Lt-#6940374-v1-approved_judgment.doc

Neutral Citation Number: 2011 EWHC 1606 (Pat) IN THE HIGH COURT OF JUSTICE
CHANCERY DIVISION
PATENTS COURT
MR JUSTICE FLOYD
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WARNER-LAMBERT COMPANY LLC
Claimant
(1) TEVA UK LIMITED
(2) PHOENIX HEALTHCARE
DISTRIBUTION LIMITED
(3) AAH PHARMACEUTICALS LIMITED
Defendants
- - - - - - - - - - - - - - - - - - - - - Digital Transcription by Marten Walsh Cherer Ltd., 1st Floor, Quality House, 6-9 Quality Court Tel No: 020 7067 2900, Fax No: 020 7831 6864, DX: 410 LDE - - - - - - - - - - - - - - - - - - - - - Mr Simon Thorley QC and Mr Joe Delaney (instructed by
Messrs Allen & Overy) for the Claimant.
Mr Tom Mitcheson (instructed by Messrs Taylor Wessing)
for the First Defendant.
The Second and Third Defendants did not appear and were not represented.
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Mr Justice Floyd
Mr Justice Floyd :
This is an application by Warner-Lambert Company LLC (“Warner-Lambert”), which is a subsidiary of Pfizer Inc., for an interim injunction to restrain infringement of Supplementary SPC/GB97/011. The application is made, unusually for this type of application, on a without notice basis, that is to say it has been made at very short notice to the First Defendant, Teva UK Limited (“Teva”), and without notice at all to Phoenix Healthcare Distribution Limited (“Phoenix”) and AAH Pharmaceutical Limited (“AAH”), who are the Second and Third Defendants. The SPC relates to the drug atorvastatin, which is marketed by the Warner Lambert as Lipitor. It is a drug which operates against cholesterol. The expiry date of the SPC is currently 6th November 2011, although there is in progress an application for a paediatric extension which would imply a limited further extension to the SPC of some six months.
The underlying patent is European Patent UK No. 0247633. That patent was the subject of an application for a declaration of non-infringement by two generics companies, Arrow Generics Limited and Ranbaxy UK Limited. The Court of Appeal gave judgment on those applications in June 2006, holding that the relevant compound fell within the claims of the patent. There was no attack at that stage by either of those companies on the validity of the 633 patent. The position of Teva, was taken up in correspondence in the course of 2010. On 25th June 2010, solicitors instructed on behalf of Teva wrote to Warner-Lambert Technologies Inc., a related company of Warner Lambert, principally in relation to European Patent UK No 0 680 320, which I am told is a formulation patent based on atorvastatin. In that letter, they said this: “We write to inform you that our client is preparing to launch an atorvastatin tablet formulation in the UK in November 2011 on expiry of SPC/GB97/011. As our client’s proposed formulation is confidential, we will not disclose details of the formulation until a confidentiality club has been established. If you would like to see details of our formulation, please let us know as soon as possible so that we can agree a confidentiality club.” The letter continued by explaining that Teva did not believe that launching atorvastatin would infringe the 320 formulation. Obviously launching atorvastatin at the date contemplated would not then have infringed the SPC either. They concluded by saying: High Court Approved Judgment
Mr Justice Floyd
“If we do not receive a response, we will assume that you have no objections to our client launching an atorvastatin tablet formulation in the UK in November 2011.” Pfizer responded on 12th July 2010 simply pointing out that there had been approval for the paediatric use of Atorvastatin and that they were seeking a six months extension to the SPC. There matters remained until today. Today, Pfizer discovered that the Second Defendant, AAH, was offering atorvastatin in a range of tablet forms. Although proper witness statements have not yet been prepared, the attendance note of Miss Dagg has been produced. It is clear to me that she appreciates that this attendance note is to be used as the basis for a witness statement. She says that she had understood from her clients that around one million packets of atorvastatin had been sold this morning alone. What is more, atorvastatin tablets are also currently being offered by the proposed Third Defendant. I have been shown a screen-shot of a website which indicates that atorvastatin tablets in the 10, 20, 40 and 80mg doses are available and in stock. Next, I have been informed that Mr Simon Cooper, who is an account manager at Pfizer, discovered that the senior buyer at Superdrug was being offered generic atorvastatin and had received not only one telephone call but a follow up call as well. It is clear that Superdrug have been offered atorvastatin by the pharmaceutical wholesalers AAH. Mr Cooper also confirms that the Co-operative Group, who run the Co-operative Pharmacy, have been offered atorvastatin by AAH. Finally, I was told that another account manager at Pfizer has been told today by a pharmacy in Exeter that atorvastatin from AAH had been delivered that afternoon. It is clear, therefore, that there has been a significant and concerted launch of generic atorvastatin. Mr Mitcheson, who has appeared today on very short notice for Teva, confirms that the atorvastatin being marketed by both AAH and Phoenix is sourced from Teva.
Mr Thorley QC, who appears on behalf of the Claimant, submits that what the Defendants are doing here is jumping the gun. Having given the impression in 2010 that they would not launch their product until the expiry of the SPC, they have, without any form of notice, to the Claimant surreptitiously entered the market and commenced sales. He says that the indications are that the Defendants are selling the product at a discount of 22½% below the Claimant’s price, that being a launch, he says, in direct competition with sales made by the Claimants or their licensees of Atorvastatin. He submits that, even over the short period which it would take to enable this matter to be dealt High Court Approved Judgment
Mr Justice Floyd
with on an inter partes basis, which I take to be some two and a half to three weeks, his clients would suffer irreparable harm. The fact that it is possible to sell the generic drug at such a substantial discount would be out, and it would be difficult, if not impossible, for the Claimants to raise their prices back to the levels that they are presently at.
Mr Mitcheson submitted that there was no real evidence that over that sort of period Pfizer would suffer any unquantifiable damage. He said there is no evidence specifically directed to that question. If between now and the effective hearing of the application his clients sell atorvastatin, the number of packs sold will be quantifiable and the Claimants will be appropriatelycompensated. He says that the position which Teva adopt is based on their belief that the patent in suit is invalid. He accepts that it is unlikely that there will be any available argument on infringement, but submits that all I need to be satisfied of at this moment is whether there is a triable issue on questions of infringement and validity. He says that, in those circumstances, the right course is to refuse the relief pending the effective hearing of the application.
It seems to me that this is an appropriate case for the Court to intervene by way, exceptionally, of granting relief without notice. The position until todayappears to have been that both the Claimants and Teva were proceeding on the basis that there would be no launch of this product until November 2011. Whatever the position may be about the obligation on a defendant to clear the way, there was nothing to stop the Defendants from at least informing the Claimants that they intended to launch at an earlier date. Instead of taking that course, they have, as Mr Thorley characterises it, “launched surreptitiously”and without any form of notice. What is more, I am unable to see at the moment why it is that as long ago as 2010 the Defendants did not take steps at least to let their contentions about the validity of the patent be known to the Claimants. They had nothing to hide, so far as their intention to market a product was concerned, for their interest in the market for atorvastatin has been shared with the Claimants. I fail to see why it is that they, therefore, did not start those proceedings in at least 2010 if it was really their contention that this patent is invalid. It does seem to me that, even over a relatively short period until the application can be heard, there is a real risk of damage being caused to the market in this product, which, even on this limited amount of evidence, it is possible to discern. The launch is obviously on a very large scale, involving at least two pharmaceutical retailers and millions of tablets. To suggest that that is not going to have a real impact on the market over three weeks is, in my view, not correct. What is more, the fact that these pharmaceuticals are being offered over the internet suggests, to me at least, that the availability of thisproduct is likely to spread extremely rapidly – faster than if it was being marketed by sales representatives on a one-to-one basis.
High Court Approved Judgment
Mr Justice Floyd
Given those considerations, in my view, the balance of convenience over the very short period until the effective hearing of the application is in favour of the Claimants. I bear in mind that the Second and Third Defendants have not been notified, but it is not as if atorvastatin is not available from other sources. What is more, it is difficult to see how being deprived of atorvastatin from this particular source could cause damage to those Defendants on a scale anything approaching that which would occur to the Claimants. Bearing those considerations in mind, I propose to grant an injunction. The relief which is sought also seeks a measure of disclosure from the Defendants, firstly as to the names and addresses so far as known to them of each and every person, firm or company other than Pfizer Ireland, the Claimants’ licensee, who has offered to supply or has supplied them. That is sought against the Second and Third Defendants. The relief also seeks disclosure from the First Defendant of the names and addresses of every person, firm or company to whom it has supplied or offered to supply atorvastatin. As to the First Defendant, I see no reason why it should not provide that information. I am reasonably confident that that will adequately protect the Claimants over the period until the effective hearing. I am not persuaded that without notice to the Second and Third Defendants it will be appropriate to require them to disclose information about other suppliers. That is a matter which the Claimants can pursue if they wish to do so at the effective hearing. In summary, I propose to grant the injunction against all three Defendants, but to grant only the disclosure relief identified in paragraph 3(a) of the draft order.
For further legal argument, please
see separate transcript of proceedings
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Source: http://clientlink.allenovery.com/pressrelease/Judgment.pdf