Taking the p*** -- or merely retaining it? When trospium chloride can't be overstuck

It's a long time since this Kat has had a chance to contemplate a legal ruling on parallel importation and over-stickering of pharmaceutical products, so he's delighted to bring you this one now. Indeed, Speciality European Pharma Ltd v Doncaster Pharmaceuticals Group Ltd & Madaus GmbH [2013] EWHC 3624 (Ch) is a 20 November decision of Mrs Justice Asplin in the Chancery Division (High Court, England and Wales) which would have been posted here ages ago if the IPKat had fewer interesting cases to write about and more time in which to write about them.

Specialty -- the claimant in these proceedings -- specialised in the distribution and sale of pharmaceutical products, particularly in the fields of urology and urogynaecology [one has to be careful with these medical terms, says this Kat, whose mother was once erroneously sent to see "an urologist" instead of "a neurologist"]. Among the products it sold was a treatment for over-active bladders, trospium chloride, which it sold and distributed in various European countries. Trospium chloride, made by Madaus, was sold as "Céris" in France, as "uriVesc" in Germany and as “Regurin” in the United Kingdom -- where Madaus owned the United Kingdom trade mark REGURIN for pharmaceutical preparations etc in Class 5. This commodity was sold in the United Kingdom in two formats: a 20mg product and a 60mg XL product. In 2009, Madaus appointed Specialty as the exclusive licensee of the REGURIN trade mark in the United Kingdom.

Our attention now turns to Doncaster Pharmaceuticals.  Doncaster had previously imported trospium chloride sold in France as “Céris” into the United Kingdom by overstickering the box with the words "trospium chloride", this being an accurate if unexciting description of the contents of the box. However, in late 2009 when importing “Céris”, Doncaster decided to oversticker it with the trade mark REGURIN instead.  A little later, it started to do the same thing with its imports of the German version, “uriVesc”.

At this point Specialty, as exclusive licensee, decided it was time to act and commenced proceedings against Doncaster Pharmaceuticals for trade mark infringement (Madaus was joined in the proceedings but no claim was made against that company).

In these proceedings Asplin J was required to determine (i) whether Doncaster was entitled under Articles 34 and 36 of the Treaty on the Functioning of the European Union 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 to re-brand the products as REGURIN in order to gain effective market access in the United Kingdom.

Asplin J held for Specialty. In her view:

* In order to decide whether there was effective market access for an imported product, it was first necessary to define the market. In this context, the market in question could not simply be defined by reference to the market for products sold under the REGURIN trade mark -- such a definition was entirely self-fulfilling and failed to satisfy the underlying principles of free trade between Member States.

* The court didn't need 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 the trade mark REGURIN in order to gain effective access to the trospium chloride market in the United Kingdom. On the evidence, there was no need to replace the other marks with the REGURIN mark. This was so, 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.

* Taking the products together, Doncaster had immediate and effective access to 90% of prescriptions written for the 20mg version of the product and to 68% of the 60mg XL version. Given the high percentage of the market open to Doncaster, even where it could not use the REGURIN trade mark, the exclusive use of the REGURIN mark by Specialty in the UK did not contribute to the artificial partitioning of the markets between Member States in relation to trospium chloride.

* Even if one took into account the number of prescriptions written generically for trospium chloride which were currently satisfied by the supply of Regurin, the percentage of the market to which Doncaster had effective access was still 60%.

* There was no evidence Doncaster could not compete effectively against the generic producers. Nor was there evidence of the existence of any rules or structures within the UK market which hindered Doncaster from gaining effective access to the market if it would not be permitted to use the REGURIN mark. In fact, National Health Service policy in the UK 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 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. That company was trying to avoid the need to brand and market the 60mg product for itself, preferring to "piggy back" on Specialty's marketing efforts.

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.

Happier days in court for Doncaster Pharmaceuticals here
What is trospium chloride, here
Things you can do with urine here, here and here