to the determination of the proceedings and threatened that if an undertaking was not forthcoming then BMS would issue proceedings seeking an injunction and related relief in respect of such indicated launch. In order to facilitate the expeditious progress of the proceedings BMS's solicitors agreed directions in the revocation proceedings and agreed to the request for a trial date of June/July 2022. On 26 July 2021, when the proceedings were mentioned to the judge in charge of the Commercial List, he fixed the hearing date for the trial of the revocation proceedings for 21 June 2022.

11 . The undertaking sought by BMS was not provided by Teva, so BMS instituted infringement proceedings on 26 July 2021 seeking a declaration that the two products which Teva had indicated it intended to launch would infringe the SPC; an injunction restraining Teva from infringing the SPC; and an inquiry as to damages and related relief. Barniville J. (as he then was) gave a return date for the application for entry into the Commercial List of the infringement proceedings of 7 September 2021. The Statement of Claim was delivered on 3 August 2021 together with the Particulars of Breaches. An appearance was entered the following day and Notices for Particulars were raised and replied to on 3 and 17 September 2021 respectively. The infringement proceedings were duly admitted into the Commercial List. The defence was delivered on 1 October 2021.

12 . On 18 October 2021 Teva amended its Particulars of Objection in the revocation proceedings introducing a new claim in relation to the priority date. This was referred to in submissions as the Priority Issue. The patent upon which the SPC is based claims a priority date from U.S. filing U.S. 324165 (filed on 21 September 2001 (“US 165”)) in the names of Donald J Pinto and Mimi L Quan, the original applicants. Teva asserts that the right of priority arising from US 165 was not assigned from the original applicants for the patent to Bristol-Myers Squibb Company prior to the filing date of the patent. Instead, it is said, the right of priority arising from US 165 was assigned by the original applicants to Bristol-Myers Squibb Pharma Company and, that on 23 April 2007 – long after the filing date of the patent by Bristol-Myers Squibb Company – US 165 was assigned from Bristol Myers Squibb Pharma Company to Bristol-Myers Squibb Company. Accordingly, it is said, Bristol-Myers Squibb Company was therefore not the owner of US 165 at the filing date. This, it is said, is critical as, in the intervening period between the priority date of US 165 – 21 September 2001 – and the application by Bristol-Myers Squibb Company for the patent – which was filed on 17 September 2002 – there was an intervening patent filing which destroyed the novelty of the patent. Accordingly, Teva says the patent is invalid as it cannot validly claim priority based upon US 165.

13 . BMS consented to the application to amend the Particulars of Objection and an order was made on 18 October 2021 permitting the amendments.

14 . On 29 November 2021 the parties reached an agreement on discovery and on 17 December 2021 the court made an order by consent that BMS make discovery of certain categories of documents by 21 February 202. Category 9 related to the documents relevant to the priority issue. The court brought the trial date forward to 15 June 2022 to allow an additional four days to the duration of the case to reflect the additional time needed to accommodate the priority issue.

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