Eli Lilly and Company v Janssen Sciences Ireland UC (formerly Janssen Alzheimer Immunotherapy)
| Jurisdiction | England & Wales |
| Judge | Mrs Justice Rose |
| Judgment Date | 18 February 2016 |
| Neutral Citation | [2016] EWHC 313 (Pat) |
| Court | Chancery Division (Patents Court) |
| Date | 18 February 2016 |
| Docket Number | Case No: HP 2015 000060 |
[2016] EWHC 313 (Pat)
IN THE HIGH COURT OF JUSTICE CHANCERY DIVISION
PATENTS COURT
Royal Courts of Justice
Strand, London, WC2A 2LL
Mrs Justice Rose
Case No: HP 2015 000060
Mr Andrew Waugh QC and Dr Stuart Baran (instructed by Simmons & Simmons LLP) for the Claimant
Mr Daniel Alexander QC (instructed by Linklaters LLP) for the Defendant
Hearing date: 10 February 2016
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.
The Defendant ('Janssen') has applied for an order that patent proceedings brought by the Claimant ('Eli Lilly') in this court should be stayed pending the decision of the European Patent Office on the validity of the divisional patent challenged in these proceedings. The claim brought by Eli Lilly in this court seeks to revoke the specified claims of Janssen's patent EP (UK) 2 305 282 and also seeks a declaration of non-infringement ('DNI') in respect of the Eli Lilly's product solanezumab. The claim form was issued on 2 December 2015 and Janssen's defence was served on 13 January 2016. Solanezumab is an antibody proposed to be used in the treatment of Alzheimer's disease.
The procedural history relating to the divisional patent and to the parent patent, EP 1 994 937 in the EPO and the English Patent Court is as follows. In 2011 Eli Lilly commenced a claim in this jurisdiction to revoke the UK parent patent and included in those proceedings a claim for a DNI in respect of solanezumab. The UK parent patent was held to be invalid in a judgment of Arnold J in June 2013: [2013] EWHC 1737 (Pat). His conclusions on the issues before him were:
i) the parent patent was not invalid on the grounds of added matter;
ii) claim 1 in the parent patent was novel and was not obvious;
iii) the parent patent was however invalid on the ground of insufficiency;
iv) if the parent patent were valid, Eli Lilly's product would infringe claims 1 and 5.
As to that point (iv), Eli Lilly had argued that it was implicit in the parent patent claim that in order to treat Alzheimer's disease, the antibody to amyloid beta had to raise an immune response. Since solanezumab does not work by prompting an immune response in the patient, Eli Lilly argued that it was not covered by the patent. Arnold J rejected that argument on the proper construction of the patent. Eli Lilly assert, however, that Arnold J accepted the evidence that solanezumab does not prompt an immune response in the patient. There is a dispute in the proceedings currently on foot in this jurisdiction as to whether the court determining issues arising on the divisional patent is bound by those findings of Arnold J in relation to the parent patent. Janssen lodged an appeal against Arnold J's judgment but withdrew the appeal before it was heard.
Also in June 2013 the EPO Opposition Division held that the European parent patent was invalid. That opposition had been brought by Lilly on three grounds, insufficiency, obviousness and lack of novelty. The Opposition Division determined that the patent was insufficient and did not consider the other two grounds. Janssen lodged an appeal against that decision in October 2013. The oral proceedings before the Technical Board of Appeal are scheduled to take place on 12 – 13 May 2016.
The divisional patent, the UK designation of which is at issue in these proceedings, was granted by the EPO shortly after the UK parent patent was held to be invalid in Arnold J's judgment. There has been opposition to it at the EPO by Lilly and others. The oral proceedings of the Opposition Division in the opposition to the grant of the divisional patent are scheduled to take place on 22 – 23 June 2016. It is expected that the EPO will announce the result of the opposition immediately and give reasons after — that is the Opposition Division's usual practice though it is not guaranteed that it will follow that practice. The divisional and parent patents will expire in November 2018.
In July 2015 Lilly started proceedings in France seeking revocation of the French designations of both the parent and the divisional patents. Janssen has applied to stay those proceedings and Eli Lilly has resisted the grant of a stay. A decision of the French court is expected by the end of February.
The principles to be applied when the court is considering whether to stay proceedings are set out in IPCom GmbH & Co KG v HTC Europe Co Ltd [2013] EWCA Civ 1496 (' IPCom'). The leading judgment in that case was given by Floyd LJ. He described the history of guidance on stays in the earlier case of Glaxo Group Ltd v Genentech Inc [2008] EWCA Civ 23; [2008] FSR 18 ("the Glaxo guidance"). The Glaxo guidance was regarded as generally discouraging the grant of a stay. The Supreme Court, in the course of judgments given in Virgin Atlantic Airways Ltd v Zodiac Seats UK Ltd [2013] UKSC 46 (" Virgin") questioned the correctness of the Glaxo guidance. That guidance was revised by the Court of Appeal in IPCom. At paragraph 68 of his judgment in IPCom, Floyd LJ restated the approach that the court should adopt in these cases as follows:
"68. In the light of the observations in Virgin and the arguments on this appeal I would recast the Glaxo guidance as follows:
1. The discretion, which is very wide indeed, should be exercised to achieve the balance of justice between the parties having regard to all the relevant circumstances of the particular case.
2. The discretion is of the Patents Court, not of the Court of Appeal. The Court of Appeal would not be justified in interfering with a first instance decision that accords with legal principle and has been reached by taking into account all the relevant, and only the relevant, circumstances.
3. Although neither the EPC nor the 1977 Act contains express provisions relating to automatic or discretionary stay of proceedings in national courts, they provide the context and condition the exercise of the discretion.
4. It should thus be remembered that the possibility of concurrent proceedings contesting the validity of a patent granted by the EPO is inherent in the system established by the EPC. It should also be remembered that national courts exercise exclusive jurisdiction on infringement issues.
5. If there are no other factors, a stay of the national proceedings is the default option. There is no purpose in pursuing two sets of proceedings simply because the Convention allows for it.
6. It is for the party resisting the grant of the stay to show why it should not be granted. Ultimately it is a question of where the balance of justice lies.
7. One important factor affecting the exercise of the discretion is the extent to which refusal of a stay will irrevocably deprive a party of any part of the benefit which the concurrent jurisdiction of the EPO and the national court is intended to confer. Thus, if allowing the national court to proceed might allow the patentee to obtain monetary compensation which is not repayable if the patent is subsequently revoked, this would be a weighty factor in favour of the grant of a stay. It may, however, be possible to mitigate the effect of this factor by the offer of suitable undertakings to repay.
8. The Patents Court judge is entitled to refuse a stay of the national proceedings where the evidence is that some commercial certainty would be achieved at a considerably earlier date in the case of the UK proceedings than in the EPO. It is true that it will not be possible to attain certainty everywhere until the EPO proceedings are finally resolved, but some certainty, sooner rather than later, and somewhere, such as in the UK, rather than nowhere, is, in general, preferable to continuing uncertainty everywhere.
9. It is permissible to take account of the fact that resolution of the national proceedings, whilst not finally resolving everything, may, by deciding some important issues, promote settlement.
10. An important factor affecting the discretion will be the length of time that it will take for the respective proceedings in the national court and in the EPO to reach a conclusion. This is not an independent factor, but needs to be considered in conjunction with the prejudice which any party will suffer from the delay, and lack of certainty, and what the national proceedings can achieve in terms of certainty.
11. The public interest in dispelling the uncertainty surrounding the validity of monopoly rights conferred by the grant of a patent is also a factor to be considered.
12. In weighing the balance it is material to take into account the risk of wasted costs, but this factor will normally be outweighed by commercial factors concerned with early resolution.
13. The hearing of an application for a stay is not to become a mini-trial of the various factors affecting its grant or refusal. The parties' assertions need to be examined critically, but at a relatively high level of generality."
Arnold J applied these factors in Actavis Group PTC EHF v Pharmacia LLC [2014] EWHC 2265 (Pat) (' Actavis'). That was a claim for revocation of a patent and it was accepted that the Actavis product would infringe the patent if the patent were valid. At the time the application for a stay came before Arnold J the deadline for opposition to the patent had expired only shortly before and two opponents, Actavis and an undisclosed undertaking, had lodged oppositions. There had as yet been no hearing date set in the Opposition Division. Arnold J considered the relative timing of the two sets of proceedings. It was common ground there that it was possible that English proceedings would be resolved...
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