Novartis AG v Hospira UK Ltd
| Jurisdiction | England & Wales |
| Judge | Mr. Justice Birss,Mr Justice Birss,JUSTICE BIRSS |
| Judgment Date | 14 May 2013 |
| Neutral Citation | [2013] EWHC 1285 (Pat) |
| Court | Chancery Division (Patents Court) |
| Docket Number | Case No: HP 13 C 00034 |
| Date | 14 May 2013 |
[2013] EWHC 1285 (Pat)
IN THE HIGH COURT OF JUSTICE
CHANCERY DIVISION
PATENTS COURT
Royal Courts of Justice
The Rolls Building
7 Rolls Buildings
Fetter Lane
London EC4A 1NL
Mr. Justice Birss
Case No: HP 13 C 00034
Dr. Justin Turner QC and Mr. James Whyte (instructed by Bristows LLP) for the Claimant
Mr. Adrian Speck QC and Mr. Thomas Mitcheson (instructed by Taylor Wessing LLP) for the Defendant
This is an application for an interim injunction. I will say now that I am not going to grant an interim injunction and the reasons for that are as follows.
The application arises as follows. Novartis have two patents, United Kingdom EP (UK) 1296689 and EP (UK) 1591122. They cover the use of zoledronic acid for the treatment of osteoporosis. The point of the invention is that zoledronic acid can be administered as a single intravenous injection half-yearly or even annually. Other older bisphosphonate compounds in this class are administered orally, which would seem to be more convenient than by injection. However, the problem with oral administration is gastric intolerance. Thus, when a patient takes the tablets, they have to remain standing for half an hour after taking the tablets to seek to mitigate the side effects. The tablets also have to be taken relatively frequently.
Although it was known that intravenous administration would avoid the gastric side effects, the problem was that it was thought that the bisphosphonate injections would have to be given frequently, which is also undesirable. The invention in this case was based on the discovery that zoledronic acid, a known bisphosphonate, could be effective when administered intravenously half-yearly or yearly.
5 mg of zoledronic acid is authorised by the relevant medicines authority for osteoporosis. Zoledronic acid is also authorised for two other indications. The 5 mg presentation is authorised for Paget's disease and a 4 mg presentation is authorised for certain uses relating to cancer.
Novartis also has a compound patent and an SPC covering zoledronic acid. The SPC expires on 15th May 2013. The two patents in this case have a number of years to run after the SPC expires. The date of the expiry of the SPC has been known for a long time. In 2011, a generic pharmaceutical supplier, Hospira, decided that it wished to launch a generic zoledronic acid. Hospira's view was that the two patents were invalid and it applied to revoke. The proceedings are commenced in sufficient time to ensure that the trial was heard before the SPC on the compounds expired. That took place and the trial was heard by Arnold J in February of this year, with judgment given in March. The hearing to settle the final order and deal with costs and permission to appeal took place on 12th April.
Arnold J held that the two patents were invalid. Although he held the invention was not obvious, he also held that the claims were not entitled to claim priority from the relevant priority document, and Novartis accepted that as a result of a publication in the intervening priority year, if the claims lost priority, they could not survive.
Arnold J gave permission to Novartis to appeal. In doing so, he commented: "Notwithstanding Mr. Tappin's eloquence, I am just about persuaded [the] proposed grounds of appeal have a real (as opposed to fanciful) prospect of success, and accordingly I will grant permission to appeal."
The proceedings were an action for revocation. There was no counterclaim for infringement. In late November 2012, Hospira obtained a marketing authorisation for zoledronic acid. This would include the 4 mg presentation and also the 5 mg presentation for osteoporosis and Paget's disease. Novartis asked Hospira what their plans were. On 18th December 2012, Novartis' solicitors wrote asking about Hospira's plans. Amongst other things, they said:
"So that our client knows where it stands, we request that you confirm that, if any of the claims of either of the Patents asserted as having independent validity is held valid by the Court following the trial in February, your client will undertake not to launch its Zoledronic Acid Hospira 5 mg/100ml solution for infusion medicine in the UK after 15 May 2013."
We now know that Hospira are in a position to and wish to launch their generic zoledronic acid as soon as possible after 15th May when the SPC expires. The position today is that Hospira wish to launch the product in accordance with their marketing authorisation. Novartis, on the other hand, seek an interim injunction to restrain that launch pending appeal. Novartis offer a cross-undertaking in damages. In addition, I should note that the Secretary of State for Health has written asking that the court should require that any cross-undertaking given by Novartis extends to cover losses suffered by the NHS in the interim. Novartis are prepared to offer a cross-undertaking in the form required.
Dr. Turner, who appears for Novartis, leading Mr. James Whyte, and instructed by Bristows, argues as follows. First, he focuses on claim 7 of the '689 patent. That claim calls for a 2 to 10 mg dose administered by intravenous injection for osteoporosis once a year. He says Hospira would plainly infringe that claim if the patent was valid and so the only issue is invalidity.
Second, he says that if one examines the judgment of Arnold J in this case the obviousness attack was unsuccessful. There was a good invention here. Validity of claim 7 turns only on the priority question. On that point, Novartis will say that Arnold J's judgment is flawed. Before me Dr. Turner says that all I have to do is see that the appeal on priority turns on an issue of construction, which he says is plainly arguable, and that I am not in a position to say who will win the appeal. As I have said already, he draws a distinction from the position on an appeal in relation to a finding of obviousness.
Third, Dr. Turner submits that there is a good arguable case on appeal and thus, he says, I should turn to the balance of convenience as in American Cyanamid, and on that basis the familiar arguments arise. The market is still a (perfectly lawful) monopoly, the Novartis 5 mg osteoporosis presentation is a called Aclasta. That earned something like £5.7 million worth of sales in the United Kingdom last year. It is essentially a hospital prescribed medicine and the customer is the NHS. If Hospira start selling 5 mg zoledronic acid for osteoporosis there is a real risk of a downward price spiral. That will be irreversible and in practice it will not be possible to raise the price again even if Novartis win the appeal. So I should grant an interim injection pending appeal just as in similar circumstances the court would be likely to grant an interim injunction pending trial.
Mr. Speck, who appears leading Mr Thomas Mitcheson instructed by Taylor Wessing, argues to the contrary. He accepts that as a matter of jurisdiction the court can grant the order sought, but he says it would be extraordinary to grant an injunction in this case when the patent has been found invalid. He says as a matter of principle the fact that we have had a trial is not something which can be ignored. The merits of the case are a matter to be given considerable weight. He points out that taking into account the merits on an application for an interim injunction is entirely permissible in an appropriate case and that American Cyanamid, when properly understood, does not say differently.
Mr. Speck refers to the well-known judgment of Laddie J in Series 5 Software Limited v Philip Clarke and Others [1996] FSR 273 and also to paragraph 18 of the judgment of Walker LJ in Guardian Media Group plc, greater Manchester Newspapers Limited, Manchester Morning News Limited v Associated Newspapers Limited [2000] EWHC 461 (Ch) (CA) 20th January 2000 (unreported). I will quote paragraph 18 of that judgment:
"I take these four main points in that order. The American Cyanamid principles have a degree of flexibility and they do not prevent the court from giving proper weight to any clear view which the court can form at the time of the application for interim relief (and without the need for a mini-trial on copious affidavit evidence) as to the likely outcome at trial. That is particularly so when the grant or withholding of interim relief may influence the ultimate commercial outcome. It is not necessary to consider today whether the court's entitlement to give effect to its provisional view of the merits goes quite so far as Laddie J sought in Series 5 Software v Clarke [1996] 1 All ER 853. In the end, there was not any significant difference between counsel on that point."
Mr. Speck argues that the litigation up till now has been on the basis that if Hospira won at trial it would be free to launch when the SPC expires on 15th May. He points to the 18th December letter as an example of this. He says it would be wrong to force generics such as his clients to start cases like this so far before the SPC expires that an appeal to the Court of Appeal or even the Supreme Court will automatically be able to be done in advance.
On the question of the quantifiability of the loss and adequacy of damages as a remedy, Mr. Speck says that this case would not merit an interim injunction even if we were at the outset of proceedings at first instance. First, he says the interim injunction would deprive Hospira of what has been described as a first mover advantage. The point is that if...
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