Merck Sharp Dohme Corporation and Another v Teva Pharma BV and Another
| Jurisdiction | England & Wales |
| Judge | HIS HONOUR JUDGE BIRSS QC,His Honour Judge Birss QC |
| Judgment Date | 15 March 2012 |
| Neutral Citation | [2012] EWHC 627 (Pat) |
| Court | Chancery Division (Patents Court) |
| Docket Number | Case No: HC 12 C 00541 |
| Date | 15 March 2012 |
[2012] EWHC 627 (Pat)
IN THE HIGH COURT OF JUSTICE CHANCERY DIVISION
PATENTS COURT
Rolls Buildings
7 Rolls Buildings
London EC4A 1NL
His Honour Judge Birss QC
(Sitting as a Judge of the High Court)
Case No: HC 12 C 00541
Justin Turner QC (instructed by Hogan Lovells) for the Claimants
John Baldwin QC and Mark Chacksfield (instructed by Winston & Strawn) for the Defendants
Hearing dates: 8th March 2012
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.
I have before me two applications. One is by the claimants, Merck Sharp & Dohme Corp. and Bristol-Myers Squibb Pharmaceuticals Ltd (together "BMS") for an interim injunction pending trial to restrain the defendants Teva Pharma B.V. and Teva UK Ltd (together "Teva") from infringing European Patent (UK) No. 0,582,455. The other application before me is by Teva for an order that the action be struck out in its entirety.
The patent includes compound claims directed to a drug known as efavirenz which is marketed by BMS as SUSTIVA. It is an anti-retroviral compound used in combination therapy for the treatment of HIV and AIDS. In the four years to December 2011 sales of SUSTIVA in the UK amounted to approximately $150 million.
BMS are represented by Justin Turner QC instructed by Hogan Lovells and Teva are represented by John Baldwin QC leading Mark Chacksfield instructed by Winston & Strawn.
The position is that some time prior to October 2011 Teva applied for a Europe wide marketing authorisation for a generic form of efavirenz. That application bore fruit and on 20 th October 2011 the Committee for Medicinal Products for Human Use ("CHMP") adopted a positive opinion and recommended the grant to Teva of a marketing authorisation for efavirenz in the form of 600mg film-coated tablets for the combination treatment of human HIV infection. Teva's product is known as "Efavirenz Teva". This positive opinion and recommendation is not the same thing as the actual grant of a marketing authorisation but it is a clear indication that one will be granted soon afterwards.
BMS are the proprietors of the patent. They also hold a Supplementary Protection Certificate ("SPC") which extends the period of protection somewhat. The patent will expire on 3 rd August 2013 and the SPC on 20 th November 2013. BMS hold corresponding patent rights throughout Europe. The dates are essentially the same, the patent(s) will expire on or about 3 rd August 2013 and the SPCs will expire on or about 20 th November 2013.
On 1 st December 2011 BMS' solicitors wrote to Teva about the matter. In fact the letter was from the Dutch office of Hogan Lovells but nothing turns on that for present purposes. The letter pointed out that it followed from the CHMP's positive opinion that in all probability Teva would be in a position, from a regulatory standpoint, to market their efavirenz product throughout Europe within the next few months. The letter pointed out that the patent in question was enforceable and would prevent any form of generic efavirenz from being sold. The letter ended by requesting that Teva provide an undertaking not to market their efavirenz product in any country in which the patent remains in force. The undertaking was sought within 8 days.
Teva did not respond. Hogan Lovells wrote again on 25 th January 2012. By now they understood that the marketing authorisation had been issued or was about to be issued. The request for an undertaking was repeated and sought within 5 days. In fact it appears that Teva's marketing authorisation had by then been granted sometime between 22 nd December 2011 and 9 th January 2012. The precise date does not matter.
On 7 th February 2012 Teva responded, apologising that the letter may have been missed as a result of an office move but stating that a response would be given before the end of the week. On the same day Hogan Lovells responded stating that if Teva were not prepared to provide the undertaking sought then alternatively BMS required an undertaking not to take steps to market the product without giving 8 weeks prior notice. The letter ends with the following:
"If I do not receive an undertaking from you in either of the forms set out above by 5pm today, my clients have no choice but to presume that it is your intention to commence marketing Efavirenz Teva imminently and will protect their position by seeking injunctive relief."
On 8 th February Hogan Lovells London wrote to Teva stating that since their clients had not received the requested undertaking or any indication that Teva was prepared to provide the undertaking sought, their clients "therefore believe that it is your intention to commence marketing Efavirenz Teva imminently in the UK." Consequently they said they would apply to the High Court for an interim injunction on the very same day.
The matter came before Floyd J on 8 th February. By the time the parties were before the court it had been agreed how to regulate the position pending a full inter partes hearing of the interim injunction application. Essentially Teva gave an undertaking that they would give the claimants' solicitors 7 days notice in writing of any launch of the product in the UK. The point of this was to allow BMS to apply for an interim injunction if notice was given. On the basis of the undertaking and with a cross-undertaking in damages from BMS, no further order was made save for directions to bring this matter to a hearing expeditiously and for the claimants to issue and serve proceedings. I am told that at the hearing, when giving the undertakings, the defendants' counsel submitted that the application for interim relief was premature because the claimants had been told by Teva that they would receive a response by the end of the week.
On 9 th February BMS issued the claim form in this case.
On 10 th February Teva's substantive reply to BMS's solicitors' letter of 7 th February was provided in correspondence. It states:
"It is not Teva's policy to disclose to its competitors information relating to the date on which any product the subject of a Marketing Authorisation will be launched in any given country. This is regarded by Teva, and we believe by all our competitors, as being confidential information.
The grant of a marketing authorisation to Teva permits but does not require Teva to market the product in any given territory at any particular time. In reaching a decision whether, where and when to market, Teva will take into account all relevant commercial factors including Teva's policy of not infringing valid patents.
In the present case, without waiting for a substantive response to your letter, proceedings have been commenced in England seeking interim relief. In those circumstances we consider that it is appropriate for the court to consider whether those proceedings are well founded and whether it is appropriate to grant interim relief.
Teva is therefore not prepared to give the undertakings you request."
On 14 th February the Particulars of Claim were served. The claim is pleaded on a quia timet basis, in other words the claimants allege that the defendants are threatening and intend to commit an act (marketing efavirenz) which the claimants contend would infringe the patent. In support of the allegation that there is a threat by the defendants to import and sell efavirenz the claimants rely on three things: (i) the obtaining of the marketing authorisation itself on or about 22 nd December or 9 th January, (ii) the correspondence up to 10 th February which I have mentioned and (iii) the manner of the relatively recent launch by Teva of generic atorvastatin. It is said that Teva's statement about a policy of not infringing valid patents needs to be seen in the context of Teva's conduct over atorvastatin. In that case, in June 2011, Teva launched the generic drug in question in the face of patent protection and without notice to the patentee. I will return to the atorvastatin point below.
The parties exchanged written evidence in relation to the interim injunction. Following service of the Particulars of Claim, Teva applied to strike the claim out. As I said both matters now come before me.
It is convenient to summarise Teva's case first. Teva submit that this case should be struck out because no reasonable grounds for bringing the claim have been disclosed. The submission is nothing to do with the validity of the patent nor any question of whether Teva's efavirenz product infringes any claim of the patent. The point is, as Mr Baldwin submits, that there is no case that his clients have made a threat to infringe at all. No reasonable grounds for the pleaded threat are given and none exist. He points out, correctly, that obtaining a marketing authorisation is not an infringement of BMS's patent rights. That has been the position in the UK since at least Upjohn v Kerfoot [1988] FSR 1 and was made clear by the amendment to the Patents Act 1977 to insert s60(5)(i) in order to comply with the Medicines Directive 2001/83/EC.
Thus, Mr Baldwin submits, all there is here is an obtaining of such a marketing authorisation (which is not an infringement) coupled with a refusal to answer questions. That is not a threat to infringe and is not sufficient to justify a claim for patent infringement. He submits that Teva's intentions are their own private confidential information. They are not obliged and should not be coerced into divulging them to their competitors. That is the end of the matter and the claim should be...
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