The claimant ('SEP') specialised in the distribution and sale of pharmaceutical products, particularly in the fields of urology and urogynaecology; since 2009 SEP was the exclusive licensee of the REGURIN trade mark for trospium chloride made by Madaus, who owned the mark. This product was sold and distributed as " Céris" in France, "uriVesc" in Germany and as REGURIN in the United Kingdom.
Doncaster Pharmaceuticals (the first defendant) had previously imported trospium chloride sold in France as “Céris” into the United Kingdom by overstickering the box with the name of the generic active ingredient, trospium chloride. However, in late 2009 it started to import “Céris” by affixing the trade mark REGURIN instead; it later did the same thing with “uriVesc” from Germany. Trospium chloride was sold in the United Kingdom in two formats: a 20mg product and a 60mg XL product.
SEP sued Doncaster Pharmaceuticals for trade mark infringement, joining Madaus to the proceedings but making no claim against it. At trial the court was required to determine (i) whether Doncaster Pharmaceuticals was entitled under Articles 34 and 36 of the Treaty on the Functioning of the European Union (TFEU) to affix the REGURIN trade mark to the pharmaceutical products made by Madaus and which they imported from other Member States; (ii) whether it was necessary for Doncaster Pharmaceuticals to re-brand the products as REGURIN in order to gain effective market access in the United Kingdom.
Judgment was entered for SEP on the following grounds. According to the trial judge, Mrs Justice Asplin:
* To decide whether there was effective market access for an imported product, it was necessary to define that market. The market here could not be defined by reference to the market for products sold under REGURIN alone: such a definition was entirely self-fulfilling and failed to satisfy the underlying principles of free trade between Member States.
* It was not necessary for the court to decide whether, for the purposes of re-branding, the test of necessity was to be applied to the market as a whole or to a substantial part of the market. The question was whether, in all the circumstances prevailing at the time of marketing, it was objectively necessary to replace the original trade mark with REGURIN in order to gain effective access to the trospium chloride market in the UK. The evidence did not lead to the conclusion that it was objectively necessarily to replace the other marks with the REGURIN mark, whether one took into account the market for trospium chloride as a whole or whether one examined the markets for the 20mg and 60mg XL products separately.
* If the products were taken together, Doncaster Pharmaceuticals had immediate and effective access to 90 per cent of prescriptions written for the 20mg version of the product and to 68 per cent of the 60mg XL version. Given the high percentage of the market open to Doncaster Pharmaceuticals even where it could not use the REGURIN trade mark, SEP's exclusive use of the REGURIN mark in the UK did not contribute to the artificial partitioning of the markets between Member States for trospium chloride. Even if one took into account the number of prescriptions written generically for trospium chloride which were currently satisfied by REGURIN, the percentage of the market to which Doncaster Pharmaceuticals had effective access was 60 per cent.
* There was no evidence before the court that Doncaster Pharmaceuticals could not compete effectively against the generic producers. Nor was there evidence of the existence of any rules or structures in the UK market which hampered Doncaster Pharmaceuticals in gaining effective access to the market if it would not be allowed to use the REGURIN mark. In fact, the policy of the National Health Service in the United Kingdom pointed to the opposite conclusion, being in favour of generically written prescriptions.
* There was no significant resistance on the part of consumers or pharmacists to an over-stickered product.
* Given the percentage of prescriptions written generically, Doncaster Pharmaceuticals was merely seeking a commercial advantage in the sense of seeking a greater margin on its imports than it would otherwise be able to achieve. It was seeking to avoid the need to brand and market the 60mg product for itself but, rather, sought to "piggy back" on SEP's marketing efforts.
The defendants, submitting that the trial judge failed to give reasons why she rejected the evidence of Doncaster Pharmaceuticals and decided that it was open to that company to adopt a brand of its own and compete directly with REGURIN. It was also argued that enforcement of the REGURIN trade mark had the effect of applying quantitative restrictions on imports in breach of Article 36 of the TFEU.
On Friday the Court of Appeal (Lady Justice Arden and Lords Justices Floyd and Bean) allowed the appeal, Floyd LJ delivering a single judgment with which the others concurred. In essence, said the Court of Appeal:
* Rebranding the manufacturer’s product as REGURIN went no further than was necessary to overcome artificial barriers to effective market access so that the enforcement of the trade mark created an artificial partition in the market which was unlawful under Article 36 of the TFEU.
When commenting on the decision of Asplin J, this Kat said:
This Kat thinks this decision is quite an important one, but not so much in legal terms. There was no startling exposition of a new legal doctrine or miserable failure to apply an old one. Rather, its significance lies in the application of the law to the facts. Had Asplin J reached the opposite conclusion, and allowed the use of restickered REGURIN labels on these facts, importers of pharma products would be falling over themselves to emulate Doncaster's actions and the prospects of manufacturers of pharma producers such as Madaus deriving any benefits from their trade marks following the expiry of their patents (as was the case with the patent for trospium chloride, which expired in 2009) would be grim.While this Kat agrees that it would have been appropriate for Asplin J to give reasons for dismissing the evidence of Doncaster Pharmaceuticals' witness, he remains unhappy about the Court of Appeal's decision for two reasons. First, he stands by the comment he made above. Secondly, he has a residual queasiness about appellate courts setting aside a trial judge's assessment of the facts. Quite correctly Floyd LJ states:
"I have to remind myself that the circumstances in which we could set to one side the judge's conclusion on an essentially factual issue are very limited".Yet the trial judge's findings, following four days of hearings and with a good deal of reflection as to the commercial reality of the market for trospium chloride, do not seem to this Kat to be so untenable as to warrant being set aside.
Doubtless readers will have opinions to express on both the IP and competition law dimensions of this decision. The Supreme Court may not have the chance to express theirs, though, unless a ground of appeal can be articulated with sufficient care as to show that a significant point of law is at stake.
Fool's errand here
Gooseberry fool here
April fool here