Boehringer Ingelheim Ltd and Others v Vetplus Ltd
| Jurisdiction | England & Wales |
| Judge | Lord Justice Jacob,Lord Justice Longmore,Lord Justice Pill |
| Judgment Date | 05 July 2007 |
| Neutral Citation | [2007] EWCA Civ 661,[2007] EWCA Civ 583 |
| Docket Number | Case No: A3/2007/0873 |
| Court | Court of Appeal (Civil Division) |
| Date | 05 July 2007 |
The Rt Hon Lord Justice Pill
The Rt Hon Lord Justice Longmore and
The Rt Hon Lord Justice Jacob
Case No: A3/2007/0873
IN THE SUPREME COURT OF JUDICATURE
COURT OF APPEAL (CIVIL DIVISION)
ON APPEAL FROM THE HIGH COURT OF JUSTICE
CHANCERY DIVISION (PATENTS COURT)
The Hon Mr Justice Pumfrey
HC 07 C00710
Royal Courts of Justice
Strand, London, WC2A 2LL
Dr Justin Turner and Miles Copeland (instructed by Messrs Clarkslegal LLP) for the Appellant
Desmond Browne QC and Jonathan Barnes (instructed by Messrs DWF) for the Respondent
Hearing dates: 16/17 May 2007
Lord Justice Jacob
This is an appeal with permission granted by me from a decision of Pumfrey J of 26th April 2007, [2007] EWHC 972 (Ch).
The basic facts
The claimants (collectively “Boehringer”) sought, and were refused, an interim injunction to restrain certain publicity proposed to be put forward by the defendant, VetPlus. Both sides make and sell nutritional supplements for dogs. Boehringer's product is called Seraquin, VetPlus' product, Synoquin. They are supposed to have a beneficial effect on dogs' joints.
The Judge described the commercial position thus:
[6] Competition between VetPlus and Boehringer is intense. VetPlus appears to have been earlier in this market and is the market leader. Other products (Cosequin, Glycoflex, Flexadin) are also in the market, the first of these also sold by a pharmaceutical company (Schering Plough).
The tablets concerned contain, or are claimed to contain, amongst their active ingredients, a sulphate of a polysaccharide called chondroitin. The other active ingredients are glucosamine and curcumin. The tablet as a whole also contains excipient. Chondroitin is much the most expensive ingredient. The Judge summarised the chemical nature of chondroitin:
[4] …. Chondroitin is a naturally-occurring material which is extracted from cartilaginous material and purified. Broadly speaking its monomers are disaccharides which differ in their sulphation; and the weight of molecules considered to be properly called chondroitin sulphate range from about 5,000 Daltons, or thereabouts, to 40,000 Daltons, or more.
[5] A natural sample from a particular source would consist of a mixture of molecules of different weights (and therefore lengths) and the mixture will differ depending upon the source. I understand that different sources will yield material not merely with different molecular weight distributions but also with different degrees of sulphonation.
The significance of its chemical nature is that chondroitin is not a homogeneous material. So a test which detects one form of it may not detect another.
In 2006 VetPlus decided to test rivals' products to see whether they had a chondroitin content consistent with that claimed on their label. The Judge described what happened:
[7] … I have seen results, I believe, for all the principal products in the market. In doing these tests or causing them to be carried out, Mr. Haythornthwaite [VetPlus' MD] says that VetPlus used the single assay set out in the United States Pharmacopeia called the “CPC assay”. Mr. Haythornthwaite took the view that on several occasions Seraquin failed to comply with its contents claimed on the label, which specified 380 mg chondroitin sulphate per tablet. He made no complaint until tablets from two batches, numbers 326768 and 406774, were tested by VetPlus using the CPC test, no chondroitin was detected in the tablets at all. This assay has subsequently been repeated using the CPC technique on a number of occasions on tablets from these batches. I see no reason to doubt that on each such occasion the same result was obtained, or substantially the same result.
Following these results VetPlus entered into correspondence with Boehringer. The Judge sets out the salient details at [8–20]. Neither side comes out of it well. Boehringer also wrote to the veterinary press threatening action if the VetPlus allegations were published, a matter now forming part of a counterclaim (Part 20 claim). I do not think that much of the detail matters for present purposes.
One matter initially the subject of complaint is no longer relevant. VetPlus published (Boehringer say selectively and unfairly) matter sent to it purely for the purposes of attempting to resolve the dispute under an express indication that it was sent for that purpose. The complaint about that (the Judge having refused to enjoin further publication on the grounds that none was threatened) was resolved before us on the basis that VetPlus undertook to give an agreed notice period if they did intend to republish the matter concerned.
What is left is that VetPlus threatens and intends to publish what is in effect a comparative advertisement. The Judge describes it and I borrow with gratitude:
[21] On 1st March, a copy of a proposed advertisement together with a document entitled “Are all chondroprotective joint supplements created equal?”, intended to be made available to those accepting the invitation in the advertisement to apply, was supplied to Boehringer's solicitors. This document is called “The report”. It is pleaded by Boehringer that the advertisement which refers directly to no manufacturer and no product would nevertheless be understood by the interested public to relate to Seraquin because that product is the only one sold in a box in the United Kingdom. Seraquin's box is of a similar colour to that in the advertisement and it is the only product in the United Kingdom to be sold with a claimed content of 380 mg per tablet.
[22] As a basis for identifying Seraquin as the subject matter of the advertisement, this seems to me to be thin; but I cannot at this stage say that it is unarguable. The real sting comes in the report. I shall read two passages from the report because I think that these are the only passages to which attention really needs to be drawn. The first is a section headed “Label Claims and Purity—Essential for Maximum Benefit” and it is as follows:
“Nutritional supplements are currently not required to conform to pharmaceutical standards of production and therefore purity of raw ingredients and label claim content can vary amongst manufacturers. A simple rule when selecting a joint supplement is to read the labels carefully, look for stated purity, high ingredient levels and a product that has been independently verified to meet stated purity and label claims.
“The level of the components within some joint supplements can vary greatly due to the differing grades of ingredients that are available. Cheaper ingredients of low purity will obviously lead to a cheaper product on the shelf, but not the desired maximum benefit that would be obtained from a product of proven high levels and purity. Chondroitin sulphate is an expensive raw material, with high purity pharmaceutical grade raw material costing approximately five times the amount of glucosamine hydrochloride. As a result, there are a number of poorer quality and low purity chondroitin products on the market, many of which do not achieve label claims.
“Studies to evaluate the components in oral joint supplement products when compared to label claims have found that 40% of Glucosamine products did not meet their label claim (17% containing less than 30% of the claim), and 60% did not meet label claim for Chondroitin. This means that many products will provide sub-therapeutic doses of the required component making it difficult for veterinary surgeons and owners to assess efficacy and to objectively select a proper supplement.”
[23] Three published documents are referred to in the conventional manner by way of footnote.
“These studies highlight the importance of selecting a supplement with proven purity and label claim.”
[24] Then there is a lengthy discussion of the importance of glycosaminoglycans, of which chondroitin is one, in the formation of cartilage in joints.
[25] What is called the “Back Page” of the report contains a table. The table is divided into eight horizontal rows. It reports, or purports to report, variations in consistency of chondroitin sulphate analysis content in leading joint UK supplements in February 2007. It states that the analysis was carried out to the United States Pharmacopeia methods, that certain of the results contain the average of more than one test on the same batch, and they set out two for VetPlus, which are said to have achieved about 110% to 115% of label claim by this test, and then two of Boehringer's, one of which is said to have contained 85% of label and the second of which is alleged to have achieved 8.69% of label.
[26] Then two products of Schering Plough are set out, both of which contain more than 100% apparently of label claim, and two from Vetoquinol, who make material called Flexadin, equally slightly in excess of 100%.
[27] These results, as far as Seraquin is concerned are a mixture of results obtained by Bioiberica on batch number 768 and VetPlus's own results as well. VetPlus's own results taken between 20th December 2006 in relation to the lower content batch had, with one exception only, been nil. The exception was an 11% reading obtained three times. Their results on batch 773 had been uniformly nil. The whole position from VetPlus's point of view is summarised in exhibit DH10 to Mr. Haythornthwaite's witness statement, which sets out in summary all the tests that had been performed by early February this year.
Mr Justin Turner for Boehringer submits that no reasonable man could honestly publish this document – that it cannot be justified...
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