Novartis AG v Hospira Uk Ltd
| Jurisdiction | England & Wales |
| Judge | Lord Justice Floyd,Lord Justice Kitchin,Lord Justice Lewison |
| Judgment Date | 22 May 2013 |
| Neutral Citation | [2013] EWCA Civ 583 |
| Docket Number | Case No: A3/2013/1301 |
| Court | Court of Appeal (Civil Division) |
| Date | 22 May 2013 |
[2013] EWCA Civ 583
Lord Justice Lewison
Lord Justice Kitchin
and
Lord Justice Floyd
Case No: A3/2013/1301
IN THE COURT OF APPEAL (CIVIL DIVISION)
ON APPEAL FROM THE HIGH COURT OF JUSTICE
CHANCERY DIVISION
MR JUSTICE BIRSS
Royal Courts of Justice
Strand, London, WC2A 2LL
Justin Turner QC and James Whyte (instructed by Bristows) for the Appellant
Adrian Speck QC and Tom Mitcheson (instructed by Taylor Wessing) for the Respondent
Hearing date: 17 May 2013
Approved Judgment
This is an appeal from the judgment of Birss J dated 14 May 2013 by which he refused Novartis AG an interim injunction in a patent action pending an appeal to this court. The appeal raises a question about the grant of interim injunctive relief pending appeal when the patent in suit has been held invalid. We heard the appeal on an urgent basis on 17 May 2013 in view of Hospira UK Limited's intention imminently to launch a generic drug which is alleged to infringe the patent.
Background
The appeal arises in the following circumstances. Novartis AG is the proprietor of two European patents (UK) Nos. 1296689 and 1591122 which cover the use of zoledronic acid for the treatment of osteoporosis. These patents both have a number of years to run. I will call them "the use patents". The use patents cover Novartis' drug Aclasta. Worldwide sales of Aclasta were some US$590 million in 2012, of which about £5.7 million represented UK sales. The market is said by Novartis to be an expanding one.
Birss J described the invention of the use patents in this way:
"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."
Novartis is also the proprietor of an earlier patent and corresponding SPC covering zoledronic acid itself. The SPC expired on 15 th May 2013, that is to say in the course of last week. I will refer to it as "the SPC". Whilst the SPC was in force no one could sell zoledronic acid for any purpose, let alone for intravenous use for the treatment of osteoporosis.
On 20 December 2011 Hospira, a well known and well respected generic medicine manufacturer and supplier, commenced revocation proceedings against the use patents ("the revocation proceedings"). The revocation proceedings were commenced, so far as Hospira were concerned, because they had it in mind to market a generic zoledronic acid product. The revocation proceedings were not expedited in any way, and a trial date, some 14 months from the issue of proceedings, was fixed for February 2013. That is a normal or slightly attenuated period for revocation proceedings to come to trial in the Patents Court.
In November 2012, before the revocation proceedings had come to trial, but after the trial date had been fixed for February 2013, Hospira obtained a marketing authorisation for zoledronic acid for amongst other things osteoporosis. The marketing authorisation also covered the use of zoledronic acid for the treatment of Paget's disease, a fact which has some relevance to one of the arguments about the balance of convenience.
The fact of Hospira's marketing authorisation came to Novartis' attention at the end of November 2012 or early December 2012. Until that date Novartis were not in a position to take any steps to obtain an interim injunction. When the marketing authorisation did come to their attention, Bristows, the solicitors acting for Novartis in the revocation proceedings, wrote promptly to Hospira on 4 December 2012. The letter asked for:
i) an undertaking not to sell any zoledronic acid product prior to the expiry of the SPC on 15 th May 2013;
ii) an undertaking not to infringe the use patents until the handing down of judgment in the revocation proceedings;
iii) an acknowledgement that the 5mg/100ml formulation of zoledronic acid covered by the marketing authorisation would infringe the use patents.
Bristows also said in that letter that if the acknowledgment on the issue of infringement was not given, then the issue of infringement should be heard at the trial in February.
Taylor Wessing, the solicitors acting for Hospira, replied on 14 December 2012. They gave the undertaking which had been requested in relation to the SPC, thus securing Novartis' position until 15 May 2013. Taylor Wessing resisted the introduction of infringement issues into the February trial. Those issues should, according to them, have been raised earlier.
Bristows wrote again on 18 December 2012. This is a letter to which the judge attached considerable significance. The whole of the letter needs to be read to understand the context. In the first paragraph Bristows recorded Hospira's undertaking based on the SPC not to sell any zoledronic acid product before 15 May 2013. In the next paragraph they took issue in strong terms with the suggestion that they should have raised infringement earlier, given that they were unaware of any marketing authorisation, amongst other things. The third paragraph deals with the position after 15 May 2013 and was in these terms:
"So that our client knows where it stands, we request that you confirm that, if any of the claims of [the use 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."
Such an undertaking was necessary because a finding of validity of the use patents would not of itself prevent Hospira from launching the product covered by its marketing authorisation in the absence of an acknowledgment from Hospira that their product would infringe. The letter was not addressing itself to the question of what would happen if the patents were held invalid.
Hospira continued to resist the introduction of any issues of infringement into the revocation proceedings. On 10 January 2013 Taylor Wessing wrote that
"Hospira wishes to review which products and indications it may market in the future in the UK once it knows the outcome of these proceedings".
In the end the issue of infringement was not added to the revocation proceedings. The parties agreed that the correct time to address the issue was when judgment was handed down in the revocation proceedings.
The trial of the revocation proceedings took place between 20 and 26 February 2013 before Arnold J. Arnold J's judgment was handed down on 15 th March. He held both of the use patents invalid. This was on the ground that although the allegations of obviousness failed, the patents were not entitled to their claimed priority date, and hence were rendered invalid by an intervening prior publication. He also upheld an allegation of insufficiency in relation to some but not all of the claims.
On 18 March 2013, following the handing down of judgment, Bristows wrote to Taylor Wessing saying that they were concerned that in the light of the judgment Hospira would be introducing their zoledronic acid solution after 15 th May 2013, that is to say after the date of expiry of the SPC, which of course at that date still remained an obstacle to the introduction of any zoledronic acid product. They asked Taylor Wessing to let them know within 7 days whether it was Hospira's settled intention to launch on or shortly after 15 May 2013.
Despite reminders, Hospira did not answer this question. Instead, on 4 April 2013, Taylor Wessing wrote asking whether Novartis intended to seek an injunction pending appeal under either or both of the use patents. They pointed out that they did not accept that Novartis would be entitled to an injunction given the finding of invalidity. Bristows replied the next day saying that they believed Arnold J's approach to priority and insufficiency had been wrong. They said it was indeed their client's intention to seek an interim injunction against any company which threatened to launch an infringing formulation. They offered a standard form of cross undertaking. They also enquired whether Hospira would support an application by Novartis for the appeal to be expedited. Taylor Wessing replied on 10 April saying that the enforceability of the patents and the timing of any appeal depended on the application for permission to appeal which had not yet been heard.
At a further hearing on 12 April Arnold J gave permission to appeal. In giving permission he said that the grounds of appeal just about persuaded him that an appeal would have a real, as opposed to a fanciful, prospect of success.
On 24 April Taylor Wessing wrote to Bristows saying that it was Hospira's intention to launch in the UK "following expiry of the SPC on 15 May 2013." On the same day,...
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