Novartis Pharma AG v Eli Lilly and Company Ltd
| Jurisdiction | Ireland |
| Judge | Mr. Justice Twomey |
| Judgment Date | 26 April 2022 |
| Neutral Citation | [2022] IEHC 234 |
| Court | High Court |
| Docket Number | [2021 No. 2527 P] |
and
and
And by Order
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[2022] IEHC 234
[2021 No. 2527 P]
2021/2/PAP
THE HIGH COURT
COMMERCIAL
Discovery – Revocation – Patent infringement – Parties seeking discovery – Whether categories of discovery were relevant and necessary
Facts: The first set of proceedings was a revocation action taken by the defendants, Eli Lilly, against the plaintiff, Novartis, on the 13th April, 2021 in relation to European patent (IE) 2 784 084, entitled ‘Antagonist antibodies to IL-17A/F heterologous polypeptides’ owned by Novartis. The second set of proceedings were patent infringement proceedings taken by Novartis against Eli Lilly on the 15th April, 2021 in relation to Eli Lilly’s product, Taltz, which Novartis alleged breached Novartis’ patent. Discovery was sought by both parties against the other in both the revocation and the infringement actions.
Held by the High Court (Twomey J) that, regarding the discovery sought by Eli Lilly in the revocation action: (Categories 1-4) the Court would not apply a 20 year time period as sought, but would impose a period of four years; (Category 5) as it related to an article which was published in 2021, a reasonable time period for discovery would be for a period 3 years prior to the publication date of the article; (Category 6) Novartis was ordered to list privileged documents in the ordinary way. Twomey J held that, regarding the discovery sought by Novartis in the revocation action: (Categories, 1-2 and 4) the appropriate time to make discovery was when Eli Lilly knew for certain what documents it would be relying upon, i.e. upon the delivery of the witness statements; (Categories 3 and 5-8) it was not necessary for the fair disposal of the trial that discovery be ordered in respect of documentation, answerable to this category, which was created on or after 12th February, 2017. Twomey J held that, regarding the discovery sought by Novartis in the infringement action: (Categories 1-2) the offer of the product description by Eli Lilly was sufficient discovery in this case and accordingly these categories, in addition thereto, were not necessary; (Category 3) it was appropriate to postpone the requirement to disclose this confidential information until it became necessary; (Category 4) the Court did not see any prejudice in Novartis not having discovery of details regarding the market authorisation holder and concluded that this category of discovery was not relevant to these proceedings; (Categories 5-6) the Court did not accept Novartis’ claim that products due to come through its pipeline at some future date had a bearing on alleged dominance. Twomey J held that, regarding the discovery sought by Eli Lilly in the infringement action: (Category 6) sub-category (a) should read ‘from 2015 to present for Ireland, the EEA as a whole and the United Kingdom’ instead, the term ‘final version of’ should be inserted on the first line of sub-category (b) before the word ‘business’, and clinical trials and clinical studies should be excluded from the second paragraph of the category; (Category 7) this category had been agreed; (Categories 8-11) Categories 8 to 11 would be ordered as they were relevant, Category 10 dealt with the alleged enforceability of the IL-17A/F portfolio against third parties so the appropriate time period was from the 15th January, 2015 since that was the date when Novartis was granted a marketing authorisation for Cosentyx, and in relation to the two options in square brackets in Category 11, the reference should be to ‘the Patent EP ‘084 and/or EP’ 822’; (Category 13) there appeared to be agreement between the parties regarding this category, subject to there being a confidentiality club; (Category 14(b)) the Court would order this category but it acknowledged Novartis’ point that when it comes to inspection and production, as distinct from listing documents as part of discovery, that the issue of confidentiality may have to be considered at that stage; (Category 16) this category would be ordered as documents which might indicate the poor performance of Cosentyx were relevant and necessary to Novartis’ alleged motivation for seeking to abuse its alleged dominant position; (Category 17) this category was agreed between the parties.
Twomey J ordered discovery of the categories of documents in line with this judgment.
Discovery ordered.
JUDGMENT OF Mr. Justice Twomey delivered on the 26 th day of April, 2022
. This is a dispute between two multinational pharma companies, the plaintiff, Novartis Pharma AG (“Novartis”) and the defendants (“Eli Lilly”), relating to European patent (IE) 2 784 084, entitled ‘Antagonist antibodies to IL-17A/F heterologous polypeptides’ (the “Patent” or the “084 Patent”) owned by Novartis. The Patent covers products directed towards antibodies that act as antagonists to a protein that is implicated in immunity related diseases like psoriasis.
. The first set of proceedings is a revocation action (the “revocation action”) taken by Eli Lilly against Novartis on the 13 th April, 2021 in relation to the Patent.
. Eli Lilly's application for the revocation of the Patent is brought in circumstances where it claims that the Patent is directed towards antibodies that act as antagonists to IL-17A/F but where the scope that Novartis asserts for the Patent extends to antibodies that bind to IL-17A/F and function to antagonise IL-17A/F irrespective of whether they bind to other proteins including the prior art related proteins, IL-17A/A or IL-17F/F. This is the basis upon which Novartis asserts the Patent over Eli Lilly's own antibody ixekizumab, which is a therapy for immunity-related illnesses supplied to patients, sold under the product name Taltz. Novartis' competing product is called Cosentyx.
. Eli Lilly claims, inter alia, that the Patent currently owned by Novartis should not have been granted as it lacks novelty, it is obvious and lacks sufficiency.
. The second set of proceedings are patent infringement proceedings (the “infringement action”) taken by Novartis against Eli Lilly on the 15 th April, 2021 in relation to Eil Lilly's product, Taltz, which Novartis alleges breaches Novartis' Patent.
. Eli Lilly claims, as a defence to the infringement action, that the Patent is invalid, that Taltz does not come within the claims of the Patent, as properly construed and that Novartis' acquisition of the Patent, and its alleged use by Novartis to seek to prevent competition from Eli Lilly, constitutes an abuse of a dominant position in breach of competition law.
. In this regard, Eli Lilly claims that Novartis has a dominant position in the market for products targeted at the treatment of psoriasis where a high degree of efficacy and speed is required. Eli Lilly relies on these same competition law issues to support its counterclaim in the infringement action. It also claims that the injunctive remedy, which is being sought by Novartis, would impose a disproportionate hardship to patients who rely on Taltz.
. The Patent was originally held by a company called Genentech Inc. The Patent was filed by Genentech Inc. on 2 nd June, 2004 and the priority date of the Patent is 8 th July, 2003. Genentech Inc. did not develop any product on the basis of the Patent.
. Novartis acquired the Patent after entering into an ‘Asset Purchase, License, and Settlement Agreement’ dated 23 rd April, 2020 with Genentech Inc, which is some 17 years after the Patent was granted. The Patent was then assigned to Novartis by Genentech Inc. on 25 th September, 2020.
. Prior to Novartis' acquisition of the Patent from Genentech Inc., European Patent EP 1 641 822 (the “Patent '822”) the parent patent of the Patent, was successfully challenged in Opposition proceedings before the European Patent Office (“EPO”). This was because prior to its acquisition of the Patent from Genentech Inc. Novartis objected to the EPO against the granting of the '822 Patent on the basis that the European patent was already being asserted against Eli Lilly's product Taltz in national proceedings beyond the scope of any valid monopoly that could be claimed for it. It is also the case that Novartis objected to the Patent on grounds of invalidity, prior to its acquisition of the Patent from Genentech Inc.
. Novartis had also initiated challenges to the parent patent, the '822 Patent, in 2014 and 2019.
. Eli Lilly claims that this factual background is relevant to the discovery process, as it claims these are an unusual set of facts and it points out that it spans a long period of time from the priority date of 8 th July, 2003 to date.
. It is against this background that discovery is sought by both parties against the other in both the revocation and the infringement actions. Hence there are four separate motions for discovery. First the two discovery motions in the revocation action will be addressed, followed by the two discovery motions in the infringement action.
. What is unusual in these proceedings, compared say to other litigation, is that in some respects both parties are looking for similar types of documents from each other e.g. it is common case that Novartis' categories 3 and 6 which it seeks in the revocation action are very similar to Eli Lilly's Categories 1–6 which it seeks in the revocation action e.g. documents which either party has which relates to any antibody which binds to and inhibits IL-17A/F.
. It is...
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